Introduction. The efficacy of phosphodiesterase type 5 inhibitors for a broad spectrum of erectile dysfunction (ED) is largely reported in literature. Data are lacking concerning medium and long-term effects and safety of these treatments.
Aim. The aim of this study was to evaluate the efficacy and safety of medium and long-term use of tadalafil in subjects with ED because of spinal cord injury (SCI).
Methods. Phase 1: From March 2003 to March 2007, 103 SCI patients with ED, mean age 39 years, were given 10 mg of tadalafil after a 4-week treatment-free period. For patients with a score lower than 26 in the erectile domain of the International Index of Erectile Function (IIEF15) and with total unsuccessful sexual attempts of more than 25% according to the Sexual Encounter Profile questions 2 and 3 (SEP2–3), the dosage of tadalafil was increased to 20 mg.
Phase 2: Only responding patients entered phase 2 where the subjects were evaluated in office visits every 6 months using the IIEF15 questionnaire and a diary reporting the day and time the drug was taken. All final visits were concluded by May 2008.
Main Outcome Measures. The improvement of ED was measured using the IIEF15 and the SEP2–3 questions.
Results. Twenty-nine patients were excluded from phase 2: Twenty-seven did not respond to the drug and two left the study because of mild drawbacks. During the 6-month follow-up, nine left the study. Sixty-five individuals continued treatment with median follow-up of 33.6 months, 31 of whom took 10 mg and 34 who used 20 mg. Each group maintained up until the final visit a significant statistical improvement in erectile function, sexual satisfaction, overall satisfaction and percentages of “yes” responses to the SEP2–3 compared with baseline using the Wilcoxon test (P < 0.05).
Conclusion. Tadalafil represents an effective and safe long-term option for SCI patients with ED. Lombardi G, Macchiarella A, Cecconi F, and Popolo GD. Efficacy and safety of medium and long-term tadalafil use in spinal cord patients with erectile dysfunction. J Sex Med 2009;6:535–543.