A Double‐Blind Randomized Placebo‐Controlled Trial of Sibutramine

Bray, George A.; Ryan, Donna H.; Gordon, Douglas; Heidingsfelder, Sylvia A.; Cerise, Frederick P.; Wilson, Krause

doi:10.1002/j.1550-8528.1996.tb00544.x

Cited by 185 publications

(103 citation statements)

References 18 publications

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“…In a previous 24-week dose-ranging study in normotensive obese patients, weight loss at week 12 in patients on sibutramine 20 mg once daily was 5.7% of body weight. 7 These losses are comparable to those observed with the treatment duration in the present study, indicating that the concomitant use of ␤-blockers does not appear to diminish the efficacy of the compound.…”

Section: Discussionsupporting

confidence: 83%

“…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.…”

Section: Discussionmentioning

confidence: 52%

“…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.…”

Section: Journal Of Human Hypertensionmentioning

confidence: 99%

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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

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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

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 52%

Section: Journal Of Human Hypertensionmentioning

confidence: 99%

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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

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“…A common approach, free care, is to provide a study intervention free of charge hoping that the weight loss induced by the study will be a sufficient enticement for the subject to complete the trial. Another approach is to offer participation in a follow-up study (3). A third approach, paid participation, is to pay the subjects to participate in a study and to make the payment contingent upon completion of the study unless the dropout is for a side effect and beyond the subject's control.…”

Section: Introductionmentioning

confidence: 99%

Methods to Maximize Retention in Weight Loss Studies

1999

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GREENWAY, FRANK L., GEORGE A. BRAY, AND ROBERT L. MARLIN. Methods to maximize retention in weight loss studies. Obes Res. 1999;7:593-596. Objective: Dropouts from clinical trials decrease quality and increase costs. Free participation, paid participation, and contingency contracting are three study retention methods. Contingency contracting, or depositing a fee to be refunded contingent upon attendance in a clinical trial, has been reported to decrease dropouts without affecting weight loss. These three methods of retention were compared with a commercial weight loss clinic's practice of charging nonrefundable fees. Methods and Procedures: Dropouts were compared in two studies testing mazindol, with one study using free care and the other using contingency contracting; two studies testing phenylpropanolamine, one using free care and the other using contingency contracting; and in studies with phenylpropanolamine on file with Thompson Medical Company using free care, paid participation, and contingency contracting. Results: The dropout rate was 50% at 8 weeks in a trial of mazindol with free care vs. 7% for contingency contracting (~0 . 0 0 1). The two phenylpropanolamine studies gave the same weight losses, but the dropouts were 37% at 8 weeks for free care vs. 1 1 % for contingency contracting (p

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“…[3][4][5][6][7][8][9] Weight losses at 1 year were approximately 15-17% of initial body weight with phen-fen [3][4][5][6][7][8][9] compared to losses of 6-10% of initial body weight with single-drug treatment using fenfluramine. [10][11][12][13][14][15][16][17][18][19] When fenfluramine and dexfenfluramine were removed from the market in September 1997 because of concerns about cardiac valve lesions, 4,6,[20][21][22][23][24][25][26][27][28][29][30][31][32][33] some physicians turned to combinations of phentermine and other serotonin-active drugs such as fluoxetine and sertraline in an attempt to reproduce the phen-fen effect. However, there are very few studies published on the efficacy of these combinations for obesity, and none have compared results with phen-fen.…”

Section: Introductionmentioning

confidence: 99%

Comparison of combinations of drugs for treatment of obesity: body weight and echocardiographic status

et al. 2006

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Background: Obesity treatment with single drugs produces weight losses of about 8-10% of initial body weight. Few studies of combinations of drugs for treating obesity have been published. The combination of phentermine, an adrenergic agent, and fenfluramine, a serotonergic agent, (phen-fen) produced weight losses of about 15% of initial body weight. Fenfluramine is no longer available because it was associated with cardiac valve lesions. Phentermine-fluoxetine (phen-flu) has been proposed as an alternative for phen-fen. Objective: To compare the efficacy of treatment and prevalence of cardiac valve abnormalities on phen-flu vs phen-fen. Design: Retrospective chart review of all patients treated for at least 3 months with phen-flu (N ¼ 97) to a random sample of patients treated with phen-fen (N ¼ 98) in the Clinical Nutrition Clinic at the University of Wisconsin. Comparison of echocardiograms in all patients treated solely with phen-flu (N ¼ 21) to a random sample of patients treated with phen-fen (N ¼ 47), and to a group of subjects never treated with obesity drugs (N ¼ 26). Results: With last observation carried forward analysis (LOCF), at 6 months of treatment the phen-fen patients lost 12.670.6% of baseline weight and phen-flu patients lost 9.070.6% (Po0.001). With completers analysis, there were no significant differences in weight loss as a percent of baseline weight at 6 months (14.470.6 vs 13.370.9%). LOCF decreases in body mass index (BMI) at 6 months were À5.3 and À3.6 kg/m 2 for phen-fen and phen-flu, respectively (Po0.001), and 6.270.3 vs 5.470.4 kg/m 2 , respectively, for the completers analysis (P -NS). Dropout rate at 6 months was higher in phen-flu subjects (44 vs 28%). In subjects without atherosclerosis of valves (presumably pre-existing), cardiac valve lesions occurred in eight of 38 phen-fen subjects and in none of 15 phen-flu subjects or 25 control subjects who had not been treated with drugs. Conclusions: The combination of phentermine and fluoxetine was not as effective as phen-fen, but was not associated with cardiac valve lesions. Longer term, larger scale studies of phen-flu are warranted.

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A Double‐Blind Randomized Placebo‐Controlled Trial of Sibutramine

Cited by 185 publications

References 18 publications

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

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

Methods to Maximize Retention in Weight Loss Studies

Comparison of combinations of drugs for treatment of obesity: body weight and echocardiographic status

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