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NEUROLOGY 2006;66:210-216
© 2006 American Academy of Neurology

Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury

F. Giuliano, MD, E. Rubio-Aurioles, MD, M. Kennelly, MD, F. Montorsi, MD, E. D. Kim, MD, A. E. Finkbeiner, MD, P. J. Pommerville, MD, M. W. Colopy, PhD, H. J. Wilkins, MD, B. H. Wachs, MD for the Vardenafil Study Group*

From the Department of Urology (F.G.), Academic Hospital of Bicêtre, Le Kremlin Bicêtre, France; Asociación Mexicana Para la Salud Sexual (E.R.-A.), Tlalpan, Mexico; McKay Urology (M.K.), Charlotte, NC; Department of Urology (F.M.), Università Vita Salute San Raffaele, Milan, Italy; UT Medical Center at Knoxville (E.D.K.), Knoxville, TN; Department of Urology (A.E.F.), University of Arkansas for Medical Sciences, Little Rock, AK; Can-Med Clinical Research Inc. (P.J.P.), Victoria, BC, Canada; GlaxoSmithKline (M.W.C.), Research Triangle Park, NC; GlaxoSmithKline (H.J.W.), King of Prussia, PA; Atlantic Urology Medical Group (B.H.W.), Long Beach, CA.

Address correspondence and reprint requests to Dr. Francois Giuliano, Department of Urology, Academic Hospital of Bicêtre, AP-HP, 78 Rue du Général Leclerc, 94270 Le Kremlin Bicêtre, France; e-mail: giuliano{at}cyber-sante.org

Objective: To assess the efficacy and tolerability of vardenafil in men with erectile dysfunction (ED) due to traumatic spinal cord injury (SCI).

Methods: In this multicenter, double-blind, placebo-controlled, parallel-group 12-week study, 418 men aged 18 years and older with ED for more than 6 months consequent to SCI were randomized to vardenafil (n = 207) or placebo (n = 211) (10 mg for 4 weeks, then maintained or titrated to 5 or 20 mg at weeks 4 and 8). Efficacy assessments included the erectile function (EF) domain score of the International Index of Erectile Function questionnaire and diary questions regarding penetration, maintenance of erection to completion of intercourse, and ejaculation.

Results: Baseline patient characteristics were similar in the vardenafil (mean age 40 years) and placebo (mean age 39 years) groups. Mean baseline EF domain scores were 11.6 in the vardenafil group and 12.1 (moderate ED) in the placebo group. EF domain score in the vardenafil group improved to 22.0 (mild ED) at last observation carried forward vs 13.5 in the placebo group (p < 0.001). Over 12 weeks of treatment, mean per-patient penetration (76% vs 41%), maintenance (59% vs 22%), and ejaculation (19% vs 10%) success rates were significantly greater vs placebo (all p < 0.001). The most frequently reported drug-related adverse events were headache (vardenafil 15%, placebo 4%), flushing (vardenafil 6%, placebo 0%), nasal congestion (vardenafil 5%, placebo 0%), and dyspepsia (vardenafil 4%, placebo 0%).

Conclusion: Vardenafil significantly improved erectile and ejaculatory function and was generally well tolerated in men with erectile dysfunction due to spinal cord injury.

*See the Appendix for a list of Group members.

Supported by Bayer Corporation, Pharmaceutical Division, West Haven, CT, and GlaxoSmithKline, King of Prussia, Philadelphia, PA.

Disclosure: Drs. Guiliano, Rubio-Aurioles, Kennelly, Montorsi, Kim, Finkbeiner, Pommerville, and Wachs are study investigators for Bayer and GlaxoSmithKline. Drs. Colopy and Wilkins are employees of GlaxoSmithKline. Dr. Rubio-Aurioles has received honoraria from GlaxoSmithKline in excess of $10,000. Dr. Montorsi has received consultancy support in excess of $10,000. Dr. Pommerville has received honoraria of less than $10,000. All authors had access to the study data. GlaxoSmithKline Biostatistics in Philadelphia, PA conducted the data management and GlaxoSmithKline Biostatistics in Research Triangle Park, NC, prepared the statistical analysis for this study. All authors contributed to the preparation of this paper.

Received May 19, 2005. Accepted in final form October 7, 2005.


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