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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.

AbstractBACKGROUND:
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.
METHODS AND 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.
AuthorsWen-Ling Zhu, Yuan-Dong Shan, Jing-Xuan Guo, Jia-Ping Wei, Xin-Chun Yang, Tian-De Li, San-Qing Jia, Qing He, Jun-Zhu Chen, Zong-Gui Wu, Zhan-Quan Li, Kai You
JournalCirculation journal : official journal of the Japanese Circulation Society (Circ J) Vol. 71 Issue 6 Pg. 826-33 (Jun 2007) ISSN: 1346-9843 [Print] Japan
PMID17526976 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Arrhythmia Agents
  • Vasodilator Agents
  • isosorbide-5-mononitrate
  • Nicorandil
  • Nitroglycerin
  • Isosorbide Dinitrate
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Angina Pectoris (drug therapy)
  • Anti-Arrhythmia Agents (administration & dosage)
  • China
  • Double-Blind Method
  • Exercise
  • Female
  • Humans
  • Isosorbide Dinitrate (administration & dosage, analogs & derivatives)
  • Male
  • Middle Aged
  • Nicorandil (administration & dosage)
  • Nitroglycerin (administration & dosage)
  • Vasodilator Agents (administration & dosage)

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