Qnexa was well-tolerated, with no drug-related serious adverse events. The most common drug-related adverse events reported over the 56 weeks for the treatment and placebo groups, respectively, were tingling, nausea, dry mouth, dizziness, insomnia and constipation. Patients were monitored for depression and suicidality using the PHQ-9 questionnaire, the FDA's preferred mental health assessment tool. Patients treated with Qnexa demonstrated greater improvements in PHQ-9 scores from baseline to the end of the study than the placebo group, providing further assurance that Qnexa treatment does not produce significant adverse mood changes or suicidality.
Despite a mean baseline HbA1c level of 8.7 percent, 53 percent of the subjects treated with Qnexa were able to achieve the ADA recommended goal of 7.0 percent or lower, versus 40 percent of the subjects in the placebo arm (p<0.05). The incidence of treatment-related hypoglycemia was similar in the treatment and placebo arms (2.7% and 1.8%, respectively). There were no cases of severe hypoglycemia.
Diabetes, a chronic medical condition, affects more than 23 million people in the United States and nearly 250 million people worldwide. An estimated 17.9 million have been diagnosed with the disease, however, nearly one quarter are unaware that they have diabetes. New cases of diabetes doubled over the last ten years due to obesity and lifestyle and it is now calculated that the lifetime risk of diabetes in this century is approximately 35 per
|SOURCE VIVUS, Inc.|
Copyright©2009 PR Newswire.
All rights reserved