title: A randomised, multicentre, double blind, placebo controlled trial to evaluate the efficacy and safety of cilostazol in patients with vasospastic angina.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT01444885.
authors.affiliation: Division of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Eun-Seok
authors.initials: ES
authors.lastname: Shin
authors.affiliation: Department of Cardiology, Internal Medicine, School of Medicine, Chungnam National University Hospital, Daejeon, Korea.
authors.forename: Jae-Hwan
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Division of Cardiology, University of Ulsan College of Medicine, GangNeung Asan Hospital, Gangneung, Korea.
authors.forename: Sang-Yong
authors.initials: SY
authors.lastname: Yoo
authors.affiliation: Division of Cardiology, Department of Internal Medicine Gyeongsang National University Hospital and Gyeongsang National University School of Medicine, Jinju, Korea.
authors.forename: Yongwhi
authors.initials: Y
authors.lastname: Park
authors.affiliation: Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea.
authors.forename: Young Joon
authors.initials: YJ
authors.lastname: Hong
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Dong-A University Hospital, Busan, Korea.
authors.forename: Moo Hyun
authors.initials: MH
authors.lastname: Kim
authors.affiliation: Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Jong-Young
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Keimyung University, Dongsan Medical Center, Daegu, Korea.
authors.forename: Chang-Wook
authors.initials: CW
authors.lastname: Nam
authors.affiliation: Ajou University Hospital, Suwon, Korea.
authors.forename: Seung-Jea
authors.initials: SJ
authors.lastname: Tahk
authors.affiliation: Division of Cardiology, Department of Internal Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University, Yangsan Hospital, Yangsan, Korea.
authors.forename: Jeong-Su
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine Gyeongsang National University Hospital and Gyeongsang National University School of Medicine, Jinju, Korea.
authors.forename: Young-Hoon
authors.initials: YH
authors.lastname: Jeong
authors.affiliation: Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Cheol Whan
authors.initials: CW
authors.lastname: Lee
authors.affiliation: School of Korean Medicine, Pusan National University, Yangsan, Korea.
authors.forename: Hwa Kyoung
authors.initials: HK
authors.lastname: Shin
authors.affiliation: Division of Cardiology, Department of Internal Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University, Yangsan Hospital, Yangsan, Korea.
authors.forename: June-Hong
authors.initials: JH
authors.lastname: Kim
mesh_terms: D000328:Adult; D000787:Angina Pectoris / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D002637:Chest Pain / Q000503:physiopathology*; D000077407:Cilostazol; D003329:Coronary Vasospasm / Q000150:complications / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016903:Drug Monitoring; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D058987:Phosphodiesterase 3 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D056910:Republic of Korea; D012720:Severity of Illness Index; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D058987:Phosphodiesterase 3 Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol
keywords: CORONARY ARTERY DISEASE