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The efficacy and safety of ivabradine hydrochloride versus atenolol in Chinese patients with chronic stable angina pectoris

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单位: [1]Chinese Acad Med Sci, Key Lab Clin Trial Res Cardiovasc Drugs, Natl Ctr Cardiovasc Dis,Ctr Clin Pharmacol, State Key Lab Cardiovasc Dis,Fuwai Hosp,Minist Hl, 167 Beilishi Rd, Beijing 100037, Peoples R China [2]Peking Union Med Coll, Beijing 100037, Peoples R China [3]Qinghai Prov Peoples Hosp, Dept Cardiol, Xining, Qinghai Provinc, Peoples R China [4]Tongji Univ, Tongji Hosp, Dept Cardiol, Shanghai 200092, Peoples R China [5]Xuzhou Med Coll, Affiliated Hosp, Dept Cardiol, Xuzhou, Jiangsu, Peoples R China [6]Xi An Jiao Tong Univ, Affiliated Hosp 2, Dept Cardiol, Xian 710049, Shanxi Province, Peoples R China [7]Hebei Med Univ, Hosp 4, Dept Cardiol, Shijiazhuang, Hebei Province, Peoples R China [8]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Cardiol, Wuhan 430074, Hubei Province, Peoples R China [9]Wuhan Univ, Renmin Hosp, Dept Cardiol, Wuhan 430072, Hubei Province, Peoples R China [10]Affiliated Hosp Hainan Med Coll, Dept Cardiol, Haikou, Hainan, Peoples R China [11]Shanghai First Peoples Hosp, Dept Cardiol, Shanghai, Peoples R China [12]Haikou Peoples Hosp, Dept Cardiol, Haikou, Hainan, Peoples R China [13]Wuxi Peoples Hosp, Dept Cardiol, Wuxi, Jiangsu, Peoples R China [14]Shandong Univ, Hosp 2, Dept Cardiol, Jinan 250100, Shandong, Peoples R China [15]Sichuan Acad Med Sci, Dept Cardiol, Chengdu, Sichuan Provinc, Peoples R China [16]Gansu Prov Hosp, Dept Cardiol, Lanzhou, Gansu, Peoples R China [17]Shanxi Prov Peoples Hosp, Dept Cardiol, Xian, Shanxi Province, Peoples R China [18]Hosp Tradit Chinese Med Xinjiang Uygur Autonomous, Dept Cardiol, Urumqi, Xinjiang Provin, Peoples R China
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关键词: ivabradine chronic stable angina pectoris efficacy safety pharmacoepidemiology

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PurposeThe aim of this study was to assess the efficacy and safety of ivabradine (Iva) noninferiority to atenolol (Aten) in Chinese patients with chronic stable angina pectoris. MethodsIn this double-blind, double-dummy trial, patients with symptomatic angina pectoris and positive exercise tolerance test were randomized into the Iva [5 or 7.5mg bis in die (BID)] or Aten group (12.5 or 25mg BID) according to computer-generated random numbers for 12weeks. ResultsOne hundred and sixty-eight patients were randomized to the Iva group and 166 to the Aten group. In a full analysis set, increases in the total exercise duration (TED) were 54.3120.1seconds with Iva 5mg and 58.8 +/- 114.7seconds with Aten 12.5mg at the fourth week, and at the 12th week, TED improved by 84.1 +/- 130.5seconds with Iva and 77.8 +/- 126.6seconds with Aten (95%CI: -21.4-34.1seconds, p=0.0011 for noninferiority). The analysis of per protocol set yielded similar results (95%CI: -31.4-33.0seconds, p=0.0131 for noninferiority). Heart rate was reduced in both groups at rest and during peak exercise. There were small, nonsignificant differences in the number of adverse events between the two groups (66 in Iva and 73 in Aten, p>0.05). Nine patients (5.42%) were reported to develop phosphenes/luminous phenomena and blurred vision in the Iva group (p=0.0035). ConclusionsIva is effective in reducing heart rates and improving exercise capacity and noninferior to Aten in Chinese patients with chronic stable angina pectoris. Iva is well tolerated and safe. Copyright (c) 2014 John Wiley & Sons, Ltd.

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出版当年[2013]版:
大类 | 3 区 医学
小类 | 3 区 药学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 药学 3 区 公共卫生、环境卫生与职业卫生
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出版当年[2012]版:
Q2 PHARMACOLOGY & PHARMACY
最新[2024]版:
Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Q3 PHARMACOLOGY & PHARMACY

影响因子: 最新[2024版] 最新五年平均 出版当年[2012版] 出版当年五年平均 出版前一年[2011版] 出版后一年[2013版]

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第一作者单位: [1]Chinese Acad Med Sci, Key Lab Clin Trial Res Cardiovasc Drugs, Natl Ctr Cardiovasc Dis,Ctr Clin Pharmacol, State Key Lab Cardiovasc Dis,Fuwai Hosp,Minist Hl, 167 Beilishi Rd, Beijing 100037, Peoples R China [2]Peking Union Med Coll, Beijing 100037, Peoples R China
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通讯机构: [1]Chinese Acad Med Sci, Key Lab Clin Trial Res Cardiovasc Drugs, Natl Ctr Cardiovasc Dis,Ctr Clin Pharmacol, State Key Lab Cardiovasc Dis,Fuwai Hosp,Minist Hl, 167 Beilishi Rd, Beijing 100037, Peoples R China [2]Peking Union Med Coll, Beijing 100037, Peoples R China
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