NEW ORLEANS — Regardless of glycemic control, vardenafil significantly improves intercourse success rates, compared with placebo, for diabetic men who do not respond to sildenafil, Culley Carson, M.D., reported in a series of posters presented at the annual meeting of the Endocrine Society.
Men with the worst control with hemoglobin A1c (HbA1c) greater than 8%–12% had the biggest increase in successful intercourse attempts, said Dr. Carson, chief of urology at the University of North Carolina at Chapel Hill.
Dr. Carson, who is a paid investigator for GlaxoSmithKline and a member of its advisory board, presented a posthoc subgroup analysis of the Patient Response With Vardenafil in Sildenafil Nonresponders (PROVEN) trial. The trial assessed the improvement of erectile function in 463 men with moderate to severe erectile dysfunction who were not responsive to sildenafil therapy. The subgroup analysis applied to 153 men in the group who had diabetes. The mean age of the patients was 60 years; 90% of the group was white.
After a 1-month treatment-free run-in period, the men were randomized to either placebo or one 10-mg vardenafil tablet/day, taken 1 hour before intercourse. They had the option to maintain that dose over the 12-week study, or, at weeks 4 and 8, to titrate to 5 mg or 20 mg based on the efficacy and tolerability of the drug.
After 12 weeks, diabetic men in the active group reported a fivefold increase in the number of successful intercourse attempts over baseline (33% vs. 6%). Men in the placebo group reported a nonsignificant increase in successful attempts of 13% over 11% at baseline.
Improvements in successful intercourse attempts were noted across all levels of glycemic control, Dr. Carson said. The greatest increase occurred in men with the worst glycemic control, who had nearly a sevenfold increase in successful intercourse attempts, from 6% of attempts at baseline to 41% at the study's end. Men with the best control (HbA1c less than 6.5%) had about a fourfold increase in successful attempts, from about 12% of attempts at baseline to 53% of attempts at the study's end.
Men with intermediate control (HbA1c 6.5%–8%) also had about a fourfold increase in successful attempts, from about 6% at baseline to 26% at the study's end.
The most frequently reported adverse events in the study were dyspepsia (8% of active group vs. 0% placebo), flushing (6% active group vs. 2% placebo), nasal congestion (6% active group vs. 0% placebo), headache (5% active group vs. 2% placebo), and upper respiratory tract infection (5% active group vs. 2% placebo). Three patients in the placebo group and five in the active group withdrew due to adverse events.