Interim analysis of LIGHT study of Contrave (naltrexone HCl/bupropion) in CV Risk with obese patients- Orexigen/Takeda

The LIGHT Study which the FDA had asked Orexigen not to disclose (but whose results were disclosed with a new patent application) enrolled approximately 8900 patients who were treated with Contrave (naltrexone HCl/bupropion) or placebo. LIGHT study has shown in interim results that people treated with Contrave, particularly smokers and people with diabetes for less than 6 years, had a lower risk of adverse CV events than those on placebo. The risk of death was cut by 41% for patients who received Contrave.There were 24 myocardial infarctions (heart attacks) in the Contrave arm versus 34 in the placebo arm (HR=0.70; p<0.0001); seven versus 11 strokes (HR=0.63; p=0.0088); and five versus 19 cardiovascular deaths (HR=0.26; p<0.0001). A further cardiovascular outcomes trial is to proceed.

Comment: The positive interim results have to be sustained as the study proceeds and there were a high rate of discontinuations seen in the trial (62% of Contrave patients). The FDA considers that it is too early to draw conclusions from the trial.