For the last 13 years there have been no new medications designed specifically for weight reduction that have received FDA (Food and Drug Administration) approval. The long drought came on the heels of the reported adverse effects of the successful weight reduction combination of phentaramine and fenfluramine. While patients lost weight successfully on this combination of medications plus diet they additionally risked developing disease of the heart valves and its consequences. In July the FDA approved Belviq or lorcasrin HCl for weight reduction. Pharmaceutical manufacturer Vivus received approval for its weight reduction product Qsymia recently which is a combination of phentermine and topiramate. Topiramate has been on the market as a medicine to treat vascular and migraine type headaches and to treat seizures.
Vivus submitted data to the FDA involving 756 obese subjects, which showed that over seven months of treatment obese patients lost 10% or more of their body weight 38% of the time among those taking Qsymmia 7.5 /46 mg and 43% of the time when they used the higher dose of 15/92 mg. Patients taking placebo plus diet lost 10% of their body weight only 6.8%. The dose of topiramate in this combination drug is significantly lower than the starting dose for that drug when treating neurological issues. When the researchers looked at statistical significance the lower dose combination was actually more successful than the higher dose combination.
Adverse effects were more common in the higher dose group and included parasthesia (23%), dry mouth in 18.5%, headache and constipation. The drug was released to a limited number of pharmacies in April but has been slow to catch on. Its use is cautioned in individuals with existing heart, liver and kidney disease.
Obesity is epidemic in this country. Increased activity and dietary intervention are always our first line of therapy. Dietary counseling, organized diet programs with meal replacement therapy and bariatric surgery are available to help. Adding new medications to a difficult treatment problem is always a welcome step but will require that we closely watch their risk and side effect profile as the drugs become more popular and are used more frequently.
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