Publications
2023
Scholarly publications
Aakjær, M.
, De Bruin, M. L., & Andersen, M. (Accepted/In press).
Epidemiological surveillance of drug safety using cumulative sequential analysis in electronic healthcare data.
Basic and Clinical Pharmacology and Toxicology.
https://doi.org/10.1111/bcpt.13955Aakjær, M.
, De Bruin, M. L., & Andersen, M. (Accepted/In press).
Epidemiological surveillance of drug safety using cumulative sequential analysis in electronic healthcare data.
Basic and Clinical Pharmacology and Toxicology.
https://doi.org/10.1111/bcpt.13955Aakjaer, M.
, De Bruin, M. L., & Andersen, M. (2023).
Epidemiological surveillance of drug safety using cumulative sequential analysis in electronic healthcare data.
Basic & Clinical Pharmacology & Toxicology, (1). Advance online publication.
https://doi.org/10.1111/bcpt.13955Essink, S. C. M., Zomerdijk, I. M., Straus, S. M. J. M.
, Gardarsdottir, H., & De Bruin, M. L. (2023).
Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021.
Drug Safety, (10).
https://doi.org/10.1007/s40264-023-01341-0 Hogervorst, M. A., Møllebæk, M.
, Vreman, R. A., Lu, T. A.
, Wang, J., De Bruin, M. L., Leufkens, H. G. M., Mantel-Teeuwisse, A., & Goettsch, W. (2023).
Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts.
BMJ Open,
13(8), Article e072309.
https://doi.org/10.1136/bmjopen-2023-072309 Sindahl, P., Overgaard-Steensen, C., Wallach-Kildemoes, H.
, De Bruin, M. L., Kemp, K.
, & Gardarsdottir, H. (2023).
Impact of a Treatment Guide on Intravenous Fluids in Minimising the Risk of Hospital-Acquired Hyponatraemia in Denmark.
Journal of Clinical Medicine,
12(15), Article 5105.
https://doi.org/10.3390/jcm12155105Eskola, S. M.
, Leufkens, H. G. M., Bate, A.
, De Bruin, M. L., & Gardarsdottir, H. (2023).
The role of Real-World Data and evidence in oncology medicines approved in EU in 2018-2019.
Journal of Cancer Policy,
36, Article 100424.
https://doi.org/10.1016/j.jcpo.2023.100424Wang, T., McAuslane, N.
, Goettsch, W. G., Leufkens, H. G. M., & De Bruin, M. L. (2023).
Regulatory, health technology assessment and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement.
International Journal of Technology Assessment in Health Care,
39(1), e20. Article e20.
https://doi.org/10.1017/S0266462323000144Hino, Y., Okada, M., Hallgreen, C. E.
, De Bruin, M. L., Doty, R. E., Matsumaru, N., & Tsukamoto, K. (2023).
Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan.
Biological and Pharmaceutical Bulletin,
46(5), 700-706.
https://doi.org/10.1248/bpb.b22-00868,
https://doi.org/10.1248/BPB.B22-00868https://dspace.library.uu.nl/bitstream/handle/1874/428433/46_b22_00868.pdf?sequence=1Beer, N., Kaae, S., Genina, N., Sporrong, S. K., Alves, T. L.
, Hoebert, J., De Bruin, M. L., & Hegger, I. (2023).
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine.
Therapeutic Innovation and Regulatory Science,
57(1), 26-36.
https://doi.org/10.1007/s43441-022-00436-7Professional publications
European Commission, Directorate-General for Health and Food Safety
, Mantel - Teeuwisse, A., Bloem, L. T., Boon, W., De Bruin, M. L., Hoekman, J., Klein, K., Stolk, P.
, & Vreman, R. (2023).
Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation: Analytical Report. Publications Office of the European Union.
https://doi.org/10.2875/780874European Commission, Directorate-General for Health and Food Safety
, Mantel - Teeuwisse, A., Bloem, L. T., Boon, W., De Bruin, M. L., Hoekman, J., Klein, K., Stolk, P.
, & Vreman, R. (2023).
Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation: Evaluation Report. Publications Office of the European Union.
https://doi.org/10.2875/627092022
Scholarly publications
Christiansen, H.
, De Bruin, M. L., & Hallgreen, C. E. (2022).
Mandatory requirements for pediatric drug development in the EU and the US for novel drugs-A comparative study.
Frontiers in Medicine,
9, Article 1009432.
https://doi.org/10.3389/fmed.2022.1009432Wang, T., McAuslane, N.
, Goettsch, W. G., Leufkens, H. G. M., & De Bruin, M. L. (2022).
Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile.
Frontiers in Pharmacology,
13, 1-10. Article 948161.
https://doi.org/10.3389/fphar.2022.948161Aakjaer, M., Werther, S. K.
, De Bruin, M. L., & Andersen, M. (2022).
Serious arrhythmia in initiators of citalopram, escitalopram, and other selective serotonin reuptake inhibitors: A population-based cohort study in older adults.
Clinical and Translational Science,
15(9), 2105-2115.
https://doi.org/10.1111/cts.13319Christiansen, H.
, De Bruin, M. L., Frokjaer, S., & Hallgreen, C. E. (2022).
Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US.
PLoS One,
17(4), 1-14. Article e0266353.
https://doi.org/10.1371/journal.pone.0266353Morrow, R. L., Mintzes, B.
, Souverein, P. C., Hallgreen, C. E., Ahmed, B., Roughead, E. E.
, De Bruin, M. L., Kristiansen, S. B., Lexchin, J., Kemp-Casey, A., Sketris, I., Mangin, D., Pearson, S-A., Puil, L., Lopert, R., Bero, L., Gnjidic, D., Sarpatwari, A., & Dormuth, C. R. (2022).
Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study.
Drug Safety,
45(6), 623-638.
https://doi.org/10.1007/s40264-022-01175-2Aakjær, M., Kristiansen, S. B., Pape, K., Sessa, M., Dalhoff, K. P.
, De Bruin, M. L., & Andersen, M. (2022).
Investigation of the potential association between the use of fluoxetine and occurrence of acute pancreatitis: a Danish register-based cohort study.
International Journal of Epidemiology,
51(5), 1656-1665.
https://doi.org/10.1093/ije/dyac071Morrow, R. L., Mintzes, B.
, Souverein, P. C., De Bruin, M. L., Roughead, E. E., Lexchin, J., Kemp-Casey, A., Puil, L., Sketris, I., Mangin, D., Hallgreen, C. E., Pearson, S-A., Lopert, R., Bero, L., Ofori-Asenso, R., Gnjidic, D., Sarpatwari, A., Perry, L. T., & Dormuth, C. R. (2022).
Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis.
BMJ Quality & Safety,
31(3), 179-190. Article 013910.
https://doi.org/10.1136/bmjqs-2021-013910Druedahl, L. C., Kälvemark Sporrong, S., Minssen, T., Hoogland, H.
, De Bruin, M. L., van de Weert, M., & Almarsdóttir, A. B. (2022).
Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.
PLoS One,
17(1), 1-13. Article e0262537.
https://doi.org/10.1371/journal.pone.0262537Eskola, S. M.
, Leufkens, H. G. M., Bate, A.
, De Bruin, M. L., & Gardarsdottir, H. (2022).
Use of Real World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018-2019.
Clinical Pharmacology and Therapeutics,
111(1), 310-320.
https://doi.org/10.1002/cpt.2462Sindahl, P., Ofori-Asenso, R., Hallgreen, C. E., Kemp, K.
, Gardarsdottir, H., & De Bruin, M. L. (2022).
Impact of regulatory interventions to restrict the combined use of renin–angiotensin system blockers: A Danish nationwide drug utilisation study.
British Journal of Clinical Pharmacology,
88(3), 1379-1384.
https://doi.org/10.1111/bcp.150802021
Scholarly publications
Beer, N., Hegger, I., Kaae, S.
, De Bruin, M. L., Genina, N., Leonardo Alves, T., Hoebert, J., & Kalvermark Sporrong, S. (2021).
Scenarios for 3D printing of personalized medicines - A case study.
Exploratory Research in Clinical and Social Pharmacy,
4, 1-9. Article 100073.
https://doi.org/10.1016/j.rcsop.2021.100073Sabaté, M., Vidal, X., Ballarin, E., Rottenkolber, M., Schmiedl, S., Grave, B., Huerta, C., Martin-Merino, E., Montero, D., Leon-Muñoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjær, M., Andersen, M.
, De Bruin, M. L., Souverein, P., Klungel, O. H., ... Ibáñez, L. (2021).
Adherence to Direct Oral Anticoagulants in Patients With Non-Valvular Atrial Fibrillation: A Cross-National Comparison in Six European Countries (2008-2015).
Frontiers in Pharmacology,
12, 1-14. Article 682890.
https://doi.org/10.3389/fphar.2021.682890Aakjær, M.
, De Bruin, M. L., Kulahci, M., & Andersen, M. (2021).
Surveillance of Antidepressant Safety (SADS): Active Signal Detection of Serious Medical Events Following SSRI and SNRI Initiation Using Big Healthcare Data.
Drug Safety,
44(11), 1215-1230.
https://doi.org/10.1007/s40264-021-01110-xvan den Ham, H. A., Souverein, P. C., Klungel, O. H., Platt, R. W., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Martín Merino, E., León-Muñoz, L. M., Montero, D., Andersen, M., Aakjær, M.
, De Bruin, M. L., & Gardarsdottir, H. (2021).
Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies.
Pharmacoepidemiology and Drug Safety,
30(10), 1339-1352.
https://doi.org/10.1002/pds.5317 Sindahl, P., Overgaard-Steensen, C., Wallach-Kildemoes, H.
, De Bruin, M. L., Kjær, M. B. N., Kemp, K.
, & Gardarsdottir, H. (2021).
A cross-sectional survey of knowledge pertaining to IV fluid therapy and hyponatraemia among nurses working at emergency departments in Denmark.
International Emergency Nursing,
57, 1-8. Article 101010.
https://doi.org/10.1016/j.ienj.2021.101010Klein, K.
, Stolk, P., De Bruin, M. L., & Leufkens, H. (2021).
Regulatory density as a means to refine current regulatory approaches for increasingly complex medicines.
Drug Discovery Today,
26(10), 2221-2225.
https://doi.org/10.1016/j.drudis.2021.04.005Druedahl, L. C., Kälvemark Sporrong, S., van de Weert, M.
, De Bruin, M. L., Hoogland, H., Minssen, T., & Almarsdóttir, A. B. (2021).
Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.
BioDrugs,
35(3), 351-361.
https://doi.org/10.1007/s40259-021-00478-7https://dspace.library.uu.nl/bitstream/handle/1874/412271/Druedahl2021_Article_EvolvingBiosimilarClinicalRequ.pdf?sequence=1Ofori-Asenso, R., Sahle, B. W., Chin, K. L., Mazidi, M., Ademi, Z.
, De Bruin, M. L., & Liew, D. (2021).
Poor adherence and persistence to sodium glucose co-transporter 2 inhibitors in real-world settings: Evidence from a systematic review and meta-analysis.
Diabetes/Metabolism Research and Reviews,
37(1), Article e3350.
https://doi.org/10.1002/dmrr.3350https://dspace.library.uu.nl/bitstream/handle/1874/409356/dmrr.3350.pdf?sequence=1Ogundipe, O., Mazidi, M., Chin, K. L., Gor, D., McGovern, A., Sahle, B. W., Jermendy, G., Korhonen, M. J., Appiah, B., Ademi, Z.
, De Bruin, M. L., Liew, D., & Ofori-Asenso, R. (2021).
