Drug safety study Publications

• Differential effects on out-of-hospital cardiac arrest of dihydropyridines: real-world data from population-based cohorts across two European countries.Abstract

  AIMS: Various drugs increase the risk of out-of-hospital cardiac arrest (OHCA) in the general population by impacting cardiac ion channels, thereby causing ventricular tachycardia/fibrillation (VT/VF). Dihydropyridines block L-type calcium channelsbut their association with OHCA risk is unknown. We aimed to study whether nifedipine and/or amlodipine, often-used dihydropyridines, are associated with increased OHCA risk, and how these drugs impact on cardiac electrophysiology

  Eroglu TE, Mohr GH, Blom MT, Verkerk AO, Souverein PC, Torp-Peder sen C, Folke F, Wissenberg M, van den Brink L, Davis RP, deBoer A, Gislason GH, Tan HL. Eur Heart J Cardiovasc Pharmacother. 2019 Sep 11;

• Amiodarone use and the risk of acute pancreatitis: Influence of different exposure definitions.Abstract

  PURPOSE: The antiarrhythmic drug amiodarone has a long half-life of 60 days, which is often ignored in observational studies. This study aimed to investigate the impact of different exposure definitions on the association between amiodarone use andthe risk of acute pancreatitis. METHOD: Using data from the Dutch PHARMO Database Network, incident amiodarone users were compared to incident users of a different type of antiarrhythmic drug

  Hempenius M, Groenwold RHH, de Boer A, Klungel OH, Gardarsdottir H. Pharmacoepidemiol Drug Saf. 2019 Aug 2; 28 1563-1571.

• Non-steroidal anti-inflammatory drugs and the risk of out-of-hospital cardiac arrest: a case-control study.Abstract

  Aims: Non-steroidal anti-inflammatory drugs (NSAIDs), particularly selective COX-2 inhibitors, are associated with an increased risk of cardiovascular adverse events. However, the association between these drugs and out-of-hospital cardiac arrest wth electrocardiogram-documented ventricular tachycardia/ventricular fibrillation (VT/VF-OHCA) has not been studied yet

  Bakhriansyah M, Souverein PC, Klungel OH, de Boer A, Blom MT, Tan HL. Europace. 2019 Aug 10; 21 99-105.

• Risk of myocardial infarction associated with non-steroidal anti-inflammatory drugs: Impact of additional confounding control for variables collected from self-reported data.Abstract

  WHAT IS KNOWN AND OBJECTIVE: Important risk factors and over-the-counter (OTC) dispensing of non-steroidal anti-inflammatory drugs (NSAIDs) are often not routinely recorded in electronic health records. This study aimed to assess the impact of patint’s reports on these factors on the risk of acute myocardial infarction (AMI) for NSAID use

  Bakhriansyah M, Souverein PC, de Boer A, Klungel OH. J Clin Pharm Ther. 2019 Apr 7; 44 623-631.

• Real-world insights into risk of developing cardiovascular disease following GnRH agonists versus antagonists for prostate cancer: a methodological protocol to a study using five European databases.Abstract

  One of the more recently investigated adverse long-term side effects of gonadotropin-releasing hormone (GnRH) agonists for prostate cancer (PCa) is cardiovascular disease (CVD). Studies suggest lower risk of CVD following GnRH antagonists (degareli) than GnRH agonists. This protocol describes precise codes used to extract variables from five European databases for a study that compares risk of CVD following GnRH agonists and antagonists for PCa

  George G, Scailteux LM, Garmo H, Balusson F, Cardwell C, DeCoster G, DeSchutter H, Kuiper JG, McMenamin U, Verbeeck J, VanHemelrijck M. Fundam Clin Pharmacol. 2019 Feb 18; 33 479-499.

• All-cause mortality with current and past use of antidepressants or benzodiazepines after major osteoporotic and hip fracture.Abstract

  In the first year, after an osteoporotic fracture of a hip, forearm, upper arm, or spine, the dispensing rates of antidepressants and benzodiazepines increased significantly. After those fractures, recent and past use of antidepressants and benzodizepines was associated with increased all-cause mortality; current use was not associated with mortality risk

  deBruin IJA, Klop C, Wyers CE, Overbeek JA, Geusens Ppmm, van den Bergh JPW, Driessen JHM, deVries F. Osteoporos Int. 2019 Feb 8; 30 573-581.

• Type 2 Diabetes, but Not Insulin (Analog) Treatment, Is Associated With More Advanced Stages of Breast Cancer: A National Linkage of Cancer and Pharmacy Registries.Abstract

  OBJECTIVE: To investigate whether women with type 2 diabetes (T2D) develop a more advanced stage of breast cancer and whether treatment with insulin (analogs) is associated with specific breast cancer characteristics. RESEARCH DESIGN AND METHODS: Fr this nested case-control study, women with breast cancer diagnosed in 2002-2014 were selected from the linked Netherlands Cancer Registry-PHARMO Database Network (N = 33,377)

  Overbeek JA, van Herk-Sukel MPP, Vissers PAJ, van der Heijden Aawa, Bronsveld HK, Herings RMC, Schmidt MK, Nijpels G. Diabetes Care. 2019 Jan 24; 42 434-442.

• Nierfunctie en ernstige bloedingen bij patienten behandeld met cumarines.Abstract

  BACKGROUND: Although anticoagulation therapy is closely monitored in the Netherlands, coumarin-induced serious bleeding events are still observed. Current literature suggests that renal impairment may contribute to this. OBJECTIVE: To explore the asociation between renal function and bleeding events during coumarin treatment

  Houben E, Smits E, Overbeek JA, Penning-van Beest FJA, Herings RMC, van Herk-Sukel MPP, Teichert M, de Smet Pagm. Pharmaceutisch Weekblad. 2019 154 19-28.

• No Evidence for an Association Between Renal Function and Serious Bleeding Events in Patients Treated With Coumarins: A Population-Based Study.Abstract

  BACKGROUND: Although anticoagulation therapy is closely monitored in the Netherlands, coumarin-induced serious bleeding events are still observed. Current literature suggests that renal impairment may contribute to this. OBJECTIVE: To explore the asociation between renal function and bleeding events during coumarin treatment

  Houben E, Smits E, Overbeek JA, Penning-van Beest FJA, Herings RMC, van Herk-Sukel MPP, Teichert M, de Smet Pagm. Ann Pharmacother. 2018 Oct 01; 52 221 - 234.

• A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation – JOELLE study).Abstract

  Background: There is a concern that topical tacrolimus and pimecrolimus, indicated for second-line treatment of atopic dermatitis, may increase the risk of lymphoma and skin cancer, particularly in children. Objective: The aim of this study was toompare incidence rates (IRs) of lymphoma and skin cancer between new users of topical tacrolimus or pimecrolimus and users of moderate- to high-potency topical corticosteroids (TCSs) and untreated subjects

  Castellsague J, Kuiper JG, Pottegard A, Anveden Berglind I, Dedman D, Gutierrez L, Calingaert B, van Herk-Sukel MP, Hallas J, Sundstrom A, Gallagher AM, Kaye JA, Pardo C, Rothman KJ, Perez-Gutthann S. Clin Epidemiol. 2018 10 299-310.