Eun-Seok Shin1, Jae-Hwan Lee2, Sang-Yong Yoo3, Yongwhi Park4, Young Joon Hong5, Moo Hyun Kim6, Jong-Young Lee7, Chang-Wook Nam8, Seung-Jea Tahk9, Jeong-Su Kim10, Young-Hoon Jeong4, Cheol Whan Lee7, Hwa Kyoung Shin11, June-Hong Kim10. 1. Division of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea. 2. Department of Cardiology, Internal Medicine, School of Medicine, Chungnam National University Hospital, Daejeon, Korea. 3. Department of Internal Medicine, Division of Cardiology, University of Ulsan College of Medicine, GangNeung Asan Hospital, Gangneung, Korea. 4. Division of Cardiology, Department of Internal Medicine Gyeongsang National University Hospital and Gyeongsang National University School of Medicine, Jinju, Korea. 5. Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea. 6. Division of Cardiology, Department of Internal Medicine, Dong-A University Hospital, Busan, Korea. 7. Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. 8. Division of Cardiology, Department of Internal Medicine, Keimyung University, Dongsan Medical Center, Daegu, Korea. 9. Ajou University Hospital, Suwon, Korea. 10. Division of Cardiology, Department of Internal Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University, Yangsan Hospital, Yangsan, Korea. 11. School of Korean Medicine, Pusan National University, Yangsan, Korea.
Abstract
OBJECTIVES: We conducted a randomised, double blind, placebo controlled trial to assess the efficacy and safety of cilostazol, a selective inhibitor of phosphodiesterase 3, in patients with vasospastic angina (VSA). BACKGROUND:Cilostazol has been shown to induce vascular dilatation, but its efficacy in patients with VSA is unknown. METHODS:Between October 2011 and July 2012, 50 patients with confirmed VSA who had ≥1 angina episodes/week despite amlodipine therapy (5 mg/day) were randomly assigned to receive either cilostazol (up to 200 mg/day) or placebo for 4 weeks. All patients were given diaries to record the frequency and severity of chest pain (0-10 grading). The primary endpoint was the relative reduction of the weekly incidence of chest pain. RESULTS: Baseline characteristics were similar between the two groups. Among 49 evaluable patients (25 in the cilostazol group, 24 in theplacebo group), the primary endpoint was significantly greater in the cilostazol group compared with the placebo group (-66.5±88.6% vs -17.6±140.1%, respectively, p=0.009). The secondary endpoints, including a change in the frequency of chest pain (-3.7±0.5 vs -1.9±0.6, respectively, p=0.029), a change in the chest pain severity scale (-2.8±0.4 vs -1.1±0.4, respectively, p=0.003), and the proportion of chest pain-free patients (76.0% vs 33.3%, respectively, p=0.003) also significantly favoured cilostazol. Headache was the most common adverse event in both groups (40.0% vs 20.8%, respectively, p=0.217). CONCLUSIONS:Cilostazol is an effective therapy for patients with VSA uncontrolled by conventionalamlodipine therapy, and has no serious side effects. TRIAL REGISTRATION NUMBER: NCT01444885. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVES: We conducted a randomised, double blind, placebo controlled trial to assess the efficacy and safety of cilostazol, a selective inhibitor of phosphodiesterase 3, in patients with vasospastic angina (VSA). BACKGROUND:Cilostazol has been shown to induce vascular dilatation, but its efficacy in patients with VSA is unknown. METHODS: Between October 2011 and July 2012, 50 patients with confirmed VSA who had ≥1 angina episodes/week despite amlodipine therapy (5 mg/day) were randomly assigned to receive either cilostazol (up to 200 mg/day) or placebo for 4 weeks. All patients were given diaries to record the frequency and severity of chest pain (0-10 grading). The primary endpoint was the relative reduction of the weekly incidence of chest pain. RESULTS: Baseline characteristics were similar between the two groups. Among 49 evaluable patients (25 in the cilostazol group, 24 in the placebo group), the primary endpoint was significantly greater in the cilostazol group compared with the placebo group (-66.5±88.6% vs -17.6±140.1%, respectively, p=0.009). The secondary endpoints, including a change in the frequency of chest pain (-3.7±0.5 vs -1.9±0.6, respectively, p=0.029), a change in the chest pain severity scale (-2.8±0.4 vs -1.1±0.4, respectively, p=0.003), and the proportion of chest pain-freepatients (76.0% vs 33.3%, respectively, p=0.003) also significantly favoured cilostazol. Headache was the most common adverse event in both groups (40.0% vs 20.8%, respectively, p=0.217). CONCLUSIONS:Cilostazol is an effective therapy for patients with VSA uncontrolled by conventional amlodipine therapy, and has no serious side effects. TRIAL REGISTRATION NUMBER: NCT01444885. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.