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安慰剂对照比较每日一次莫索尼定和依那普利治疗轻至中度原发性高血压的疗效和耐受性。

Placebo-controlled comparison of the efficacy and tolerability of once-daily moxonidine and enalapril in mild to moderate essential hypertension.

作者信息

Prichard Brian N C, Jäger Bodo A, Luszick Joachim H, Küster Leslie J, Verboom Caes N, Hughes Peter R, Sauermann Wilhelm, Küppers Hartmut E

机构信息

Division of Clinical Pharmacology & Toxicology, University College London Medical School, The Rayne Institute, UK.

出版信息

Blood Press. 2002;11(3):166-72. doi: 10.1080/080370502760050403.

DOI:10.1080/080370502760050403
PMID:12126263
Abstract

OBJECTIVES

To compare the antihypertensive efficacy and tolerability of the imidazoline I1-receptor agonist moxonidine, administered as a single daily dose of 0.6 mg, with the angiotensin-converting enzyme inhibitor enalapril (20 mg o.d.) in patients with mild to moderate essential hypertension.

METHODS

A total of 154 patients were enrolled and randomized to placebo (n = 50), moxonidine (0.2 mg o.d.; n = 51) or enalapril (5 mg o.d.; n = 53) for 2 weeks. Dosages were then increased to moxonidine 0.6 mg o.d. or enalapril 20 mg o.d. for a further 6 weeks. Blood pressure responses to therapy were measured using conventional office techniques and by 24-h ambulatory blood pressure monitoring.

RESULTS

The average reduction in sitting blood pressure with moxonidine was similar to that achieved with enalapril (24.9 +/- 20.7/13.2 +/- 8.4 mmHg vs 21.9 +/- 17.1/11.9 +/- 7.5 mmHg, respectively) and significantly superior to that seen with placebo (1.2 +/- 14.4/2.3 +/- 7.0 mmHg; p < 0.001). Reductions in blood pressure after 8 weeks of treatment were as follows: moxonidine, from 166.2 +/- 15.5/101.3 +/- 4.0 to 141.2 +/- 15.7/88.1 +/- 7.7mmHg; enalapril, from 165.4 +/- 14.3/101.1 +/- 4.4 to 143.5 +/- 12.7/89.2 +/- 7.4 mmHg; and placebo, from 162.5 +/- 14.4/99.9 +/- 3.9 to 161.3 +/- 17.9/97.6 +/- 6.6 mmHg. Both moxonidine and enalapril produced sustained reductions in blood pressure during 24-h recording (p < 0.01 for overall effect of either drug vs placebo). Average 24-h blood pressure was reduced from 149.8 +/- 14.3/92.2 +/- 7.0 to 134.0 +/- 13.1/82.3 +/- 8.9 mmHg with moxonidine and from 146.5 +/- 13.0/ 92.5 +/- 7.2 to 131.1 +/- 11.0/82.1 +/- 8.8 mmHg with enalapril; the change with placebo was small (from 147.3 +/- 13.3/90.0 +/- 6.2 to 144.8 +/- 12.9/89.5 +/- 8.0 mmHg). Both drugs were generally well tolerated. No patients withdrew from the study because of drug-attributed adverse events.

CONCLUSION

Moxonidine 0.6 mg o.d. and enalapril 20 mg o.d. have similar antihypertensive efficacy.

摘要

目的

比较每日单次服用0.6毫克的咪唑啉I1受体激动剂莫索尼定与血管紧张素转换酶抑制剂依那普利(每日20毫克)对轻至中度原发性高血压患者的降压疗效和耐受性。

方法

共纳入154例患者,随机分为安慰剂组(n = 50)、莫索尼定组(每日0.2毫克;n = 51)或依那普利组(每日5毫克;n = 53),治疗2周。然后剂量分别增加至莫索尼定每日0.6毫克或依那普利每日20毫克,再治疗6周。采用传统诊室技术和24小时动态血压监测来测量治疗后的血压反应。

结果

莫索尼定使坐位血压的平均降幅与依那普利相似(分别为24.9±20.7/13.2±8.4毫米汞柱和21.9±17.1/11.9±7.5毫米汞柱),且显著优于安慰剂组(1.2±14.4/2.3±7.0毫米汞柱;p<0.001)。治疗8周后的血压降幅如下:莫索尼定,从166.2±15.5/101.3±4.0降至141.2±15.7/88.1±7.7毫米汞柱;依那普利,从165.4±14.3/101.1±4.4降至143.5±12.7/89.2±7.4毫米汞柱;安慰剂,从162.5±14.4/99.9±3.9降至161.3±17.9/97.6±6.6毫米汞柱。在24小时记录期间,莫索尼定和依那普利均使血压持续下降(两种药物与安慰剂相比的总体效应p<0.01)。莫索尼定使24小时平均血压从149.8±14.3/92.2±7.0降至134.0±13.1/82.3±8.9毫米汞柱,依那普利使血压从146.5±13.0/92.5±7.2降至131.1±11.0/82.1±8.8毫米汞柱;安慰剂组的变化较小(从147.3±13.3/90.0±6.2降至144.8±12.9/89.5±8.0毫米汞柱)。两种药物总体耐受性良好。没有患者因药物相关不良事件退出研究。

结论

每日0.6毫克的莫索尼定和每日20毫克的依那普利具有相似的降压疗效。

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