Real-world adherence, persistence, and in-class switching during use of dipeptidyl peptidase-4 inhibitors: a systematic review and meta-analysis involving 594,138 patients with type 2 diabetes.
Acta Diabetologica,
58, 39–46.
https://doi.org/10.1007/s00592-020-01590-whttps://dspace.library.uu.nl/bitstream/handle/1874/428438/s00592_020_01590_w.pdf?sequence=1Bhasale, A. L., Sarpatwari, A.
, De Bruin, M. L., Lexchin, J., Lopert, R., Bahri, P., & Mintzes, B. J. (2021).
Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States.
Clinical Pharmacology and Therapeutics,
109(6), 1424-1442.
https://doi.org/10.1002/cpt.2010https://dspace.library.uu.nl/bitstream/handle/1874/428436/Clin_Pharma_and_Therapeutics_2020_Bhasale_Postmarket_Safety_Communication_for_Protection_of_Public_Health_A.pdf?sequence=1Souverein, P. C., van den Ham, H. A., Huerta, C., Merino, E. M., Montero, D., León-Muñoz, L. M., Schmiedl, S., Heeke, A., Rottenkolber, M., Andersen, M., Aakjaer, M.
, De Bruin, M. L., Klungel, O. H., & Gardarsdottir, H. (2021).
Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation.
British Journal of Clinical Pharmacology,
87(3), 988-1000.
https://doi.org/10.1111/bcp.14450 2020
Scholarly publications
Ofori-Asenso, R., Hallgreen, C. E.
, & De Bruin, M. L. (2020).
Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges.
Frontiers in Medicine,
7, Article 582634.
https://doi.org/10.3389/fmed.2020.582634Coppens, D. G.
, Gardarsdottir, H., Bruin, M. L. D., Meij, P.
, Gm Leufkens, H., & Hoekman, J. (2020).
Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries.
Regenerative Medicine,
15(8), 2015-2028.
https://doi.org/10.2217/rme-2020-0008https://dspace.library.uu.nl/bitstream/handle/1874/428437/rme_2020_0008.pdf?sequence=1Druedahl, L. C., Almarsdóttir, A. B., Kälvemark Sporrong, S.
, De Bruin, M. L., Hoogland, H., Minssen, T., van de Weert, M., Kesselheim, A. S., & Sarpatwari, A. (2020).
A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways.
Nature Biotechnology,
38(11), 1253-1256.
https://doi.org/10.1038/s41587-020-0717-7https://dspace.library.uu.nl/bitstream/handle/1874/409562/s41587_020_0717_7.pdf?sequence=1Maliepaard, M., Toiviainen, T.
, De Bruin, M. L., & Meulendijks, D. (2020).
Pharmacogenetic-Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017.
Clinical Pharmacology and Therapeutics,
108(2), 338-349.
https://doi.org/10.1002/cpt.1834Højer, M. M. G.
, De Bruin, M. L., Boskovic, A., & Hallgreen, C. E. (2020).
Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018.
BMJ Open,
10(5), Article e036498.
https://doi.org/10.1136/bmjopen-2019-036498Ofori-Asenso, R., Ogundipe, O., Agyeman, A. A., Chin, K. L., Mazidi, M., Ademi, Z.
, de Bruin, M. L., & Liew, D. (2020).
Cancer is associated with severe disease in COVID-19 patients: a systematic review and meta-analysis.
ecancermedicalscience,
14, Article 1047.
https://doi.org/10.3332/ECANCER.2020.1047Sindahl, P., Overgaard-Steensen, C., Wallach-Kildemoes, H.
, De Bruin, M. L., Leufkens, H. G., Kemp, K.
, & Gardarsdottir, H. (2020).
Are further interventions needed to prevent and manage hospital-acquired hyponatraemia? A nationwide cross-sectional survey of IV fluid prescribing practices.
Journal of Clinical Medicine,
9(9), 1-16. Article 2790.
https://doi.org/10.3390/jcm9092790Coppens, D. G. M., Hoekman, J., De Bruin, M. L., Slaper-Cortenbach, I. C. M.
, Leufkens, H. G. M., Meij, P.
, & Gardarsdottir, H. (2020).
Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries.
Cytotherapy,
22(10), 592-600.
https://doi.org/10.1016/j.jcyt.2020.04.092 Coppens, D. G., Gardarsdottir, H., van den Bogert, C. A., De Bruin, M. L., Leufkens, H. G., & Hoekman, J. (2020).
Publication rates and reported results in a cohort of gene- and cell-based therapy trials.
Regenerative Medicine,
15(1), 1215-1227.
https://doi.org/10.2217/rme-2019-0066 2019
Scholarly publications
Souverein, P. C., Van Den Ham, H. A., Huerta, C., Merino, E. M., Montero, D., León-Muñoz, L. M., Schmiedl, S., Rottenkolber, M., Andersen, M., Aakjær, M.
, De Bruin, M. L., Klungel, O. H., & Gardarsdottir, H. (2019).
Risk of major bleeding associated with the use of direct oral anticoagulants compared to vitamin K antagonists in patients with atrial fibrillation: A European multicountry population-based cohort study.
Pharmacoepidemiology and Drug Safety,
28(S2), 553-553.
https://doi.org/10.1002/pds.4864 Van Den Ham, H., Souverein, P., Klungel, O., Platt, R., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Merino, E. M., León-Muñoz, L., Montero, D., Andersen, M., Aakjær, M.
, De Bruin, M., & Gardarsdottir, H. (2019).
Risk of major bleeding associated with the use of individual direct oral anticoagulants compared to vitamin K antagonists in patients with non-valvular atrial fibrillation: A metaanalysis of results from multiple population based cohort studies using a common protocol in Europe and Canada.
Pharmacoepidemiology and Drug Safety,
28(S2), 410-411.
https://doi.org/10.1002/pds.4864 Rottenkolber, M., Schmiedl, S., Ibanez, L., Sabaté, M., Ballarín, E., Vidal, X., Leon-Munoz, L. M., Huerta, C., Martin Merino, E., Montero, D., Gasse, C., Andersen, M., Aakjær, M.
, De Bruin, M. L., Gerlach, R., Tauscher, M.
, Souverein, P. C., Van Den Ham, R., Klungel, O., & Gardarsdottir, H. (2019).
Prescribers' compliance with SmPC recommendations for dabigatran, rivaroxaban, and Apixaban: A European comparative drug utilization study.
Pharmacoepidemiology and Drug Safety,
28(S2), 148-149.
https://doi.org/10.1002/pds.4864Ibanez, L., Sabaté, M., Vidal, X., Ballarín, E., Rottenkolber, M., Schmiedl, S., Heeke, A., Huerta, C., Merino, E. M., Montero, D., Leon-Muñoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjaer, M., Andersen, M.
, De Bruin, M. L., Groenwold, R., ... Gardarsdottir, H. (2019).
Incidence of direct oral anticoagulation use for non valvular atrial fibrillation and characteristics of users in six European countries (2008-2015): A cross-national drug utilization study.
Pharmacoepidemiology and Drug Safety,
28(S2), 397.
https://doi.org/10.1002/pds.4864Ibáñez, L., Sabaté, M., Vidal, X., Ballarin, E., Rottenkolber, M., Schmiedl, S., Heeke, A., Huerta, C., Martin Merino, E., Montero, D., Leon-Muñoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjær, M., Andersen, M.
, De Bruin, M. L., Groenwold, R., ... Gardarsdottir, H. (2019).
Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008–2015): A cross-national drug utilization study.
British Journal of Clinical Pharmacology,
85(11), 2524-2539.
https://doi.org/10.1111/bcp.14071Nøhr-Nielsen, A.
, De Bruin, M. L., Thomsen, M., Pipper, C. B., Lange, T., Bjerrum, O. J., & Lund, T. M. (2019).
Body of evidence and approaches applied in the clinical development programme of fixed-dose combinations in the European Union from 2010 to 2016.
British Journal of Clinical Pharmacology,
85(8), 1829-1840.
https://doi.org/10.1111/bcp.13986https://dspace.library.uu.nl/bitstream/handle/1874/382543/N_hr_Nielsen_et_al_2019_British_Journal_of_Clinical_Pharmacology_1_.pdf?sequence=1Møllebæk, M., Kaae, S.
, De Bruin, M. L., Callréus, T., Jossan, S., & Hallgreen, C. E. (2019).
The effectiveness of direct to healthcare professional communication: A systematic review of communication factor studies.
Research in Social and Administrative Pharmacy,
15(5), 475-482.
https://doi.org/10.1016/j.sapharm.2018.06.015https://dspace.library.uu.nl/bitstream/handle/1874/384256/1_s2.0_S1551741118300901_main.pdf?sequence=1Klein, K.
, Stolk, P., De Bruin, M. L., Leufkens, H. G. M., Crommelin, D. J. A., & De Vlieger, J. S. B. (2019).
The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations.
European Journal of Pharmaceutical Sciences,
133, 228-235.
https://doi.org/10.1016/j.ejps.2019.03.029Bloem, L. T., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., De Bruin, M. L., Klungel, O. H., & Hoekman, J. (2019).
Postauthorization Changes to Specific Obligations of Conditionally Authorized Medicines in the European Union: A Retrospective Cohort Study.
Clinical Pharmacology and Therapeutics,
105(2), 426-435.
https://doi.org/10.1002/cpt.1169 Hjellvik, V.
, De Bruin, M. L., Samuelsen, S. O., Karlstad, Ø., Andersen, M., Haukka, J., Vestergaard, P.
, de Vries, F., & Furu, K. (2019).
Adjusting for unmeasured confounding using validation data: Simplified two-stage calibration for survival and dichotomous outcomes.
Statistics in Medicine,
38(15), 2719-2734.
https://doi.org/10.1002/sim.8131Opstal-van Winden, A. W. J., de Haan, H. G., Hauptmann, M., Schmidt, M. K., Broeks, A., Russell, N. S., Janus, C. P. M., Krol, A. D. G.
, van der Baan, F. H., De Bruin, M. L., van Eggermond, A. M., Dennis, J., Anton Culver, H., Haiman, C. A., Sawyer, E. J., Cox, A., Devilee, P., Hooning, M. J., Peto, J., ... van Leeuwen, F. E. (2019).
Genetic susceptibility to radiation-induced breast cancer after Hodgkin Lymphoma.
Blood,
133(10), 1130-1139.
https://doi.org/10.1182/blood-2018-07-862607https://dspace.library.uu.nl/bitstream/handle/1874/380285/1130.full.pdf?sequence=12018
Scholarly publications
Rietbergen, C., Stefansdottir, G., Leufkens, H. G., Knol, M. J., De Bruin, M. L., & Klugkist, I. (2018).
Evidence Synthesis in Harm Assessment of Medicines Using the Example of Rosiglitazone and Myocardial Infarction.
Frontiers in Medicine,
4, Article 228.
https://doi.org/10.3389/fmed.2017.00228 Coppens, D. G. M., de Wilde, S., Guchelaar, H. J.
, De Bruin, M. L., Leufkens, H. G. M., Meij, P.
, & Hoekman, J. (2018).
A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
Cytotherapy,
20(6), 769-778.
https://doi.org/10.1016/j.jcyt.2018.03.038 de Jong, R. G. P. J.
, Peeters, P. J. H. L., Burden, A. M.
, de Bruin, M. L., Haak, H. R., Masclee, A. A. M.
, de Vries, F., & Janssen-Heijnen, M. L. G. (2018).
Gastrointestinal cancer incidence in type 2 diabetes mellitus: results from a large population-based cohort study in the UK.
Cancer Epidemiology,
54, 104-111.
https://doi.org/10.1016/j.canep.2018.04.008de Wilde, S.
