Memorandum

LEADER: What thought leaders are saying about the LEADER results and liraglutide’s CV benefits – FDA OPH by Payal Marathe – June 20, 2017

Executive Highlights

Good afternoon. First, I want to thank you for this opportunity to speak on what I believe could be a very valuable and important label update for diabetes patients and healthcare providers. My name is Payal Marathe, and I speak as a representative of Close Concerns, a healthcare information company that aims to improve patient outcomes by making everyone smarter about diabetes and obesity – inevitably, this also involves research and writing on cardiovascular health, and the discussion on heart-related diabetes complications is only growing. The Close Concerns team, myself included, attends more than 50 scientific meetings each year, conversing often with a wide range of thought leaders in the diabetes field. As far as disclosures, almost 300 for- and non-profit organizations, including today’s sponsor, subscribe to our fee-based newsletter called Closer Look.

I was in the room, or rather the large conference hall absolutely overflowing with people, last year when full LEADER results were presented at the ADA’s Scientific Sessions. There was an unmistakable excitement in that crowded hall, and the risk reduction for each study endpoint was met with resounding applause. Since then, we’ve heard strong support, time and time again, for the cardiovascular benefits associated with liraglutide.

Subsequent analyses since the initial presentation of LEADER results have underscored liraglutide’s robust cardiovascular benefit. Most recently, at ADA 2017 just last week, we learned that the cardiovascular data in LEADER consistently favors liraglutide over placebo even when controlling for possible intermediate factors. These include concomitant medications from beta-blockers to statins, concomitant insulin use, recurrent cardiovascular events, episodes of severe hypoglycemia, and more. Previously, we learned at the European Association for the Study of Diabetes meeting that there’s no significant interaction between baseline heart failure and reduced risk for MACE events on liraglutide therapy. And, we heard at EASD that there’s plenty of evidence from animal models to support how a GLP-1 agonist confers cardiovascular benefit independent of glucose-lowering, possibly through anti-atherosclerotic effects. In this context, experts have argued for the validity of LEADER results and what they imply about cardioprotection inherent to the liraglutide molecule.

Regardless of mechanism, thought leaders are bringing attention to how these landmark results should affect clinical practice based on the compelling outcomes data. A couple select quotes:

From Dr. Hertzel Gerstein: “A stone falls today the same way it fell 200 years ago, but our theory of gravity has changed dramatically. You don’t need to know exactly how a drug works to benefit from it once you know what those benefits are.”

From Dr. Juris Meier: “At a certain point, it’s okay to be pragmatic and say even if we don’t know exactly how we’re saving lives, let’s save lives.”

And this is the full weight of LEADER results – liraglutide can extend and save lives among people with type 2 diabetes at high-risk for cardiovascular events. As the latest CDC numbers show, cardiovascular disease remains the leading cause of death for people with diabetes. We’re clearly in-need of cardioprotective diabetes therapies, and now that we have one in liraglutide, we need to get it safely into the hands of patients and providers.

The bottom line is that a 13% risk reduction for major cardiovascular events, including MI, stroke, and death, is huge for people living with type 2 diabetes, and it’s huge for healthcare providers who want to be more successful in treating diabetes. The cardiovascular finding has been well-received in the diabetes field. It is a missed opportunity – if not unacceptable – to keep this information tucked away, when so many patients could benefit from liraglutide’s cardiovascular effects displayed clearly on a product label.

I look forward to the rest of the day’s discussion. Thank you again for this time and opportunity.

 

-- by Payal Marathe and Kelly Close