Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study):: a multicentre, randomised, double-blind, controlled trial-猫眼课题宝

DOI：

10.1016/s0140-6736(08)61236-2

发表时间：

2008-08-16

期刊：

LANCET

影响因子：

168.9

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

Mann, Johannes F. E.;Schmieder, Roland E.;Yusuf, Salim

血管紧张素受体阻滞剂（ARB）和血管紧张素转换酶（ACE）抑制剂已知可减少蛋白尿。它们的联合治疗可能比单独使用任何一种治疗更有效，但没有关于肾功能比较变化的长期数据。我们研究了雷米普利（一种ACE抑制剂）、替米沙坦（一种ARB）及其联合用药对55岁及以上已确诊的动脉粥样硬化性血管疾病或伴有终末器官损害的糖尿病患者的肾脏影响。方法2001 ~ 2007年进行试验。在3周的磨合期后，25620名参与者被随机分配到每天10毫克雷米普利（n=8576），每天80毫克替米沙坦（n=8542），或两种药物的组合（n=8502，中位随访时间为56个月），并测量肾功能和蛋白尿。主要肾脏结局是透析、血清肌酐加倍和死亡的综合结果。分析的目的是治疗。本研究已在ClinicalTrials.gov注册，注册号NCT00153101。784例患者在试验期间因低血压症状永久停止随机治疗（406例联合治疗，149例雷米普利治疗，229例替米沙坦治疗）。替米沙坦（n=1147[13.4%]）和雷米普利（1150[13.5%]）的综合主要结局事件数相似，风险比[HR] 1.00, 95% Cl = 0。92 - 1。09)，但联合治疗增加(1233 [14.5%]；9,1.01 -1.18, p=0.037)。继发性肾脏结局，透析或血清肌酐加倍，与替米沙坦相似(189[2]。21%])和雷米普利（174 [2.03%];HR 1.09, 0.89-1.34），联合用药更常见（212 [2.49%]:HR 1.24, 1.01-1.51, p=0.038）。与替米沙坦相比，雷米普利估计肾小球滤过率（eGFR）下降最少(-2-82 [SD 17.2] mL/min/1。73 m(2) vs -4.12 [17.4], p

Background Angiotensin receptor blockers (ARB) and angiotensin converting enzyme (ACE) inhibitors are known to reduce proteinuria. Their combination might be more effective than either treatment alone, but long-term data for comparative changes in renal function are not available. We investigated the renal effects of ramipril (an ACE inhibitor), telmisartan (an ARB), and their combination in patients aged 55 years or older with established atherosclerotic vascular disease or with diabetes with end-organ damage.Methods The trial ran from 2001 to 2007. After a 3-week run-in period, 25 620 participants were randomly assigned to ramipril 10 mg a day (n=8576), telmisartan 80 mg a day (n=8542), or to a combination of both drugs (n=8502; median follow-up was 56 months), and renal function and proteinuria were measured. The primary renal outcome was a composite of dialysis, doubling of serum creatinine, and death. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00153101.Findings 784 patients permanently discontinued randomised therapy during the trial because of hypotensive symptoms (406 on combination therapy, 149 on ramipril, and 229 on telmisartan). The number of events for the composite primary outcome was similar for telmisartan (n=1147 [13.4%]) and ramipril (1150 [13.5%]; hazard ratio [HR] 1.00, 95% Cl 0 . 92-1. 09), but was increased with combination therapy (1233 [14.5%]; HR 1. 09, 1.01-1.18, p=0.037). The secondary renal outcome, dialysis or doubling of serum creatinine, was similar with telmisartan (189 [2 . 21%]) and ramipril (174 [2.03%]; HR 1.09, 0.89-1.34) and more frequent with combination therapy (212 [2.49%]: HR 1.24, 1.01-1.51, p=0.038). Estimated glomerular filtration rate (eGFR) declined least with ramipril compared with telmisartan (-2-82 [SD 17.2] mL/min/1 . 73 m(2) vs -4.12 [17.4], p

Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study):: a multicentre, randomised, double-blind, controlled trial

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