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SEQUEL Trial Results for Qnexa® Published in AJCN Show 10% Sustained Weight Loss Over 2 Years
Date:12/8/2011

kelihood to progress to type 2 diabetes compared to subjects receiving top-dose Qnexa and a two times greater likelihood than patients on mid-dose Qnexa.

 

Qnexa therapy was well tolerated, with no new adverse events observed in the second year of study. The most common side effects were upper respiratory infection, constipation, tingling, sinus infection, dry mouth and runny nose. There were no drug-related serious adverse events reported. The completion rate in SEQUEL was approximately 83% for both Qnexa doses and 86% for the placebo group. Discontinuations due to adverse events were 4.5% and 4.4% for the mid- and top-dose, respectively, and 3.1% for the placebo group.

About the SEQUEL Study

SEQUEL (OB-305) was a double-blind, placebo-controlled, three-arm, extension study. Patients continued receiving the same treatment assignment to which they had been randomized in the 56-week CONQUER study in a blinded fashion: either once-daily treatment with top-dose Qnexa (n=295), mid-dose Qnexa (n=153), or placebo (n=227). The SEQUEL study was a 52-week extension study for a subset of patients who completed the CONQUER study. The total study period was 108 weeks. SEQUEL included 676 obese or overweight patients, all of whom had two or more weight-related co-morbidities and an average baseline BMI of 36.1. Throughout the 108-week treatment period, all patients were advised to follow a modest lifestyle modification program including reduction of food intake by 500 calories per day.  The SEQUEL study was conducted at 36 sites in the United States.

Approximately 20% of SEQUEL subjects had type 2 diabetes at baseline and had been treated with lifestyle modifications alone or single-agent metformin. In this subgroup, weight loss associated with Qnexa had a favorable impact on glycemic control without a need for added oral hypoglycemic agents. In subjects without type 2 diabetes at baseline, the favo
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SOURCE VIVUS, Inc.
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