Results of the trial were published online September 10 and scheduled for the November issue of the Archives of Neurology.
"As in other ED studies that included patients who were difficult to treat owing to preexisting conditions (eg, prostatectomy, diabetes mellitus), tadalafil was efficacious for the treatment of ED after a traumatic SCI," the researchers, with first author François Giuliano MD, PhD, from Raymond Poincaré Hospital, in Garches, France, conclude. "On-demand treatment with tadalafil (10 mg or 20 mg) may help improve the sex lives of patients with ED and SCI and their partners."
Erectile Dysfunction in Spinal Cord Injury
Erectile dysfunction is common in men with spinal cord injury, depending on the extent and level of the neurological lesion, the authors note. "Only 25% of men with SCI have erections adequate for intercourse," they write. "A current treatment option for patients with ED and SCI is an oral phosphodiesterase 5 [PDE5] inhibitor, which is a first-line treatment for most men with ED."
Tadalafil is a PDE5 inhibitor already approved and marketed for men with ED. The current study was a randomized, multicenter, double-blind, placebo-controlled, flexible-dose study to assess the efficacy and safety of tadalafil in men with ED secondary to SCI.
Patients were drawn from clinical practices in France, Germany, Italy, and Spain and were included with SCI at any spinal level sustained 6 months or longer before the first study visit. Mean age of participants was 38 years.
After a 4-week run-in period, 186 patients were randomly assigned in a 3:1 ratio to receive either tadalafil 10 mg or placebo for a 12-week on-demand treatment period, with assessment at 4-week intervals. The tadalafil dose was maintained or titrated (10 mg or 20 mg) at 4 and 8 weeks.
Efficacy was measured using the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEPP), and the Global Assessment Questionnaire (GAQ). Treatment-emergent adverse events and vital signs were monitored at each visit.
Mean baseline score on the IIEF was 13.4, indicating moderate ED — scores below 25 on this scale indicate ED. After 12 weeks of treatment, the mean score improved to 22.6 in the tadalafil group, indicating mild ED, compared with 13.6 in the placebo group, a significant difference (P < .001). After 12 weeks, 54% of treated patients had an IIEF score of 26 or more, indicating normal erectile function.
Men receiving tadalafil reported improvements in mean per-patient percentage of successful penetration and intercourse attempts, percentage of improved erections, and ejaculatory frequency.
The 2 most common treatment-emergent adverse events (AEs) in men receiving tadalafil vs placebo were headache and urinary tract infection.
"In our study, efficacy data with tadalafil were similar to those observed with the other 2 available PDE5 inhibitors, and the safety profile showed a lower incidence of classic PDE5 inhibitor–related AEs," they write. "However, because this was not a head-to-head comparative trial, no other conclusions can be made in this respect."
The researchers do point out, though, that the longer half-life of tadalafil compared with sildenafil (Viagra, Pfizer) or vardenafil (Levitra, Bayer Healthcare) may allow more flexibility in terms of timing of sexual activity for patients.
They point out that 1 limitation of this study is that subjects who had previously not responded to PDE5 inhibitors were excluded from this trial.
Funding for the study was provided by Lilly ICOS LLC, in Indianapolis, Indiana and Bothwell, Washington. Dr. Giuliano reports being an investigator, speaker, and consultant for Eli Lilly and for Pfizer, an investigator and speaker for Bayer, and a consultant for Schwartz-Pharma. Disclosures for other coauthors appear in the paper.
Arch Neurol. 2007. Published online Sept 10. 2007. Abstract
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