Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury.

Author(s): Giuliano F, Sanchez-Ramos A, Lochner-Ernst D, Del Popolo G, Cruz N, Leriche A, Lombardi G, Reichert S, Dahl P, Elion-Mboussa A, Casariego J

Affiliation(s): Raymond Poincare Hospital, Garches, France (Dr Giuliano); Sexuality and Reproduction, Hospital Nacional De Paraplejicos, Toledo, Spain (Dr Sanchez-Ramos); Urologische Abteilung, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany (Dr Lochner-Ernst); Neuro-Urology AOU, Careggi, Florence, Italy (Dr Del Popolo); Servicio de Urologia, Hospital Universitario Virgen del Rocio, Seville, Spain (Dr Cruz); Service d'Urologie, Hospital Henry Gabriel, Laval, France (Dr Leriche); Spinal Unit, Careggi Hospital, Florence (Dr Lombardi); Urologische Klinik, Krankenhaus Hohe Warte Bayreuth, Bayreuth, Germany (Dr Reichert); Eli Lilly Denmark A/S, Lyngby, Denmark (Mr Dahl); Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana (Mr Elion-Mboussa); Eli Lilly Spain, Madrid (Dr Casariego).

Publication date & source: 2007-09-10, Arch Neurol., [Epub ahead of print]

Publication type:

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). DESIGN AND SETTING: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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.Trial Registration clinicaltrials.gov Identifier: NCT00421083.Published online September 10, 2007 (doi:10.1001/archneur.64.11.nct70001).