Castellsague J, Calingaert B, Poblador-Plou B, Giner-Soriano M, Linder M, Scholle O, Arana A, Bui C, Laguna C, Prados-Torres A, Roso-Llorach A, Perez-Gutthann S. Impact of risk minimization measures on the use of cilostazol in Europe. Poster presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 29, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):428. doi: 10.1002/pds

BACKGROUND: Cilostazol is indicated in Europe to improve walking distance in patients with intermittent claudication. The European Medicines Agency evaluated its benefit/risk and recommended labeling changes to minimize risks.

OBJECTIVES: To evaluate the impact of cilostazol labeling changes in diverse European health systems.

METHODS: Observational study of new users of cilostazol in five health care databases: THIN (United Kingdom), EpiChron and SIDIAP (Spain), Swedish National Databases, and GePaRD (Germany).

We evaluated the impact of labeling changes by comparing the characteristics of new users of cilostazol before (2002-2012) and after (2014) the implementation of labeling changes (2013). Characteristics evaluated were smoking, early monitoring of users, new cardiovascular (CV) contraindications, concurrent use of ≥2 antiplatelets, monitoring of users at high CV risk, and dose reduction in users treated with potent CYP3A4/CYP2C19 inhibitors.

RESULTS:  Overall, 22,593 and 1,821 new users of cilostazol were included before and after labeling changes, respectively. After labeling changes, the prevalence of cilostazol use decreased in all the study populations (13% to 57% reduction). Smoking decreased only in EpiChron (16% of users before vs. 8% after). Early monitoring increased in THIN (50% of users vs. 69%), EpiChron (21% vs. 24%), and Sweden (9% vs. 13%). New CV contraindications decreased in all study populations: THIN, 2% vs. 1%; EpiChron, 2% vs. 0.3%; SIDIAP, 3% vs. 1%; Sweden, 5% vs. 3%; and GePaRD, 12% vs. 11%. Use of ≥2 antiplatelet drugs decreased in THIN (10% vs. 3%), EpiChron (14% vs. 7%), and Sweden (8% vs. 7%). Monitoring of users at high CV risk, compared to users not at high risk, increased in SIDIAP (32% increase of visits rate ratio), Sweden (9%), and GePaRD (17%). Concurrent use of cilostazol 200 mg and potent inhibitors decreased in all study populations: THIN, 20% vs. 6%; EpiChron, 10% vs. 0%; Sweden, 2% vs. 1%; and GePaRD, 4% vs. 2%. Few patients had dose reduction before or after labeling changes.

CONCLUSIONS: This study found a decrease in cilostazol use after labelling changes; results are compatible with a positive effect of these changes in the UK, Spain, Sweden, and Germany.