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Drug safety study Publications

Drug safety study Publications

  • Risk of fracture with thiazolidinediones: an individual patient data meta-analysis.Abstract

    Background: The use of thiazolidinediones (TZDs) has been associated with increased fracture risks. Our aim was to estimate the risk of fracture with TZDs in three different healthcare registries, using exactly the same study design, and to performan individual patient data meta-analysis of these three studies

    Bazelier MT, de Vries F, Vestergaard P, Herings RM, Gallagher AM, Leufkens HG, van Staa TP. Front Endocrinol (Lausanne). 2013 4 11.
  • Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project.Abstract

    OBJECTIVE: Data from electronic healthcare records (EHR) can be used to monitor drug safety, but in order to compare and pool data from different EHR databases, the extraction of potential adverse events must be harmonized. In this paper, we descrie the procedure used for harmonizing the extraction from eight European EHR databases of five events of interest deemed to be important in pharmacovigilance: acute myocardial infarction (AMI); acute renal failure (ARF); anaphylactic shock (AS); bullous eruption (BE); and rhabdomyolysis (RHABD)

    Avillach P, Coloma PM, Gini R, Schuemie M, Mougin F, Dufour JC, Mazzaglia G, Giaquinto C, Fornari C, Herings R, Molokhia M, Peder sen L, Fourrier-Reglat A, Fieschi M, Sturkenboom M, van der Lei J, Pariente A, Trifiro G. J Am Med Inform Assoc. 2013 Jan 1; 20 (1): 184-192.
  • Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues?.Abstract

    BACKGROUND: Data on utilization patterns and safety of non-steroidal anti-inflammatory drugs (NSAIDs) in children are scarce. The purpose of this study was to investigate the utilization of NSAIDs among children in four European countries as part othe Safety Of non-Steroidal anti-inflammatory drugs (SOS) project

    Valkhoff VE, Schade R, tJong GW, Romio S, Schuemie MJ, Arfe A, Garbe E, Herings R, Lucchi S, Picelli G, Schink T, Straatman H, Villa M, Kuipers EJ, Sturkenboom MC, investigatorsofTheSafetyofNon-steroidalAnti-inflammatoryDrugs project. BMC Pediatr. 2013 13 192.
  • Drug-induced acute myocardial infarction: identifying ‘prime suspects’ from electronic healthcare records-based surveillance system.Abstract

    BACKGROUND: Drug-related adverse events remain an important cause of morbidity and mortality and impose huge burden on healthcare costs. Routinely collected electronic healthcare data give a good snapshot of how drugs are being used in ‘real-world’settings. OBJECTIVE: To describe a strategy that identifies potentially drug-induced acute myocardial infarction (AMI) from a large international healthcare data network

    Coloma PM, Schuemie MJ, Trifiro G, Furlong L, van Mulligen E, Bauer-Mehren A, Avillach P, Kors J, Sanz F, Mestres J, Oliveira JL, Boyer S, Helgee EA, Molokhia M, Matthews J, Prieto-Merino D, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Peder sen L, van der Lei J, Sturkenboom M, consortium Eu-Adr. PLoS One. 2013 8 (8): e72148.
  • Use of rivastigmine or galantamine and risk of adverse cardiac events: a database study from the Netherlands.Abstract

    BACKGROUND: Two cholinesterase inhibitors (ChEIs), rivastigmine and galantamine, are used to treat Alzheimer disease in the Netherlands. Several adverse cardiac events have been reported for these medications. OBJECTIVE: We aimed to assess if the ue of ChEIs increased the risk of cardiac events in the Netherlands

    Kroger E, Berkers M, Carmichael PH, Souverein P, van Marum R, Egberts T. Am J Geriatr Pharmacother. 2012 Dec; 10 (6): 373-80.
  • Using Electronic Health Care Records for Drug Safety Signal Detection: A Comparative Evaluation of Statistical Methods.Abstract

    BACKGROUND:: Drug safety monitoring relies primarily on spontaneous reporting, but electronic health care record databases offer a possible alternative for the detection of adverse drug reactions (ADRs). OBJECTIVES:: To evaluate the relative perforance of different statistical methods for detecting drug-adverse event associations in electronic health care record data representing potential ADRs

    Schuemie MJ, Coloma PM, Straatman H, Herings RM, Trifiro G, Matthews JN, Prieto-Merino D, Molokhia M, Peder sen L, Gini R, Innocenti F, Mazzaglia G, Picelli G, Scotti L, van der Lei J, Sturkenboom MC. Med Care. 2012 Oct; 50 (10): 890-897.
  • Electronic healthcare databases for active drug safety surveillance: is there enough leverage?.Abstract

    PURPOSE: To provide estimates of the number and types of drugs that can be monitored for safety surveillance using electronic healthcare databases. METHODS: Using data from eight European databases (administrative claims, medical records) and in thcontext of a cohort study, we determined the amount of drug exposure required for signal detection across varying magnitudes of relative risk (RR)

    Coloma PM, Trifiro G, Schuemie MJ, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Picelli G, Corrao G, Peder sen L, van der Lei J, Sturkenboom M. Pharmacoepidemiol Drug Saf. 2012 Jun; 21 (6): 611-21.
  • Use of thiazolidinediones and risk of osteoporotic fracture: disease or drugs?.Abstract

    PURPOSE: Clinical and observational studies suggest that use of thiazolidinediones (TZDs) is associated with an increased fracture risk. In addition, type 2 diabetes mellitus (T2DM) is a risk factor for osteoporotic fracture. Our aim was to estimatfracture risks in TZD users and users of other antidiabetic drugs, classified according to proxies of disease severity

    Bazelier MT, Gallagher AM, van Staa TP, Cooper C, Leufkens HG, Vestergaard P, de Vries F. Pharmacoepidemiol Drug Saf. 2012 May; 21 (5): 507-14.
  • The risk of new onset heart failure associated with dopamine agonist use in Parkinson’s disease.Abstract

    The aim of present study was to investigate the risk of heart failure associated with dopamine agonist use in patients with Parkinson’s disease. The data sources of this study were four different population-based, healthcare databases in United Kindom, Italy and Netherlands. A case control study nested within a cohort of Parkinson’s disease patients who were new users of either dopamine agonist or levodopa was conducted

    Mokhles MM, Trifiro G, Dieleman JP, Haag MD, van Soest EM, Verhamme KM, Mazzaglia G, Herings R, de Luise C, Ross D, Brusselle G, Colao A, Haverkamp W, Schade R, van Camp G, Zanettini R, Sturkenboom MC. Pharmacol Res. 2012 Mar; 65 (3): 358-64.
  • Lower risk of cancer in patients on metformin in comparison with those on sulfonylurea derivatives: results from a large population-based follow-up study.Abstract

    OBJECTIVE: Numerous studies have suggested a decreased risk of cancer in patients with diabetes on metformin. Because different comparison groups were used, the effect magnitude is difficult to estimate. Therefore, the objective of this study was tfurther analyze whether, and to what extent, use of metformin is associated with a decreased risk of cancer in a cohort of incident users of metformin compared with users of sulfonylurea derivatives

    Ruiter R, Visser LE, van Herk-Sukel MP, Coebergh JW, Haak HR, Geelhoed-Duijvestijn PH, Straus SM, Herings RM, Stricker BH. Diabetes Care. 2012 Jan; 35 (1): 119-24.