力滴定缬沙坦/氢氯噻嗪与氨氯地平/氢氯噻嗪对2期高血压患者动态血压的影响：EVALUATE研究

Effects of force-titrated valsartan/hydrochlorothiazide versus amlodipine/hydrochlorothiazide on ambulatory blood pressure in patients with stage 2 hypertension: the EVALUATE study.

作者信息

Lacourcière Yves, Wright Jackson T, Samuel Rita, Zappe Dion, Purkayastha Das, Black Henry R

机构信息

Centre Hospitalier de l'Université Laval, Sainte-Foy, Quebec, Canada.

出版信息

Blood Press Monit. 2009 Jun;14(3):112-20. doi: 10.1097/MBP.0b013e32832a9da7.

DOI:10.1097/MBP.0b013e32832a9da7

PMID:19384192

Abstract

BACKGROUND

Previous studies using the combination of angiotensin-receptor blockers and hydrochlorothiazide (HCTZ) have shown superior ambulatory blood pressure (ABP) reduction in study participants with stage 2 hypertension compared with monotherapy.

OBJECTIVE

This multicenter, double-blind, parallel group, forced-titration study of individuals with stage 2 hypertension, compared the efficacy of valsartan and amlodipine in combination with HCTZ on ABP reduction.

METHODS

After a 2-week washout period, participants (n=482) with mean office sitting systolic BP >or=160 mmHg and <or=200 mmHg were randomized to receive treatment with either valsartan 160 mg (n=241) or amlodipine 5 mg (n=241), force-titrated to a maximum dose of valsartan/HCTZ 320/25 mg or amlodipine/HCTZ 10/25 mg over 6 weeks and continued through week 10. The primary endpoint was change in mean 24-h ambulatory systolic BP from baseline to week 10.

RESULTS

At week 10, changes from baseline in mean office BP were significantly (P<0.0001) decreased by both valsartan/HCTZ (-34.2/-14.2 mmHg) and amlodipine/HCTZ (-34.1/-14.7 mmHg). Changes from baseline in mean 24-h ABP were significantly (P<0.0001) decreased by both valsartan/HCTZ (-21.1/-12.5 mmHg) and amlodipine/HCTZ (-18.1/-9.9 mmHg). However, treatment with valsartan/HCTZ provided significant additional systolic BP (-3.8 mmHg; P=0.0042) and diastolic BP (-2.7 mmHg; P=0.0002) reduction compared with the amlodipine/HCTZ group. The proportion of individuals reaching the office goal BP (<140/80 mmHg) were similar in the valsartan/HCTZ (55.3%) versus amlodipine/HCTZ (54.9%) group, ABP control rates for the recommended ABP goal (<130/80 mmHg) were greater (P=0.0170) in the valsartan/HCTZ group (54.3%) than the amlodipine/HCTZ group (42.7%). Both treatments were well tolerated.

CONCLUSION

On the basis of ABP monitoring but not office measurements, the fixed-dose combination of valsartan/HCTZ is a significantly more effective treatment regimen than amlodipine/HCTZ, with similar tolerability.

摘要

背景

既往使用血管紧张素受体阻滞剂与氢氯噻嗪（HCTZ）联合治疗的研究表明，与单药治疗相比，2期高血压研究参与者的动态血压（ABP）降低效果更佳。

目的

这项针对2期高血压患者的多中心、双盲、平行组、强制滴定研究，比较了缬沙坦和氨氯地平联合HCTZ降低ABP的疗效。

方法

经过2周的洗脱期后，平均诊室坐位收缩压≥160 mmHg且≤200 mmHg的参与者（n = 482）被随机分配接受缬沙坦160 mg（n = 241）或氨氯地平5 mg（n = 241）治疗，在6周内强制滴定至缬沙坦/HCTZ 320/25 mg或氨氯地平/HCTZ 10/25 mg的最大剂量，并持续至第10周。主要终点是从基线到第10周24小时动态收缩压的变化。

结果

在第10周时，缬沙坦/HCTZ组（-34.2/-14.2 mmHg）和氨氯地平/HCTZ组（-34.1/-14.7 mmHg）的平均诊室血压相对于基线的变化均显著降低（P<0.0001）。缬沙坦/HCTZ组（-21.1/-12.5 mmHg）和氨氯地平/HCTZ组（-18.1/-9.9 mmHg）的平均24小时ABP相对于基线的变化均显著降低（P<0.0001）。然而，与氨氯地平/HCTZ组相比，缬沙坦/HCTZ治疗在收缩压（-3.8 mmHg；P = 0.0042）和舒张压（-2.7 mmHg；P = 0.0002）方面有显著额外降低。达到诊室目标血压（<140/80 mmHg）的个体比例在缬沙坦/HCTZ组（55.3%）和氨氯地平/HCTZ组（54.9%）中相似，缬沙坦/HCTZ组（54.3%）达到推荐ABP目标（<130/80 mmHg）的ABP控制率高于氨氯地平/HCTZ组（42.7%）（P = 0.0170）。两种治疗的耐受性均良好。