Contrave (naltrexone and bupropion)

COR-I

• Naltrexone 16 mg plus bupropion 360 mg daily−5.0%
• Naltrexone 32 mg plus bupropion 360 mg daily−6.1%
• Placebo−1.3%

Average change in body weight. Every bar uses one scale, 0 to 25 percent.

People studied

1,742 adults with obesity, or overweight plus high cholesterol or high blood pressure

Length

56 weeks

Compared with

Placebo, with a mild reduced-calorie diet and exercise advice in all groups

What was measured

Average change in body weight at week 56

Analysis approach

Last observation carried forward, in participants with a starting and at least one later weight

Other results

Weight loss of at least 5%: 48% (32 mg group) and 39% (16 mg group) vs 16% with placebo. Only about half of participants (50%) completed 56 weeks.

Safety

Nausea was the most common side effect: 29.8% (32 mg group) and 27.2% (16 mg group) vs 5.3% with placebo. Headache, constipation, dizziness, vomiting and dry mouth were also more frequent. Blood pressure rose slightly at first, then fell slightly below the starting level. Depression and suicidality events were not higher than with placebo.

Limits

Funded by the manufacturer. Half of participants did not finish, so the average depends on how missing data were handled. The marketed Contrave amount matches the 32 mg group. Group averages do not predict one person's result.

Sources: Greenway FL 2010