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

F. Giuliano, E. Rubio-Aurioles, M. Kennelly, F. Montorsi, Edward Kim, A. E. Finkbeiner, P. J. Pommerville, M. W. Colopy, H. J. Wilkins, B. H. Wachs

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)210-216
Number of pages7
JournalNeurology
Volume66
Issue number2
DOIs
StatePublished - Jan 1 2006
Externally publishedYes

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Erectile Dysfunction
Spinal Cord Injuries
Placebos
Safety
Ejaculation
Maintenance
Vardenafil Dihydrochloride
Dyspepsia
Drug-Related Side Effects and Adverse Reactions
Nose
Headache
Observation

All Science Journal Classification (ASJC) codes

  • Clinical Neurology

Cite this

Giuliano, F., Rubio-Aurioles, E., Kennelly, M., Montorsi, F., Kim, E., Finkbeiner, A. E., ... Wachs, B. H. (2006). Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology, 66(2), 210-216. https://doi.org/10.1212/01.wnl.0000194260.43583.32

Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. / Giuliano, F.; Rubio-Aurioles, E.; Kennelly, M.; Montorsi, F.; Kim, Edward; Finkbeiner, A. E.; Pommerville, P. J.; Colopy, M. W.; Wilkins, H. J.; Wachs, B. H.

In: Neurology, Vol. 66, No. 2, 01.01.2006, p. 210-216.

Research output: Contribution to journalArticle

Giuliano, F, Rubio-Aurioles, E, Kennelly, M, Montorsi, F, Kim, E, Finkbeiner, AE, Pommerville, PJ, Colopy, MW, Wilkins, HJ & Wachs, BH 2006, 'Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury', Neurology, vol. 66, no. 2, pp. 210-216. https://doi.org/10.1212/01.wnl.0000194260.43583.32
Giuliano, F. ; Rubio-Aurioles, E. ; Kennelly, M. ; Montorsi, F. ; Kim, Edward ; Finkbeiner, A. E. ; Pommerville, P. J. ; Colopy, M. W. ; Wilkins, H. J. ; Wachs, B. H. / Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. In: Neurology. 2006 ; Vol. 66, No. 2. pp. 210-216.
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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.",
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AU - Kim, Edward

AU - Finkbeiner, A. E.

AU - Pommerville, P. J.

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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.

AB - 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.

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