, Coppens, D. G. M., Hoekman, J., de Bruin, M. L., Leufkens, H. G. M., Guchelaar, H-J., & Meij, P. (2018).
EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.
Drug Discovery Today,
23(7), 1328-1333.
https://doi.org/10.1016/j.drudis.2018.03.008Bronsveld, H. K., De Bruin, M. L., Wesseling, J., Sanders, J., Hofland, I., Jensen, V. F.
, Bazelier, M. T., ter Braak, B.
, de Boer, A., Vestergaard, P., & Schmidt, M. K. (2018).
The association of diabetes mellitus and insulin treatment with expression of insulin-related proteins in breast tumors.
BMC Cancer,
18(1), Article 224.
https://doi.org/10.1186/s12885-018-4072-8 Klein, K., Scholl, J. H. G.
, De Bruin, M. L., van Puijenbroek, E. P.
, Leufkens, H. G. M., & Stolk, P. (2018).
When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection.
Clinical Pharmacology and Therapeutics,
103(2), 296-303.
https://doi.org/10.1002/cpt.879https://dspace.library.uu.nl/bitstream/handle/1874/362855/klein.pdf?sequence=1Coppens, D. G. M., De Bruin, M. L., Leufkens, H. G. M., & Hoekman, J. (2018).
Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation.
Clinical Pharmacology and Therapeutics,
103(1), 120-127.
https://doi.org/10.1002/cpt.894 2017
Scholarly publications
Bazelier, M., Ekstrom, N., Karlstad, O., Vestergaard, P., Haukka, J., de Vries, F., Furu, K., Andersen, M., & De Bruin, M. (2017). Understanding the Treatment Choice Between Insulin Glargine, Detemir and Human Insulin: Characteristics of Patients with Type 2 Diabetes Starting Insulin in Five European Countries. Pharmacoepidemiology and Drug Safety, 26, 124-124.
van Eggermond, A. M., Schaapveld, M., Janus, C. P., de Boer, J. P., Krol, A. D., Zijlstra, J. M., van der Maazen, R. W., Kremer, L. C., van Leerdam, M. E., Louwman, M. W., Visser, O.
, De Bruin, M. L., Aleman, B. M., & van Leeuwen, F. E. (2017).
Infradiaphragmatic irradiation and high procarbazine doses increase colorectal cancer risk in Hodgkin lymphoma survivors.
British Journal of Cancer,
117(3), 306-314.
https://doi.org/10.1038/bjc.2017.177https://dspace.library.uu.nl/bitstream/handle/1874/428442/bjc2017177.pdf?sequence=1de Wilde, S.
, Coppens, D., De Bruin, M. L., Leufkens, H. G., Guchelaar, H. J.
, Hoekman, J., & Meij, P. (2017).
Decision-making on marketing authorization of advanced therapy medicinal products in the European union.
Cytotherapy,
19(5), S63.
https://doi.org/10.1016/j.drudis.2018.03.008Coppens, D., DeWilde, S., Guchelaar, H. J.
, De Bruin, M., Leufkens, H., Meij, P.
, & Hoekman, J. (2017).
Decision-making for marketing approval of cell and gene based therapy products in the European union, United States and Canada.
Cytotherapy,
19(5), S62-S63.
https://doi.org/10.1016/j.jcyt.2017.02.144 Krul, I. M., Opstal-van Winden, A. W. J., Aleman, B. M. P., Janus, C. P. M., van Eggermond, A. M.
, De Bruin, M. L., Hauptmann, M., Krol, A. D. G., Schaapveld, M., Broeks, A., Kooijman, K. R., Fase, S., Lybeert, M. L., Zijlstra, J. M., van der Maazen, R. W. M., Kesminiene, A., Diallo, I., de Vathaire, F., Russell, N. S., & van Leeuwen, F. E. (2017).
Breast Cancer Risk After Radiation Therapy for Hodgkin Lymphoma: Influence of Gonadal Hormone Exposure.
International journal of radiation oncology, biology, physics,
99(4), 843-853.
https://doi.org/10.1016/j.ijrobp.2017.07.016https://dspace.library.uu.nl/bitstream/handle/1874/361848/1_s2.0_S0360301617335988_main.pdf?sequence=1Gardarsdottir, H., Kant, A.
, De Bruin, M. L., Hallgren, C. E., Pan, G. D., & Way, D. (2017).
How to measure the impact of pharmacovigilance activities on public health? Pharmacoepidemiology and Drug Safety,
26, 31.
https://doi.org/10.1002/pds.4275 But, A.
, De Bruin, M. L., Bazelier, M. T., Hjellvik, V., Andersen, M., Auvinen, A., Starup-Linde, J., Schmidt, M. K., Furu, K.
, de Vries, F., Karlstad, Ø., Ekström, N., & Haukka, J. (2017).
Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study.
Diabetologia,
60(9), 1691-1703.
https://doi.org/10.1007/s00125-017-4312-5Bronsveld, H. K., Jensen, V. F., Vahl, P.
, De Bruin, M. L., Cornelissen, S., Sanders, J., Auvinen, A., Haukka, J., Andersen, M., Vestergaard, P., & Schmidt, M. K. (2017).
Diabetes and breast cancer subtypes.
PLoS One,
12(1), Article e0170084.
https://doi.org/10.1371/journal.pone.0170084 Bouvy, J. C., Blake, K., Slattery, J.
, De Bruin, M. L., Arlett, P., & Kurz, X. (2017).
Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.
Pharmacoepidemiology and Drug Safety,
26(12), 1442-1450.
https://doi.org/10.1002/pds.4196https://dspace.library.uu.nl/bitstream/handle/1874/379409/Bouvy_et_al_2017_Pharmacoepidemiology_and_Drug_Safety.pdf?sequence=1 Bronsveld, H. K., Peeters, P. J. H. L., de Groot, M. C. H., de Boer, A., Schmidt, M. K.
, & De Bruin, M. L. (2017).
Trends in breast cancer incidence among women with type-2 diabetes in British general practice.
Primary Care Diabetes,
11(4), 373-382.
https://doi.org/10.1016/j.pcd.2017.02.001 Engel, P., Ferreira Almas, M.
, de Bruin, M. L., Starzyk, K., Blackburn, S., & Dreyer, N. A. (2017).
Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.
British Journal of Clinical Pharmacology,
83(4), 884-893.
https://doi.org/10.1111/bcp.13165https://dspace.library.uu.nl/bitstream/handle/1874/362116/Engel_et_al_2017_British_Journal_of_Clinical_Pharmacology.pdf?sequence=1Knapen, L. M., de Jong, R. G. P. J.
, Driessen, J. H. M., Keulemans, Y. C., van Erp, N. P.
, De Bruin, M. L., Leufkens, H. G. M., Croes, S.
, & de Vries, F. (2017).
Use of incretin agents and risk of acute and chronic pancreatitis: a population-based cohort study.
Diabetes, Obesity and Metabolism,
19(3), 401–411.
https://doi.org/10.1111/dom.12833Other output
Bloem, L. T., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., De Bruin, M. L., Klungel, O. H., & Hoekman, J. (2017).
Risk factors associated with post-marketing changes in specific obligations of conditionally authorised products in the EU.
Pharmacoepidemiology and Drug Safety,
26, 605.
https://doi.org/10.1002/pds.4275 2016
Scholarly publications
de Jong, R. G. P. J.
, Peeters, P. J. H. L., Burden, A. M.
, de Bruin, M. L., Haak, H. R., Masclee, A. A. M.
, de Vries, F., & Janssen-Heijnen, M. L. G. (2016).
Gastrointestinal Cancer Incidence in Type 2 Diabetes Mellitus; Results from a Large Retrospective Population-Based Cohort Study in the UK.
Pharmacoepidemiology and Drug Safety,
25(Suppl 3), 70-71. Article 113.
https://doi.org/10.1002/pds.4070Knapen, L. M., de Jong, R. G. P. J.
, Driessen, J. H. M., Keulemans, Y. C., van Erp, N. P.
, de Bruin, M. L., Leufkens, H. G. M., Croes, S.
, & de Vries, F. (2016).
Use of Incretin Agents and Risk of Acute and Chronic Pancreatitis: A Population-Based Cohort Study.
Pharmacoepidemiology and Drug Safety,
25, 246-246. Article 421.
https://doi.org/10.1002/pds.4070But, A.
, De Bruin, M. L., Bazelier, M. T., Hjellvik, V., Andersen, M., Auvinen, A., Starup-Linde, J., Schmidt, M. K., Furu, K.
, de Vries, F., Karlstad, O., Ekstrom, N., & Haukka, J. (2016).
Cancer Risk Among Insulin Users: Comparing Analogues with Human Insulin in the CARING Five-Country Study.
Pharmacoepidemiology and Drug Safety,
25, 547-547.
https://researchportal.helsinki.fi/en/publications/cancer-risk-among-insulin-users-comparing-analogues-with-human-in-2de Jong, R.
, Peeters, P., Burden, A.
, de Bruin, M., Haak, H.
, de Vries, F., Masclee, A., & Janssen-Heijnen, M. (2016).
Gastrointestinal Cancer Incidence in Type 2 Diabetes Mellitus; Results From a Large Retrospective Population-Based Cohort Study.
Gastroenterology,
150(4), S649-S649.
https://doi.org/10.1016/S0016-5085(16)32223-5N., E.
, M.T., B., V., H.
, F., D. V., J., H., P., V.
, M.L., D. B., & M., A. (2016).
Combining observational data from multiple databases: Comparison of individual patient data and aggregate data meta-analysis in the CARING study. 129-130. Abstract from 32nd International conference on Pharmacoepidemiology & Therapeutic Risk Management, Dublin, Ireland.
https://doi.org/10.1002/pds.4070Aleman, B. M. P., Krul, I. M., Opstal Van Winden, A. W. J., Janus, C. P. M., Van Eggermond, A. M., De Bruin, M. L., Hauptmann, M., Krol, A. D. G., Schaapveld, M., Broeks, A., Kooijman, K. R., Fase, S., Lybeert, M., Zijlstra, J. M., Van Der Maazen, R. W. M., Kesminiene, A., Diallo, I., De Vathaire, F., Russell, N. S., & Van Leeuwen, F. E. (2016). Breast cancer after Hodgkin lymphoma: Influence of endogenous and exogenous gonadal hormones on the radiation dose-response relationship. Haematologica, 101, 63. Article P117.
Knapen, L. M., De Jong, R. G. P. J.
, Driessen, J. H. M., Keulemans, Y. C., van Erp, N. P.
, De Bruin, M. L., Leufkens, H. G. M., Croes, S.
, & De Vries, F. (2016).
Use of incretin agents and risk of acute and chronic pancreatitis: A population-based cohort study.
Pharmacoepidemiology and Drug Safety,
25, 246.
https://doi.org/10.1002/pds.4070But, A.
, De Bruin, M. L., Bazelier, M. T., Hjellvik, V., Andersen, M., Auvinen, A., Starup-Linde, J., Schmidt, M. K., Furu, K.
, De Vries, F., Karlstad, Ø., Ekström, N., & Haukka, J. (2016).
Cancer risk among insulin users: Comparing analogues with human insulin in the CARING five-country study.
Pharmacoepidemiology and Drug Safety,
25, 545-546.
https://doi.org/10.1002/pds.4070Peeters, P. J. H. L., Bazelier, M. T., Leufkens, H. G. M., Auvinen, A.
, van Staa, T. P., de Vries, F., & De Bruin, M. L. (2016).
Insulin glargine use and breast cancer risk: Associations with cumulative exposure.
Acta Oncologica,
55(7), 851-858.
https://doi.org/10.3109/0284186X.2016.1155736 Hoekman, J., Klamer, T. T.
