老年人动态收缩期高血压监测：依普罗沙坦/氢氯噻嗪与氯沙坦/氢氯噻嗪的比较（INSIST 试验）。

Ambulatory monitoring of systolic hypertension in the elderly: Eprosartan/hydrochlorothiazide compared with losartan/hydrochlorothiazide (INSIST trial).

机构信息

Department of Internal Medicine 1, University of Bologna, Sant'Orsola Hospital, Bologna, Italy.

出版信息

Adv Ther. 2010 Jun;27(6):365-80. doi: 10.1007/s12325-010-0032-7. Epub 2010 Jun 16.

DOI:10.1007/s12325-010-0032-7

PMID:20556561

Abstract

INTRODUCTION

Systolic hypertension is very common in the elderly and is strongly associated with the risk of cardiovascular and cerebrovascular events. The control of systolic hypertension is difficult and most patients require combination antihypertensive therapy. Few data are available regarding the efficacy of angiotensin II receptor antagonists on systolic hypertension of the elderly. The aim of this double-blind, double-dummy, randomized, parallel-group, multicenter study was to assess the efficacy of eprosartan 600 mg in combination with hydrochlorothiazide (HCTZ) 12.5 mg in comparison with losartan 50 mg in combination with HCTZ 12.5 mg, in reducing blood pressure in elderly patients with grade 2 systolic hypertension who did not optimally respond to eprosartan or losartan monotherapy.

METHODS

After a 3-week placebo wash-out, 155 patients with an Office trough sitting systolic blood pressure (Office sitSBP) >or=160 mmHg and <180 mmHg were randomized to eprosartan 600 mg (n=78) or losartan 50 mg (n=77) once daily for 6 weeks. In patients not optimally responding to monotherapy (Office sitSBP>or=130 mmHg) 12.5 mg HCTZ was added as fixed combination once daily for 6 weeks. A 24-hour ambulatory blood pressure monitoring (ABPM) was performed at the end of wash-out and at the end of the fixed-combination period.

RESULTS

No statistically significant difference was found between eprosartan/HCTZ and losartan/HCTZ on the primary endpoint (24-hour ABPM SBP) with an adjusted mean difference between treatments of 3.1 mmHg (95% CI: -0.32-6.59). However, the mean 24-hour ABPM SBP significantly decreased by 16.7 mmHg with eprosartan/HCTZ and 20.3 mmHg with losartan/HCTZ (P<0.001 vs. baseline). The mean Office sitSBP significantly decreased by 28.7 mmHg and 29.6 mmHg respectively, with eprosartan/HCTZ and losartan/HCTZ (P<0.001 vs.baseline and vs. monotherapy).

CONCLUSION

In this study, eprosartan/HCTZ did not demonstrate to be superior to losartan/HCTZ in reducing ABPM systolic hypertension in the elderly.

摘要

简介

收缩期高血压在老年人中非常常见，与心血管和脑血管事件的风险密切相关。收缩期高血压的控制较为困难，大多数患者需要联合降压治疗。关于血管紧张素 II 受体拮抗剂对老年收缩期高血压的疗效，数据较少。本双盲、双模拟、随机、平行分组、多中心研究旨在评估依普罗沙坦 600mg 联合氢氯噻嗪（HCTZ）12.5mg 与氯沙坦 50mg 联合 HCTZ 12.5mg 治疗未接受依普罗沙坦或氯沙坦单药治疗的 2 级收缩期高血压老年患者的降压疗效。

方法

在 3 周安慰剂洗脱期后，将 155 例诊室谷坐位收缩压（Office sitSBP）≥160mmHg 且<180mmHg 的患者随机分为依普罗沙坦 600mg（n=78）或氯沙坦 50mg（n=77）组，每日一次，治疗 6 周。对单药治疗未达标的患者（Office sitSBP>或=130mmHg），加用氢氯噻嗪 12.5mg 作为固定剂量联合治疗，持续 6 周。在洗脱期结束和固定剂量联合治疗结束时，进行 24 小时动态血压监测（ABPM）。

结果

依普罗沙坦/HCTZ 与氯沙坦/HCTZ 治疗组在主要终点（24 小时 ABPM SBP）上无统计学差异，治疗组间平均差异为 3.1mmHg（95%CI：-0.32-6.59）。然而，依普罗沙坦/HCTZ 治疗组 24 小时 ABPM SBP 平均下降 16.7mmHg，氯沙坦/HCTZ 治疗组下降 20.3mmHg（与基线相比，P<0.001）。依普罗沙坦/HCTZ 组和氯沙坦/HCTZ 组平均诊室坐位收缩压分别下降 28.7mmHg 和 29.6mmHg（与基线相比，P<0.001）。