Overweight individuals may soon have a new weapon in the struggle to lose pounds. Medically-supervised weight-loss clinics were awaiting the decision this month on the new weight-loss drug originally called Qnexa, now Qsymia. Qsymia has, until now, been an investigational drug that the FDA had previously declined for approval to treat obesity. Qsymia is actually 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 it is also used for treating binge eating disorder.
In the largest clinical trial Qsymia produced modest weight loss over a fifty-six week period as reported in the Lancet. The average weight loss for the patients who completed the entire study ranged from 22-28 pounds. The percent of weight loss at fifty-six weeks was 7.8 % of body weight for the mid dose given and 9.8% weight loss for the top dose of the drug, compared to 1.2% for the placebo group in the trial. This large study, involving 2,487 patients was reported in April of 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 II 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 betting that the FDA will approve the drug this time around. The obesity epidemic continues to adversely affect record numbers of Americans and claim many lives. The FDA cited theoretical risks of birth defects and increased heart rate as a concern for Qsymia in its first ruling. But advocates for obese patients have voiced concern that the FDA has 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 of 2012, 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.
Kent C. Sasse, MD is the founder and Medical Director of the childhood Obesity Prevention Foundation, and an integrated medically-supervised and surgical weight-loss center in Reno, NV.