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
机构:[1]Division of Cardiology, Peking Union Medical College Hospital,[2]Research Center for Clinical Pharmacology, Peking Union Medical College Hospital,[3]Division of Cardiology, The Third Hospital of the Peking University,[4]Division of Cardiology, The Xuan Wu Hospital of The Capital University,心脏科(内科专业)首都医科大学宣武医院[5]Division of Cardiology, The Beijing Chao Yan Hospital of The Capital University,[6]Division of Cardiology, The PLA General Hospital,[7]Division of Cardiology, The Beijing Friendship Hospital of the Capital University of Medical Sciences,[8]Division of Cardiology, The Beijing Hospital, Beijing,[9]Division of Cardiology, The No. 1 Hospital of the Zhen Jiang University, Hangzhou,[10]Division of Cardiology, The Shanghai Changzheng Hospital, Shanghai[11]Division of Cardiology, The Ren Min Hospital of Liao Ning Province, Shenyang, 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. 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 I 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.
第一作者机构:[1]Division of Cardiology, Peking Union Medical College Hospital,[*]Division of Cardiology, Peking Union Medical College Hospital, Shuai Fu Yuan Wang Fu Jing, Beijing 100730, China.
通讯作者:
通讯机构:[*]Division of Cardiology, Peking Union Medical College Hospital, Shuai Fu Yuan Wang Fu Jing, Beijing 100730, China.
推荐引用方式(GB/T 7714):
Wen-Ling Zhu,Yuan-Dong Shan,Jing-Xuan Guo,et al.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[J].CIRCULATION JOURNAL.2007,71(6):826-833.doi:10.1253/circj.71.826.
APA:
Wen-Ling Zhu,Yuan-Dong Shan,Jing-Xuan Guo,Jia-Ping Wei,Xin-Chun Yang...&Kai You.(2007).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.CIRCULATION JOURNAL,71,(6)
MLA:
Wen-Ling Zhu,et al."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".CIRCULATION JOURNAL 71..6(2007):826-833