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FDA Approves Diabetes Medication as Obesity Treatment

>> Sunday, January 4, 2015




For those of us involved in the care of type 2 diabetic patients, we are well aware that the last several years have brought the opportunity to treat type 2 diabetes with medications that also help patients lose weight.   One of these medications, called liraglutide, has now been approved in USA as a weight loss medication for people with or without diabetes, under the trade name Saxenda.

Liraglutide is a derivative of a human hormone called GLP-1, which is released in response to meals.  It works to tell the pancreas to release insulin, and suppresses another hormone involved in blood sugar regulation, called glucagon.  It helps with weight loss by sending a message to the satiety (fullness) centre of your brain, and it has an effect, particularly in the early weeks of treatment, to slow down the stomach.

Clinical trial results are summarized in the FDA press release:

Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.5 percent from baseline compared to treatment with a placebo (inactive pill) at one year. In this trial, 62 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 34 percent of patients treated with placebo. Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 3.7 percent from baseline compared to treatment with placebo at one year. In this trial, 49 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 16 percent of patients treated with placebo.

Liraglutide has been in use for several years as a treatment for type 2 diabetes, under the trade name Victoza, at a dose of 1.2 to 1.8 mg per day.  As an obesity treatment, it will be marketed in the USA under the trade name Saxenda, at a dose of 3.0 mg per day.

As for any medication, there are potential risks with using liraglutide.  Common side effects include stomach upset, particularly nausea as the stomach is slowed initially, but this usually improves in the first weeks on the medication.  As for more severe side effects, the question has been raised as to whether this class of medications could cause inflammation of the pancreas (called pancreatitis), but to date, a causative connection has not been established (see more from the FDA and European Medicines Agency on this here).  Liraglutide has been shown to cause a rare form of thyroid cancer in rodents; this has not been seen in humans but is being monitored.  (For further discussion of side effects, see the FDA press release on Saxenda).

My take on this? The approval of liraglutide for obesity is a landmark, in that this is the first time that a human gut hormone has been approved for obesity treatment.  There are many gut hormones involved in the feeling of fullness, many of which are being actively studied; combinations of these hormones look promising as well.  

Note that liraglutide is not currently approved for obesity treatment in Canada.

Disclaimer: I was involved in the research trials of liraglutide as an obesity treatment.  I receive honoraria on behalf of the makers of liraglutide (Novo Nordisk) to provide continuing medical education. I am on the advisory board for Novo Nordisk.  I am involved in research of medications similar to liraglutide for the treatment of type 2 diabetes. 

Follow me on twitter! @drsuepedersen

www.drsue.ca © 2015




2 comments:

Annrv September 28, 2017 at 9:57 PM  

Any updates. Interested in mechanism of action

Dr. Sue Pedersen September 29, 2017 at 5:12 AM  

Yes - you can read about the mechanisms of action here: http://drsuetalks.blogspot.ca/2015/03/health-canada-approves-new-obesity.html

Best,
Dr Sue

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