Efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by β-adrenergic blocking agents: a placebo-controlled, double-blind, randomised trial

Abstract

Sibutramine is a serotonin-noradrenaline reuptake inhibitor that is effective for long-term weight reduction and maintenance in obese patients when used as an adjunct to dietary and behavioural measures. Because the inhibition of noradrenaline reuptake may be expected to increase systolic and diastolic blood pressure (SBP and DBP) and pulse rate (PR), a 12-week multi-centre, placebo-controlled, double-blind study was designed to evaluate the efficacy and tolerability of sibutramine for weight loss in obese patients whose hypertension was well controlled (DBP р95 mm Hg) by ␤-adrenergic blocking agents (␤-blockers), with or without concomitant thiazide diuretics. Of the 61 patients randomised to sibutramine 20 mg once daily or placebo, 55 patients (90%) completed the study. After 12 weeks, sibutramine-treated patients lost significantly more weight than placebo-treated patients: mean weight reductions were 4.2 kg (4.5%) in the sibutramine group vs 0.3 kg (0.4%) in the placebo group (P Ͻ0.001). Greater weight reduction on sibutramine was accompanied by trends for greater mean reductions in serum triglycerides and very low density lipoprotein cholesterol. Sibutramine was well tolerated, and most adverse events were mild or moderate in severity. No sibutramine patient discontinued treatment because of an adverse event. Mean supine and standing DBP and SBP were not

Influence of Sibutramine on blood pressure: evidence from placebo-controlled trials

“…12 Nonetheless, in chronic studies, sibutramine reduced body weight in obese hypertensive patients treated with a beta-adrenoreceptor blocker. 30 In the present study, patients who were treated with either angiotensinconverting enzyme inhibitors or AT1 receptor blockers had a similar weight loss response to sibutramine as patients who were untreated. In our analysis, we did not see a major difference in the blood pressure response to sibutramine in patients with or without antihypertensive medications.…”

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

“…The current Summary of Product Characteristics (SmPC) 14 does not contraindicate the use of sibutramine in patients with well-controlled hypertension, and several studies conducted over the dose range 10-20 mg for periods of upto 12 months have indicated that sibutramine is safe and effective in these patients. [15][16][17]51 Patients with coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmias, and cerebrovascular disease are contraindicated in the SmPC and it also recommends regular monitoring of blood pressure and heart rate in all patients. 14 In conclusion, this study demonstrates that sibutramine treatment safely produced clinically significant weight loss in a primary-care setting for 12 weeks in obese adults who had cardiovascular risk factors.…”

“…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.…”