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

MOUNTAIN VIEW, Calif., April 4, 2011 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced long-term data that demonstrated patients treated with the investigational drug QNEXA® for two years showed reductions in blood pressure and the use of antihypertensive medications as well as improvements in lipid levels following significant reductions in weight loss as compared to those in the placebo group over two years.

The data – additional results from the SEQUEL study – were presented Sunday at the 60th Annual Scientific Meeting of The American College of Cardiology by Michael Davidson, M.D., clinical professor and director of preventive cardiology at The University of Chicago.

Specific results are as follows:

  • Patients on QNEXA had significant reductions in weight loss as compared to those in the placebo group over two years. Least-squares mean percent weight loss at week 108 was -9.3% and -10.5%, respectively, for the mid and top dose as compared to -1.8% for the placebo group.
  • Overall, patients taking QNEXA showed a significant reduction in the number of antihypertensive medications they required as compared to those taking a placebo over two years of treatment.
  • Specifically, patients with hypertension at the beginning of the study taking QNEXA mid and top dose showed a significant reduction in the number of antihypertensive medications they required of -9.8% and -18.9%, respectively, while patients taking a placebo showed a net increase of +4.2%.
  • Dyslipidemic patients at baseline treated with the mid and top dose of QNEXA had decreases in triglycerides of -25.9% and -26.3%, respectively, as compared to -14.3% for the placebo group.
  • Dyslipidemic patients at baseline treated with the mid and top dose of QNEXA had improvements in HDL-C of +11.4% and +16.7%, respectively, as compared 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 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.  

About QNEXA Controlled Release Capsules

QNEXA [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 VIVUS

VIVUS 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. The Balance-Based Torso-Weighting® Treatment for Multiple Sclerosis Receives a NIH Recovery Act Grant
2. Medizone Internationals Mass-Market Sterilization Technology to be Produced by Canadian Medical Device Heavyweights
3. The Spatz Adjustable Balloon System® for Weight Loss Becomes the First Intragastric Balloon to Receive Regulatory Approval for 1 Year Implantation Time
4. Results of Innovative Clinical Study Show New Combination for Weight Loss Success
5. New Long-Term Data on QNEXA® Show Significant and Sustained Weight Loss of Greater Than 10% Over Two Years
6. New Data Demonstrates Victoza® (liraglutide [rDNA] injection) Provided Superior and Sustained Blood Sugar Control and Weight Reduction Compared to Januvia® (sitagliptin) at One Year
7. New Data Demonstrates Victoza® (liraglutide [rDNA] injection) Provided Superior and Sustained Blood Sugar Control and Weight Reduction Compared to Januvia® (sitagliptin) at 52 Weeks
8. The Results are in: Users of BodyMedias Wearable Body-Monitoring Technology Lose 3 Times More Weight
9. ReShape Medical Announces Initiation of U.S. Clinical Study for Weight Loss
10. Womens Digital Imaging Using DXA Total Body Fat Analysis to Help Patients in Weight Management and Fitness Programs
11. New Survey Shows Seniors Struggle Under the Weight of Multiple Medication Use
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... or "Company") (NASDAQ: UNIS ; ASX: UNS), a developer ... results for the second quarter of fiscal 2016 (three months ended ... Financial Results for the Second Quarter of Fiscal 2016 ... for the second quarter of fiscal 2016 was $4.5 million, compared ... from customers for the second quarter of fiscal 2016 were $17.8 ...
(Date:2/9/2016)... Bermuda, Feb. 9, 2016  Axovant Sciences Ltd. ... on the treatment of dementia, today announced further ... cognitive, behavioral and functional aspects of Lewy body ... in the U.S. Two out of the three ... expected to start later this quarter. In addition, ...
(Date:2/9/2016)... Feb. 9, 2016 Hearing protection devices refer ... energy transmitted to the inner ear. Hearing protection devices ... These devices are recommended for users exposed to noise ... refer to HPD that are inserted in the ear ... designed to provide more natural sound perception with the ...
Breaking Medicine Technology:
(Date:2/9/2016)... ... February 09, 2016 , ... A new ... schedule rates and Medicare rates for a variety of medical services in Illinois ... Evaluation of the 2015 Fee Schedule Rates in Illinois, are professional medical ...
(Date:2/9/2016)... ... February 09, 2016 , ... Establishment Labs, a global ... David Hung to the company´s Board of Directors. , “We are honored ... and an exceptional entrepreneur.” said Juan Jose Chacon Quiros, CEO of Establishment Labs. "David’s ...
(Date:2/9/2016)... County, CA (PRWEB) , ... February 09, 2016 , ... ... on home whitening packages. Teeth whitening is among the most popular cosmetic procedures in ... for their whitening needs. This can put them at risk of teeth whitening-related damage. ...
(Date:2/9/2016)... ... February 09, 2016 , ... Two renowned photographers, Robert ... a photographic adventure on the island, June 14-19, 2016, hosted by Four Seasons Resort ... , After a successful debut in 2015, the Maui Photo Expedition workshop ...
(Date:2/9/2016)... ... February 09, 2016 , ... Shark Finds and Kevin Harrington, and the ... with GRIP-DRY. , GRIP-DRY is a newly patented product that has solved some of the ... the wet and early morning dew or right after a rain shower, might understand the ...
Breaking Medicine News(10 mins):