, Mantel-Teeuwisse, A. K., Leufkens, H. G. M., & De Bruin, M. L. (2016).
Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.
British Journal of Clinical Pharmacology,
82(1), 213-226.
https://doi.org/10.1111/bcp.12940 Klungel, O. H., Kurz, X.
, de Groot, M. C. H., Schlienger, R. G., Tcherny-Lessenot, S., Grimaldi, L., Ibáñez, L.
, Groenwold, R. H. H., Reynolds, R. F., Alvarez, Y., Candore, G., Durand, J., Slattery, J., Hasford, J., Rottenkolber, M., Schmiedl, S., de Abajo Iglesias, F., Gil, M., Gonzalez, R., ... On behalf of the members of work-package 2 of PROTECT (2016).
Multi-centre, multi-database studies with common protocols: Lessons learnt from the IMI PROTECT project.
Pharmacoepidemiology and Drug Safety,
25(supplement S1), 156-165.
https://doi.org/10.1002/pds.3968 Souverein, P. C., Abbing-Karahagopian, V., Martin, E., Huerta, C., de Abajo, F.
, Leufkens, H. G. M., Candore, G., Alvarez, Y., Slattery, J., Miret, M., Requena, G., Gil, M. J.
, Groenwold, R. H. H., Reynolds, R., Schlienger, R. G., Logie, J. W.
, de Groot, M. C. H., Klungel, O. H., van Staa, T. P., ... Gardarsdottir, H. (2016).
Understanding inconsistency in the results from observational pharmacoepidemiological studies: the case of antidepressant use and risk of hip/femur fractures.
Pharmacoepidemiology and Drug Safety,
25 (Suppl 1), 88-102.
https://doi.org/10.1002/pds.3862 Udo, R., Tcherny-Lessenot, S., Brauer, R., Dolin, P., Irvine, D., Wang, Y., Auclert, L., Juhaeri, J., Kurz, X., Abenhaim, L., Grimaldi, L.
, & De Bruin, M. L. (2016).
The risk of acute liver injury associated with the use of antibiotics-evaluating robustness of results in the pharmacoepidemiological research on outcomes of therapeutics by a European consortium (PROTECT) project.
Pharmacoepidemiology and Drug Safety,
25(Suppl. S1), 47–55.
https://doi.org/10.1002/pds.3841https://dspace.library.uu.nl/bitstream/handle/1874/345901/risk.pdf?sequence=1 Vermeer, N. S., Ebbers, H. C., Straus, S. M. J. M.
, Leufkens, H. G. M., Egberts, T. C. G., & De Bruin, M. L. (2016).
The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: A simulation study.
Pharmacoepidemiology and Drug Safety, 297-306.
https://doi.org/10.1002/pds.3929 Klein, K., Scholl, J. H. G.
, Vermeer, N. S., Broekmans, A. W., Van Puijenbroek, E. P.
, De Bruin, M. L., & Stolk, P. (2016).
Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports.
Drug Safety,
39(2), 185-192.
https://doi.org/10.1007/s40264-015-0383-8Ampadu, H. H.
, Hoekman, J., de Bruin, M. L., Pal, S. N., Olsson, S., Sartori, D.
, Leufkens, H. G. M., & Dodoo, A. N. O. (2016).
Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase(®).
Drug Safety.
https://doi.org/10.1007/s40264-015-0387-4Grimaldi-Bensouda, L.
, Klungel, O., Kurz, X.
, de Groot, M. C. H., Maciel Afonso, A. S., de Bruin, M. L., Reynolds, R., & Rossignol, M. (2016).
Calcium channel blockers and cancer: a risk analysis using the UK Clinical Practice Research Datalink (CPRD).
BMJ Open,
6(1).
https://doi.org/10.1136/bmjopen-2015-009147Udo, R., Maitland-van der Zee, A. H., Egberts, T. C. G., den Breeijen, J. H.
, Leufkens, H. G. M., van Solinge, W. W., & De Bruin, M. L. (2016).
Validity of diagnostic codes and laboratory measurements to identify patients with idiopathic acute liver injury in a hospital database.
Pharmacoepidemiology and Drug Safety,
25(Suppl. S1), 21–28.
https://doi.org/10.1002/pds.3824 Knapen, L. M., van Dalem, J., Keulemans, Y. C., van Erp, N. P.
, Bazelier, M. T., De Bruin, M. L., Leufkens, H. G. M., Croes, S., Neef, C.
, de Vries, F., & Driessen, J. H. M. (2016).
Use of Incretin Agents and Risk of Pancreatic Cancer: A Population-Based Cohort Study.
Diabetes, Obesity & Metabolism,
18(3), 258–265.
https://doi.org/10.1111/dom.12605Huerta, C.
, Abbing-Karahagopian, V., Requena, G., Oliva, B., Alvarez, Y.
, Gardarsdottir, H., Miret, M., Schneider, C., Gil, M.
, Souverein, P. C., De Bruin, M. L., Slattery, J.
, De Groot, M. C. H., Hesse, U., Rottenkolber, M., Schmiedl, S., Montero, D., Bate, A., Ruigomez, A., ... de Abajo, F. J. (2016).
Exposure to benzodiazepines (anxiolytics, hypnotics and related drugs) in seven European electronic healthcare databases: a cross-national descriptive study from the PROTECT-EU Project.
Pharmacoepidemiology and Drug Safety,
25(S1), 56–65.
https://doi.org/10.1002/pds.3825Essers, I., Stolwijk, C., Boonen, A.
, De Bruin, M. L., Bazelier, M. T., de Vries, F., & van Tubergen, A. (2016).
Ankylosing spondylitis and risk of ischaemic heart disease: a population-based cohort study.
Annals of the Rheumatic Diseases,
75(1), 203-209.
https://doi.org/10.1136/annrheumdis-2014-206147Other output
De Jong, R. G. P. J.
, Peeters, P. J. H. L., Burden, A. M.
, De Bruin, M. L., Haak, H. R., Masclee, A. A. M.
, De Vries, F., & Janssen-Heijnen, M. L. G. (2016).
Gastrointestinal cancer incidence in Type 2 Diabetes Mellitus; Results from a large retrospective population-based cohort study in the UK.
Pharmacoepidemiology and Drug Safety,
25(S3), 70-71. Article 113.
https://doi.org/10.1002/pds.40702015
Scholarly publications
Peeters, P. J. H. L., Bazelier, M. T., Van Staa, T. P., Auvinen, A., Leufkens, H. G. M., de Vries, F., & De Bruin, M. L. (2015). Insulin Glargine and Breast Cancer Risk: Comparison of Different Exposure Definitions. Pharmacoepidemiology and Drug Safety, 24, 430-431.
Abbing-Karahagopian, V., Souverein, P. C., Korevaar, J. C.
, Leufkens, H. G. M., Egberts, T. C. G., Gardarsdottir, H., & De Bruin, M. L. (2015).
Concomitant medication use and its implications on the hazard pattern in pharmacoepidemiological studies: Example of antidepressants, benzodiazepines and fracture risk.
Epidemiology Biostatistics and Public Health,
12(3), Article e11273.
https://doi.org/10.2427/11273 Bronsveld, H. K., Ter Braak, B., Karlstad, Ø., Vestergaard, P., Starup-Linde, J.
, Bazelier, M. T., de Bruin, M., De Boer, A., Siezen, C. L. E., Van De Water, B., Van Der Laan, J. W., & Schmidt, M. K. (2015).
Insulin treatment and breast cancer risk; A systematic review of in vitro, animal and epidemiological evidence.
Pharmacoepidemiology and Drug Safety,
24, 51-52.
https://doi.org/10.1002/pds.3838 Segec, A., Keller-Stanislawski, B.
, Vermeer, N. S., Macchiarulo, C., Straus, S. M., Hidalgo-Simon, A.
, & De Bruin, M. L. (2015).
Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy.
Clinical Pharmacology and Therapeutics,
98(5), 502-505.
https://doi.org/10.1002/cpt.199https://dspace.library.uu.nl/bitstream/handle/1874/330056/Segec_et_al_2015_Clinical_Pharmacology_Therapeutics.pdf?sequence=1Bouvy, J. C., de Bruin, M. L., & Koopmanschap, M. A. (2015).
Epidemiology of Adverse Drug Reactions in Europe: A Review of Recent Observational Studies.
Drug Safety.
https://doi.org/10.1007/s40264-015-0281-0 De Bruin, M. L., Ampadu, H. H.
, Hoekman, J., Kurz, X.
, Leufkens, H. G. M., Sekine, S., & Pan, G. D. (2015).
Data driven regulatory science.
Pharmacoepidemiology and Drug Safety,
24(S1), 46.
https://doi.org/10.1002/pds.3838 Klein, K.
, De Bruin, M. L., Broekmans, A. W.
, & Stolk, P. (2015).
Classification of Recombinant Biologics in the EU: Divergence between National Pharmacovigilance Centers.
BioDrugs,
29(6), 373-379.
https://doi.org/10.1007/s40259-015-0149-yVermeer, N. S., Straus, S. M. J. M.
, Mantel-Teeuwisse, A. K., Hidalgo-Simon, A.
, Egberts, A. C. G., Leufkens, H. G. M., & De Bruin, M. L. (2015).
Drug-induced progressive multifocal leukoencephalopathy: Lessons learned from contrasting natalizumab and rituximab.
Clinical Pharmacology and Therapeutics,
98(5), 542-550.
https://doi.org/10.1002/cpt.207https://dspace.library.uu.nl/bitstream/handle/1874/330037/Multifocal.pdf?sequence=1 Warnier, M. J., Rutten, F. H.
, Souverein, P. C., de Boer, A., Hoes, A. W.
, & De Bruin, M. L. (2015).
Are ECG monitoring recommendations before prescription of QT-prolonging drugs applied in daily practice? The example of haloperidol.
Pharmacoepidemiology and Drug Safety,
24(7), 701-8.
https://doi.org/10.1002/pds.3792 Bronsveld, H. K., ter Braak, B., Karlstad, Ø., Vestergaard, P., Starup-Linde, J.
, Bazelier, M. T., De Bruin, M. L., de Boer, A., Siezen, C. L. E., van de Water, B., van der Laan, J. W., & Schmidt, M. K. (2015).
Treatment with insulin (analogues) and breast cancer risk in diabetics; a systematic review and meta-analysis of in vitro, animal and human evidence.
Breast Cancer Research,
17(1), Article 100.
https://doi.org/10.1186/s13058-015-0611-2 Hoekman, J., Boon, W., Bouvy, J. C., Ebbers, H. C., de Jong, J. P., & De Bruin, M. L. (2015).
Use of the conditional marketing authorization pathway for oncology medicines in Europe.
Clinical Pharmacology and Therapeutics,
98(5), 534-541.
https://doi.org/10.1002/cpt.174 Goossens, M. E., Buntinx, F., Zeegers, M. P.
, Driessen, J. H. M., De Bruin, M. L., & de Vries, F. (2015).
Influence of metformin intake on the risk of bladder cancer in type 2 diabetes patients.
British Journal of Clinical Pharmacology,
80(6), 1464-1472.
https://doi.org/10.1111/bcp.12740Ebbers, H. C., Langedijk, J., Bouvy, J. C., Hoekman, J., Boon, W. P. C., de Jong, J. P.
, & De Bruin, M. L. (2015).
An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe.
European Journal of Clinical Pharmacology,
71(10).
https://doi.org/10.1007/s00228-015-1904-1 Bazelier, M. T., Eriksson, I.
, de Vries, F., Schmidt, M. K., Raitanen, J., Haukka, J., Starup-Linde, J.
