Real-World Safety and Effectiveness of Controlled-Release Cilostazol in Patients with Symptomatic Peripheral Artery Disease.

ABSTRACT

BACKGROUND: Cilostazol is the only first-line medication for treating intermittent claudication, and the controlled-release (CR) formulation is associated with a lower prevalence of adverse events (AEs). OBJECTIVE: The objective of the study was to assess the safety and effectiveness of cilostazol CR in patients with symptomatic peripheral artery disease (PAD). METHODS: In this multicentre (113 sites), open-label, prospective observational study, we evaluated the real-world safety and effectiveness of cilostazol CR 200 mg once daily in patients with symptomatic PAD treated in routine clinical settings. The primary endpoint was the incidence and severity of AEs, and their causal relationship with cilostazol CR. The secondary endpoint was the effectiveness of the drug, as assessed by each patient's physician, for improving intermittent claudication. RESULTS: Among 2063 participants who received cilostazol CR for a mean duration of 88.6 days, 99 (4.80 %) experienced adverse drug reactions (ADRs), although no unexpected adverse reactions were observed. There was no significant difference in the incidence of ADRs according to patient demographics and comorbidities (all p > 0.05). The treatment was 'effective' in 1600 patients (78.93 %), although effectiveness significantly differed according to the patients' sex and the presence of comorbidities, including diabetes mellitus, hypertension, and coronary artery disease (all p < 0.01). CONCLUSIONS: This study demonstrated the tolerability and effectiveness of cilostazol CR treatment in patients with symptomatic PAD.