Efficacy and Safety of Fixed-Dose Combination Therapy with Cilostazol and Rosuvastatin in Patients with Symptomatic Lower Extremity Peripheral Artery Disease: A Multicenter Randomized Controlled Trial

초록

Purpose To evaluate whether combined cilostazol and rosuvastatin therapy improves health-related quality of life, walking performance, and lipid profiles compared with rosuvastatin alone in patients with symptomatic lower extremity peripheral artery disease (PAD).Methods This multicenter, double-blind, randomized placebo-controlled trial enrolled 260 patients with chronic lower extremity PAD (Rutherford category 2 or 3) at 52 sites in Korea. Participants were randomly assigned (1:1) to receive cilostazol 200 mg plus rosuvastatin or a matching placebo plus rosuvastatin for 24 weeks. The primary endpoint was the change in the Korean Peripheral Artery Questionnaire (KPAQ) summary score from baseline to week 24.Results A total of 257 patients were included in the full analysis set. The combination therapy group showed significantly greater improvement in the KPAQ summary score than in the rosuvastatin monotherapy group (least-squares mean change: 15.4 vs. 10.3 points; between-group difference 5.1 points, 95% confidence interval 1.5-8.7; P = 0.005). The treatment effect became statistically significant at week 12 and continued to increase through week 24. Treadmill walking distances improved in both groups; improvements were numerically greater with combination therapy but between-group differences were not significant at weeks 12 or 24. Compared with rosuvastatin monotherapy, combination therapy resulted in greater reductions in triglycerides and smaller increases in ApoB, together with greater increases in HDL cholesterol. Adverse events, adverse drug reactions, and discontinuations due to adverse events were numerically more frequent in the combination therapy group. Diarrhea was the only adverse event that occurred significantly more frequently, whereas no unexpected safety signals were observed.Conclusion In patients with symptomatic PAD, the addition of cilostazol to rosuvastatin significantly improved patient-reported health status and provided additional favorable effects on atherogenic lipid profiles beyond rosuvastatin therapy alone.Trial registration ClinicalTrials.gov, NCT07600385.

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