Effectiveness of risk minimization measures for the use of cilostazol in United Kingdom, Spain, Sweden, and Germany

• Published in: Pharmacoepidemiology and drug safety Vol. 27; no. 9; pp. 953 - 961
• Main Authors: Castellsague, Jordi, Poblador‐Plou, Beatriz, Giner‐Soriano, Maria, Linder, Marie, Scholle, Oliver, Calingaert, Brian, Bui, Christine, Arana, Alejandro, Laguna, Clara, Gonzalez‐Rubio, Francisca, Roso‐Llorach, Albert, Prados‐Torres, Alexandra, Perez‐Gutthann, Susana
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.09.2018; John Wiley and Sons Inc
• Subjects: Aged; Cardiovascular diseases; Cardiovascular Diseases - chemically induced; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - prevention & control; cilostazol; Cilostazol - administration & dosage; Cilostazol - adverse effects; database study; Databases, Factual - statistics & numerical data; Dose-Response Relationship, Drug; Drug addiction; Drug Labeling; Female; Germany - epidemiology; Health Plan Implementation - statistics & numerical data; Health risks; Humans; Inhibitors; intermittent claudication; Intermittent Claudication - drug therapy; Intermittent Claudication - etiology; Intermittent Claudication - prevention & control; Male; Medicin och hälsovetenskap; Original Report; Original Reports; peripheral artery disease; pharmacoepidemiology; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Population studies; Prevalence; Preventive Health Services - methods; Preventive Health Services - organization & administration; Program Evaluation - statistics & numerical data; risk minimization; Risk reduction; Smoking; Smoking - adverse effects; Smoking - epidemiology; Smoking Prevention - methods; Smoking Prevention - organization & administration; Spain - epidemiology; Sweden - epidemiology; United Kingdom - epidemiology; United Kingdom; Sweden; Germany; Spain; United Kingdom > UK; cilostazol; database study; peripheral artery disease; risk minimization; intermittent claudication; pharmacoepidemiology
• ISSN: 1053-8569; 1099-1557; 1099-1557
• DOI: 10.1002/pds.4584

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 targeted by 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 potent CYP3A4/CYP2C19 inhibitors and high‐dose cilostazol, early monitoring of all users, and continuous monitoring of users at high cardiovascular risk. Results We included 22 593 and 1821 new users of cilostazol before and after implementation 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.