Efficacy and safety of tadalafil in men with erectile dysfunction following spinal cord injury.
OBJECTIVE
To determine the efficacy and safety of tadalafil when taken on demand by men with erectile dysfunction (ED) secondary to traumatic spinal cord injury (SCI).


METHODS
Multicenter, randomized, double-blind, placebo-controlled, flexible dose-titration, parallel-group study in clinical practices in Europe. Patients Enrolled patients had ED secondary to SCI (all spinal levels) and sustained 6 months or longer before visit 1.


METHODS
After a 4-week run-in period, patients were randomly assigned to tadalafil, 10 mg, (n = 142) or placebo (n = 44) for a 12-week, on-demand treatment period with assessments at 4-week intervals. The dose of tadalafil was maintained or titrated (10 or 20 mg) at 4 and 8 weeks.


METHODS
Efficacy was measured using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ). Treatment-emergent adverse events and vital signs were collected at each visit.


RESULTS
Mean age was 38 years. Mean baseline IIEF erectile function domain score was 13.4, and following 12 weeks of treatment, 22.6 for tadalafil and 13.6 for placebo (P < .001). After treatment, the tadalafil group compared with the placebo group was significantly greater (P < .001) in mean per-patient percentage of successful penetration attempts (SEP question 2; 75.4% vs 41.1%) and intercourse attempts (SEP question 3; 47.6% vs 16.8%); percentage of improved erections (GAQ question 1; 84.6% vs 19.5%); and ejaculatory frequency (IIEF question 9; P = .03). The 2 most common treatment-emergent adverse events in the tadalafil group compared with placebo were headache (8.5% vs 4.5%) and urinary tract infection (7.7% vs 6.8%).


CONCLUSIONS
Tadalafil (10 mg and 20 mg) improved erectile function and was well tolerated by men with ED secondary to traumatic SCI.
Giuliano
François
F
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 104 Boulevard Raymond Poincaré, 92380 Garches, France. giuliano@cyber-sante.org
Sanchez-Ramos
Antonio
A
Löchner-Ernst
Dieter
D
Del Popolo
Giulio
G
Cruz
Natalio
N
Leriche
Albert
A
Lombardi
Giuseppe
G
Reichert
Susanne
S
Dahl
Palle
P
Elion-Mboussa
Albert
A
Casariego
Joaquin
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D005060:Europe; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013119:Spinal Cord Injuries / Q000150:complications*; D000068581:Tadalafil; D016896:Treatment Outcome
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil