title: Characterization of new users of cilostazol in the UK, Spain, Sweden, and Germany.
abstract: OBJECTIVE
  To describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency.
  
  
  METHODS
  New users of cilostazol were identified in populations enrolled in five European health automated databases in the UK (The Health Improvement Network [THIN]), Spain (EpiChron cohort and Information System for the Improvement of Research in Primary Care [SIDIAP]), Sweden (National Registers), and Germany (German Pharmacoepidemiological Research Database [GePaRD]) between 2002 and 2012. New users were characterized according to the prevalence of cardiovascular disease and other comorbidities, concurrent use of interacting medications, new contraindications, duration of use, and potential off-label prescribing.
  
  
  RESULTS
  We identified 22 593 new users of cilostazol. The median age was between 68.0 (THIN) and 73.7 (Sweden) years. More than 78% of users had concomitant cardiovascular disease, and between 78.8% (GePaRD) and 91.6% (THIN) were treated with interacting medications. Prevalence of new cardiovascular contraindications ranged from 1.5% (THIN) to 11.6% (GePaRD), and concurrent use of two or more antiplatelet drugs ranged from 6.3% (SIDIAP) to 13.5% (EpiChron cohort). Between 39.4% (Sweden) and 52.9% (THIN) of users discontinued cilostazol in the first 3 months. Between 41.0% (SIDIAP) and 93.4% (THIN) were considered to have received cilostazol according to the European Medicines Agency labeling.
  
  
  CONCLUSIONS
  In this collaborative European study, most cilostazol users were elderly patients with a high prevalence of cardiovascular diseases and other comorbidity and concurrent use of interacting drugs, indicating that this is a vulnerable population at high risk of complications, especially cardiovascular events. © 2017 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
authors.affiliation: Department of Epidemiology, RTI Health Solutions, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Castellsague
authors.affiliation: Department of Epidemiology, RTI Health Solutions, Barcelona, Spain.
authors.forename: Susana
authors.initials: S
authors.lastname: Perez-Gutthann
authors.affiliation: Department of Epidemiology, RTI Health Solutions, Durham, NC, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Calingaert
authors.affiliation: Department of Epidemiology, RTI Health Solutions, Durham, NC, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Bui
authors.affiliation: Department of Epidemiology, RTI Health Solutions, Barcelona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Varas-Lorenzo
authors.affiliation: Department of Epidemiology, RTI Health Solutions, Barcelona, Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Arana
authors.affiliation: EpiChron Research Group on Chronic Diseases, IIS Aragón, Aragon Health Sciences Institute (IACS), REDISSEC, Zaragoza, Spain.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Prados-Torres
authors.affiliation: EpiChron Research Group on Chronic Diseases, IIS Aragón, Aragon Health Sciences Institute (IACS), REDISSEC, Zaragoza, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Poblador-Plou
authors.affiliation: EpiChron Research Group on Chronic Diseases, IIS Aragón, Aragon Health Sciences Institute (IACS), REDISSEC, Zaragoza, Spain.
authors.forename: Francisca
authors.initials: F
authors.lastname: Gonzalez-Rubio
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Giner-Soriano
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Roso-Llorach
authors.affiliation: Centre for Pharmacoepidemiology, Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Marie
authors.initials: M
authors.lastname: Linder
authors.affiliation: Centre for Pharmacoepidemiology, Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Citarella
authors.affiliation: Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Scholle
authors.affiliation: Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany.
authors.forename: Tilo
authors.initials: T
authors.lastname: Blenk
authors.affiliation: Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany.
authors.forename: Edeltraut
authors.initials: E
authors.lastname: Garbe
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000453:epidemiology; D000077407:Cilostazol; D016208:Databases, Factual / Q000706:statistics & numerical data / Q000639:trends*; D004348:Drug Labeling / Q000639:trends*; D004363:Drug Utilization / Q000706:statistics & numerical data / Q000639:trends*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D013030:Spain / Q000453:epidemiology; D013548:Sweden / Q000453:epidemiology; D013777:Tetrazoles / Q000627:therapeutic use*; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol
keywords: cilostazol; database study; drug utilization study; intermittent claudication; peripheral artery disease; pharmacoepidemiology