title: Oral nicorandil reduces ischemic attacks in patients with stable angina: A prospective, multicenter, open-label, randomized, controlled study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of oral nicorandil in coronary heart disease (CHD) patients with stable angina.
  
  
  METHODS
  Eligible patients were randomized 1:1 to the nicorandil or control group. Current standard antianginal treatment was continued in both groups, while the patients in the nicorandil group received an additional 12-week treatment of nicorandil (5mg thrice daily). Primary endpoint was the number of myocardial ischemia measured by 24h Holter after 12-week treatment. Secondary endpoints included various 24h Holter indicators, angina occurrence, 6-min walking test (6MWT), ECG QT dispersion (QTd), safety and compliance.
  
  
  BACKGROUND
  NCT01396395.
  
  
  RESULTS
  A total of 402 adult patients with stable angina were enrolled. Two hundred patients were randomized to standard therapy plus nicorandil and 202 patients to standard therapy only. The baseline characteristics of the two groups were comparable. The number of myocardial ischemia attacks after treatment was significantly lower in the nicorandil group (LSMEANS 0.896) than the control group (LSMEANS 1.782), with an adjusted ratio of 0.503 (95% CI: 0.301, 0.840; P=0.0086). No significant differences in total myocardial ischemic burden, maximum ST-depression, longest duration of ST-depression, 6MWT, or heart rate variability were noted between the two groups. Twenty three (11.7%) of nicorandil group and 13 (6.3%) patients of control group reported at least one treatment emergent adverse event, respectively.
  
  
  CONCLUSIONS
  Nicorandil significantly reduced the number of ischemic attacks when added to standard antianginal treatment in CHD patients with stable angina. It was well tolerated with no new safety signal identified.
authors.affiliation: First Hospital Peking University, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Jiang
authors.affiliation: 305 Military Hospital, Beijing, China.
authors.forename: Yuntian
authors.initials: Y
authors.lastname: Li
authors.affiliation: Guangdong Provincial People's Hospital, Guangzhou, Guangdong Province, China.
authors.forename: Yingling
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Harbin Medical University Fourth Affiliated Hospital, Heilongjiang, China.
authors.forename: Xueqi
authors.initials: X
authors.lastname: Li
authors.affiliation: Daqing Oilfield General Hospital, Daqing, Heilongjiang, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.affiliation: The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China.
authors.forename: Baopeng
authors.initials: B
authors.lastname: Tang
authors.affiliation: People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China.
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Dai
authors.affiliation: Merck Serono Co Ltd, Beijing, China, an affiliate of Merck KGaA, Darmstadt, Germany.
authors.forename: Tianrong
authors.initials: T
authors.lastname: Ma
authors.affiliation: Merck Serono Co Ltd, Beijing, China, an affiliate of Merck KGaA, Darmstadt, Germany.
authors.forename: Lei
authors.initials: L
authors.lastname: Li
authors.affiliation: First Hospital Peking University, Beijing, China. Electronic address: Huoyong@263.net.cn.
authors.forename: Yong
authors.initials: Y
authors.lastname: Huo
mesh_terms: D000328:Adult; D000368:Aged; D060050:Angina, Stable / Q000175:diagnosis / Q000188:drug therapy*; D016903:Drug Monitoring / Q000379:methods; D004562:Electrocardiography / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020108:Nicorandil / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D014665:Vasodilator Agents; D020108:Nicorandil
keywords: Angina; Antianginal treatment; Myocardial ischemia; Nicorandil; Randomized clinical trial