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Weight Loss With QNEXA® Over Two Years Provides Patients With Substantial Cardiovascular Benefits
Date:4/4/2011

ompared to +9.1% for the placebo group.

"In this study, QNEXA patients on the top dose had sustained weight loss greater than 10% over two years. This weight loss led to clinically relevant reductions in blood pressure, triglyceride reduction greater than 25%, and a dramatic increase in HDL levels," stated Dr. Davidson. "Achieving and maintaining this degree of weight loss, one that impacts cardiovascular risk in a clinically meaningful way, is often difficult for patients. Maintaining double-digit weight loss over two years, with resulting improvements in cardiovascular risk factors and an overall reduction in medications used to treat comorbidities makes this important data for clinicians."  

QNEXA therapy was well tolerated, with no new safety signals seen between 56 and 108 weeks. The most common side effects were upper respiratory infection, constipation, tingling, sinus infection, dry mouth and runny nose. Serious adverse event rates over two years were low (mid and top dose 5.9%, 8.1%) and placebo (6.2%), with 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 4.6% 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, prospective study. Patients continued receiving the same treatment assignment to which they had been randomized in the 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 56-week CONQUER study. The total study period was 108 weeks. SEQUEL included 675 obese or overweight patients, all of whom had two or more weight-related co-morbidities and an average baseli
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SOURCE VIVUS, Inc.
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