, De Bruin, M. L., & Andersen, M. (2015).
Data management and data analysis techniques in pharmacoepidemiological studies using a pre-planned multi-database approach: a systematic literature review.
Pharmacoepidemiology and Drug Safety,
24(9), 897-905.
https://doi.org/10.1002/pds.3828 Goossens, M. E., Zeegers, M. P.
, Bazelier, M. T., De Bruin, M. L., Buntinx, F.
, & de Vries, F. (2015).
Risk of bladder cancer in patients with diabetes: a retrospective cohort study.
BMJ Open,
5(6), e007470.
https://doi.org/10.1136/bmjopen-2014-007470Stolwijk, C., Essers, I., van Tubergen, A., Boonen, A.
, Bazelier, M. T., De Bruin, M. L., & de Vries, F. (2015).
The epidemiology of extra-articular manifestations in ankylosing spondylitis: a population-based matched cohort study.
Annals of the Rheumatic Diseases,
74(7), 1-6.
https://doi.org/10.1136/annrheumdis-2014-205253Vermeer, N. S., Spierings, I.
, Mantel-Teeuwisse, A. K., Straus, S. M.
, Giezen, T. J., Leufkens, H. G., Egberts, T. C., & De Bruin, M. L. (2015).
Traceability of biologicals: present challenges in pharmacovigilance.
Expert Opinion on Drug Safety,
14(1), 63-72.
https://doi.org/10.1517/14740338.2015.972362https://dspace.library.uu.nl/bitstream/handle/1874/314342/62.pdf?sequence=1 Other output
Bazelier, M. T., Eriksson, I.
, De Vries, F., Schmidt, M. K., Raitanen, J., Haukka, J., Starup-Linde, J.
, De Bruin, M. L., & Andersen, M. (2015).
Data management and data analysis techniques used in pharmacoepidemiological multi-database studies: A systematic literature review. 732. Abstract from European congress of Epidemiology 2015, Maastricht, Netherlands.
http://www.embase.com/search/results?subaction=viewrecord&from=export&id=L72274361 2014
Scholarly publications
Essers, I., Stolwijk, C., Boonen, A., De Bruin, M. L., Bazelier, M., de Vries, F., & Van Tubergen, A. (2014). Female Patients but Not Male Patients with Ankylosing Spondylitis Are at Increased Risk of Developing Ischemic Heart Disease: A Population-Based Cohort Study. Arthritis & Rheumatology, 66, S254-S254.
Essers, I., Stolwijk, C., Boonen, A., De Bruin, M. L., Bazelier, M. T., De Vries, F., & van Tubergen, A. (2014). Ankylosing spondylitis and risk of ischemic heart disease: A population-based cohort study. Clinical and Experimental Rheumatology, 32(5), 797.
Van Haelst, I. M. M., Van Klei, W. A., Doodeman, H. J.
, Warnier, M. J., De Bruin, M. L., Kalkman, C. J.
, & Egberts, T. C. G. (2014).
QT interval prolongation in users of selective serotonin reuptake inhibitors in an elderly surgical population: A cross-sectional study.
Journal of Clinical Psychiatry,
75(1), 15-21.
https://doi.org/10.4088/JCP.13m08397Stolwijk, C., Essers, I., Van Tubergen, A.
, Boonen, A., Bazelier, M., De Bruin, M., & De Vries, F. (2014).
The epidemiology of extra-articular manifestations in ankylosing spondylitis: A population-based matched cohort study.
Annals of the Rheumatic Diseases,
73.
https://doi.org/10.1136/annrheumdis-2014-eular.2833Essers, I., Stolwijk, C., Van Tubergen, A.
, Boonen, A., De Bruin, M. L., Bazelier, M., & De Vries, F. (2014).
Cardiovascular morbidity in patients with ankylosing spondylitis: A population-based cohort study.
Annals of the Rheumatic Diseases,
73.
https://doi.org/10.1136/annrheumdis-2014-eular.1853Abbing-Karahagopian, V., Huerta, C.
, Souverein, P. C., De Abajo, F.
, Leufkens, H. G. M., Slattery, J., Alvarez, Y., Miret, M., Gil, M., Oliva, B., Hesse, U., Requena, G.
, De Vries, F., Rottenkolber, M., Schmiedl, S., Reynolds, R., Schlienger, R. G.
, De Groot, M. C. H., Klungel, O. H., ... De Bruin, M. L. (2014).
Antidepressant prescribing in five European countries: Application of common definitions to assess the prevalence, clinical observations, and methodological implications.
European Journal of Clinical Pharmacology,
70(7), 849-857.
https://doi.org/10.1007/s00228-014-1676-z Requena, G.
, Abbing-Karahagopian, V., Huerta, C.
, De Bruin, M. L., Alvarez, Y., Miret, M., Hesse, U.
, Gardarsdottir, H., Souverein, P. C., Slattery, J., Schneider, C., Rottenkolber, M., Schmiedl, S., Gil, M.
, De Groot, M. C. H., Bate, A., Ruigómez, A., García Rodríguez, L. A., Johansson, S., ... De Abajo, F. J. (2014).
Incidence rates and trends of hip/femur fractures in five European countries: Comparison using e-healthcare records databases.
Calcified Tissue International,
94(6), 580-589.
https://doi.org/10.1007/s00223-014-9850-yPeeters, P. J. H. L., Bazelier, M. T., Uitdehaag, B. M. J.
, Leufkens, H. G. M., De Bruin, M. L., & de Vries, F. (2014).
The risk of venous thromboembolism in patients with multiple sclerosis: the Clinical Practice Research Datalink.
Journal of Thrombosis and Haemostasis,
12(4), 444-51.
https://doi.org/10.1111/jth.12523 Warnier, M. J., Holtkamp, F. A., Rutten, F. H., Hoes, A. W.
, de Boer, A., Mol, P. G. M.
, & De Bruin, M. L. (2014).
Safety information on QT-interval prolongation: comparison of European Union and United States drug labeling.
Drug Discovery Today,
19(9), 1294-1297.
https://doi.org/10.1016/j.drudis.2014.06.017 Warnier, M. J., Rutten, F. H.
, De Boer, A., Hoes, A. W.
, & De Bruin, M. L. (2014).
Resting heart rate is a risk factor for mortality in chronic obstructive pulmonary disease, but not for exacerbations or pneumonia.
PLoS One,
9(8), Article e105152.
https://doi.org/10.1371/journal.pone.0105152 Blom, M. T., van Hoeijen, D. A., Bardai, A., Berdowski, J.
, Souverein, P. C., De Bruin, M. L., Koster, R. W.
, de Boer, A., & Tan, H. L. (2014).
Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest: rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry.
Open Heart,
1(1), Article e000112.
https://doi.org/10.1136/openhrt-2014-000112 Peeters, P. J. H. L., Bazelier, M. T., Leufkens, H. G. M., de Vries, F., & De Bruin, M. L. (2014).
The Risk of Colorectal Cancer in Patients With Type 2 Diabetes: Associations With Treatment Stage and Obesity.
Diabetes Care.
https://doi.org/10.2337/dc14-1175 Vermeer, N. S., Duijnhoven, R. G., Straus, S. M. J. M.
, Mantel - Teeuwisse, A. K., Arlett, P. R.
, Egberts, A. C. G., Leufkens, H. G. M., & De Bruin, M. L. (2014).
Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in europe.
Clinical Pharmacology and Therapeutics,
96(6), 723-31.
https://doi.org/10.1038/clpt.2014.184 Duijnhoven, R. G., Straus, S. M. J. M.
, Souverein, P. C., de Boer, A., Bosch, J. L. H. R., Hoes, A. W.
, & De Bruin, M. L. (2014).
Long-term Use of 5α-Reductase Inhibitors and the Risk of Male Breast Cancer. Cancer Causes & Control,
25(11), 1577-1582.
https://doi.org/10.1007/s10552-014-0455-6 Warnier, M. J., Holtkamp, F. A., Rutten, F. H., Hoes, A. W.
, de Boer, A., Mol, P. G. M.
, & de Bruin, M. L. (2014).
Quality of drug label information on QT interval prolongation.
International Journal of Risk and Safety in Medicine,
26(2), 89-98.
https://doi.org/10.3233/JRS-140612 Other output
Peeters, P. J. H. L., Bazelier, M. T., Leufkens, H. G. M., de Vries, F., & De Bruin, M. L. (2014).
The Risk of Colorectal Cancer in Patients with Type 2 Diabetes: Associations with Treatment Stage and Obesity. 169-169.
https://doi.org/10.1002/pds.3701 Abbing-Karahagopian, V., Souverein, P., Martin, E., Huerta, C., de Abajo, F., Leufkens, H., Candore, G., Alvarez, Y., Slattery, J., Miret, M., Requena, G., Gil, M., Groenwold, R., Reynolds, R., Schlienger, R., de Groot, M., Klungel, O. H., van Staa, T., Egberts, T., ... Gardarsdottir, H. (2014). Understanding Inconsistent Results from Observational Pharmacoepidemiological Studies: the Case of Antidepressant Use and Risk of Hip Fracture. Pharmacoepidemiology and Drug Safety, 23, 36-36.
Duijnhoven, R. G., Van Leeuwen, R., Straus, S. M., Imhof, S. M., Hoes, A. W.
, De Boer, A., & De Bruin, M. L. (2014).
Effect of long-term aspirin use on the risk for neovascular age-related macular degeneration.
Pharmacoepidemiology and Drug Safety,
23(S1), 323.
https://doi.org/10.1002/pds.3701 Ryan, P., Anderson, M., Schuemie, M., Burke, A., Haynes, K., Man, K.
, Gardarsdottir, H., & De Bruin, M. L. (2014).
The common data model: Lessons from past projects and ongoing initiatives.
Pharmacoepidemiology and Drug Safety,
23(S1), 361-362.
https://doi.org/10.1002/pds.3701Kurz, X., Martin, D.
, Hoekman, J., Bouvy, J. C., Roddam, A.
, Ebbers, H., Leufkens, H. G. M., Chan, K. A., Dal Pan, G., Reynolds, R.
, & De Bruin, M. L. (2014).
Challenges in implementing findings of regulatory science to evaluate and improve the drug regulatory system.
Pharmacoepidemiology and Drug Safety,
23(S1), 204-205.
https://doi.org/10.1002/pds.3701Bouvy, J. C., De Bruin, M. L., Hoekman, J., & Stolk, P. (2014).
The costs and effects of post-authorisation safety studies for new active substances.
Value in Health,
17(7), 445-446.
https://doi.org/10.1016/j.jval.2014.08.1184 2013
Scholarly publications
Abbing-Karahagopian, V., Huerta, C., Souverein, P. C., de Abajo, F., Leufkens, H. G. M., Slattery, J., Alvarez, Y., Montserrat, M., Gil, M., Hesse, U., Requena, G., de Vries, F., Rottenkolber, M., Schmiedl, S., Reynolds, R., Schlinger, R., de Groot, M., Klungel, O. H., van Staa, T. P., ... De Bruin, M. L. (2013). Antidepressant Prescribing in Five European Countries: Application of Common Methods to Assess the Variation in Prevalence. Pharmacoepidemiology and Drug Safety.
Starup-Linde, J., Vestergaard, P., Karlstad, O., Eriksen, S. A., Bronsveld, H. K., Peeters, P. J. H. L., De Vries, F., & De Bruin, M. L. (2013). CARING: Does Subgroup Analysis by Gender Modify the Potential Association Between Diabetes Mellitus and Cancer? A Meta-Analysis. Pharmacoepidemiology and Drug Safety, 22, 402-402.
