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A randomised, multicentre, double blind, placebo controlled trial to evaluate the efficacy and safety of cilostazol in patients with vasospastic angina
  1. Eun-Seok Shin1,
  2. Jae-Hwan Lee2,
  3. Sang-Yong Yoo3,
  4. Yongwhi Park4,
  5. Young Joon Hong5,
  6. Moo Hyun Kim6,
  7. Jong-Young Lee7,
  8. Chang-Wook Nam8,
  9. Seung-Jea Tahk9,
  10. Jeong-Su Kim10,
  11. Young-Hoon Jeong4,
  12. Cheol Whan Lee7,
  13. Hwa Kyoung Shin11,
  14. June-Hong Kim10
  1. 1Division of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea
  2. 2Department of Cardiology, Internal Medicine, School of Medicine, Chungnam National University Hospital, Daejeon, Korea
  3. 3Department of Internal Medicine, Division of Cardiology, University of Ulsan College of Medicine, GangNeung Asan Hospital, Gangneung, Korea
  4. 4Division of Cardiology, Department of Internal Medicine Gyeongsang National University Hospital and Gyeongsang National University School of Medicine, Jinju, Korea
  5. 5Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
  6. 6Division of Cardiology, Department of Internal Medicine, Dong-A University Hospital, Busan, Korea
  7. 7Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
  8. 8Division of Cardiology, Department of Internal Medicine, Keimyung University, Dongsan Medical Center, Daegu, Korea
  9. 9Ajou University Hospital, Suwon, Korea
  10. 10Division of Cardiology, Department of Internal Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University, Yangsan Hospital, Yangsan, Korea
  11. 11School of Korean Medicine, Pusan National University, Yangsan, Korea
  1. Correspondence to Professor June-Hong Kim, Division of Cardiology, Department of Internal Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, South Korea; junehongk{at}gmail.com

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 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-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 conventional amlodipine therapy, and has no serious side effects.

Trial registration number NCT01444885.

  • CORONARY ARTERY DISEASE

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