Cardiovascular Outcome

Liraglutide CV Outcomes: A Milestone for Diabetes and Obesity

A major new study shows that people treated with liraglutide for type 2 diabetes have fewer strokes, heart attacks, and deaths from heart disease.

Six years ago, cardiovascular outcomes had doctors scratching their heads about diabetes and obesity drugs. A hearing on a flawed outcome study with sibutramine resulted in its withdrawal from the market. Rosiglitazone came close to being withdrawn for troubling cardiovascular outcome data. And FDA drew up new requirements for every diabetes and obesity drug to have a rigorous study of cardiovascular outcomes.

It’s bearing fruit. Late on Friday, Novo Nordisk announced topline results for liraglutide – an injection approved for both type 2 diabetes and obesity – in the third major cardiovascular outcome study to result from the new FDA requirements. The company described outstanding results:

The primary endpoint of the study was defined as the composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. The superior reduction of major adverse cardiovascular events demonstrated by Victoza [liraglutide] was derived from all three components of the endpoint.

In other words, they are seeing fewer cardiovascular deaths, heart attacks, and strokes in people who receive liraglutide for type 2 diabetes. These are topline data, released without fanfare late on Friday because the data represents “price-sensitive” information that might affect stock prices. And indeed it did. Novo Nordisk’s stock went up by 8% after the data were released. Though the good news is out, the full details won’t be presented in a scientific forum until June at the American Diabetes Association’s scientific sessions in New Orleans. Look for a peer reviewed manuscript to garner a lot of attention, too.

But there can be no doubt that this is big news. Liraglutide is the first drug with efficacy in both type 2 diabetes and obesity to have favorable cardiovascular outcome data. The only caveat is that the dosage used in this study was the lower dose used in diabetes. More research will be needed on outcomes in obesity.

The other two drugs that have posted big news recently on cardiovascular outcomes are strictly for diabetes and insulin resistance: empagliflozin and pioglitazone. Both of those studies represent important milestones in clinical care for type 2 diabetes. The new liraglutide data brings us one step closer to having outcome data to guide clinical care for obesity.

Click here for more from Novo Nordisk on their study, here for more from MedPage Today, and here for more on the implications of this news for Novo Nordisk.

Cardiovascular Landmark, photograph © Mr. Nixter / flickr

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March 7, 2016