VIVUS, a pharmaceutical company, has reported that a subset analysis of subjects with higher cardiovascular risk factors at baseline had significantly greater improvements on Qnexa as compared to placebo in the 28-week Qnexa phase 2 study in type 2 diabetics.
The analysis population is comprised of subjects with elevated baseline risk factors that were in the upper quartile of the overall study population, according to VIVUS.
Specifically, the company said the higher-risk subjects treated with Qnexa reduced their systolic blood pressure by 11.2 mm Hg from a baseline mean of 138.1 mm Hg, as compared to a reduction of 1.9 mm Hg from a baseline mean of 140.7 mm Hg in the placebo group.
Similarly, diastolic blood pressure was reduced by 7.9 mm Hg from a baseline mean of 83.5 mm Hg in the Qnexa group, as compared to a reduction of 3.3 mm Hg from a baseline mean of 86.3 mm Hg in the placebo group, VIVUS said. The current standard of care for diabetics includes a target SBP <130 and DBP <80 mm Hg.
Higher-risk subjects with elevated triglyceride levels at baseline that were treated with Qnexa experienced a reduction of 86.9 mg/dL, or 32 percent, from baseline as compared to a reduction of 25.3 mg/dL, or 8.7 percent, in the placebo group, according to VIVUS.
The company said that fasting plasma glucose in the higher-risk population was reduced by 85.2 mg/dL, or 35 percent, from a baseline mean of 245 mg/dL in the Qnexa group as compared to a reduction of 42.2 mg/dL or 17 percent, from a baseline mean of 242.4 mg/dL in the placebo group.
“Treatment of these diabetic patients with Qnexa resulted in significant improvements in blood pressure and triglycerides, in addition to weight loss and improved glycemic control,” said Charles H. Bowden, MD, director of clinical development at VIVUS.