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The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy

BACKGROUND: Extended-release (ER) naltrexone/bupropion (NB) was associated with greater weight loss than placebo in four randomized, 56-week trials. The association of NB with longer-term maintenance of weight loss remains unknown. METHODS: We conducted a post-hoc analysis of four phase III, randomi...

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Autores principales: le Roux, Carel W., Fils-Aimé, Nadège, Camacho, Fernando, Gould, Errol, Barakat, Maxime
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9156890/
https://www.ncbi.nlm.nih.gov/pubmed/35747175
http://dx.doi.org/10.1016/j.eclinm.2022.101436
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author le Roux, Carel W.
Fils-Aimé, Nadège
Camacho, Fernando
Gould, Errol
Barakat, Maxime
author_facet le Roux, Carel W.
Fils-Aimé, Nadège
Camacho, Fernando
Gould, Errol
Barakat, Maxime
author_sort le Roux, Carel W.
collection PubMed
description BACKGROUND: Extended-release (ER) naltrexone/bupropion (NB) was associated with greater weight loss than placebo in four randomized, 56-week trials. The association of NB with longer-term maintenance of weight loss remains unknown. METHODS: We conducted a post-hoc analysis of four phase III, randomized, double-blind, placebo-controlled, 56-week studies (COR-I, COR-II, COR-BMOD, and COR-DM), the placebo-controlled cardiovascular outcomes trial LIGHT (208 weeks), and the randomized, open-label trial IGNITE (78 weeks). Included subjects were treated with NB 32 mg/360 mg or placebo, with baseline, week 16, and final time point data. The primary outcome was Kaplan-Meier-estimated weight loss maintenance in each study for up to 204 weeks. FINDINGS: Our analysis included data from 10,198 particpants (NB=5412; placebo=4786). Proportions of patients with ≥5% or ≥10% weight loss maintenance were numerically higher for NB vs. placebo in all studies and time points. Differences were statistically significant for ≥5% weight loss maintenance in COR-BMOD and COR-I/-II at weeks 52 and 56 and the LIGHT study at weeks 52, 104, and 208. For ≥10% weight loss maintenance, differences were statistically significant in COR-I/COR-II at weeks 52 and 56. INTERPRETATION: These data suggest that NB could be used as part of long-term, comprehensive weight loss and weight loss maintenance strategies. FUNDING: Orexigen Therapeutics, Inc. and Bausch Health Canada.
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spelling pubmed-91568902022-06-22 The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy le Roux, Carel W. Fils-Aimé, Nadège Camacho, Fernando Gould, Errol Barakat, Maxime eClinicalMedicine Articles BACKGROUND: Extended-release (ER) naltrexone/bupropion (NB) was associated with greater weight loss than placebo in four randomized, 56-week trials. The association of NB with longer-term maintenance of weight loss remains unknown. METHODS: We conducted a post-hoc analysis of four phase III, randomized, double-blind, placebo-controlled, 56-week studies (COR-I, COR-II, COR-BMOD, and COR-DM), the placebo-controlled cardiovascular outcomes trial LIGHT (208 weeks), and the randomized, open-label trial IGNITE (78 weeks). Included subjects were treated with NB 32 mg/360 mg or placebo, with baseline, week 16, and final time point data. The primary outcome was Kaplan-Meier-estimated weight loss maintenance in each study for up to 204 weeks. FINDINGS: Our analysis included data from 10,198 particpants (NB=5412; placebo=4786). Proportions of patients with ≥5% or ≥10% weight loss maintenance were numerically higher for NB vs. placebo in all studies and time points. Differences were statistically significant for ≥5% weight loss maintenance in COR-BMOD and COR-I/-II at weeks 52 and 56 and the LIGHT study at weeks 52, 104, and 208. For ≥10% weight loss maintenance, differences were statistically significant in COR-I/COR-II at weeks 52 and 56. INTERPRETATION: These data suggest that NB could be used as part of long-term, comprehensive weight loss and weight loss maintenance strategies. FUNDING: Orexigen Therapeutics, Inc. and Bausch Health Canada. Elsevier 2022-05-27 /pmc/articles/PMC9156890/ /pubmed/35747175 http://dx.doi.org/10.1016/j.eclinm.2022.101436 Text en © 2022 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Articles
le Roux, Carel W.
Fils-Aimé, Nadège
Camacho, Fernando
Gould, Errol
Barakat, Maxime
The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy
title The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy
title_full The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy
title_fullStr The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy
title_full_unstemmed The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy
title_short The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy
title_sort relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9156890/
https://www.ncbi.nlm.nih.gov/pubmed/35747175
http://dx.doi.org/10.1016/j.eclinm.2022.101436
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