Dataset Information

Effects of a novel weight-loss combination product containing orlistat and acarbose on obesity: A randomized, placebo-controlled trial.

ABSTRACT:

Objective

The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo.

Methods

The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI ≥30 kg/m² or ≥28 kg/m² with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement.

Results

Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50.

Conclusions

This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.

SUBMITTER: Holmback U

PROVIDER: S-EPMC9826204 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Effects of a novel weight-loss combination product containing orlistat and acarbose on obesity: A randomized, placebo-controlled trial.

Holmbäck Ulf U Grudén Stefan S Litorp Helena H Willhems Daniel D Kuusk Sandra S Alderborn Göran G Söderhäll Arvid A Forslund Anders A

Obesity (Silver Spring, Md.) 20220919 11

<h4>Objective</h4>The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo.<h4>Methods</h4>The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI ≥30 kg/m<sup>2</sup> or ≥28 kg ...[more]

PMID: 36123783

Similar Datasets

Project description:ObjectiveThis study was a randomized placebo-controlled trial testing the addition of orlistat to behavioral weight loss for obesity in Spanish-speaking-only Latino/as with versus without binge eating disorder (BED) performed at a community mental health center serving educationally- and economically-disadvantaged patients. Latino/as have high rates of obesity but are under-represented in obesity treatment studies and despite comparable-to-or-higher rates of BED than Whites, Latino/as are under-represented in BED treatment studies. BED is associated with obesity but whether it predicts/moderates treatment outcomes remains uncertain. Thus, this study also tested whether BED prospectively predicts/moderates outcomes.MethodsSeventy-nine obese Spanish-speaking-only Latino/as with BED (N=40) versus without BED (N=39) at a community mental health center were randomly assigned to four-months of orlistat-plus-BWL or placebo-plus-BWL. BWL was culturally-enhanced modification of Diabetes-Prevention-Program delivered in weekly sessions in Spanish. Orlistat (120 mg tid) and matching-placebo delivered with standard clinical-management. Participants were assessed independently throughout treatment, post-treatment, and six-month follow-up.Results78% completed treatments; completion rates did not differ significantly by medication or BED. Intent-to-treat mixed-models analyses revealed significant improvements in binge eating, eating-psychopathology, and depression, and significant--albeit modest--weight-loss. Overall, the addition of orlistat to BWL was not associated with greater improvements; however, BED moderated weight-loss: orlistat-plus-BWL produced significantly greater weight-loss in non-BED group but not in BED. Improvements were maintained through 6-month follow-up; BED significantly predicted/moderated increases in eating concerns and depression following treatment. Within BED-group, binge-eating remission rates were 65% (post-treatment) and 50% (follow-up).ConclusionsIn this controlled trial performed at community mental health center serving educationally- and economically-disadvantaged Spanish-speaking-only Latino/as with co-morbid psychiatric needs, we observed outcomes for the BWL plus orlistat/placebo medication that approximate or are slightly dampened relative to the literature for efficacy trials with much more restrictive obese and BED samples. In this complex patient group, adding orlistat to BWL produced greater weight-loss than adding placebo among obese patients without BED but not among those with BED. Although 50% of BED patients maintained abstinence from binge-eating following these specific obesity treatments (BWL plus orlistat/placebo), BED was a negative prognostic indicator for some outcome variables.Trial registrationclinicaltrials.gov Identifier: NCT00516919.

Dataset Information

Effects of a novel weight-loss combination product containing orlistat and acarbose on obesity: A randomized, placebo-controlled trial.

Objective

Methods

Results

Conclusions

Publications

Effects of a novel weight-loss combination product containing orlistat and acarbose on obesity: A randomized, placebo-controlled trial.

Similar Datasets

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