Navigation Links
QNEXA® Phase 3 Data in The Lancet Show Significant Weight Loss and Broad Improvements in Co-Morbidities
Date:4/11/2011

MOUNTAIN VIEW, Calif., April 11, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that detailed results from the 56-week CONQUER study were published in The Lancet evaluating the efficacy and safety of investigational drug QNEXA in 2,487 patients across 93 sites in the US. Data published in the peer-reviewed journal provided an in-depth look at weight loss and improvements in the full spectrum of co-morbidities studied as secondary endpoints, including cardiovascular, metabolic and inflammatory risk factors.

"Obesity is a serious medical condition associated with increased mortality from cardiovascular diseases, diabetes, cancer and other diseases, yet there is a lack of treatment options for the one-third of American adults who are obese," said Kishore Gadde, MD, director of obesity clinical trials at Duke University and lead investigator. "Half the patients in the study had at least three co-morbidities including diabetes, representing a population with the greatest medical need for weight loss. We observed significant weight loss, improvements in co-morbidities and a reduction in the need for concomitant medications in patients treated with QNEXA."

Specific results for all patients through 56 weeks as published in The Lancet are as follows:

Weight Loss

  • Average weight loss for QNEXA patients who completed the CONQUER study on the study drug was 28 pounds and 22 pounds with top-dose QNEXA and mid-dose QNEXA, respectively, compared to 4 pounds in the placebo group;
  • In the ITT-LOCF analysis, least-squares mean percent weight loss at week 56 was -7.8%* and -9.8%*, respectively, for the mid and top dose as compared to -1.2% for the placebo group;
  • Categorical weight loss from baseline (ITT-LOCF) was:

  • >5%>10%Top dose

    70%*48%*Mid dose

    62%*37%*Placebo

    21%7%*p<0.0001 vs placeboBlood Pressure

  • Reduction in systolic blood pressure of -4.7 mm Hg (p=0.0008) and -5.6 mm Hg (p<0.0001), respectively, for the mid and top dose as compared to -2.4 mm Hg for the placebo group;
  • Reduction in diastolic blood pressure of -3.4 mm Hg (p=0.1281) and -3.8 mm Hg (p=0.0031), respectively, for the mid and top dose as compared to -2.7 mm Hg for the placebo group;
  • More patients had a reduction in the number of blood pressure medications with QNEXA treatment compared to placebo.

  • Lipids

  • Improvements in HDL cholesterol of 5.2% (p<0.0001) and 6.8% (p<0.0001), respectively, for the mid and top dose as compared to 1.2% for the placebo group;
  • Reduction in LDL cholesterol of -3.7% (p=0.7391) and -6.9% (p=0.0069), respectively, for the mid and top dose as compared to -4.1% for the placebo group;
  • Reduction in triglyceride levels of -8.6% (p<0.0001) and -10.6% (p<0.0001), respectively, for the mid and top dose as compared to an increase of 4.7% for the placebo group.

  • Metabolic Parameters

  • Reduction in fasting insulin of -24.0 pmol/L (p=0.0004) and -27.6 pmol/L (p<0.0001), respectively, for the mid and top dose as compared to an increase of 5.1 pmol/L for the placebo group;
  • Fewer non-diabetic patients on QNEXA progressed to type 2 diabetes; relative risk (vs placebo) was 0.47 (0.25 – 0.88) with top-dose QNEXA;
  • More patients in the placebo group required an increase in the number of antidiabetic drugs than those treated with QNEXA.

  • More patients completed one year of treatment in the QNEXA groups, mid dose (69%) and top dose (64%) respectively, as compared to 57% in the placebo group. QNEXA therapy was well tolerated, with no unexpected adverse events. The most common side effects were dry mouth, paresthesia (tingling), constipation, insomnia, dizziness and dysgeusia (altered taste). Rates of serious adverse events were similar across treatment groups: 4% with placebo, 3% with mid-dose QNEXA and 5% with top-dose QNEXA. Most adverse events were seen early in treatment and there was a low dropout rate due to adverse events, 12% and 19% for mid and top dose respectively, compared to 9% for placebo.

    About the CONQUER StudyThe CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States. The average baseline BMI of the study population was 36.6 kg/m2 and baseline weight was 227 pounds. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with mid-dose QNEXA, top dose QNEXA or placebo. Patients had a 4-week dose titration period followed by 52 weeks of treatment. Throughout the 56-week treatment period, all patients were advised to follow a modest lifestyle modification program including reduction of food intake by 500 calories per day. Patients were actively managed to standard of care for weight-related co-morbidities, which included the ability for physicians to adjust or alter medications for these conditions, including in the placebo group.

    About QNEXA Controlled-Release CapsulesQNEXA [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program.

    About VIVUSVIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development, QNEXA, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.com


    '/>"/>

    SOURCE VIVUS, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. New Long-Term Data on QNEXA® Show Significant and Sustained Weight Loss of Greater Than 10% Over Two Years
    2. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
    3. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
    4. Long-Term Data on QNEXA® to be Presented at The American College of Cardiology Annual Meeting
    5. Weight Loss With QNEXA® Over Two Years Provides Patients With Substantial Cardiovascular Benefits
    6. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
    7. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
    8. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
    9. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
    10. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
    11. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:2/22/2017)... , February 22, 2017 ... the Dow Jones Industrial Average, and the S&P ... out of nine sectors ended Tuesday,s trading session ... sentiment, Stock-Callers.com assessed the following Medical Instruments & ... (NASDAQ: TNDM), C. R. Bard Inc. (NYSE: BCR), ...
    (Date:2/22/2017)... Calif. , Feb. 22, 2017  Bioness, Inc., ... therapies, today announced the first series of successful StimRouter ... at Radboud University Medical Center (Nijmegen, Netherlands ... ( Cork, Ireland ), and Kliniek Park ... the successful launch continuing, Bioness plans to further support ...
    (Date:2/22/2017)... PUNE, India , February 22, 2017 According ... (Spectroscopy, Chromatography), Measurement (On-Line, In-Line, At-Line), Products and Services (Analyzers, Probes & ... to 2021", published by MarketsandMarkets, the global market is poised to reach ... a CAGR of 13.3% from 2016 to 2021. ... ...
    Breaking Medicine Technology:
    (Date:2/22/2017)... ... February 22, 2017 , ... Sideline Products participated in the World Horse Expo ... Tom Seay and his production crew. Tom Seay’s program “Best of America by ... Saddle Sidekicks will be featured on April 6, 2017. After the broadcast, the ...
    (Date:2/22/2017)... ... February 22, 2017 , ... ANGLESTRONG , the new ... now available on the App Store and Google Play . Florida-based ... the addiction and recovery industry, partnered with Angle to build ANGLESTRONG. The new recovery ...
    (Date:2/22/2017)... ... , ... A product of digesting a micronutrient found in soy may hold ... soy foods, while others do not, a University of Pittsburgh Graduate School of Public ... made by some types of “good” gut bacteria when they metabolize isoflavones (micronutrients found ...
    (Date:2/22/2017)... ... , ... Super-Sod will attend the Athens Home Show with a brand new ... from Super-Sod’s simple Athens Home Show booth of 2016, this year’s exhibit space includes ... Chris Roquemore constructed furniture from recycled pallet wood at the Super-Sod farm in Fort ...
    (Date:2/22/2017)... ... ... BrightStar Care Charleston , a home care and medical staffing agency, will ... on Aging’s Senior Expo on Thursday, March 23, 2017, at the Omar Convention ... our community. We are thrilled to participate in this event because we believe it ...
    Breaking Medicine News(10 mins):