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for use as weight loss treatments. Still, the results above are certainly promising, and if these results are replicated The Obesity Society
by vincent wu

Recently, we journeyed south to the sunny city of San Diego for the 28th Annual Scientific Meeting of The Obesity Society (TOS), where we learned about the latest developments in obesity treatment, research, and policy. At the meeting, we heard much discussion on the use of GLP-1 agonists (Amylin/Eli Lilly’s Byetta [exenatide] and Novo Nordisk’s Victoza [liraglutide]), and the off-label use of medications for the treatment of obesity and type 2 diabetes, which we share with you below.

glp-1 therapy update
Perhaps more importantly, Byetta seemed to have an impressively durable effect, with the curve of weight loss demonstrating a gradual, persistent reduction in weight over three years.
These days, GLP-1s (Amylin/Eli Lilly’s Byetta and Novo Nordisk’s Victoza) are generating a lot of buzz for their abilities to induce insulin secretion when blood glucose levels are high, to promote weight-loss, and to potentially provide heart protection (for more information on GLP-1s, please see What We’re Reading in diaTribe issue # 5). At TOS 2010, a number of presenters elaborated on the weight-loss effects of GLP-1s. Dr. Steven Chen, Director of Medical Development at Amylin Pharmaceuticals, noted that people with type 2 diabetes in pivotal trials lost an average of approximately 12 pounds over the course of three years on Byetta. Perhaps more importantly, Byetta seemed to have an impressively durable effect, with the curve of weight loss demonstrating a gradual, persistent reduction in weight over three years. Notably, Dr. Chen also presented weight loss data from the several clinical trials for Bydureon (Amylin/Eli Lilly/Alkermes’ exenatide once-weekly), confirming a similar trend in weight loss over 26 weeks compared to Byetta. This was striking in our view, as Bydureon seems much easier to prescribe and to take. (Sadly, Bydureon will not become available commercially for a while due to recent regulatory setbacks.)
Meanwhile, Dr. Alan Moses, Global Chief Medical Officer of Novo Nordisk, highlighted a study in which high doses of Victoza (liraglutide 3.0 mg) were demonstrated to reduce weight by an average of 22 pounds over 104 weeks in obese adults without diabetes. It is important to note, however, that the 3.0 mg dose is higher than the current doses (1.2 and 1.8 mg) approved for use to treat diabetes. We stress that GLP-1s are not currently intended in further clinical trials, we may soon see use of GLP-1s extend beyond diabetes and into obesity and weight management.

off-label use 101: what you need to know
Before using medications off-label, even if your healthcare provider says it’s fine: 1) Be sure your healthcare provider can provide strong scientific evidence supporting off-label use of the medication; and 2) Make sure you fully understand the risks and benefits associated with off-label use before taking the medications.
Usually, when drugs are approved for use in the United States, the FDA specifies the medical condition(s) that the drug is intended to treat. However, occasionally, healthcare providers choose to use a medication to treat a condition that it has not yet been approved for by the FDA. This is referred to as “off-label” use of a drug. This is not to say that the medication is necessarily unsafe or ineffective at treating this other condition (although it can be); rather, the company that produces the drug may not have realized during development that its product had these other therapeutic effects and may not yet have provided the FDA with the necessary data from clinical trials to gain approval for their drug to treat this additional condition. (Unfortunately, reimbursement for off-label use is often challenging as a result.)

Currently, with only one drug currently approved in the US for the long-term treatment of obesity, some healthcare providers have turned to off-label prescriptions for their patients in need of pharmaceutical options. During the meeting, after noting that off-label prescriptions are perfectly legal, the past president of The Obesity Society Dr. Louis Aronne, outlined a few practical considerations that should be taken regarding the off-label use of medications. Before using medications off-label, even if your healthcare provider says it’s fine: 1) Be sure your healthcare provider can provide strong scientific evidence supporting off-label use of the medication; and 2) Make sure you fully understand the risks and benefits associated with off-label use before taking the medications. Dr. Aronne mentioned Dr. Arya Sharma’s book, “Best Weight,” as a great reference that provides evidence for or against the off-label use of specific drugs for the treatment of obesity.

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