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


CONCLUSIONS
Vardenafil significantly improved erectile and ejaculatory function and was generally well tolerated in men with erectile dysfunction due to spinal cord injury.
Giuliano
F
F
Department of Urology, Academic Hospital of Bicêtre, Le Kremlin Bicêtre, France. giuliano@cyber-sante.org
Rubio-Aurioles
E
E
Kennelly
M
M
Montorsi
F
F
Kim
E D
ED
Finkbeiner
A E
AE
Pommerville
P J
PJ
Colopy
M W
MW
Wilkins
H J
HJ
Wachs
B H
BH
D000328:Adult; D003075:Coitus; D004311:Double-Blind Method; D004415:Dyspepsia / Q000139:chemically induced; D004542:Ejaculation / Q000187:drug effects; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology*; D005483:Flushing / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008499:Medical Records; D015508:Nasal Obstruction / Q000139:chemically induced; D010410:Penile Erection / Q000187:drug effects; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use*; D013119:Spinal Cord Injuries / Q000150:complications*; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride