A Randomized, Phase 3 Trial of Naltrexone SR/bupropion SR on Weight and Obesity-Related Risk Factors (COR-II)
Caroline M. Apovian,Louis J. Aronne,Domenica Rubino,Christopher D. Still,Holly R. Wyatt,Colleen Burns,Dennis Dong Hwan Kim,Eduardo Dunayevich +7 more
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TLDR
To examine the effects of naltrexone/bupropion (NB) combination therapy on weight and weight‐related risk factors in overweight and obese participants, a large number of participants were obese or overweight.Abstract:
Objective:
To examine the effects of naltrexone/bupropion (NB) combination therapy on weight and weight-related risk factors in overweight and obese participants.
Design and Methods:
CONTRAVE Obesity Research-II (COR-II) was a double-blind, placebo-controlled study of 1,496 obese (BMI 30-45 kg/m2) or overweight (27-45 kg/m2 with dyslipidemia and/or hypertension) participants randomized 2:1 to combined naltrexone sustained-release (SR) (32 mg/day) plus bupropion SR (360 mg/day) (NB32) or placebo for up to 56 weeks. The co-primary endpoints were percent weight change and proportion achieving ≥5% weight loss at week 28.
Results:
Significantly (P < 0.001) greater weight loss was observed with NB32 versus placebo at week 28 (−6.5% vs. −1.9%) and week 56 (−6.4% vs. −1.2%). More NB32-treated participants (P < 0.001) experienced ≥5% weight loss versus placebo at week 28 (55.6% vs. 17.5%) and week 56 (50.5% vs. 17.1%). NB32 produced greater improvements in various cardiometabolic risk markers, participant-reported weight-related quality of life, and control of eating. The most common adverse event with NB was nausea, which was generally mild to moderate and transient. NB was not associated with increased events of depression or suicidality versus placebo.
Conclusion:
NB represents a novel pharmacological approach to the treatment of obesity, and may become a valuable new therapeutic option.read more
Citations
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Pharmacotherapy in obesity: a systematic review and meta-analysis of randomized controlled trials of anti-obesity drugs
Awadhesh Kumar Singh,Ritu Singh +1 more
TL;DR: A meta-analysis finds a significant reduction in body weight with orlistat compared to placebo, and the effect of these anti-obesity drugs on other cardio-metabolic parameters including key adverse events is reviewed.
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Preclinical and Clinical Evidence for a Distinct Regulation of Mu Opioid and Type 1 Cannabinoid Receptor Genes Expression in Obesity
Mariangela Pucci,Maria Vittoria Micioni Di Bonaventura,Valeria Vezzoli,Elizabeta Zaplatic,Marcella Massimini,Stefania Mai,Alessandro Sartorio,Massimo Scacchi,Luca Persani,Mauro Maccarrone,Carlo Cifani,Claudio D'Addario,Claudio D'Addario +12 more
TL;DR: Evidence of selective, synergistic and time-dependent transcriptional regulation of CNR1 and OPRM1 genes in overweight rats, as well as in human subjects is provided.
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American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.
Lawrence Blonde,Guillermo E. Umpierrez,Janet B. McGill,Sreedevi S. Reddy,Sarah L. Berga,Michael A. Bush,Suchitra Chandrasekaran,Ralph A. DeFronzo,Daniel Einhorn,Rodolfo J. Galindo,Thomas W. Gardner,Rajesh Garg,W. Timothy Garvey,Irl B. Hirsch,Daniel L. Hurley,Kenneth E. Izuora,Mikhail Kosiborod,Darin E. Olson,Shailendra Patel,Rodica Pop-Busui,Archana R. Sadhu,Susan L. Samson,Carla Stec,William V. Tamborlane,Katherine R. Tuttle,Christine Twining,Adrian Vella,Priyathama Vellanki,Sandra L. Weber +28 more
TL;DR: The American Association of Clinical Endocrinology selected a task force of medical experts and staff who updated and assessed clinical questions and recommendations from the prior 2015 version of this guideline and conducted literature searches for relevant scientific papers published from January 1, 2015, through May 15, 2022 as mentioned in this paper .
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Anti-Obesity Drugs: Long-Term Efficacy and Safety: An Updated Review
Young Jin Tak,Sang Yeoup Lee +1 more
TL;DR: An overview of the latest developments in weight loss medications is provided, which may serve as one of the strategies for long-term obesity control.
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Naltrexone sustained-release/bupropion sustained-release for the management of obesity: review of the data to date.
TL;DR: The systematic review presented here focuses on naltrexone sustained- release/bupropion sustained-release combination (Contrave®) and concludes that its effectiveness in the treatment of obesity can be estimated as a placebo-subtracted weight loss of around 4.5%.
References
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