A clinical trial of the use of Sibutramine for the treatment of patients suffering essential obesity

Abstract

OBJECTIVE: To evaluate the safety and ef®cacy of Sibutramine 10 mg per os, once a day in obese patients over a period of 6 months. DESIGN: A monocenter, double-blind, placebo-controlled, parallel, prospective clinical trial. SUBJECTS: 109 male and female obese patients (BMI b b 30 kgam 2 ) from 16 to 65 y entered the trial. MEASUREMENTS: Body weight, body mass index (BMI), waist and waistahip ratio, medical history, assessment of hunger, satiety and diet compliance, standard laboratory assessments, blood pressure, heart rate and ECG. RESULTS: 40 out of 55 patients in the Sibutramine group and 44 out of 54 patients in the placebo group completed the trial. Using the method of last observation carried forward (LOCF), the weight loss in the Sibutramine group was 7.52 kg (95% con®dence intervals (95% CI) 6.15; 8.9) and that in the placebo group was 3.56 kg (95% CI 2.41; 4.7). The BMI loss was 3.14 kgam 2 (95% CI 2.58; 3.69) in the Sibutramine group and 1.46 kgam 2 (95% CI 0.99; 1.93) in the placebo group. The waist reduction was 12.51 cm (95% CI 9.25; 15.77) in the Sibutramine group and 3.26 cm (95% CI 1.38; 5.14) in the placebo group (P`0.05 by paired Student's t-test for all the intragroup comparisons). 32 Sibutramine patients had 45 adverse events, the most frequent adverse events in the Sibutramine group being dry mouth (n 19), increase in blood pressure (n 5), constipation (n 5) and tachycardia (n 5); 23 placebo patients had 29 adverse events, mainly increase in blood pressure (n 11) and dry mouth (n 10). Two Sibutramine patients withdrew from the trial due to adverse events. CONCLUSION: Sibutramine induces signi®cant loss of body weight, BMI and waist, but does not signi®cantly affect cardiovascular function. Sibutramine was well tolerated by most of the patients.

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

“…Although the effects of sibutramine on decreasing BP may not be entirely commensurate with the extent of the weight loss achieved, obesity itself has recently been recognised as a major, independent, modifiable risk factor for coronary heart disease, 27 and weight loss and the maintenance of weight are clearly superior when adjunctive sibutramine therapy is used. [6][7][8][15][16][17]28 In the present study, improvements associated with weight loss resulting from sibutramine use included greater improvement in BMI, greater reduction in serum triglyceride and VLDL cholesterol, and increase in HDL cholesterol. Greater improvements in lipids paralleled greater weight loss, as reported previously.…”

“…5 In recent, large, placebo-controlled trials with sibutramine, however, the numbers of patients in whom an increase in BP became clinically significant, or in whom mild hypertension appeared, leading to withdrawal from treatment, were generally not significantly different between sibutramine-and placebo-treated patients. 6,7,[15][16][17] The objective of this study was to evaluate the efficacy of sibutramine on weight loss, BP, and PR in hypertensive obese patients whose BP was well controlled by stable doses of a ␤-adrenergic blocking agent (␤-blocker). This study was part of a series of three studies evaluating the efficacy and tolerability of sibutramine in patients with hypertension well controlled with angiotensin-converting enzyme inhibitors, calcium channel blockers, or ␤-blockers.…”

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

“…5,6,21,22 The beneficial effect on body weight was similar in normotensive patients and in patients with different degrees of hypertension. The reduction in body weight with sibutramine was not associated with a critical change in SBP compared with placebo regardless of the blood pressure class.…”

Sibutramine and blood pressure: a therapeutic dilemma

“…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.…”

“…In the case with sibutramine, the potentially detrimental effect due to the failure of blood pressure to fall with weight loss that might occur with continued use of sibutramine may be offset by the reduction in lipids, insulin, and uric acid that do occur with weight loss. [11][12][13] There are at least two strategies that might reduce the potential concerns about the rise in blood pressure during treatment with sibutramine. The first would be to use sibutramine intermittently.…”