Naltrexone plus bupropion can assist weight loss

January 01, 0001

Naltrexone plus bupropion can assist weight loss

Despite increasing public health concerns regarding obesity, few safe and effective drug treatments are available. Combination treatment with sustained-release naltrexone and bupropion was developed to produce complementary actions in CNS pathways regulating bodyweight. People aged 18—65 years who had a body-mass index (BMI) of 30—45 kg/m2 and uncomplicated obesity or BMI 27—45 kg/m2 with dyslipidaemia or hypertension were enrolled. Participants were prescribed mild hypocaloric diet and exercise and were randomly assigned in a 1:1:1 ratio to receive both naltrexone 32 mg per day plus bupropion 360 mg per day, naltrexone 16 mg per day plus bupropion 360 mg per day (all sustain-released), or matching placebo twice a day, given orally for 56 weeks. 1742 participants were enrolled and randomised to double-blind treatment, evenly spread. 50% of participants completed 56 weeks of treatment and 83% were included in the primary analysis, evenly spread.

Mean change in bodyweight was -1.3% in the placebo group, -6.1% in the naltrexone 32 mg plus bupropion group (significant) and -5.0% in the naltrexone 16 mg plus bupropion group (significant). 16% of participants assigned to placebo had a decrease in bodyweight of 5% or more compared with 48% assigned to naltrexone 32 mg plus bupropion (significant) and 39% assigned to naltrexone 16 mg plus bupropion (significant). The most frequent adverse event in participants assigned to combination treatment was nausea (naltrexone 32 mg plus bupropion, 29.8%; naltrexone 16 mg plus bupropion, 27.2%; placebo, 5.3%). Headache, constipation, dizziness, vomiting, and dry mouth were also more frequent in the naltrexone plus bupropion groups than in the placebo group. A transient increase of around 1.5 mm Hg in mean systolic and diastolic blood pressure was followed by a reduction of around 1 mm Hg below baseline in the naltrexone plus bupropion groups. Combination treatment was not associated with increased depression or suicidality events compared with placebo.

The researchers concluded: "A sustained-release combination of naltrexone plus bupropion could be a useful therapeutic option for treatment of obesity."

Perhaps helpful for those unfit for, or do not wish for, surgery and having difficulties losing weight by other methods.

For the full abstract, click here.

The Lancet published online 30 July 2010 © 2010 Elsevier Ltd
Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Frank L Greenway, Ken Fujioka, Raymond A Plodkowski, et al for the COR-I Study Group. Correspondence to Prof Frank Greenway: [email protected]

Category: T. Endocrine/Metabolic/Nutritional. Keywords: naltrexone, bupropion, weight loss, overweight, obese, COR-I, randomised, double-blind, placebo-controlled, phase 3 trial, journal watch.
Synopsis edited by Dr Stephen Wilkinson, Melbourne, Australia. Posted on Global Family Doctor 20 August 2010

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.