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Study Shows Weight-Loss Drug Qsymia (Phentermine/Topiramate) Improves Cardiovascular Risk Factors

Improvements greater in patients who lost 10% or more of starting weight (Feb. 1)

A study published online in the American Journal of Cardiology has concluded that weight loss resulting from treatment with Qsymia (extended-release phentermine and topiramate; Vivus, Inc.) led to significant improvements in cholesterol, blood pressure, and triglycerides in obese and overweight patients experiencing one or more of these associated conditions. The improvements were significantly greater among patients who lost 10% or more of their starting weight.

Obesity and smoking are the leading causes of preventable death in the U.S., and obesity contributes directly to numerous life-threatening conditions, including diabetes, cardiovascular disease, hypertension, and stroke. According to the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), more than 500 million people worldwide and approximately one-third of American adults (more than 78 million people) are obese. In addition to obesity, high cholesterol, blood pressure, and triglycerides are significant risk factors for cardiovascular disease.

Participants in the new study with a body mass index (BMI) of 27 to 45 kg/m2 were randomly assigned to treatment with recommended-dose (7.5/46 mg) or top-dose (15/92 mg) Qsymia or placebo. The participants also received lifestyle-modification counseling. The study’s primary endpoints were the percentage weight loss and the proportion of participants achieving at least 5% weight loss. Additional endpoints included changes in lipid variables in patients with dyslipidemia and changes in blood pressure in patients with hypertension, stratified by treatment assignment and the magnitude of weight loss.

Treatment with Qsymia resulted in significantly greater dose-related mean percentage weight loss compared with placebo in participants with dyslipidemia and those with hypertension.

In the subgroup with dyslipidemia, treatment-emergent adverse events (AEs) occurred in 76%, 87%, and 88% of the placebo, recommended-dose, and top-dose groups, respectively. In the subgroup with hypertension, the rates were 77%, 85%, and 89%, respectively. The most common treatment-emergent AEs in the subgroup with dyslipidemia and in the subgroup with hypertension were dry mouth, paraesthesia, constipation, upper respiratory tract infection, and nasopharyngitis.

Qsymia (extended-release phentermine and topiramate) is approved in the U.S. as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition, such as hypertension, type 2 diabetes, or high cholesterol.

The effect of Qsymia on cardiovascular morbidity and mortality has not been established.

Sources: Vivus, Inc.; February 1, 2013; and AJC; January 29, 2013.

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