Abstract
PurposeThe 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.MethodsObservational 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.ResultsWe 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).ConclusionsThis 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.
Highlights
Cilostazol is a platelet aggregation inhibitor approved in Europe in 2002 to improve walking distances in patients with intermittent claudication
We evaluated the effectiveness of risk minimization measures for the use of cilostazol in the UK, Spain, Sweden, and Germany
The study addressed the concerns raised during the European Medicines Agency (EMA) Article 31 cilostazol referral and the requirement to evaluate the risk minimization measures through drug utilization studies
Summary
Cilostazol is a platelet aggregation inhibitor approved in Europe in 2002 to improve walking distances in patients with intermittent claudication. Cilostazol has been associated with spontaneous reports of serious bleeding and cardiovascular effects including heart attacks, angina, and arrhythmias. The European Medicines Agency (EMA) evaluated the benefits and risks of cilostazol in a referral and recommended implementation of risk minimization measures to restrict the use of cilostazol to patients that could benefit from treatment and in which important risks are minimized.[1] Risk minimization measures included labeling changes (Table 1) and educational communications directed to health care professionals through the Otsuka Europe website and “Dear Doctor” letters implemented in 2013. To evaluate the impact of these risk minimization measures, we compared the prevalence of cilostazol use and of the conditions targeted by these risk minimization measures before and after these measures were implemented
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