缬沙坦与氨氯地平相比对高危高血压患者预防2型糖尿病的作用：VALUE试验

Effects of valsartan compared to amlodipine on preventing type 2 diabetes in high-risk hypertensive patients: the VALUE trial.

作者信息

Kjeldsen Sverre E, Julius Stevo, Mancia Giuseppe, McInnes Gordon T, Hua Tsushung, Weber Michael A, Coca Antonio, Ekman Steffan, Girerd Xavier, Jamerson Kenneth, Larochelle Pierre, MacDonald Thomas M, Schmieder Roland E, Schork M Anthony, Stolt Pelle, Viskoper Reuven, Widimský Jiri, Zanchetti Alberto

机构信息

Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan, USA.

出版信息

J Hypertens. 2006 Jul;24(7):1405-12. doi: 10.1097/01.hjh.0000234122.55895.5b.

DOI:10.1097/01.hjh.0000234122.55895.5b

PMID:16794491

Abstract

CONTEXT

Type 2 diabetes is emerging as a major health problem, which tends to cluster with hypertension in individuals at high risk of cardiovascular disease.

OBJECTIVE

To test for the first time the hypothesis that treatment of hypertensive patients at high cardiovascular risk with the angiotensin-receptor blocker (ARB) valsartan prevents new-onset type 2 diabetes compared with the metabolically neutral calcium-channel antagonist (CCA) amlodipine.

DESIGN

Pre-specified analysis in the VALUE trial. Follow-up averaged 4.2 years. The risk of developing new diabetes was calculated as an odds ratio (OR) with 95% confidence intervals (CI) for different definitions of diabetes.

PATIENTS

A sample of 9995 high-risk, non-diabetic hypertensive patients.

INTERVENTIONS

Valsartan or amlodipine with or without add-on medication [hydrochlorothiazide (HCTZ) and other add-ons, excluding other ARBs, angiotensin-converting enzyme (ACE) inhibitors, CCAs].

MAIN OUTCOME MEASURE

New diabetes defined as an adverse event, new blood-glucose-lowering drugs and/or fasting glucose > 7.0 mmol/l.

RESULTS

New diabetes was reported in 580 (11.5%) patients on valsartan and in 718 (14.5%) patients on amlodipine (OR 0.77, 95% CI 0.69-0.87, P < 0.0001). Using stricter criteria (without adverse event reports) new diabetes was detected in 495 (9.8%) patients on valsartan and in 586 (11.8%) on amlodipine (OR 0.82, 95% CI 0.72-0.93, P = 0.0015).

CONCLUSION

Compared with amlodipine, valsartan reduces the risk of developing diabetes mellitus in high-risk hypertensive patients.

摘要

背景

2型糖尿病正成为一个主要的健康问题，在心血管疾病高危个体中，它往往与高血压聚集出现。

目的

首次检验以下假设：与代谢中性的钙通道拮抗剂（CCA）氨氯地平相比，使用血管紧张素受体阻滞剂（ARB）缬沙坦治疗心血管疾病高危的高血压患者可预防新发2型糖尿病。

设计

VALUE试验中的预先设定分析。随访平均4.2年。根据不同的糖尿病定义，将发生新发糖尿病的风险计算为比值比（OR）及95%置信区间（CI）。

患者

9995例高危非糖尿病高血压患者样本。

干预措施

缬沙坦或氨氯地平，加用或不加用其他药物[氢氯噻嗪（HCTZ）及其他加用药物，不包括其他ARB、血管紧张素转换酶（ACE）抑制剂、CCAs]。

主要结局指标

新发糖尿病定义为不良事件、新使用降糖药物和/或空腹血糖>7.0 mmol/L。

结果

缬沙坦组有580例（11.5%）患者报告发生新发糖尿病，氨氯地平组有718例（14.5%）患者发生新发糖尿病（OR 0.77，95% CI 0.69 - 0.87，P<0.0001）。采用更严格的标准（无不良事件报告）时，缬沙坦组495例（9.8%）患者检测到新发糖尿病，氨氯地平组586例（11.8%）患者检测到新发糖尿病（OR 0.82，95% CI 0.72 - 0.93，P = 0.0015）。