坎地沙坦酯与依那普利每日一次治疗轻度至中度高血压患者的疗效持续时间比较。

The effect duration of candesartan cilexetil once daily, in comparison with enalapril once daily, in patients with mild to moderate hypertension.

作者信息

Himmelmann A, Keinänen-Kiukaanniemi S, Wester A, Redón J, Asmar R, Hedner T

机构信息

Department of Clinical Pharmacology, Sahlgrenska University Hospital, Göteborg, Sweden.

出版信息

Blood Press. 2001;10(1):43-51. doi: 10.1080/080370501750183381.

DOI:10.1080/080370501750183381

PMID:11332334

Abstract

OBJECTIVE

To determine the antihypertensive efficacy, effect duration and safety of the angiotensin II type 1 receptor blocker candesartan cilexetil and the angiotensin converting enzyme inhibitor enalapril once daily in patients with mild to moderate hypertension.

METHODS

A multicenter, randomised, double-blind parallel group study was performed in Finland, France, the Netherlands, Spain and Sweden. Three-hundred-and-ninety-five men and women in the age range 20-80 years with primary hypertension were randomised to an 8-week double-blind treatment period with either candesartan cilexetil 8-16 mg or enalapril 10-20 mg once daily, with forced dose titration after 4 weeks. Non-invasive ambulatory blood pressure was measured for 36 h at baseline and after 8 weeks. The primary efficacy variable was the change in mean diastolic and systolic ambulatory blood pressure 22-24 h post-dose.

RESULTS

There was a significant difference in the adjusted mean difference for the change from baseline to week 8 between candesartan cilexetil and enalapril 22-24 h post-dose by -3.5 mmHg (95% confidence interval, CI: -6.8 to -0.3 mmHg; p < 0.032) in ambulatory systolic blood pressure and -3.0 mmHg (95% CI: -5.1 to -0.8 mmHg; p < 0.008) in ambulatory diastolic blood pressure. There was a significant difference in adjusted mean daytime ambulatory blood pressure 24-36 h post-dose by -4.2 mmHg (95% CI: -6.8 to -1.6 mmHg; p < 0.002)/-3.5 mmHg (95% CI: -5.1 to -1.8 mmHg; p < 0.001). Both drugs were generally well tolerated.

CONCLUSION

The results of the present study suggest that advantages may be attributed to the use of candesartan cilexetil, as compared to enalapril in the treatment of patients with essential hypertension. In comparison with enalapril 20 mg, candesartan cilexetil 16 mg more effectively lowered blood pressure at trough and in particular on the day following the day after the last dose.

摘要

目的

确定1型血管紧张素II受体阻滞剂坎地沙坦酯和血管紧张素转换酶抑制剂依那普利每日一次用于轻至中度高血压患者的降压疗效、作用持续时间及安全性。

方法

在芬兰、法国、荷兰、西班牙和瑞典进行了一项多中心、随机、双盲平行组研究。395名年龄在20 - 80岁的原发性高血压男性和女性被随机分配到一个为期8周的双盲治疗期，每日一次服用8 - 16 mg坎地沙坦酯或10 - 20 mg依那普利，并在4周后强制进行剂量滴定。在基线和8周后测量36小时的无创动态血压。主要疗效变量是给药后22 - 24小时动态舒张压和收缩压的变化。

结果

坎地沙坦酯和依那普利给药后22 - 24小时，从基线到第8周的调整后平均差异在动态收缩压方面有显著差异，为-3.5 mmHg（95%置信区间，CI：-6.8至-0.3 mmHg；p < 0.032），在动态舒张压方面为-3.0 mmHg（95%CI：-5.1至-0.8 mmHg；p < 0.008）。给药后24 - 36小时调整后的平均日间动态血压有显著差异，为-4.2 mmHg（95%CI：-6.8至-1.6 mmHg；p < 0.002）/-3.5 mmHg（95%CI：-5.1至-1.8 mmHg；p < 0.001）。两种药物总体耐受性良好。