Sistema de Salut de Catalunya
Castellsagué, Jordi
Linder, Marie
Scholle, Oliver
Calingaert, Brian
Bui, Christine
Arana, Alejandro
Laguna, Clara
Gonzalez-Rubio, Francisca
Giner-Soriano, Maria
Roso-Llorach, Albert
Poblador-Plou, Beatriz
Prados-Torres, Alexandra
Perez-Gutthann, Susana
[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
IDIAP Jordi Gol
2019-02-21T10:01:44Z
2019-02-21T10:01:44Z
2018-09-27
Cilostazol; Intermittent claudication; Peripheral artery disease; Risk minimization
Claudicació intermitent; Malaltia vascular perifèrica; Minimització del risc
Claudicación intermitente; Enfermedad vascular periférica; Minimización del riesgo
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
Otsuka Pharmaceutical Europe Ltd.
English
Claudicació intermitent - Tractament; Medicaments - Eficàcia; Claudicació intermitent - Estudi de casos; DISEASES::Cardiovascular Diseases::Vascular Diseases::Arterial Occlusive Diseases::Arteriosclerosis::Intermittent Claudication; Other subheadings::Other subheadings::Other subheadings::/drug therapy; PUBLICATION CHARACTERISTICS::Study Characteristics::Comparative Study; ENFERMEDADES::enfermedades cardiovasculares::enfermedades vasculares::arteriopatías oclusivas::arteriosclerosis::claudicación intermitente; Otros calificadores::Otros calificadores::Otros calificadores::/tratamiento farmacológico; CARACTERÍSTICAS DE PUBLICACIONES::características del estudio::estudio comparativo
John Wiley and Sons
Pharmacoepidemiology and Drug Safety;27(9)
https://onlinelibrary.wiley.com/doi/full/10.1002/pds.4584
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
