The FDA previously declined Qsymia for full approval to treat obesity. Qsymia is a combination of two drugs that currently have a limited role in treating obesity, Phentermine and Topiramate. Phentermine is an appetite suppressant with decades of use in producing real, if modest, weight loss. It acts as a mild stimulant for many people, similar in effect to caffeine while suppressing appetite. Topiramate has decades of use in treating migraines and seizures, but also it is used for treating binge-eating disorder.
In the largest clinical trial Qsymia produced significant weight loss over a 56-week period as reported in the Lancet. The average weight loss for the patients who completed the entire study ranged from 22 to 28 pounds. The percent of weight loss at 56 weeks was 7.8 percent of body weight for the mid-dose and 9.8 percent weight loss for the top dose of the drug, compared to 1.2 percent for the placebo group. This large study, involving 2,487 patients, was reported in April 2011, and all patients participated in a medically supervised weight-loss program with calorie reduction and treatment of comorbid conditions. The patients enrolled all had obesity, hyperlipidemia, high blood pressure or Type 2 diabetes. The average body mass index (BMI) in the study population was 36.6 kg/m². A BMI of over 25 is considered overweight, and a BMI of 30 or greater is considered obese.
Many physicians who treat obesity in a medically supervised clinical setting are heartened that the FDA approved the drug this time around. The FDA at first cited theoretical risks of birth defects and increased heart rate as a concern for Qsymia in its preliminary ruling. But advocates for obese patients have voiced concern that the FDA has inappropriately viewed these drugs as “diet pills” and not as potentially lifesaving interventions for the treatment of diabetes, obstructive sleep apnea, hypertension, heart disease and other obesity-related complications. That attitude appears to be changing.
In 2011, the FDA approved the Lap-Band device for patients with a BMI of 30 or greater who have an obesity-related health condition, substantially lowering the weight requirement. In June, the FDA approved the drug Belviq for obesity treatment. Now, since the FDA approved Qsymia, it will add yet another tool that physicians can work with to help their patients lose weight and prevent or resolve the complications of obesity that shorten lives.
How best to use Qsymia and Belviq is a matter of some debate. Most experts agree that the drugs should be given to patients who are enrolled in a medically supervised weight-loss center with regular monitoring and follow-up. How to optimize the weight loss with these drugs is also a matter of debate. No one believes either of these drugs is a “magic bullet” that will cause pounds to melt off effortlessly, but there is great optimism that we are moving into an era in which doctors have more effective treatment options. The best approach is always going to be one in which an individual exercises, cuts excess calories, reduces carbohydrate consumption, seeks coaching and support and weighs in regularly.
Ultimately, the FDA rulings and the new treatments available reflect a sober reality that obesity is the No. 1 killer in the country today, leading to diabetes and other disease in a high proportion of individuals. For future generations, the solution will rest with obesity prevention through diet changes and increased awareness among young people. But for the millions already struggling with obesity, new low-risk and minimally invasive treatments are available that are proven to help. Not taking action to treat obesity may be the biggest risk of all.
Kent C. Sasse, MD, is the founder and medical director of the childhood Obesity Prevention Foundation, and oversees a comprehensive, integrated medically-supervised and surgical weight-loss center in Reno.