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西布曲明治疗肥胖高血压患者的随机、双盲、安慰剂对照、多中心研究。

Randomized, double-blind, placebo-controlled, multicenter study of sibutramine in obese hypertensive patients.

作者信息

Hazenberg B P

机构信息

Albert Schweitzer Ziekenhuis, Lokatie Amstelwijk, Dordrecht, The Netherlands.

出版信息

Cardiology. 2000;94(3):152-8. doi: 10.1159/000047310.

DOI:10.1159/000047310
PMID:11279320
Abstract

OBJECTIVES

To compare weight loss efficacy, safety and tolerability of sibutramine and placebo in mildly to moderately obese hypertensive subjects; to assess the effect of weight loss on blood pressure.

DESIGN

Randomized, double-blind, parallel-group; 3-week placebo run-in and 12-week treatment phase.

SETTING

Nine hospital outpatient clinics and general practices in the Netherlands.

PARTICIPANTS

127 men and women, 18-65 years old, with body mass indices (BMI) ranging from 27 to 40 kg/m(2) and stabilized hypertension - mean resting diastolic blood pressure of 90-120 mm Hg - with or without antihypertensive medication.

INTERVENTIONS

Sibutramine 10 mg once daily; placebo.

MAIN OUTCOME MEASURES

Body weight, blood pressure, routine laboratory and clinical safety monitoring.

RESULTS

Of 113 evaluable patients, 54 received sibutramine and 59 placebo. Weight reduction was significantly greater with sibutramine from week 2 onwards (last observation carried forward): mean, 4.4 kg with sibutramine and 2.2 kg with placebo (p = 0.002); mean percentage weight reduction, 4.7 and 2.3%, respectively (p < 0.001); mean BMI reduction, 1.6 and 0.8 kg/m(2), respectively (p < 0.01). Reduction in excessive body weight was associated with a reduction in blood pressure in both groups, although the mean reduction in supine diastolic blood pressure was numerically, but not statistically significantly, greater in the placebo group (5.7 mm Hg) compared with the sibutramine group (4.0 mm Hg; p = 0.21). Similar reductions were seen in supine systolic blood pressure. Both treatments were well tolerated.

CONCLUSIONS

Sibutramine 10 mg once daily is a useful, effective therapy for obesity in the presence of stable hypertension.

摘要

目的

比较西布曲明与安慰剂对轻度至中度肥胖高血压患者的减肥疗效、安全性及耐受性;评估减肥对血压的影响。

设计

随机、双盲、平行组;3周安慰剂导入期和12周治疗期。

地点

荷兰的9家医院门诊和全科诊所。

参与者

127名年龄在18 - 65岁之间的男性和女性,体重指数(BMI)在27至40kg/m²之间,患有稳定型高血压——静息舒张压平均为90 - 120mmHg——无论是否服用抗高血压药物。

干预措施

西布曲明每日10mg一次;安慰剂。

主要观察指标

体重、血压、常规实验室检查及临床安全性监测。

结果

在113名可评估患者中,54名接受西布曲明治疗,59名接受安慰剂治疗。从第2周起,西布曲明组体重减轻显著更多(末次观察结转):西布曲明组平均减轻4.4kg,安慰剂组平均减轻2.2kg(p = 0.002);平均体重减轻百分比分别为4.7%和2.3%(p < 0.001);平均BMI降低分别为1.6和0.8kg/m²(p < 0.01)。两组中,超重减轻均与血压降低相关,尽管安慰剂组仰卧位舒张压的平均降低幅度在数值上大于西布曲明组(5.7mmHg对4.0mmHg),但差异无统计学意义(p = 0.21)。仰卧位收缩压也有类似程度的降低。两种治疗耐受性均良好。

结论

对于伴有稳定型高血压的肥胖患者,每日一次服用10mg西布曲明是一种有效且有用的治疗方法。

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