Requena, G., Abbing-Karahagopian, V., Huerta, C., De Bruin, M. L., Alvarez, Y., Miret, M., Hesse, U., Gardarsdottir, H., Souverein, P., Slattery, J., Schneider, C., Rottenkolber, M., Schmiedl, S., Gil, M., De Groot, M. C. H., Bate, A., Ruigomez, A., Garcia, L. A., Johanson, S., ... De Abajo, F. J. (2013). Trends in Incidence Rates (IR) of Hip/Femur Fractures in Five European Countries: A Comparison Using Electronic Health Care Records (e-HCR). Pharmacoepidemiology and Drug Safety, 22, 408-409.
Peeters, P. J. H. L., Bazelier, M. T., Vestergaard, P., Leufkens, H. G. M., Schmidt, M. K., de Vries, F., & de Bruin, M. L. (2013). Use of metformin and survival of diabetic women with breast cancer. Current Drug Safety, 8(5), 357-363.
Duijnhoven, R. G., Straus, S. M. J. M.
, Souverein, P. C., De Boer, A., Hoes, A. W.
, & De Bruin, M. L. (2013).
Male breast cancer in users of finasteride and dutasteride: A case-control study.
Pharmacoepidemiology and Drug Safety,
22, 355.
https://doi.org/10.1002/pds.3512 Warnier, M., Holtkamp, F., Rutten, F., Hoes, A.
, De Boer, A., Mol, P.
, & De Bruin, M. (2013).
Quality of label information on qt-interval prolongation of medicinal products registered in the EU.
Drug Safety,
36(9), 827.
https://doi.org/10.1007/s40264-013-0087-x Warnier, M. J., Holtkamp, F. A., Rutten, F. H., Hoes, A. W.
, De Boer, A., Mol, P. G. M.
, & De Bruin, M. L. (2013).
Information on QTc-interval prolongation in the summary of product characteristics.
Pharmacoepidemiology and Drug Safety,
22, 248-249.
https://doi.org/10.1002/pds.3512 Warnier, M., Holtkamp, F., Rutten, F., Hoes, A.
, De Boer, A., Mol, P.
, & De Bruin, M. (2013).
Information on QT-interval prolongation properties of medicinal products in the european and american drug label.
Drug Safety,
36(9), 887.
https://doi.org/10.1007/s40264-013-0087-x Starup-Linde, J., Vestergaard, P., Karlstad, O., Eriksen, S. A., Bronsveld, H. K., De Vries, F., De Boer, A., & De Bruin, M. L. (2013). CARING: Diabetes Mellitus and Risk of Cancer - A Systematic Review and Meta-Analysis. Pharmacoepidemiology and Drug Safety, 22, 402-403.
Stefansdottir, G., Zoungas, S., Chalmers, J., Knol, M. J., Leufkens, H. G. M., Woodward, M., Patel, A., Grobbee, D. E., & De Bruin, M. L. (2013). The post hoc use of randomised controlled trials to explore drug associated cancer outcomes: methodological challenges. Current Drug Safety, 8(5), 371-8.
Vermeer, N. S., & De Bruin, M. L. (2013). Kankerrisico van biologicals vaststellen? Nederlands Tijdschrift voor Geneeskunde, 157(6), Article A5884.
Schaapveld, M., Janus, C. P., De Boer, J. P., Krol, A., Zijlstra, J. M., Raemaekers, J., Kremer, L. C., Louwman, M. W., Visser, O., De Bruin, M. L., Aleman, B. M., Van Leeuwen, F. E., & Van Leerdam, M. E. (2013). Subsite specific risk of colorectal cancer risk in patients treated for hodgkin's lymphoma: A long-term follow-up study in the Netherlands. Gastroenterology, 144(5), 39.
Duijnhoven, R. G., & De Bruin, M. L. (2013).
Re: Nonsteroidal anti-inflammatory drug use, chronic liver disease, and hepatocellular carcinoma.
Journal of the National Cancer Institute,
105(9), 667-668.
https://doi.org/10.1093/jnci/djt064 Van Eggermond, A. M., Schaapveld, M., De Bruin, M. L., Janus, C. P. M., Krol, A. D. G., Aleman, B. M. P., Russell, N. S., & Van Leeuwen, F. E. (2013). Roles of radiotherapy, chemotherapy, and hormonal factors in the risk of breast cancer following treatment for hodgkin's lymphoma. Haematologica-The Hematology Journal, 98, 57.
Bazelier, M. T., de Vries, F., Vestergaard, P., Leufkens, H. G. M., & De Bruin, M. L. (2013). Use of thiazolidinediones and risk of bladder cancer: disease or drugs? Current Drug Safety, 8(5), 364-70.
Vermeer, N., Duijnhoven, R., Straus, S., Blackburn, S., Hoogendoorn, L.
, Mantel-Teeuwisse, A., Egberts, T., Leufkens, H., & De Bruin, M. (2013).
Development of safety concerns within RMPs after approval: A cohort study of biologicals.
Drug Safety,
36(9), 908-909.
https://doi.org/10.1007/s40264-013-0087-x Karlstad, Ø., Starup-Linde, J., Vestergaard, P., Hjellvik, V.
, Bazelier, M. T., Schmidt, M. K., Andersen, M., Auvinen, A., Haukka, J., Furu, K.
, de Vries, F., & de Bruin, M. L. (2013).
Use of insulin and insulin analogs and risk of cancer - systematic review and meta-analysis of observational studies.
Current Drug Safety,
8(5), 333-348.
https://doi.org/10.2174/15680266113136660067Ankrah, D. N. A., Mantel-Teeuwisse, A. K., De Bruin, M. L., Amoo, P. K., Ofei-Palm, C. N., Agyepong, I.
, & Leufkens, H. G. M. (2013).
Incidence of adverse events among healthcare workers following H1N1 Mass immunization in Ghana: a prospective study.
Drug Safety,
36(4), 259-66.
https://doi.org/10.1007/s40264-013-0037-7 Vermeer, N. S., Straus, S. M. J. M.
, Mantel - Teeuwisse, A., Domergue, F.
, Egberts, T. C. G., Leufkens, H. G. M., & De Bruin, M. L. (2013).
Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.
Drug Safety,
36(8), 617-25.
https://doi.org/10.1007/s40264-013-0073-3 Abbing-Karahagopian, V., Huerta, C.
, Souverein, P. C., De Abajo, F.
, Leufkens, H. G. M., Slattery, J., Alvarez, Y., Montserrat, M., Gil, M., Hesse, U., Requena, G.
, De Vries, F., Rottenkolber, M., Schmiedl, S., Reynolds, R., Schlinger, R.
, De Groot, M. C. H., Klungel, O. H., Van Staa, T. P., ... De Bruin, M. L. (2013).
Antidepressant prescribing in five european countries: Application of common methods to assess the variation in prevalence.
Pharmacoepidemiology and Drug Safety,
22, 279-280.
https://doi.org/10.1002/pds.3512 Starup-Linde, J., Karlstad, O., Eriksen, S. A., Vestergaard, P., Bronsveld, H. K., de Vries, F., Andersen, M., Auvinen, A., Haukka, J., Hjellvik, V., Bazelier, M. T., Boer, A. D., Furu, K., & De Bruin, M. L. (2013). CARING (CAncer Risk and INsulin analoGues): the association of diabetes mellitus and cancer risk with focus on possible determinants - a systematic review and a meta-analysis. Current Drug Safety, 8(5), 296-332.
Warnier, M. J., van Riet, E. E. S., Rutten, F. H., de Bruin, M. L., & Sachs, A. P. (2013). Smoking cessation strategies in patients with COPD. European Respiratory Journal, 41(3), 727-34.
Duijnhoven, R. G., Straus, S. M. J. M., Raine, J. M.
, de Boer, A., Hoes, A. W.
, & De Bruin, M. L. (2013).
Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis.
PLoS Medicine,
10(3), e1001407/1-e1001407/8. Article e1001407.
https://doi.org/10.1371/journal.pmed.1001407 Warnier, M. J., Blom, M. T., Bardai, A., Berdowksi, J.
, Souverein, P. C., Hoes, A. W., Rutten, F. H.
, de Boer, A., Koster, R. W.
, De Bruin, M. L., & Tan, H. L. (2013).
Increased risk of sudden cardiac arrest in obstructive pulmonary disease: a case-control study.
PLoS One,
8(6), 1-8. Article e65638.
https://doi.org/10.1371/journal.pone.0065638 Stefansdottir, G., Zoungas, S., Chalmers, J., Kengne, A. P.
, Knol, M. J., Leufkens, H. G., Patel, A., Woodward, M., Grobbee, D. E.
, & de Bruin, M. L. (2013).
Erratum to: Intensive glucose control and risk of cancer in patients with type 2 diabetes. Diabetologia,
56(9), 2105-2106.
https://doi.org/10.1007/s00125-013-2980-3 Blom, M. T., Warnier, M. J., Bardai, A., Berdowski, J.
, Koster, R. W., Souverein, P. C., Hoes, A. W., Rutten, F. H.
, de Boer, A., De Bruin, M. L., & Tan, H. L. (2013).
Reduced in-hospital survival rates of out-of-hospital cardiac arrest victims with obstructive pulmonary disease.
Resuscitation,
84(5), 569-74.
https://doi.org/10.1016/j.resuscitation.2012.10.009 Warnier, M. J., Rutten, F. H., Numans, M. E., Kors, J. A., Tan, H. L.
, de Boer, A., Hoes, A. W.
, & De Bruin, M. L. (2013).
Electrocardiographic characteristics of patients with chronic obstructive pulmonary disease.
COPD,
10(1), 62-71.
https://doi.org/10.3109/15412555.2012.727918 Professional publications
Vermeer, N. S., & de Bruin, M. L. (2013). [Research into the risk of malignancy from biologicals: utility of meta-analysis hampered]. Nederlands Tijdschrift voor Geneeskunde, 157(6).
Other output
Starup-Linde, J., Vestergaard, P., Karlstad, O., Eriksen, S. A.
, Bronsveld, H. K., De Vries, F., de Boer, A., & De Bruin, M. L. (2013).
CARING: Diabetes mellitus and risk of cancer: A systematic review and meta-analysis. 183.
https://doi.org/10.1007/s00125-013-3012-zAbbing-Karahagopian, V., Huerta, C., Souverein, P. C., de Abajo, F., Leufkens, H. G. M., Slattery, J., Alvarez, Y., Montserrat, M., Gil, M., Hesse, U., Requena, G., de Vries, F., Rottenkolber, M., Schmiedl, S., Reynolds, R., Schlinger, R., de Groot, M., Klungel, O. H., van Staa, T. P., ... De Bruin, M. L. (2013). Antidepressant Prescribing in Five European Countries: Application of Common Methods to Assess the Variation in Prevalence. Pharmacoepidemiology and Drug Safety, 22, 279-280.
De Groot, M. C. H., Van Den Ham, R.
, De Bruin, M., Alvarez, C. H., Gill, M., Afonso, A., Requena, G., Hesse, U., Rønn, P. F.
, Souverein, P. C., Alvarez, Y., Slattery, J., Rottenkolber, M., Schmiedl, S.
, Van Dijk, L., Schlienger, R. G., Reynolds, R.
, Klungel, O. H., & Grimaldi-Bensouda, L. (2013).
Comparison of seven electronic healthcare databases in eu countries using a standardized methodology; a descriptive study on the exposure to calcium-channel blockers (CCBS).
Pharmacoepidemiology and Drug Safety,
22(s1), 290-291. Article 586.
https://doi.org/10.1002/pds.3512 Requena, G.
, Abbing-Karahagopian, V., Huerta, C.
, De Bruin, M. L., Alvarez, Y., Miret, M., Hesse, U.
