JACC:雷诺嗪可降低心绞痛发作频率
2013-03-18 高晓方 译 医学论坛网
美国学者的一项研究表明,在伴有糖尿病的慢性心绞痛患者中,雷诺嗪可降低心绞痛发作频率及舌下硝酸甘油用量,且耐受性良好。论文于2013年3月10日在线发表于《美国心脏病学会杂志》(J Am Coll Cardiol)。 此项国际性、随机、双盲试验以伴糖尿病、冠脉疾病及稳定性心绞痛并且接受1~2种抗心绞痛药物治疗的患者为受试者。在为期4周的单盲安慰剂导入期后,患者
美国学者的一项研究表明,在伴有糖尿病的慢性心绞痛患者中,雷诺嗪可降低心绞痛发作频率及舌下硝酸甘油用量,且耐受性良好。论文于2013年3月10日在线发表于《美国心脏病学会杂志》(J Am Coll Cardiol)。
此项国际性、随机、双盲试验以伴糖尿病、冠脉疾病及稳定性心绞痛并且接受1~2种抗心绞痛药物治疗的患者为受试者。在为期4周的单盲安慰剂导入期后,患者被随机给予为期8周的雷诺嗪(目标剂量1000mg bid)或安慰剂治疗。利用电子日记记录心绞痛发作和硝酸甘油应用情况。主要转归为最后6周的每周心绞痛平均发作次数。
结果显示,共有来自于14个国家的949例患者被纳入研究;平均年龄64岁,男性为61%,平均糖尿病持续时间为7.5年,基线HbA1c为7.3%。两组患者的电子日记资料采集率均为98%。雷诺嗪组的每周心绞痛发作频率显著低于安慰剂组(P=0.008),每周舌下硝酸甘油应用剂量亦为如此(P=0.003)。两组患者在严重不良事件发生率方面无差异。
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Objectives
To examine the efficacy of ranolazine versus placebo on weekly angina frequency in subjects with type 2 diabetes, CAD, and chronic stable angina who remain symptomatic despite treatment with up to 2 antianginal agents.
Background
Patients with diabetes have more extensive coronary artery disease (CAD) than those without diabetes, and a high burden of angina. Ranolazine is not only effective in treating angina but also may improve glycemic control, thus providing several potential benefits in this high-risk group. We conducted a randomized trial to test the antianginal benefit of ranolazine in patients with diabetes and stable angina.
Methods
TERISA was an international, randomized, double-blind trial of ranolazine vs. placebo in patients with diabetes, CAD, and stable angina treated with 1-2 antianginals. After a single-blind, 4-week placebo run-in, patients were randomized to 8 weeks of double-blind ranolazine (target dose 1000 mg bid) or placebo. Anginal episodes and nitroglycerin use were recorded with daily entry into a novel electronic diary. Primary outcome was the average weekly number of anginal episodes over the last 6 weeks of the study.
Results
A total of 949 patients were randomized across 104 centers in 14 countries. Mean age was 64 years, 61% were men, mean diabetes duration was 7.5 yrs, and mean baseline HbA1c was 7.3%. Electronic diary data capture was 98% in both groups. Weekly angina frequency was significantly lower with ranolazine versus placebo (3.8 [3.6-4.1] vs. 4.3 [4.0-4.5] episodes, P=0.008), as was the weekly sublingual nitroglycerin use (1.7 [1.6-1.9] vs. 2.1 [1.9-2.3] doses, P=0.003). There was no difference in the incidence of serious adverse events between groups.
Conclusions
Among patients with diabetes and chronic angina despite treatment with up to 2 agents, ranolazine reduced angina and sublingual nitroglycerin use and was well tolerated.
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