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.
Adelin Dhivi Kemalasari, Dong Woo Suh, In Tae Jin, Seung-Jun Lee, Chul-Min Ahn, Donghoon Choi, Ji Yong Jang, Cheol Woong Yu, Osung Kwon, Han Young Ryu, Ung Kim, Jong Kwon Park, Ki Hyuk Park, Jang Yong Kim, Young-Guk Ko
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引用次数: 0
Abstract
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.
期刊介绍：
Designed to objectively cover the process of bench to bedside development of cardiovascular drug, device and cell therapy, and to bring you the information you need most in a timely and useful format, Cardiovascular Drugs and Therapy takes a fresh and energetic look at advances in this dynamic field.
Homing in on the most exciting work being done on new therapeutic agents, Cardiovascular Drugs and Therapy focusses on developments in atherosclerosis, hyperlipidemia, diabetes, ischemic syndromes and arrhythmias. The Journal is an authoritative source of current and relevant information that is indispensable for basic and clinical investigators aiming for novel, breakthrough research as well as for cardiologists seeking to best serve their patients.
Providing you with a single, concise reference tool acknowledged to be among the finest in the world, Cardiovascular Drugs and Therapy is listed in Web of Science and PubMed/Medline among other abstracting and indexing services. The regular articles and frequent special topical issues equip you with an up-to-date source defined by the need for accurate information on an ever-evolving field. Cardiovascular Drugs and Therapy is a careful and accurate guide through the maze of new products and therapies which furnishes you with the details on cardiovascular pharmacology that you will refer to time and time again.
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