title: Double-blind, multicenter, active-controlled, randomized clinical trial to assess the safety and efficacy of orally administered nicorandil in patients with stable angina pectoris in China.
abstract: BACKGROUND
  The efficacy and safety of nicorandil were evaluated in Chinese patients with stable angina pectoris (AP) in a double-blind, multicenter, active-controlled, randomized clinical trial.
  
  
  RESULTS
  After a 2-week washout period, 232 patients with stable AP were randomized to receive either nicorandil (5 mg tid; 115 patients) or isosorbide mononitrate (ISMN: 20 mg bid; 117 patients) for 2 weeks. Exercise capacity, number of weekly anginal attacks, nitroglycerin (NTG) consumption, and safety were evaluated. Nicorandil and ISMN significantly prolonged the time to 1 mm ST-segment depression in an exercise tolerance test. Both drugs improved the total exercise time and the time to onset of chest pain. There was no significant difference between the 2 groups. Nicorandil significantly decreased the number of anginal attacks and NTG consumption. ISMN decreased the number of anginal attacks significantly; however, there was no significance in NTG consumption, and the ratio of anginal attack reduction was at least 50% was significantly higher with nicorandil. Nicorandil was well tolerated and there was no safety profile difference compared with ISMN. Thus, nicorandil may have equivalent or better antianginal effect than ISMN.
  
  
  CONCLUSIONS
  Nicorandil is beneficial as treatment for AP.
authors.affiliation: Division of Cardiology, Peking Union Medical College Hospital, Shuai Fu Yuan Wang Fu Jing, Beijing 100730, China. zhuwenling@263.net
authors.forename: Wen-Ling
authors.initials: WL
authors.lastname: Zhu
authors.forename: Yuan-Dong
authors.initials: YD
authors.lastname: Shan
authors.forename: Jing-Xuan
authors.initials: JX
authors.lastname: Guo
authors.forename: Jia-Ping
authors.initials: JP
authors.lastname: Wei
authors.forename: Xin-Chun
authors.initials: XC
authors.lastname: Yang
authors.forename: Tian-De
authors.initials: TD
authors.lastname: Li
authors.forename: San-Qing
authors.initials: SQ
authors.lastname: Jia
authors.forename: Qing
authors.initials: Q
authors.lastname: He
authors.forename: Jun-Zhu
authors.initials: JZ
authors.lastname: Chen
authors.forename: Zong-Gui
authors.initials: ZG
authors.lastname: Wu
authors.forename: Zhan-Quan
authors.initials: ZQ
authors.lastname: Li
authors.forename: Kai
authors.initials: K
authors.lastname: You
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000188:drug therapy*; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage*; D002681:China; D004311:Double-Blind Method; D015444:Exercise; D005260:Female; D006801:Humans; D007548:Isosorbide Dinitrate / Q000008:administration & dosage / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D020108:Nicorandil / Q000008:administration & dosage*; D005996:Nitroglycerin / Q000008:administration & dosage; D014665:Vasodilator Agents / Q000008:administration & dosage
chemical_list: D000889:Anti-Arrhythmia Agents; D014665:Vasodilator Agents; D020108:Nicorandil; D005996:Nitroglycerin; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate