VIVUS, Inc. (NASDAQ: VVUS) today presented positive results from the avanafil phase 3 study in diabetics. In the REVIVE-Diabetes study (TA-302), male diabetics receiving avanafil had significant improvement in erectile function. Dr. Irwin Goldstein, Director of Sexual Medicine at Alvarado Hospital, San Diego, CA, presented the results of the study during the poster session at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal. Results of the study have been previously reported, but this was the first public European presentation of avanafil safety and efficacy data in diabetic patients.
The study included 390 patients with type 1 and type 2 diabetes treated over 12 weeks with avanafil 100mg, 200mg, or placebo. Diabetics are disproportionately affected by erectile dysfunction (ED), which can worsen with increased duration of disease, and these patients are often considered less responsive to therapy.
This study population consisted of men with an average age of 58 years and a mean duration of diabetes of eleven years and ED of five to six years. The majority were type 2 diabetics, with approximately 10% having type 1 diabetes. Avanafil was associated with significant improvements in erectile function relative to placebo (calculated as least-squares (LS) mean change from baseline for all of the co-primary endpoints (P< 0.0001)). Subgroup analyses demonstrated that improvements in the percentage of successful intercourse attempts with avanafil 100 mg and avanafil 200 mg were observed regardless of diabetes classification (type 1 or 2), duration of diabetes, or baseline ED severity (P<0.05). Successful intercourse was achieved in some subjects in 15 minutes or less after dosing with avanafil. Some subjects had successful intercourse more than six 6 hours after dosing. The most common adverse events in the avanafil treatment groups were headache, nasopharyngitis, flushing, and sinus congestion.
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