dc.contributor
[Castellsague J, Arana A, Perez-Gutthan S] Epidemiology, RTI Health Solutions, Barcelona, Spain. [Poblador-Plou B, Laguna C, Gonzalez-Rubio F, Prados-Torres A] Aragon Health Sciences Institute (IACS), IISAragon, Hospital Universitario Miguel Servet,University of Zaragoza, Zaragoza, Spain. [Giner-Soriano M, Roso-Llorach A] Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAPJGol), Barcelona, Spain. Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain. [Linder M] Centre for Pharmacoepidemiology, Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden. [Scholle O] Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology—BIPS, Bremen, Germany. [Calingaert B, Bui C] Epidemiology, RTI Health Solutions, Research Triangle Park, NC, USA
dc.contributor
IDIAP Jordi Gol
dc.contributor.author
Castellsagué, Jordi
dc.contributor.author
Linder, Marie
dc.contributor.author
Scholle, Oliver
dc.contributor.author
Calingaert, Brian
dc.contributor.author
Bui, Christine
dc.contributor.author
Arana, Alejandro
dc.contributor.author
Laguna, Clara
dc.contributor.author
Gonzalez-Rubio, Francisca
dc.contributor.author
Giner-Soriano, Maria
dc.contributor.author
Roso-Llorach, Albert
dc.contributor.author
Poblador-Plou, Beatriz
dc.contributor.author
Prados-Torres, Alexandra
dc.contributor.author
Perez-Gutthann, Susana
dc.date.accessioned
2025-10-24T10:58:53Z
dc.date.available
2025-10-24T10:58:53Z
dc.date.issued
2019-02-21T10:01:44Z
dc.date.issued
2019-02-21T10:01:44Z
dc.date.issued
2018-09-27
dc.identifier
Castellsague J, Poblador‐Plou B, Giner‐Soriano M, Linder M, Scholle O, Calingaert B, et al. Effectiveness of risk minimization measures for the use of cilostazol in United Kingdom, Spain, Sweden, and Germany. Pharmacoepidemiol Drug Saf. 2018;27(9):953-961.
dc.identifier
https://hdl.handle.net/11351/3804
dc.identifier
10.1002/pds.4584
dc.identifier.uri
http://hdl.handle.net/11351/3804
dc.description.abstract
Cilostazol; Intermittent claudication; Peripheral artery disease; Risk minimization
dc.description.abstract
Claudicació intermitent; Malaltia vascular perifèrica; Minimització del risc
dc.description.abstract
Claudicación intermitente; Enfermedad vascular periférica; Minimización del riesgo
dc.description.abstract
Purpose: The purpose of the study is to evaluate the effectiveness of risk minimization measures—labeling changes and communication to health care professionals—recommended by the European Medicines Agency for use of cilostazol for the treatment of intermittent claudication in Europe.
Methods: Observational study of cilostazol in The Health Improvement Network (United Kingdom), EpiChron Cohort (Spain), SIDIAP (Spain), Swedish National Databases, and GePaRD (Germany). Among new users of cilostazol, we compared the prevalence of conditions targetedby the risk minimization measures in the periods before (2002‐2012) and after (2014) implementation. Conditions evaluated were prevalence of smoking, cardiovascular conditions, concurrent use of≥2 antiplatelet agents, concurrent use of potentCYP3A4/CYP2C19 inhibitors and high‐dose cilostazol, early monitoring of all users, and continuous monitoring of users at high cardiovascular risk.
Results: We included 22593 and 1821 new users of cilostazol before and afterimplementation of risk minimization measures, respectively. After implementation, the frequency of several conditions related to the labeling changes improved in all the study populations: prevalence of use decreased between 13% (EpiChron) and 57% (SIDIAP), frequency of cardiovascular contraindications decreased between 8% (GePaRD) and 84% (EpiChron), and concurrent use of high‐dose cilostazol and potent CYP3A4/CYP2C19 inhibitors decreased between 6% (Sweden) and 100% (EpiChron).The frequency of other conditions improved in most study populations, except smoking, which decreased only in EpiChron (48% reduction).
Conclusions: This study indicates that the risk minimization measures implemented by the EMA for the use of cilostazol have been effective in all European countries studied, except for smoking cessation before initiating cilostazol, which remains an area of improvement
dc.description.abstract
Otsuka Pharmaceutical Europe Ltd.
dc.format
application/pdf
dc.publisher
John Wiley and Sons
dc.relation
Pharmacoepidemiology and Drug Safety;27(9)
dc.relation
https://onlinelibrary.wiley.com/doi/full/10.1002/pds.4584
dc.rights
Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Claudicació intermitent - Tractament
dc.subject
Medicaments - Eficàcia
dc.subject
Claudicació intermitent - Estudi de casos
dc.subject
DISEASES::Cardiovascular Diseases::Vascular Diseases::Arterial Occlusive Diseases::Arteriosclerosis::Intermittent Claudication
dc.subject
Other subheadings::Other subheadings::Other subheadings::/drug therapy
dc.subject
PUBLICATION CHARACTERISTICS::Study Characteristics::Comparative Study
dc.subject
ENFERMEDADES::enfermedades cardiovasculares::enfermedades vasculares::arteriopatías oclusivas::arteriosclerosis::claudicación intermitente
dc.subject
Otros calificadores::Otros calificadores::Otros calificadores::/tratamiento farmacológico
dc.subject
CARACTERÍSTICAS DE PUBLICACIONES::características del estudio::estudio comparativo
dc.title
Effectiveness of risk minimization measures for the use ofcilostazol in United Kingdom, Spain, Sweden, and Germany
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
