Author(s): Hollander P, Gupta AK, Plodkowski R, Greenway F, Bays H,
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Abstract OBJECTIVE: To assess the efficacy and safety of 32 mg naltrexone sustained-release (SR)/360 mg bupropion SR (NB) in overweight/obese individuals with type 2 diabetes with or without background oral antidiabetes drugs. RESEARCH DESIGN AND METHODS: This was a 56-week, double-blind, placebo-controlled study in which 505 patients received standardized lifestyle intervention and were randomized 2:1 to NB or placebo. Coprimary end points were percent weight change and achievement of ≥5\% weight loss. Secondary end points included achievement of HbA1c <7\% (53 mmol/mol), achievement of weight loss ≥10\%, and change in HbA1c, waist circumference, fasting blood glucose, and lipids. RESULTS: In the modified intent-to-treat population (54\% female, 80\% Caucasian, and mean age 54 years, weight 106 kg, BMI 37 kg/m(2), and HbA1c 8.0\% [64 mmol/mol]), NB resulted in significantly greater weight reduction (-5.0 vs. -1.8\%; P < 0.001) and proportion of patients achieving ≥5\% weight loss (44.5 vs. 18.9\%, P < 0.001) compared with placebo. NB also resulted in significantly greater HbA1c reduction (-0.6 vs. -0.1\% [6.6 vs. 1.1 mmol/mol]; P < 0.001), percent of patients achieving HbA1c <7\% (53 mmol/mol) (44.1 vs. 26.3\%; P < 0.001), and improvement in triglycerides and HDL cholesterol compared with placebo. NB was associated with higher incidence of nausea (42.3 vs. 7.1\%), constipation (17.7 vs. 7.1\%), and vomiting (18.3 vs. 3.6\%). No difference was observed between groups in the incidence of depression, suicidal ideation, or hypoglycemia. CONCLUSIONS: NB therapy in overweight/obese patients with type 2 diabetes induced weight loss, which was associated with improvements in glycemic control and select cardiovascular risk factors and was generally well tolerated with a safety profile similar to that in patients without diabetes.
This article was published in Diabetes Care
and referenced in Journal of Diabetes & Metabolism