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血管紧张素II受体拮抗剂与血管紧张素转换酶抑制剂治疗高血压的比较:替米沙坦与依那普利临床研究综述

Treatment of hypertension with an angiotensin II-receptor antagonist compared with an angiotensin-converting enzyme inhibitor: a review of clinical studies of telmisartan and enalapril.

作者信息

Smith David H G

机构信息

Integrium, Orange, California 92868, USA.

出版信息

Clin Ther. 2002 Oct;24(10):1484-501. doi: 10.1016/s0149-2918(02)80056-x.

Abstract

BACKGROUND

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II (ATII)-receptor antagonists suppress the effects of ATII and are effective antihypertensive agents. However, the use of ACE inhibitors is sometimes associated with intolerable side effects (eg, cough, angioedema), and patients may develop a compensatory rise in ATII levels. ATII-receptor antagonists have tolerability profiles similar to that of placebo and inhibit the effects of ATII more completely by blocking the AT1 receptor.

OBJECTIVE

This review summarizes clinical studies comparing the efficacy and tolerability of the ATII-receptor antagonist telmisartan with the ACE inhibitor enalapril in patients with hypertension.

METHODS

Randomized, controlled clinical trials comparing telmisartan with enalapril in patients with primary hypertension were identified through a PubMed search of the English-language literature from 1998 through 2001 and from bibliographic data provided by the manufacturer of telmisartan.

RESULTS

In 2 randomized, double-blind, placebo-controlled trials (total number of patients, 647), telmisartan 40 or 80 mg/d was at least as effective as enalapril 20 mg/d for lowering blood pressure (BP) in patients with mild to moderate hypertension. An open-label, titration-to-response study involving 86 patients with severe hypertension found that telmisartan 80 to 160 mg/d was as efficacious as enalapril 20 to 40 mg/d. The antihypertensive effects of telmisartan 20 to 80 mg/d and enalapril 5 to 20 mg/d were comparable in 278 elderly patients (age > or = 65 years) with mild to moderate hypertension enrolled in a 26-week, double-blind, dose-titration study. A double-blind, titration-to-response study in 71 patients with moderate renal impairment and mild to moderate hypertension found equivalent reductions in BP with telmisartan 40 to 80 mg/d and enalapril 10 to 20 mg/d without any clinically relevant decline in renal function. Telmisartan tended to be better tolerated than enalapril in this study, with fewer patients experiencing treatment-related adverse events (8.9% vs 26.9%, respectively).

CONCLUSIONS

Based on the literature included in this review, telmisartan and enalapril produced comparable reductions in BP in a broad range of patients with hypertension. Telmisartan appeared to have a better tolerability profile.

摘要

背景

血管紧张素转换酶(ACE)抑制剂和血管紧张素II(ATII)受体拮抗剂可抑制ATII的作用,是有效的抗高血压药物。然而,ACE抑制剂的使用有时会伴有难以耐受的副作用(如咳嗽、血管性水肿),且患者的ATII水平可能会出现代偿性升高。ATII受体拮抗剂的耐受性与安慰剂相似,通过阻断AT1受体能更完全地抑制ATII的作用。

目的

本综述总结了比较ATII受体拮抗剂替米沙坦与ACE抑制剂依那普利在高血压患者中疗效和耐受性的临床研究。

方法

通过检索1998年至2001年的英文文献PubMed以及替米沙坦制造商提供的书目数据,确定了比较替米沙坦与依那普利治疗原发性高血压患者的随机对照临床试验。

结果

在2项随机、双盲、安慰剂对照试验(患者总数647例)中,替米沙坦40或80mg/d降低轻度至中度高血压患者血压的效果至少与依那普利20mg/d相当。一项纳入86例重度高血压患者的开放标签、根据反应调整剂量的研究发现,替米沙坦80至160mg/d与依那普利20至40mg/d的疗效相当。在一项为期26周的双盲、剂量滴定研究中,纳入的278例年龄≥65岁的轻度至中度高血压老年患者中,替米沙坦20至80mg/d与依那普利5至20mg/d的降压效果相当。一项纳入71例中度肾功能损害且轻度至中度高血压患者的双盲、根据反应调整剂量的研究发现,替米沙坦40至80mg/d与依那普利10至20mg/d降低血压的效果相当,且肾功能无任何临床相关下降。在本研究中,替米沙坦的耐受性往往优于依那普利,发生治疗相关不良事件的患者较少(分别为8.9%和26.9%)。

结论

基于本综述纳入的文献,替米沙坦和依那普利在广泛的高血压患者中降低血压的效果相当。替米沙坦的耐受性似乎更好。

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