Cilostazol in the Treatment of Peripheral Arterial Occlusive Disease Fontaine Stage II (Intermittent Claudication) in Daily Practice: Results of a Non-Interventional Trial in Germany

Background: Cilostazol was launched in Germany in 2007 for the treatment of patients with peripheral arterial occlusive disease (PAOD) stage II (intermittent claudication). It is indicated for second-line use when lifestyle modification or other interventions do not result in a decrease of PAOD symptoms. Materials and methods: The objective of this non-interventional study was to gain insight regarding the effectiveness and safety of cilostazol, used under “real-life” conditions. Efficacy was evaluated after 12 and 24 weeks of treatment by the following patient-relevant endpoints: overall health status rating by the treating medical practitioner, evaluation of the patients’ quality of life by the SF-36 health survey, and pain-free walking distance (PFWD). Safety was assessed by monitoring of adverse events (AEs). Results: A total of 1,311 patients were enrolled in the study and received at least one dose of cilostazol during an observational period of 24 weeks. Mean (standard deviation [SD]) duration of cilostazol treatment was 165 days (SD 47). After 24 weeks of treatment, the overall health status of 79.5% of patients was rated by the medical practitioner as satisfactory, good or very good, and the patients’ quality of life, assessed by the SF-36, had improved compared to baseline. An increase in mean PFWD from baseline measured either on flat floor or on treadmill, was observed (mean PFWD improvement: +191m or relative 203%). A total of 356 patients (27.2%) reported AEs, of whom 66 (5.0%) reported serious AEs. Cardiac AEs were among the more frequently reported, with 55 patients (4.2%) reporting heart racing, palpitations, pulse increased and/or tachycardia. Conclusions: The results illustrate that, under “real-life” conditions, treatment with cilostazol improved quality of life and increased mean PFWD in patients with POAD stage II. The safety profile of cilostazol observed in this study was comparable with that observed in the clinical development program.