The combination of phentermine and topiramate resulted in substantial weight loss and good tolerability, according to a press release from Vivus Inc, the manufacturer of the combination drug called Qnexa.
Vivus announced today positive results from two pivotal phase 3 studies, EQUIP and CONQUER, in more than 3,750 patients. The company said the studies met their primary enpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes, the company reported.
According to the company, in the EQUIP study patients lost an average of 14.7% of their body weight, or 37 pounds, in the 56 week study. 69% of patients on the combination drug completed the entire trial, significantly more than in the placebo group.
“The weight loss observed with Qnexa in these two one-year, double-blind, randomized trials far exceeds the weight loss observed for other agents reported in literature,” said Kishore Gadde, director of obesity clinical trials at Duke University and a lead investigator, in the Vivus press release. “The efficacy and safety results confirm the earlier findings of our phase 2 study, which showed a very good efficacy and benefit/risk profile. Importantly, the medical benefits of this treatment in reducing the risk of weight-related co-morbidities such as hypertension, diabetes, and dyslipidemia could establish Qnexa as a major advancement in the management of obesity.”