氯沙坦在基层医疗中用于糖尿病患者的情况：对 LIFE 和 RENAAL 研究结果的综述

Use of losartan in diabetic patients in the primary care setting: review of the results in LIFE and RENAAL.

作者信息

Egan Brent, Gleim Gilbert, Panish Jessica

机构信息

Medical University of South Carolina, Charleston, SC 29425, USA.

出版信息

Curr Med Res Opin. 2004 Dec;20(12):1909-17. doi: 10.1185/030079904X13040.

DOI:10.1185/030079904X13040

PMID:15701209

Abstract

OBJECTIVE

To review outcomes of diabetic patients treated with losartan in two recent randomized, double-blind, clinical trials and compare outcomes to similar studies in diabetics.

METHODS

The Reduction in ENdpoints with the Angiotensin II Antagonist Losartan (RENAAL) study recruited 1513 patients with type 2 diabetes and nephropathy. The Losartan Intervention For Endpoint reduction (LIFE) study recruited 9193 hypertensive patients with left ventricular hypertrophy (LVH) including 1195 with diabetes mellitus. The maximum losartan dose in both studies was 100 mg daily. All study patients could receive additional antihypertensive medications, excluding angiotensin converting enzyme inhibitors (ACEIs) and other angiotensin receptor blockers (ARBs), if blood pressures (BP) < 140/90 mmHg were not achieved. In RENAAL, the control group received placebo whereas in LIFE, controls received atenolol. BP reductions were comparable in the treatment and control groups of both studies. In RENAAL, the primary outcome was the composite of doubling of serum creatinine, end-stage renal disease, or death. In LIFE, the primary composite outcome was cardiovascular death and non-fatal myocardial infarction or stroke.

RESULTS

In RENAAL, losartan reduced the primary composite end-point 16% (p = 0.02) and the incidence of end-stage renal disease (ESRD) 28% (p = 0.002). In LIFE, the primary composite endpoint among diabetics was reduced 24% (p = 0.03), cardiovascular mortality was reduced 37% (p = 0.03) and total mortality was reduced 39% (p = 0.002).

DISCUSSION

In diabetic patients with nephropathy, losartan reduces progression to endstage renal disease. In hypertensive diabetic patients with LVH, losartan reduces cardiovascular morbidity and mortality and total mortality. Angiotensin receptor blockade with losartan appears to confer benefits beyond BP reduction in diabetic patients at high-risk for cardiovascular and renal events.

摘要

目的

回顾在两项近期的随机、双盲临床试验中接受氯沙坦治疗的糖尿病患者的治疗结果，并将结果与糖尿病患者的类似研究进行比较。

方法

氯沙坦降低终点事件（RENAAL）研究招募了1513例2型糖尿病和肾病患者。氯沙坦干预降低终点事件（LIFE）研究招募了9193例左心室肥厚（LVH）的高血压患者，其中包括1195例糖尿病患者。两项研究中氯沙坦的最大剂量均为每日100毫克。如果未达到血压（BP）<140/90 mmHg，所有研究患者均可接受额外的抗高血压药物治疗，但不包括血管紧张素转换酶抑制剂（ACEIs）和其他血管紧张素受体阻滞剂（ARBs）。在RENAAL研究中，对照组接受安慰剂，而在LIFE研究中，对照组接受阿替洛尔。两项研究的治疗组和对照组的血压降低情况相当。在RENAAL研究中，主要结局是血清肌酐翻倍、终末期肾病或死亡的复合结局。在LIFE研究中，主要复合结局是心血管死亡和非致命性心肌梗死或中风。

结果

在RENAAL研究中，氯沙坦使主要复合终点降低了16%（p = 0.02），终末期肾病（ESRD）的发生率降低了28%（p = 0.002）。在LIFE研究中，糖尿病患者的主要复合终点降低了24%（p = 0.03），心血管死亡率降低了37%（p = 0.03），总死亡率降低了39%（p = 0.002）。