May 31, 2011 - Presentations to European Medical Community Highlight the Benefits of QNEXA Treatment Including:- Prevention of Progression to Diabetes
- Sustained Weight Loss over Two Years, and
- Reduction in Cardiometabolic Risk
- VIVUS, Inc. (NASDAQ: VVUS) announced that multiple abstracts were presented over the weekend at the European Congress on Obesity (ECO) in Istanbul, Turkey. ECO is the official obesity congress of The European Association for the Study of Obesity (EASO). ECO is regularly attended by more than 2500 participants from over 75 countries and is considered to be the most important annual scientific event on obesity in Europe.
Highlights from the ECO presentations were as follows:
A poster presentation authored by W. Timothy Garvey, MD from the University of Alabama at Birmingham reported reductions in progression to type 2 diabetes and improvement in glycemic status in CONQUER patients that were ADA-defined as prediabetics at baseline. Of the 2,487 patients in the CONQUER study, 1,119 were determined to have prediabetes. In the prediabetics treated with QNEXA, hemoglobin A1c, fasting glucose and fasting insulin were significantly improved at week 56 (ITT-LOCF p<0.005 vs. placebo). In the prediabetic population significantly more QNEXA treated patients achieved normal blood sugar levels (p=0.0016) and significantly more patients on placebo were progressed to type 2 diabetics as compared to the QNEXA treated patients (p=0.0253).
"For this set of patients, QNEXA treatment led to benefits above and beyond losing weight. The results highlighted by Dr Garvey showed that weight loss after 56 weeks of treatment led to an improvement in glycemic status and reduction of progression to type 2 diabetes. This clinically important finding further strengthens the QNEXA benefit profile," added Barbara Troupin, MD, senior director of medical affairs for VIVUS.
The CONQUER study included 2,487 patients that had two or more comorbidities studied over 56 weeks. Patients were randomized to receive mid-dose QNEXA (498), top-dose QNEXA (995) or placebo (994). All patients received lifestyle modification instruction. QNEXA patients had significant weight loss at week 56 as compared to placebo (p<0.0001). Least squares mean percent weight loss at week 56 was 9.8% top-dose, 7.8% mid-dose, and 1.2% placebo. The most common side effects were dry mouth, tingling, constipation, upper respiratory infection and runny nose.
Dr Garvey also authored a poster that included the results of the SEQUEL study which showed that QNEXA treatment led to significantly greater weight loss as compared to placebo (p<0.0001, IIT-LOCF LS mean weight loss of 10.5% top-dose, 9.3% mid-dose, 1.8% placebo). The differences between both treatment groups and placebo were significant starting at week 8. Significantly more patients treated with QNEXA achieved greater than 5%, 10%, 15%, 20% weight loss in a dose-related fashion than placebo (p<0.0072). Specifically categorical weight loss over two years was as follows...VIVUS' Press Release -
Highlights from the ECO presentations were as follows:
A poster presentation authored by W. Timothy Garvey, MD from the University of Alabama at Birmingham reported reductions in progression to type 2 diabetes and improvement in glycemic status in CONQUER patients that were ADA-defined as prediabetics at baseline. Of the 2,487 patients in the CONQUER study, 1,119 were determined to have prediabetes. In the prediabetics treated with QNEXA, hemoglobin A1c, fasting glucose and fasting insulin were significantly improved at week 56 (ITT-LOCF p<0.005 vs. placebo). In the prediabetic population significantly more QNEXA treated patients achieved normal blood sugar levels (p=0.0016) and significantly more patients on placebo were progressed to type 2 diabetics as compared to the QNEXA treated patients (p=0.0253).
"For this set of patients, QNEXA treatment led to benefits above and beyond losing weight. The results highlighted by Dr Garvey showed that weight loss after 56 weeks of treatment led to an improvement in glycemic status and reduction of progression to type 2 diabetes. This clinically important finding further strengthens the QNEXA benefit profile," added Barbara Troupin, MD, senior director of medical affairs for VIVUS.
The CONQUER study included 2,487 patients that had two or more comorbidities studied over 56 weeks. Patients were randomized to receive mid-dose QNEXA (498), top-dose QNEXA (995) or placebo (994). All patients received lifestyle modification instruction. QNEXA patients had significant weight loss at week 56 as compared to placebo (p<0.0001). Least squares mean percent weight loss at week 56 was 9.8% top-dose, 7.8% mid-dose, and 1.2% placebo. The most common side effects were dry mouth, tingling, constipation, upper respiratory infection and runny nose.
Dr Garvey also authored a poster that included the results of the SEQUEL study which showed that QNEXA treatment led to significantly greater weight loss as compared to placebo (p<0.0001, IIT-LOCF LS mean weight loss of 10.5% top-dose, 9.3% mid-dose, 1.8% placebo). The differences between both treatment groups and placebo were significant starting at week 8. Significantly more patients treated with QNEXA achieved greater than 5%, 10%, 15%, 20% weight loss in a dose-related fashion than placebo (p<0.0072). Specifically categorical weight loss over two years was as follows...VIVUS' Press Release -
