Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT)
Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT)
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DOI：
10.1016/s0140-6736(00)02527-7
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发表时间：
2000-07-29
期刊：
影响因子：
168.9
通讯作者：
Ruilope, LM
中科院分区：
文献类型：
--
作者：
Brown, MJ;Palmer, CR;Ruilope, LM
背景：比利尿剂和β受体阻滞剂更新的抗高血压药物的疗效尚未确定。我们比较了钙通道阻滞剂硝苯地平每日一次与利尿剂复方氨氯吡嗪对高血压高危患者心血管死亡率和发病率的影响。方法我们在欧洲和以色列对6321例年龄在55-80岁的高血压患者进行了一项前瞻性、随机、双盲试验（血压大于或等于150/95 mm Hg，或大于或等于160 mm Hg收缩压）。患者至少有一个额外的心血管危险因素。我们将患者随机分为硝苯地平30 mg/长效胃肠道转运系统（GITS）制剂组（n=3157）或氨氯吡嗪复方制剂组（氢氯噻嗪25 μ g+阿米洛利2.5 mg; n=3164）。通过剂量加倍和添加阿替洛尔25-50 mg或依那普利5-10 mg进行剂量滴定。主要结局为心血管死亡、心肌梗死、心力衰竭或卒中。结果主要结果发生在硝苯地平组200例（6.3%）和182例（5.8%）在co-amilozide组（18.2比16.5事件每1000患者年，相对风险1.10 [95%CI 0.91-1.34]，p=0.35）。总体平均血压从173/99 mmHg（SD 14/8）降至138/82 mmHg（12/7）。硝苯地平组因外周水肿而退出治疗的患者多出8%（725 vs 518，p
Background The efficacy of antihypertensive drugs newer than diuretics and beta-blockers has not been established. We compared the effects of the calcium-channel blocker nifedipine once daily with the diuretic combination co-amilozide on cardiovascular mortality and morbidity in high-risk patients with hypertension.Methods We did a prospective, randomised, double-blind trial in Europe and Israel in 6321 patients aged 55-80 years with hypertension (blood pressure greater than or equal to 150/95 mm Hg, or greater than or equal to 160 mm Hg systolic). Patients had at least one additional cardiovascular risk factor. We randomly assigned patients nifedipine 30 mg in a long-acting gastrointestinal-transport-system (GITS) formulation (n=3157), or co-amilozide (hydrochlorothiazide 25 mu g plus amiloride 2.5 mg; n=3164). Dose titration was by dose doubling, and addition of atenolol 25-50 mg or enalapril 5-10 mg. The primary outcome was cardiovascular death, myocardial infarction, heart failure, or stroke. Analysis was done by intention to treat.Findings Primary outcomes occurred in 200 (6.3%) patients in the nifedipine group and in 182 (5.8%) in the co-amilozide group (18.2 vs 16.5 events per 1000 patient-years; relative risk 1.10 [95% CI 0.91-1.34], p=0.35). Overall mean blood pressure fell from 173/99 mm Hg (SD 14/8) to 138/82 mm Hg (12/7). There was an 8% excess of withdrawals from the nifedipine group because of peripheral oedema (725 vs 518, p