, Gardarsdottir, H., Souverein, P., Slattery, J., Schneider, C., Rottenkolber, M., Schmiedl, S., Gil, M.
, De Groot, M. C. H., Bate, A., Ruigómez, A., García, L. A., Johanson, S., ... De Abajo, F. J. (2013).
Trends in incidence rates (IR) of hip/femur fractures in five european countries: A comparison using electronic health care records (E-HCR).
Pharmacoepidemiology and Drug Safety,
22(s1), 408-409. Article 811.
https://doi.org/10.1002/pds.3512van Haelst, I. M. M., van Klei, W. A., Doodeman, H. J., Warnier, M. J., de Bruin, M. L., Kalkman, C. J., & Egberts, A. C. G. (2013). QT interval prolongation in elderly users of selective serotonin reuptake inhibitors.. Abstract from Annual International Conference on Pharmaco-epidemiology 2013, Montreal, Canada.
2012
Scholarly publications
Stefansdottir, G., & De Bruin, M. L. (2012). Innovations in post-marketing safety research. [Doctoral thesis 1 (Research UU / Graduation UU), Faculteit Geneeskunde].
Duijnhoven, R. G., Straus, S. M. J. M., Raine, J.
, De Boer, A., Hoes, A. W.
, & De Bruin, M. L. (2012).
Exposure to new medicines prior to market authorisation: Too few patients and insufficient follow-up.
Pharmacoepidemiology and Drug Safety,
21, 224-225.
https://doi.org/10.1002/pds.3324 Warnier, M. J., Blom, M., Bardai, A.
, Souverein, P. C., Hoes, A. W., Rutten, F.
, De Boer, A., De Bruin, M. L., & Tan, H. L. (2012).
Patients with obstructive pulmonary disease have an increased risk of ecg documented out-of-hospital cardiac arrest.
Pharmacoepidemiology and Drug Safety,
21, 265.
https://doi.org/10.1002/pds.3324 Stefansdottir, G., Knol, M. J., Arnardottir, A. H.
, van der Elst, M. E., Grobbee, D. E.
, Leufkens, H. G. M., & De Bruin, M. L. (2012).
Safety learning from drugs of the same class: room for improvement.
Clinical Pharmacology and Therapeutics,
91(5), 872-880.
https://doi.org/10.1038/clpt.2011.319 Linde, J.
, De Vries, F., De Bruin, M., & Vestergaard, P. (2012).
BMD decreases with increasing HbA1C levels: A cross-sectional study.
Osteoporosis International,
23, 129.
https://doi.org/10.1007/s00198-012-1928-7Van Staa, T. P., Patel, D.
, Gallagher, A. M., & De Bruin, M. L. (2012).
Glucose-lowering agents and the patterns of risk for cancer: A study with the General Practice Research Database and secondary care data.
Diabetologia,
55(3), 654-665.
https://doi.org/10.1007/s00125-011-2390-3 Warnier, M. J., Rutten, F. H., Kors, J. A., Lammers, J. W. J.
, de Boer, A., Hoes, A. W.
, & de Bruin, M. L. (2012).
Cardiac arrhythmias in adult patients with asthma.
Journal of Asthma,
49(9), 942-6.
https://doi.org/10.3109/02770903.2012.724132 Other output
Abbing-Karahagopian, V., Gardarsdottir, H., Souverein, P. C., Klungel, O. H., Leufkens, B. G. M., Egberts, T. C. G., & De Bruin, M. L. (2012).
Timing of concomitant drug use in pharmacoepidemiological studies.
Pharmacoepidemiology and Drug Safety,
21(S3), 423. Article 914.
https://doi.org/10.1002/pds.3324 2011
Scholarly publications
Stefansdottir, G., De Bruin, M. L., Knol, M. J., Grobbee, D. E.
, & Leufkens, H. G. M. (2011).
Randomized controlled trials of COX-2 inhibitors: An analysis of doses used and trends over time to investigate implications for comparative safety.
Drug Safety,
34(9), 783-792.
https://doi.org/10.2165/11590470-000000000-00000 Stefansdottir, G., Knol, M. J., Leufkens, H. G., Arnardottir, A. H., Grobbee, D. E., & De Bruin, M. L. (2011). Room for improvement in safety learning of same class drugs. Drug Safety, 34(10), 892.
Vermeer, N. S., Straus, S. M., Mantel Teeuwisse, A. K., Egberts, T. C., Leufkens, H. G., & De Bruin, M. L. (2011). Sparse batch number reporting for biologicals in FDA's adverse event reporting system (AERS). Drug Safety, 34(10), 1002.
Stefansdottir, G., Zoungas, S., Chalmers, J., Kengne, A. P., Knol, M. J., Leufkens, H. G. M., Patel, A., Woodward, M., Grobbee, D. E., & de Bruin, M. L. (2011). Intensive glucose control and risk of cancer in patients with type 2 diabetes. Diabetologia, 54, 1608-1614.
2010
Scholarly publications
Van E.ggermond, A. M., Schaapveld, M., De Bruin, M. L., Ouwens, G., Janus, C., Krol, S., Louwman, M., Aleman, B. M. P., & Van Leeuwen, F. E. (2010). Increased risk of colorectal cancer in patients treated for hodgkin lymphoma: A long-term follow-up study in The Netherlands. Haematologica, 95, 37.
Sieswerda, E., Kremer, L. C. M., Vidmar, S.
, De Bruin, M. L., Smibert, E., Sjöberg, G., Cheung, M. M. H., & Weintraub, R. G. (2010).
Exercise echocardiography in asymptomatic survivors of childhood cancer treated with anthracyclines: a prospective follow-up study.
Pediatric Blood & Cancer,
54(4), 579-84.
https://doi.org/10.1002/pbc.22371Enciso-Mora, V., Broderick, P., Ma, Y., Jarrett, R. F., Hjalgrim, H., Hemminki, K., van den Berg, A., Olver, B., Lloyd, A., Dobbins, S. E., Lightfoot, T., van Leeuwen, F. E., Försti, A., Diepstra, A., Broeks, A., Vijayakrishnan, J., Shield, L., Lake, A., Montgomery, D., ... Houlston, R. S. (2010).
A genome-wide association study of Hodgkin's lymphoma identifies new susceptibility loci at 2p16.1 (REL), 8q24.21 and 10p14 (GATA3).
Nature Genetics,
42(12), 1126-30.
https://doi.org/10.1038/ng.696Broeks, A., Braaf, L. M., Wessels, L. F. A., van de Vijver, M.
, De Bruin, M. L., Stovall, M., Russell, N. S., van Leeuwen, F. E., & Van 't Veer, L. J. (2010).
Radiation-associated breast tumors display a distinct gene expression profile.
International journal of radiation oncology, biology, physics,
76(2), 540-7.
https://doi.org/10.1016/j.ijrobp.2009.09.004Aleman, B. M. P.
, de Bruin, M. L., Dorresteijn, L. D. A., Krol, A. D. G., van 't Veer, M. B., Boogerd, W., & van Leeuwen, F. E. (2010).
Re: Late effects from radiation therapy: the hits just keep on coming.
Journal of the National Cancer Institute,
102(8), 576-7; author reply 577-8.
https://doi.org/10.1093/jnci/djq069Other output
Warnier, M. J., de Bruin, M. L., Rutten, F. H., Hoes, A. W., & de Boer, A. (2010). Drug-Induced ECG Abnormalities in Patients with COPD. S65. Abstract from Abstracts of the 26th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, 19-22 August 2010, Brighton, UK.
de Bruin, M. L., Yu, Y., den Breeijen, J. H., van Solinge, W. W., & Maitland-van der Zee, A. H. (2010). Antibiotic-Induced Liver Injury Among Hospitalized Patients. S4-2010. Abstract from Abstracts of the 26th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, 19-22 August 2010, Brighton, UK.
2009
Scholarly publications
De Bruin, M. L., Van Dulmen-den Broeder, E., Van den Berg, M. H., & Lambalk, C. B. (2009).
Fertility in female childhood cancer survivors.
Endocrine Development,
15, 135-58.
https://doi.org/10.1159/000207613 De Bruin, M. L., Burgers, J. A., Baas, P., van 't Veer, M. B., Noordijk, E. M., Louwman, M. W. J., Zijlstra, J. M., van den Berg, H., Aleman, B. M. P., & van Leeuwen, F. E. (2009).
Malignant mesothelioma after radiation treatment for Hodgkin lymphoma.
Blood,
113(16), 3679-81.
https://doi.org/10.1182/blood-2008-10-184705 De Bruin, M. L., Dorresteijn, L. D. A., van't Veer, M. B., Krol, A. D. G., van der Pal, H. J., Kappelle, A. C., Boogerd, W., Aleman, B. M. P., & van Leeuwen, F. E. (2009).
Increased risk of stroke and transient ischemic attack in 5-year survivors of Hodgkin lymphoma.
Journal of the National Cancer Institute,
101(13), 928-37.
https://doi.org/10.1093/jnci/djp147 De Bruin, M. L., Sparidans, J., van't Veer, M. B., Noordijk, E. M., Louwman, M. W. J., Zijlstra, J. M., van den Berg, H., Russell, N. S., Broeks, A., Baaijens, M. H. A., Aleman, B. M. P., & van Leeuwen, F. E. (2009).
Breast cancer risk in female survivors of Hodgkin's lymphoma: lower risk after smaller radiation volumes.
Journal of Clinical Oncology,
27(26), 4239-4246.
https://doi.org/10.1200/JCO.2008.19.9174 van den Belt-Dusebout, A. W., Aleman, B. M. P., Besseling, G.
, de Bruin, M. L., Hauptmann, M., van 't Veer, M. B., de Wit, R., Ribot, J. G., Noordijk, E. M., Kerst, J. M., Gietema, J. A., & van Leeuwen, F. E. (2009).
Roles of radiation dose and chemotherapy in the etiology of stomach cancer as a second malignancy.
International journal of radiation oncology, biology, physics,
75(5), 1420-9.
https://doi.org/10.1016/j.ijrobp.2009.01.073Other output
Stefansdottir, G., de Bruin, M. L., Knol, M. J., Grobbee, D. E., & Leufkens, H. G. M. (2009). Randomized Controlled Trials on Cox-2 Inhibitors, Changes in Comparator Dose over Time. Pharmacoepidemiology and Drug Safety, 18, S107.
van der Baan, F. H., Knol, M. J., de Bruin, M. L., Leufkens, H. G. M., Klungel, O. H., & Egberts, A. C. G. (2009). Impact of a Safety Issue on the Number and Type of Publications: The Example of Sertindole. Pharmacoepidemiology and Drug Safety, 18, S170.
de Bruin, M. L., Persson, I., Schneeweiss, S., van Staa, T. P., & Leufkens, H. G. M. (2009). Methodological and Regulatory Challenges in the Assessment of Long-Term Drug Safety. Pharmacoepidemiology and Drug Safety, 18, S172.
2008
Scholarly publications
De Bruin, M. L., Huisbrink, J., Hauptmann, M., Kuenen, M. A., Ouwens, G. M., van't Veer, M. B., Aleman, B. M. P., & van Leeuwen, F. E. (2008).
Treatment-related risk factors for premature menopause following Hodgkin lymphoma.
Blood,
111(1), 101-8.
https://doi.org/10.1182/blood-2007-05-090225 2007
Scholarly publications
Langendijk, P., De Bruin, M., Tan, H., & Wilde, A. (2007). Bewaking van QT-tijd-verlenging. Pharmaceutisch Weekblad, 142(17), 30-33.
De Bruin, M. L., Langendijk, P. N. J., Koopmans, R. P., Wilde, A. A. M.
