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Unexpectedly Positive Interim Trial Results from Obesity Drug Contrave Show Significant Heart-Health Benefits

Published: 3/3/15
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Twitter Summary: Big news! @Contrave interim #CVOT data shows it may benefit #heartdisease – not official yet, but exciting potential 4 the #obesity drug

Wow! In big news from this morning, Orexigen released new interim data on its obesity management drug Contrave. The data shows that the drug may not only help fight obesity, but potentially heart disease as well. Because the data is preliminary, the label for Contrave will not say that it protects heart health, and doctors will not officially be saying that it does either. But our view of the recent data? It is the first long-term cardiovascular (heart safety) outcomes study to show statistically significantly better results on the heart disease front for those taking the drug being studied. According to the FDA, the “cardio-protective” effects of Contrave have not been established, and of course, this is the official word. But “real life” will be interesting to watch, given Contrave is already available in the US.

The background? Orexigen’s ongoing “Light Study” of 8,910 obese patients, which accompanied its FDA submission of Contrave in December 2013, is directly examining Contrave’s effects on heart safety. Today’s results showed progress at only a quarter of the way through the full trial, but in what Orexigen has called “unexpected” findings, the results from this study show that obese patients using Contrave are about 41% less likely to experience any severe heart events (e.g. heart attack, strokes, or heart-related deaths) than those taking a placebo (basically a sugar pill), including a:

  • 30% reduction in heart attacks

  • 37% reduction in strokes

  • 74% reduction in heart-related deaths

All of these results were statistically significant, making it unlikely they are random or due to chance.

Also notable is that these findings are allegedly “unrelated to weight change,” meaning that Contrave’s heart benefits aren’t negatively (or positively) affecting its ability to help people lose weight. These results seem strong at this early stage of the trial, particularly given Contrave isn’t even designed to treat heart disease, and suggest that Contrave’s benefits for patients may be even bigger than previously understood. That said – it may not be until subsequent cardiovascular outcomes trials for Contrave are completed that the FDA will officially call the drug “cardio-protective.”

Again, these trial results are preliminary – we won’t know for sure the extent to which (if at all) Contrave actually reduces the risk of heart disease until the full Light Study is completed, and sometimes interim results such as these can lead to false hope. Even at that point, it may still take another trial to “prove” beyond doubt that Contrave is good for heart safety. Still, if the data holds, we would surely expect insurance companies to take notice – heart disease is extremely expensive! As such, these results are a major source of enthusiasm for the diabetes and obesity communities nonetheless.

Back when Contrave was approved last September, it was said to raise blood pressure and heart rate and was not recommended for anyone with high blood pressure or other heart complications. These interim results certainly suggest the opposite. If further studies prove that Contrave is in fact good for heart health, it would represent a significant win for the obesity drug and be a critical differentiating factor for Contrave versus other weight-management options (e.g. Qsymia, Belviq, and Saxenda) – although what can be shown on the official label is still unknown. On that note, we will be very eager to see heart safety trial results for those drugs too. Additionally, we await information on drugs in the GLP-1 agonist DPP-4 inhibitor, and SGLT-2 inhibitor classes to see their impact on heart health – this makes us wonder, on the oral drug front, what the impact would be for combination products (or for combination injection/oral products as well). For more information on Contrave, please see our past coverage of its approval and launch in the US.  ­– AJW/KC/AB

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