Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis - A randomized controlled trial
Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis - A randomized controlled trial
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DOI：
10.1001/jama.285.21.2719
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发表时间：
2001-06-06
影响因子：
120.7
通讯作者：
Xu, SC
中科院分区：
文献类型：
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作者：
Agodoa, LY;Appel, L;Xu, SC
近几十年来，高血压导致的终末期肾病的发病率有所增加，但治疗高血压以预防肾衰竭的最佳策略尚不清楚，尤其是在非洲裔美国人中。目的比较血管紧张素转换酶（ACE）抑制剂的作用（雷米普利），一种二氢吡啶类钙通道阻滞剂和β-受体阻滞剂美托洛尔对高血压肾病进展的影响。设计、设置和参与者对一项随机、双盲、在1094名年龄在18 - 70岁之间的高血压肾病（肾小球滤过率[GFR]为20-65 mL/min/1.73 m2）的非洲裔美国人中进行了3 x 2析因试验。1995年和1998年9月。本报告比较了2000年9月停用雷米普利干预后的雷米普利和美托洛尔组。干预参与者被随机分配接受雷米普利15 - 10 mg/d（n=217），雷米普利2.5 - 10 mg/d（n=436）或美托洛尔50 - 200 mg/d（n=441），主要结果测量主要结果测量是GFR的变化率;主要次要结局是GFR降低超过50%或25 mL/min/1.73 m2的临床终点的复合指数，结果在尿蛋白与肌酐比值>0.22的参与者中，（大约相当于蛋白尿超过300 mg/d），雷米普利组有36%的（2.02 [SE，0.74] mL/min/1.73 m2/y）3年内GFR平均下降较慢（P= 0.006），临床终点风险较安慰剂组降低48%（95%置信区间[CI]，20%-66%）。在整个队列中，治疗组之间从基线至3年的平均GFR下降无显著差异（P=.38）。然而，在校正了基线协变量后，与雷米普利组相比，雷米普利组的临床终点风险降低了38%（95%CI，13%-56%），3个月后GFR的平均下降速度减慢了36%（P= 0.002），蛋白尿减少（P
Context incidence of end-stage renal disease due to hypertension has increased in recent decades, but the optimal strategy for treatment of hypertension to prevent renal failure is unknown, especially among African Americans.Objective To compare the effects of an angiotensin-converting enzyme (ACE) inhibitor (ramipril), a dihydropyridine calcium channel blocker (amlodipine), and a beta -blocker (metoprolol) on hypertensive renal disease progression.Design, Setting, and Participants Interim analysis of a randomized, double-blind, 3 x 2 factorial trial conducted in 1094 African Americans aged 18 to 70 years with hypertensive renal disease (glomerular filtration rate [GFR] of 20-65 mL/min per 1.73 m(2)) enrolled between February. 1995 and September 1998. This report compares the ramipril and amlodipine groups following discontinuation of the amlodipine intervention in September 2000.Interventions Participants were randomly assigned to receive amlodipine, 15 to 10 mg/d (n=217), ramipril, 2.5 to 10 mg/d (n=436), or metoprolol, 50 to 200 mg/d (n=441), with other agents added to achieve 1 of 2 blood pressure goals.Main Outcome Measures The primary outcome measure was the rate of change in GFR; the main secondary outcome was a composite index of the clinical end points of reduction in GFR of more than 50% or 25 mL/min per 1.73 m(2), end-stage renal disease, or death.Results Among participants with a urinary protein to creatinine ratio of >0.22 (corresponding approximately to proteinuria of more than 300 mg/d), the ramipril group had a 36% (2.02 [SE, 0.74] mL/min per 1.73 m(2)/y) slower mean decline in GFR over 3 years (P=.006) and a 48% reduced risk of the clinical end points vs the amlodipine group (95% confidence interval [CI], 20%-66%). In the entire cohort, there was no significant difference in mean GFR decline from baseline to 3 years between treatment groups (P=.38). However,compared with the amlodipine group, after adjustment for baseline covariates the ramipril group had a 38% reduced risk of clinical end points (95% CI, 13% -56%), a 36% slower mean decline in GFR after 3 months (P=.002), and less proteinuria (P