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.
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.
Zhu
Wen-Ling
WL
Division of Cardiology, Peking Union Medical College Hospital, Shuai Fu Yuan Wang Fu Jing, Beijing 100730, China. zhuwenling@263.net
Shan
Yuan-Dong
YD
Guo
Jing-Xuan
JX
Wei
Jia-Ping
JP
Yang
Xin-Chun
XC
Li
Tian-De
TD
Jia
San-Qing
SQ
He
Qing
Q
Chen
Jun-Zhu
JZ
Wu
Zong-Gui
ZG
Li
Zhan-Quan
ZQ
You
Kai
K
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
D000889:Anti-Arrhythmia Agents; D014665:Vasodilator Agents; D020108:Nicorandil; D005996:Nitroglycerin; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate