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Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury.
Neurology. 2006 Jan 24; 66(2):210-6.Neur

Abstract

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.

Authors+Show Affiliations

Giuliano F
Department of Urology, Academic Hospital of Bicêtre, Le Kremlin Bicêtre, France. giuliano@cyber-sante.org
Rubio-Aurioles E
No affiliation info available
Kennelly M
No affiliation info available
Montorsi F
No affiliation info available
Kim ED
No affiliation info available
Finkbeiner AE
No affiliation info available
Pommerville PJ
No affiliation info available
Colopy MW
No affiliation info available
Wilkins HJ
No affiliation info available
Wachs BH
No affiliation info available
Vardenafil Study Group
No affiliation info available

MeSH

AdultCoitusDouble-Blind MethodDyspepsiaEjaculationErectile DysfunctionFlushingHeadacheHumansImidazolesMaleMedical RecordsNasal ObstructionPenile ErectionPhosphodiesterase InhibitorsPiperazinesSpinal Cord InjuriesSulfonesSurveys and QuestionnairesTreatment OutcomeTriazinesVardenafil Dihydrochloride

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16434656

Citation

Giuliano, F, et al. "Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused By Spinal Cord Injury." Neurology, vol. 66, no. 2, 2006, pp. 210-6.
Giuliano F, Rubio-Aurioles E, Kennelly M, et al. Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology. 2006;66(2):210-6.
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. (2006). Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology, 66(2), 210-6.
Giuliano F, et al. Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused By Spinal Cord Injury. Neurology. 2006 Jan 24;66(2):210-6. PubMed PMID: 16434656.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. AU - Giuliano,F, AU - Rubio-Aurioles,E, AU - Kennelly,M, AU - Montorsi,F, AU - Kim,E D, AU - Finkbeiner,A E, AU - Pommerville,P J, AU - Colopy,M W, AU - Wilkins,H J, AU - Wachs,B H, AU - ,, PY - 2006/1/26/pubmed PY - 2006/3/15/medline PY - 2006/1/26/entrez SP - 210 EP - 6 JF - Neurology JO - Neurology VL - 66 IS - 2 N2 - 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. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/16434656/Efficacy_and_safety_of_vardenafil_in_men_with_erectile_dysfunction_caused_by_spinal_cord_injury_ DB - PRIME DP - Unbound Medicine ER -