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Qnexa® Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment
Date:11/3/2011

and low-dose Qnexa, respectively, compared to 2.1% in the placebo group (p<0.0001);
  • In the ITT-LOCF analysis, LS mean percent weight loss at week 56 was 10.9%* and 5.1%* for the top and low dose, respectively, as compared to 1.6% for the placebo group (p<0.0001);
  • Among patients who completed the top-dose course of treatment, 83.5% lost >/= 5%; 67.7% lost >/= 10%; and 48.1% lost >/= 15% of their baseline weight;
  • Categorical weight loss from baseline (ITT-LOCF) was:

  • >/= 5%

    >/= 10%

    >/= 15%Top dose

    67%*

    47%*

    32%*Low dose

    45%*

    19%*

    7%+Placebo

    17%

    7%

    3%*p<0.0001 vs placebo+p < 0.05 vs placeboA significantly greater number of patients completed one year of treatment in the Qnexa groups, top dose (66%) and low dose (61%), as compared to the placebo group (53%). The most commonly reported side effects were tingling, dry mouth, constipation and altered taste. Rates of serious adverse events were the same across treatment groups. Most adverse events were seen early in treatment and there was a low dropout rate due to adverse events, 16.0% and 11.3% for top and low dose, respectively, compared to 8.4% for placebo.

    About the EQUIP StudyThe EQUIP study included 1,267 severely obese patients (1,050 females and 217 males) with an overall mean age of 42.7 years; mean BMI of 42.0 kg/m2; and mean baseline weight of 256 pounds. Eligibility criteria included age 18-70 years; BMI >/= 35 kg/m2 (no upper limit); triglycerides </= 200 mg/dl with treatment of 0-1 lipid-lowering medication; BP </= 140/90mm Hg with treatment of <3 anti-hypertensive medications; and fasting serum glucose level </= 110 mg/dl.

    The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with low-dose Qnexa, top-dose Qnexa or placebo.
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    SOURCE VIVUS, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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