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Drug safety study Publications

Drug safety study Publications

  • Risk of acute myocardial infarction during use of individual NSAIDs: A nested case-control study from the SOS project.Abstract

    BACKGROUND: Use of selective COX-2 non-steroidal anti-inflammatory drugs (NSAIDs) (coxibs) has been associated with an increased risk of acute myocardial infarction (AMI). However, the risk of AMI has only been studied for very few NSAIDs that arerequently used. OBJECTIVES: To estimate the risk of AMI for individual NSAIDs

    Masclee GMC, Straatman H, Arfe A, Castellsague J, Garbe E, Herings R, Kollhorst B, Lucchi S, Perez-Gutthann S, Romio S, Schade R, Schink T, Schuemie MJ, Scotti L, Varas-Lorenzo C, Valkhoff VE, Villa M, Sturkenboom Mcjm. PLoS One. 2018 13 e0204746.
  • 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.
  • Observational cohort study: safety outcomes in children using proton pump inhibitors or histamine-2 receptor antagonists.Abstract

    OBJECTIVE: Acid suppression with histamine-2 receptor antagonists (H2RAs) or proton pump inhibitors (PPIs) is recommended for children with persistent gastroesophageal reflux disease symptoms. In this retrospective, observational postauthorizationtudy, we aimed to assess and compare safety outcomes in pediatric first-time users of esomeprazole, other PPIs or H2RAs

    Houben E, Johansson S, Nagy P, Penning-van Beest FJA, Kuipers EJ, Herings RMC. Curr Med Res Opin. 2017 Nov 24; 34 577-583.
  • Use of antihistamines and risk of ventricular tachyarrhythmia: a nested case-control study in five European countries from the ARITMO project.Abstract

    PURPOSE: After regulatory restrictions for terfenadine and astemizole in ’90s, only scarce evidence on proarrhythmic potential of antihistamines has been published. We evaluate the risk of ventricular tachyarrhythmia (VA) related to the use of indiidual antihistamines. METHODS: A matched case-control study nested in a cohort of new users of antihistamines was conducted within the EU-funded ARITMO project

    Poluzzi E, Diemberger I, DeRidder M, Koci A, Clo M, Oteri A, Pecchioli S, Bezemer I, Schink T, PilgaardUlrichsen S, Boriani G, Sturkenboom MCJ, DePonti F, Trifiro G. Eur J Clin Pharmacol. 2017 Aug 22; 1499 - 151.
  • Use of azithromycin and risk of ventricular arrhythmia.Abstract

    BACKGROUND: There are conflicting findings from observational studies of the arrhythrogenic potential of azithromycin. Our aim was to quantify the association between azithromycin use and the risk of ventricular arrhythmia. METHODS: We conducted aested case-control study within a cohort of new antibiotic users identified from a network of 7 population-based health care databases in Denmark, Germany, Italy, the Netherlands and the United Kingdom for the period 1997-2010

    Trifiro G, deRidder M, Sultana J, Oteri A, Rijnbeek P, Pecchioli S, Mazzaglia G, Bezemer I, Garbe E, Schink T, Poluzzi E, Froslev T, Molokhia M, Diemberger I, Sturkenboom Mcjm. CMAJ. 2017 Apr 18; 189 E560-E568.
  • Psychiatric medication use before and after the onset of type 1 diabetes in children and adolescents: A population-based cohort study.Abstract

    BACKGROUND: Several studies showed a bidirectional association between type 2 diabetes and psychiatric disorders in adults. Because there is limited information on the association between type 1 diabetes (T1D) and psychiatric disorders (including pychiatric medication use) in children and adolescents, we assessed frequency of use of these medications before and after the onset of T1D

    FazeliFarsani S, Abdullah-Koolmees H, Souverein PC, de Boer A, Mantel-Teeuwisse AK. Pediatr Diabetes. 2017 Apr 24; 121 - 128.
  • Gastrointestinal toxicity among patients taking selective COX-2 inhibitors or conventional NSAIDs, alone or combined with proton pump inhibitors: a case-control study.Abstract

    PURPOSE: To assess the risk of gastrointestinal perforation, ulcers, or bleeding (PUB) associated with the use of conventional nonsteroidal anti-inflammatory drugs (NSAIDs) with proton pump inhibitors (PPIs) and selective COX-2 inhibitors, with orithout PPIs compared with conventional NSAIDs. METHODS: A case-control study was performed within conventional NSAIDs and/or selective COX-2 inhibitors users identified from the Dutch PHARMO Record Linkage System in the period 1998-2012

    Bakhriansyah M, Souverein PC, de Boer A, Klungel OH. Pharmacoepidemiol Drug Saf. 2017 Mar 31; 1141-1148.
  • Antipsychotic drug use associated with urinary tract infections in older women.Abstract

    OBJECTIVES: Antipsychotic drugs are frequently prescribed to elderly patients, but they are associated with serious adverse effects. The objective of the current study was to investigate the association between use of antipsychotics by elderly womeand the risk of urinary tract infections (UTIs). COHORT STUDY SETTING: Dispensing data were obtained from the PHARMO Database Network for the period 1998-2008

    van Strien AM, Souverein PC, Keijsers CK, Heerdink ER, Derijks HJ, van Marum RJ. Maturitas. 2017 Apr; 98 46-50.
  • Pioglitazone and risk of mortality in patients with type 2 diabetes: results from a European multidatabase cohort study.Abstract

    OBJECTIVES: Estimate and compare the risk of mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression. DESIGN: Retrospective chort study. SETTING: Pooled analysis of clinical data collected from primary and/or secondary care settings in four European countries: Finland, The Netherlands, Sweden and the UK

    Strongman H, Korhonen P, Williams R, Bahmanyar S, Hoti F, Christopher S, Majak M, Kool-Houweling L, Linder M, Dolin P, Heintjes EM. BMJ Open Diabetes Res Care. 2017 5 e000364.
  • Post authorization safety study comparing quetiapine to risperidone and olanzapine.Abstract

    OBJECTIVES: To compare rates of specific adverse outcomes between patients starting quetiapine, olanzapine, or risperidone use in the Netherlands. METHODS: Observational study using the PHARMO Database Network, including patients starting quetiapin(4658), olanzapine (5856), or risperidone (7229) in 2000-2009, comparing rates of all-cause mortality, failed suicide attempts, extrapyrimidal symptoms (EPS), diabetes mellitus (DM), hypothyroidism, and acute myocardial infarction (AMI)

    Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Hum Psychopharmacol. 2016 Jul; 31 (4): 304-12.