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
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References
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World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
TL;DR: Comparing the socialist nature of many European counties, there is a requirement that provision be made for patients to be made whole regardless of the outcomes of the trial or if they happened to have been randomized to a control group that did not enjoy the benefits of a successful experimental intervention.
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TL;DR: The Helsinki Declaration on Ethical Principles for Medical Research Involving Human Subjects, adopted by the World Medical Assembly, is presented.
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Central nervous system control of food intake
TL;DR: A model is described that delineates the roles of individual hormonal and neuropeptide signalling pathways in the control of food intake and the means by which obesity can arise from inherited or acquired defects in their function.
Journal ArticleDOI
Prevalence of overweight and obesity among us children, adolescents, and adults, 1999-2002
Allison A. Hedley,Cynthia L. Ogden,Clifford L. Johnson,Margaret D. Carroll,Lester R. Curtin,Katherine M. Flegal +5 more
TL;DR: The NHANES results indicate continuing disparities by sex and between racial/ethnic groups in the prevalence of overweight and obesity among adults and overweight among children, using the most recent national data of height and weight measurements.