Vardenafil, a New Phosphodiesterase Type 5 Inhibitor, in the Treatment of Erectile Dysfunction in Men With Diabetes
A multicenter double-blind placebo-controlled fixed-dose study
- Irwin Goldstein, MD1,
- Jay M. Young, MD2,
- Jerome Fischer, MD3,
- Keith Bangerter, PHD4,
- Thomas Segerson, MD4,
- Terry Taylor, MD4 and
- The Vardenafil Diabetes Study Group
- 1Boston University Medical Center, Boston, Massachusetts
- 2South Coast Urological Medical Center, Laguna Hills, California
- 3Diabetes and Glandular Disorders Clinic, San Antonio, Texas
- 4Bayer Corporation, West Haven, Connecticut
Abstract
OBJECTIVE—This study evaluated the efficacy and safety of vardenafil treatment for erectile dysfunction (ED) in men with diabetes.
RESEARCH DESIGN AND METHODS—In this prospective multicenter double-blind placebo-controlled fixed-dose parallel-group phase III trial, 452 patients with diabetes (type 1 or type 2) and ED were randomized to take 10 or 20 mg vardenafil or placebo as needed for 12 weeks. Efficacy responses were assessed by International Index of Erectile Function domain scores, rates of vaginal penetration and successful intercourse, and a global assessment question (GAQ) about erection improvement during the previous 4 weeks.
RESULTS—After 12 weeks of treatment, a dose-dependent (P = 0.02) improvement in erections was noted for the GAQ, with 57 and 72% of men taking 10 mg or 20 mg vardenafil, respectively, reporting improved erections, in contrast to 13% after taking placebo (P < 0.0001). For the erectile function domain, dose-dependent (P = 0.03) final scores for the 10- and 20-mg dose were 17.1 and 19.0 compared with 12.6 for placebo (P < 0.0001). Both vardenafil doses significantly enhanced the rates of successful penetration (P < 0.0001) and successful intercourse (P < 0.0001) compared with placebo. Vardenafil treatment was effective in increasing intercourse success rates at all levels of baseline ED severity, at each level of plasma HbA1c, and for type 1 and 2 diabetes. Treatment-emergent adverse events were primarily mild to moderate headache (≤13%), flushing (≤10%), and rhinitis (≤10%).
CONCLUSIONS—Vardenafil statistically improved erectile function and was generally well tolerated in these diabetic patients with ED.
- ECG, electrocardiogram
- ED, erectile dysfunction
- EF, erectile function
- GAQ, global assessment question
- IIEF, International Index of Erectile Function
- LOCF, last observation carried forward
- PDE5, phosphodiesterase type 5
Footnotes
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Address correspondence and reprint requests to Irwin Goldstein, MD, Boston University Medical Center, Department of Urology, 720 Harrison Ave., Suite P-606, Boston, MA 02118. E-mail: igoldst{at}bu.edu.
Received for publication 11 June 2002 and accepted in revised form 13 November 2002.
J.M.Y. has received honoraria for serving on the Western Section Advisory Panel. I.G. serves on advisory panels for Bayer, Abbott, Wyeth-Ayerst, Pharmacia, MacroChem, NexMed, Urometrics, Pfizer, and Lilly; has received honoraria for speaking engagements from Bayer, Pfizer, and Mentor; is a paid consultant for Bayer, MacroChem, Urometrics, Mentor, and Wyeth-Ayerst; and has received funds for clinical studies from Bayer, Pfizer, NexMed, and Vivus. J.F. is a study site investigator and a speaker for Bayer, and is an investigator for Pfizer and Lilly-Icos.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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