, Leufkens, H. G. M., & Hoes, A. W. (2007).
In-hospital cardiac arrest is associated with use of non-antiarrhythmic QTc-prolonging drugs.
British Journal of Clinical Pharmacology,
63(2), 216-223.
https://doi.org/10.1111/j.1365-2125.2006.02722.x Aleman, B. M. P., van den Belt-Dusebout, A. W.
, De Bruin, M. L., van 't Veer, M. B., Baaijens, M. H. A., de Boer, J. P., Hart, A. A. M., Klokman, W. J., Kuenen, M. A., Ouwens, G. M., Bartelink, H., & van Leeuwen, F. E. (2007).
Late cardiotoxicity after treatment for Hodgkin lymphoma.
Blood,
109(5), 1878-86.
https://doi.org/10.1182/blood-2006-07-0344052006
Scholarly publications
Langendijk, P. N. J., Van Roon, E. N., De Bruin, M. L., & Le Comte, M. (2006). Interacties tussen QT-verlengende geneesmiddelen. Pharmaceutisch Weekblad, 141(8).
Wilting, I., Smals, O. M., Holwerda, N. J., Meyboom, R. H.
, De Bruin, M. L., & Egberts, T. C. G. (2006).
QTc prolongation and torsades de pointes in an elderly woman taking fluoxetine [1].
American Journal of Psychiatry,
163(2), 325.
https://doi.org/10.1176/appi.ajp.163.2.325 Langendijk, P. N. J., Van Roon, E. N., De Bruin, M. L., & Le Comte, M. (2006). Qt verlenging. Pharmaceutisch Weekblad, 141(8), 258.
De Bruin, M. L., van Puijenbroek, E. P.
, Bracke, M., Hoes, A. W.
, & Leufkens, H. G. M. (2006).
Pharmacogenetics of drug-induced arrhythmias: a feasibility study using spontaneous adverse drug reactions reporting data.
Pharmacoepidemiology and Drug Safety,
15(2), 99-105.
https://doi.org/10.1002/pds.1194 Straus, S. M. J. M., Kors, J. A.
, De Bruin, M. L., van der Hooft, C. S., Hofman, A., Heeringa, J., Deckers, J. W., Kingma, J. H., Sturkenboom, M. C. J. M., Stricker, B. H. C., & Witteman, J. C. M. (2006).
Prolonged QTc interval and risk of sudden cardiac death in a population of older adults.
Journal of the American College of Cardiology,
47(2), 362-7.
https://doi.org/10.1016/j.jacc.2005.08.067Wilting, I., Smals, O. M., Holwerda, N. J., Meyboom, R. H.
, de Bruin, M. L., & Egberts, A. C. G. (2006).
QTc Prolongation and Torsades de Pointes in an Elderly Woman Taking Fluoxetine.
American Journal of Psychiatry,
163(2), 325.
https://dspace.library.uu.nl/bitstream/handle/1874/19726/wilting_06_qtcprolongationandtorsadesdepointes.pdf?sequence=2 Other output
de Bruin, M. L., Huisbrink, J., Aleman, B. M., & Leeuwen, F. E. (2006). Treatment-Related Risk Factors for Premature Menopause Following Hodgkin's Lymphoma. S61. Abstract from Unknown event, Asilomar, USA.
2005
Scholarly publications
De Vries, F., Souverein, PC., De Bruin, ML., Cooper, C., Van Staa, TP., & Leufkens, HGM. (2005). Use of beta-blockers and risk of hip and vertebral fractures: Associations with daily and cumulative dose. Bone, 36, S130-S130.
De Bruin, M. L., Pettersson, M., Meyboom, R. H. B., Hoes, A. W.
, & Leufkens, H. G. M. (2005).
Anti-HERG activity and the risk of drug-induced arrhythmias and sudden death.
European Heart Journal,
26(6), 590-597.
https://doi.org/10.1093/eurheartj/ehi092 de Bruin, M. L., van Staa, T. P., Belitser, S., Leufkens, H. G. M., & Hoes, A. W. (2005).
Predicting cardiac arrhythmias and sudden death in diabetic users of proarrhythmic drugs.
Diabetes Care,
28(2), 440-442.
https://dspace.library.uu.nl/bitstream/handle/1874/11865/Bruin_05_PredictingCardiacArrhytmias.pdf?sequence=2 Other output
de Bruin, M. L., Langendijk, P. N. J., Koopmans, R. P., Wilde, A. A. M., Leufkens, H. G. M., & Hoes, A. W. (2005). Proarrhythmic Drugs and Cardiac Arrest, a Hospital Based Case-Control Study. S124. Abstract from Unknown event, Asilomar, USA.
de Vries, F., Souverein, P. C., Leufkens, H. G. M., Cooper, C., van Staa, T. P., & de Bruin, M. L. (2005). Use of Beta-Blockers and Risk of Hip and Vertebral Fracture: Relationships to Daily and Cumulative Dose. S21. Abstract from Unknown event, Asilomar, USA.
2004
Scholarly publications
de Bruin, M. L. (2004). Drug-Induced Arrhythmias, quantifying the problem. [Doctoral thesis 1 (Research UU / Graduation UU), Utrecht University].
Other output
Strauss, S. M. J. M., Bleumink, G. S., van der Hooft, C. S., de Bruin, M. L., Kors, J. A., Hofman, A., Witteman, J. C. M., & Stricker, B. H. C. (2004). QTc Prolongation in a Healthy Elderly Population and the Risk of Sudden Cardiac Death. S47. Abstract from Unknown event, Asilomar, USA.
de Bruin, M. L., van Staa, T. P., Belitser, S., Leufkens, H. G. M., & Hoes, A. W. (2004). Predicting Cardiac Arrhythmias and Sudden Death among Diabetic Users of Arrhythmogenic Non-Antiarrhythmic Drugs. S124. Abstract from Unknown event, Asilomar, USA.
de Bruin, M. L., Pettersson, M., Meyboom, R. H. B., Hoes, A. W., & Leufkens, H. G. M. (2004). HERG-Activity of Drugs and the Risk for Serious Ventricular Arrhythmias and Sudden Death. S4. Abstract from Unknown event, Asilomar, USA.
2003
Scholarly publications
2002
Scholarly publications
De Bruin, M. L., van Puijenbroek, E. P., Egberts, A. C. G., Hoes, A. W., & Leufkens, H. G. M. (2002). Non-sedating antihistamine drugs and cardiac arrhythmias -- biased risk estimates from spontaneous reporting systems? British Journal of Clinical Pharmacology, 53(4), 370-4.
de Bruin, M. L., van Puijenbroek, E. P.
, Egberts, A. C. G., Hoes, A. W.
, & Leufkens, H. G. M. (2002).
Non-sedating anthistamine drugs and cardiac arrhytmias - biased risk estimates from spontaneous reporting systems? British Journal of Clinical Pharmacology,
53, 370-374.
https://dspace.library.uu.nl/bitstream/handle/1874/29313/bruin_02_nonsedatingantihistaminedrugs.pdf?sequence=1 de Bruin, M. L., Panneman, M. J. M.
, Leufkens, H. G. M., Hoes, A. W., & Herings, R. M. C. (2002).
Use of Cisapride with Contraindicated Drugs in the Netherlands.
Annals of Pharmacotherapy,
36, 338-343.
https://dspace.library.uu.nl/bitstream/handle/1874/29312/bruin_02_useofcisapridewithcontraindicateddrugs.pdf?sequence=1 Other output
de Bruin, M. L., van Puijenbroek, E. P., Egberts, A. C. G., Hoes, A. W., & Leufkens, H. G. M. (2002). Cardiac arrhytmias associated with the use of antihistamine drugs-A mass media attention reporting bias?. S65-S65. Abstract from Unknown event, Asilomar, USA.
de Bruin, M. L., Hoes, A. W., & Leufkens, H. G. M. (2002). QTc-prolonging drugs and hospitalization for cardiac arrhythmias, a population based case-control study. S90-S90. Abstract from Unknown event, Asilomar, USA.
2001
Scholarly publications
Williams, C.
, Bouvy, M. L., Heerdink, E. R., De Bruin, M. L., Herings, R. M. C.
, Leufkens, H. G. M., & Hoes, A. W. (2001).
Baseline rates of disease may account for some arrhythmia risk [3] (multiple letters).
Archives of Internal Medicine,
161(9), 1235-1236.
https://doi.org/10.1001/archinte.161.9.1235de Bruin, M. L. (2001). Toekomstige farmacotherapie bij schizofrenie: gevolgen voor gezondheid en zorg. In H. Timmerman, & A. van den Berg-Jeths (Eds.), Volksgezondheid Toekomst Verkenning 2002. Geneesmiddelen nu en in de toekomst (pp. 156-168). Bohn Stafleu van Loghum.
de Bruin, M. L. (2001). Toekomstige farmacotherapie bij reumatoide artritis: gevolgen voor gezondheid en zorg. In H. Timmerman, & A. van den Berg-Jeths (Eds.), Volksgezondheid Toekomst Verkenning 2002. Geneesmiddelen nu en in de toekomst (pp. 359-372). Bohn Stafleu van Loghum.
de Bruin, M. L. (2001). Toekomstige farmacotherapie bijs astma en COPD: gevolgen voor gezondheid en zorg. In H. Timmerman, & A. van den Berg-Jeths (Eds.), Volksgezondheid Toekomst Verkenning 2002. Geneesmiddelen nu en in de toekomst (pp. 330-348). Bohn Stafleu van Loghum.
Bouvy, M. L., Heerdink, E. R., de Bruin, M. L., Herings, R. M. C., Leufkens, H. G. M., & Hoes, A. W. (2001). Baseline Rates of Disease May Account for Some Arrhythmia Risk. Archives of Internal Medicine, 161, 1235-1236.
de Bruin, M. L. (2001). Toekomstige farmacotherapie bij diabetes mellitus: gevolgen voor gezondheid en zorg. In H. Timmerman, & A. van den Berg-Jeths (Eds.), Volksgezondheid Toekomst Verkenning 2002. Geneesmiddelen nu en in de toekomst Bohn Stafleu van Loghum.
de Bruin, M. L. (2001). Toekomstige farmacotherapie bij hartfalen: gevolgen voor gezondheid en zorg. In H. Timmerman, & A. van den Berg-Jeths (Eds.), Volksgezondheid Toekomst Verkenning 2002. Geneesmiddelen nu en in de toekomst (pp. 259-272). Bohn Stafleu van Loghum.
de Bruin, M. L. (2001). Toekomstige farmacotherapie bij beroerte: gevolgen voor gezondheid en zorg. In H. Timmerman, & A. van den Berg-Jeths (Eds.), Volksgezondheid Toekomst Verkenning 2002. Geneesmiddelen nu en in de toekomst (pp. 283-294). Bohn Stafleu van Loghum.
2000
Scholarly publications
Bouvy, M. L., Heerdink, E. R., de Bruin, M. L., Herings, R. M. C.
, Leufkens, H. G. M., & Hoes, A. W. (2000).
Use of Sympathomimetic Drugs Leads to Increased Risk of Hospitalization for Arrhythmias in Patients With Congestive Heart Failure.
Archives of Internal Medicine,
160(september,), 2477-2480.
https://dspace.library.uu.nl/bitstream/handle/1874/27754/bouvy_00_useofsympathomimeticdrugsLeadsto.pdf?sequence=1 Other output
de Bruin, M. L. (2000). Gebruik van tweede generatie orale antihistaminica is geassocieerd met hartritmestoornissen in een spontaan meldingssysteem voor bijwerkingen. 59-59. Abstract from Unknown event, Asilomar, USA.