Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors

Abstract

Sibutramine treatment in obesity results in significantly greater weight reduction compared with placebo, although weight loss with sibutramine may be accompanied by small but statistically significant mean increases in blood pressure (BP). This 52-week, placebo-controlled, double-blind, randomised study investigated the effects of sibutramine 20 mg once daily or placebo on body weight in 220 obese (body mass index (BMI) 27-40 kg/m 2 ), hypertensive patients. At randomisation, hypertension was well controlled (р95 mm Hg diastolic blood pressure (DBP)) with an angiotensinconverting enzyme (ACE) inhibitor, with or without concomitant thiazide diuretic therapy. Therapy for hypertension continued for the 52 weeks of the study. Sibutramine 20 mg produced significantly greater weight loss compared with placebo: 4.5 kg with sibutramine compared with 0.4 kg with placebo (last observation carried forward (LOCF); P р 0.05). A total of 62 patients (42.8%) treated with sibutramine lost у5% of their body weight compared with six patients (8.3%) treated with placebo; 19 patients (13.1%) treated with sibutramine lost у10% of their body weight compared with two patients (2.8%) treated with placebo (LOCF; P р 0.05 for both comparisons). Hypertension remained well controlled for the 52 weeks of the study with both sibutramine and placebo treatment. After 52 weeks, the differences between placebo treatment and sibutramine

Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice

“…65,66 The greatest improvements in glycemic control occurred in subjects with type 2 diabetes. 67,68 There were no significant effects of sibutramine therapy compared to diet-only therapy on lipids and glycemic control, but sibutramine was associated with higher systolic (1-4 mmHg) and diastolic (2-4 mmHg) blood pressure, 72,73,75,76 including subjects with treated hypertension. 73,75 Metformin had no effect on lipids or glycemic or blood pressure control in one study, 78 but in another study of subjects with impaired glucose tolerance, 77 metformin therapy conferred a 31% lower risk for type 2 diabetes.…”

“…No study reported on weight loss and its effects of cardiovascular risk factors in high-risk groups, unless the study was limited to high-risk subjects. 67,68,70,71,73,[75][76][77] …”

Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

“…14 When hypertension is well controlled with medication, treatment with sibutramine results in reduced body weight with no adverse effects on blood pressure control. [15][16][17] Table 1 highlights what this study adds to what is already known about obesity and its risk factors.…”

Sibutramine and blood pressure: a therapeutic dilemma

“…At present only two drugs are approved for long-term use in the treatment of obesity, and both have troublesome side effects. The two papers 2,3 in this issue of the Journal of Human Hypertension focus on the effect of the anti-obesity drug sibutramine on the blood pressure of hypertensive patients treated for their hypertension.…”

“…10 The observation that sibutramine, a drug that blocks the reuptake of noradrenaline and serotonin and to a lesser degree dopamine, raises blood pressure has been troubling. [11][12][13] We can get some insight into this problem and its importance from the two papers published in this issue of the Journal of Human Hypertension, 2,3 and another published elseCorrespondence: GA Bray, MD Pennington Biomedical Research Center, 6400 Perkins Road, Baton Rouge, LA 70808, USA. E-mail: BrayGAȰpbrc.edu where 14 that used sibutramine to treat the obesity in patients whose blood pressure was controlled with calcium channel blockers, with beta-blockers, or with angiotensin-converting enzyme inhibitors.…”