Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine

Apfelbaum, M; Vague, P; Ziegler, O.; Hanotin, Corinne; Thomas, Florence; Leutenegger, E.

doi:10.1016/s0002-9343(98)00411-2

Cited by 339 publications

(289 citation statements)

References 15 publications

Supporting

Mentioning

248

Contrasting

Unclassified

Order By: Relevance

“…Treatment-emergent adverse events were reported by 141 of the 146 patients (96.6%) in the sibutramine group, and by 65 of the 74 patients (87.8%) in the placebo group and were similar to those reported previously. [6][7][8]13 The nature, frequency, and severity of adverse events were not statistically significantly different in the sibutramine group compared with the placebo group. The majority of adverse events were of either mild or moderate severity.…”

Section: Safetymentioning

confidence: 87%

See 1 more Smart Citation

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

McMahon¹,

et al. 2002

View full text Add to dashboard Cite

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

show abstract

Section: Safetymentioning

confidence: 87%

“…A 52-week treatment period was chosen because the results of prior studies show that patients treated with sibutramine achieve maximal weight loss by about 24 weeks and maintain it while they continue treatment. 6,7,13 …”

Section: Treatment Schedulementioning

confidence: 99%

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

McMahon¹,

et al. 2002

View full text Add to dashboard Cite

show abstract

“…The weight loss attained in this open-label, observational study was comparable to, and in some cases exceeded, that achieved previously in placebo-controlled studies. 13,36,37 Many of the patients in this study had comorbid conditions associated with obesity such as hypertension, type II diabetes mellitus, and dyslipidaemia. The lower percentage weight loss seen especially in patients with diabetic comorbidities at baseline is a well-known phenomenon 38 and related to the fact that diabetic patients, in particular, are on concomitant medications that tend to increase body weight.…”

Section: Discussionmentioning

confidence: 99%

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

Gaciong

Placha

2005

J Hum Hypertens

View full text Add to dashboard Cite

This study aims to determine the efficacy and tolerability of sibutramine hydrochloride in overweight and obese patients with cardiovascular risk factors. This was a 12-week, open-label, observational trial carried out in primary care settings. Patients' data were obtained from questionnaires received from 153 physicians. A total of 2225 overweight and obese (BMIX27 kg/m 2 ) patients received sibutramine in single daily doses of 10 and/or 15 mg. The study population included patients in general good health and with controlled hypertension (41.2%), type II diabetes mellitus (15.6%), hyperlipidaemia (45.5%), and who were chronic tobacco users (smokers) (37.0%). The main outcome measures were changes in body weight, blood pressure and heart rate, and evaluation of reported adverse events. Reduction of body weight of at least 45% from baseline to week 12 was achieved in 2030 (91%) patients and 410% was achieved in 987 (44%) patients. Baseline differences in the percentages of male and female patients, presence or absence of hyperlipidaemia or smoking status did not appear to affect the rate of weight change. Weight loss was less in patients with type II diabetes mellitus and/or controlled systolic hypertension at baseline compared to those patients without these conditions. Mean systolic and diastolic blood pressure and heart rate decreased from baseline to week 12. Overall, sibutramine was well tolerated. In conclusions, treatment with sibutramine resulted in clinically significant weight loss during short-term therapy in obese adults with a range of cardiovascular risk factors.

show abstract

“…[1][2][3] Sibutramine (sibutramine hydrochloride monohydrate; Meridia  , Reductil  ) taken orally once daily enhances satiety and produces significant, dose-related weight reduction in obese patients when used as an adjunct to dietary and behavioural measures. [4][5][6] At doses of 5 to 20 mg once daily, sibutramine is safe and well tolerated, and weight…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2002

View full text Add to dashboard Cite

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

show abstract

Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine

Cited by 339 publications

References 15 publications

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

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

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

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

Contact Info

Product

Resources

About