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Musing on the future of GLP-1 agonists and bariatric surgery

Published: 4/30/11
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By Kelly Close

We all know that new therapies for diabetes require many years to develop and receive regulatory approval. The frustration is undeniable. So it’s always exciting to see existing therapies used in new ways, whether that means better formulations, new combinations, or new patient populations.

One such hot therapeutic area is GLP-1 agonists, injectable drugs that increase the body’s own insulin secretion in response to high blood sugar. They also reduce the secretion of glucagon, the ‘anti-insulin’ hormone that causes blood sugar to rise, and they slow the passage of food through the stomach. Some studies have suggested that GLP-1 therapy might reduce the risk of heart disease and preserve the pancreas’ beta cells. And, unlike insulin, GLP-1 agonists can cause weight loss.

The two available GLP-1 drugs, Victoza and Byetta, are currently indicated for use only in people with type 2 diabetes who are not taking insulin. However, in recent months we’ve seen considerable interest in new twists on GLP-1 therapy. Bydureon, the first once-weekly GLP-1 therapy, has been recommended for approval in Europe, and it is moving toward re-submission in the US. But in the meantime, researchers and healthcare providers are working on ways to get more mileage out of the options already available.

One major area of interest is combining GLP-1 therapy with insulin. In December, Amylin/Eli Lilly (the makers of Byetta) filed an application with the FDA asking the agency to approve the use of Byetta as an add-on to basal insulin therapy for type 2 patients. During a session at this month’s meeting for the American Association of Clinical Endocrinologists, a straw poll revealed that 37% of providers were using GLP-1-plus-insulin for more than one in every 20 of their patients (a high percentage even among an advanced group of endocrinologists). We have seen promising data in people with type 2 diabetes, so we expect this combination therapy to keep growing among both endocrinologists and primary care physicians – especially if and when the FDA gives approval, since some healthcare providers avoid “off-label use”. Some experts have also recommended GLP-1 to treat prediabetes, though this will remain an expensive option until reimbursement improves (read: starts to happen) for diabetes prevention.

Another big topic of late has been surgery, a higher-risk, higher-reward option for obese people with diabetes. Although procedures like gastric bypass and gastric banding are known as bariatric (weight-loss) surgery, many physicians now use the term “metabolic surgery,” since the benefits for type 2 diabetes go beyond what would be expected from weight loss alone. Notably, the International Diabetes Foundation recently published a position paper discussing the potential role of bariatric surgery for people with type 2 diabetes. While surgery for diabetes remains controversial, Dr. Lee Kaplan and other experts say the Holy Grail would be a drug that mimics the effects of surgery (which, interestingly, seem to involve gut hormones like GLP-1). Such a therapy may be hard to develop and will doubtless face high regulatory hurdles, but we hope that today’s high interest can someday translate into an ideal therapy.

Of course, an ideal therapy has little value if it’s not reimbursed and patients can’t afford it. So any excitement over therapeutic innovations must be tempered by the cold financial reality that payers may balk. This fact may be the ultimate frustration: that care is being compromised for profits. All we can do, with your help, is to spread the word that the best way to reduce long-term diabetic complications – and cost – is through tight glycemic control... which is the very objective of these new therapies.

Best,

Kelly L. Close

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