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Combination naltrexone/bupropion improved glycemic control, CV risk
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Sustained-release naltrexone plus bupropion therapy improved glycemic control and cardiovascular risk factors and was typically well tolerated among overweight or obese patients with type 2 diabetes, according to data published in Diabetes Care.
In the modified intent-to-treat population (54% female; 80% white; mean age 54 years; weight 106 kg; BMI 37; HbA1c 8%), sustained-release naltrexone/bupropion combination therapy (Orexigen Therapeutics) resulted in greater weight reduction (–5% vs. –1.8%; P<.001) and a greater proportion of patients with at least a 5% weight loss (44.5% vs. 18.9%; P<.001) compared with placebo, according to data.
The researchers conducted a 56-week, double blind, placebo-controlled study that included 505 patients who were administered lifestyle interventions and randomly assigned in a 2:1 fashion to naltrexone or placebo.
Those assigned to sustained-release naltrexone/bupropion combination therapy also showed significantly greater reductions in HbA1c (–0.6% vs. –0.1%; P<.001), in addition to those patients who reached HbA1c levels <7% (44.1% vs. 26.3%; P<.001), and improvements to triglycerides and HDL cholesterol vs. placebo, researchers wrote.
Higher incidence of nausea (42.3% vs. 7.1%), constipation (17.7 vs. 7.1%) and vomiting (18.3 vs. 3.6%) was linked to sustained-release naltrexone/bupropion combination therapy. According to data, there were no differences between groups regarding the incidence of depression, suicidal ideation or hypoglycemia.
Sustained-release naltrexone/bupropion combination therapy “in conjunction with a standardized lifestyle intervention, resulted in a clinically meaningful improvement in body weight, which was associated with improvement in HbA1c and other cardiovascular risk factors,” researchers wrote. “Thus, a combination drug such as naltrexone has the potential to become a useful agent for the treatment of overweight/obese patients diagnosed with prediabetes or type 2 diabetes.”
Disclosure: Hollander and other researchers report funding from Orexigen Therapeutics. See the full study for all other disclosures.
Perspective
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George A. Bray, MD
Hollander and colleagues have presented a 56-week; randomized, placebo-controlled trial with the combination of sustained release naltrexone 32 mg and bupropion 360 mg on weight loss in patients with diabetes, but the reader should remember that this drug combination has not yet been approved by the FDA.
The drug-treated group lost a modest 5% from baseline compared with 1.8% in the placebo group in the modified intent-to-treat analysis. Among those who completed the trial, the drug-treated group lost 5.9% vs. 2.2%. Of the drug-treated group, 44.5% lost ≥5% of body weight compared with 18.9% in the placebo group. Patients’ HDL-cholesterol and triglycerides improved, but blood pressure did not.
The value of medications for treatment of obesity is that they increase weight loss over what can be achieved with lifestyle, diet and exercise. This was clearly shown in the meta-analysis of lifestyle vs. placebo and of orlistat plus lifestyle versus lifestyle alone in another study. Lifestyle produced an average 4% weight loss compared to 1% in the control groups. In contrast the lifestyle control for orlistat lost 5%, a bit more than the lifestyle only, but orlistat plus lifestyle produced an 8% weight loss.
Vigorous lifestyle for patients with diabetes can achieve over 8% weight loss as shown in the Look AHEAD trial. Naltrexone/bupropion provides one additional agent, after approval, for use in the treatment of the obese patient with or without diabetes.
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