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MOUNTAIN VIEW, Calif., Oct. 8, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced new data published online in
Diabetes Care demonstrating the effects of Qsymia
® (phentermine and topiramate extended-release) capsules CIV, on the progression to type 2 diabetes.
In the study, high-risk overweight or obese patients with prediabetes and/or metabolic syndrome who were taking Qsymia over a two year period experienced reductions of up to 78.7% in the annualized incidence rate of type 2 diabetes, in addition to losing weight. The American Association of Clinical Endocrinologists recognizes obesity and prediabetes as significant risk factors for progression to diabetes and associated complications.
"These data demonstrate that medically-assisted weight loss is highly effective in preventing progression to diabetes in an at-risk population, and underscores the observation that 10% weight loss achieves beneficial effects on metabolism and risk factors in patients with prediabetes and metabolic syndrome," said Timothy Garvey, MD, Chairman of the Department of Nutrition Sciences, University of Alabama at Birmingham, the lead author and an endocrinologist specializing in metabolic diseases.
The publication analyzed 475 high-risk overweight or obese patients with prediabetes and/or metabolic syndrome at baseline from the two-year SEQUEL study, for their progression to type 2 diabetes and their changes in cardiometabolic parameters. After 108 weeks, it was observed that patients receiving Qsymia, in conjunction with lifestyle modifications, experienced significant weight loss along with markedly reduced progression to type 2 diabetes and improvements in multiple cardiometabolic disease risk factors.
Subjects in the Qsymia Recommended dose (7.5mg/46mg) and Top dose (15mg/92mg) treatment groups experienced reductions of 70.5% and 78.7% in the annualized incidence rate of type 2 diabetes, respectively, versus placebo, which was related to degree of weight lost (10.9% and 12.1%, respectively, versus 2.5% with placebo; ITT-MI;
P<0.0001). Qsymia therapy was well tolerated by this subgroup over two years.
Among patients in the study taking Qsymia, common adverse events included paraesthesia (tingling in the fingers or feet), sinusitis, dry mouth, constipation, headache, and dysgeusia (change in perception of taste). The types and severity of adverse events seen in this subgroup analysis were similar to those seen in the overall SEQUEL patient population and in other clinical trials.