VIVUS Inc released additional data from phase 3 studies of QNEXA, an investigational drug candidate being developed to address weight loss, type 2 diabetes, and obstructive sleep apnea. The research showed statistically significant improvements in quality of life compared to placebo patients.
During the American Association of Diabetes Educators (AADE) meeting in Las Vegas, Ronette L. Kolotkin, PhD, a clinical psychologist from Obesity and Quality of Life Consulting, Consulting Professor at Duke University Medical Center, and former director of the Behavioral Program at Duke University’s Diet & Fitness Center, gave an oral presentation entitled "Quality of Life Is Improved with Controlled-Release Phentermine/Topiramate In Overweight and Obese Patients."
Kolotkin, who specializes in the treatment of obesity and the study of quality of life, concluded that patients treated with QNEXA during the 56-week EQUIP and CONQUER trials showed statistically significant improvements in quality of life compared to placebo patients. Improvements in quality of life were measured using two validated surveys: the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and Medical Outcomes Study Short Form-36 (SF-36).
Kolotkin, along with Duke colleagues, developed the Impact of Weight on Quality of Life instrument to assess weight-related changes in quality of life. The IWQOL-Lite instrument was administered to all patients in the EQUIP and CONQUER studies. Additionally, the Short Form-36 questionnaire, designed to assess broader health-related quality of life elements, was administered to all patients in the CONQUER clinical study.
Patients in EQUIP who received full dose QNEXA experienced significant improvements versus placebo (P<0.004) in all IWQOL-Lite domains and total score, except work. In the CONQUER study, patients who received QNEXA experienced significant improvements versus placebo (P<0.004) in all IWQOL-Lite domains and total score, as well as the physical aspects of health-related quality of life and vitality on the SF-36 (P<0.0025).
Additional analyses looked at the percentage of patients who demonstrated quality of life improvements based on degree of weight loss. Greater weight loss, regardless of treatment group, led to greater improvements in quality of life.