Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury
Por:
Giuliano F., Rubio-Aurioles E., Kennelly M., Montorsi F., Kim E.D., Finkbeiner A.E., Pommerville P.J., Colopy M.W., Wilkins H.J., Wachs B.H.
Publicada:
1 ene 2006
Resumen:
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. Copyright © 2006 by AAN Enterprises, Inc.
Filiaciones:
Giuliano F.:
Department of Urology, Academic Hospital of Bicêtre, Le Kremlin Bicêtre, France
Department of Urology, Academic Hospital of Bicêtre, AP-HP, 78 R. du Gén. Leclerc, 94270 Le Kremlin Bicêtre, France
Rubio-Aurioles E.:
Asociación Mexicana Para la Salud Sexual, Tlalpan, Mexico
Kennelly M.:
McKay Urology, Charlotte, NC, United States
Montorsi F.:
Department of Urology, Università Vita Salute San Raffaele, Milan, Italy
Kim E.D.:
UT Medical Center at Knoxville, Knoxville, TN, United States
Finkbeiner A.E.:
Department of Urology, University of Arkansas for Medical Sciences, Little Rock, AK, United States
Pommerville P.J.:
Can-Med Clinical Research Inc., Victoria, BC, Canada
Colopy M.W.:
GlaxoSmithKline, Research Triangle Park, NC, United States
Wilkins H.J.:
GlaxoSmithKline, King of Prussia, PA, United States
Wachs B.H.:
Atlantic Urology Medical Group, Long Beach, CA, United States
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