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Efficacy and Safety of Tadalafil for Erectile Dysfunction in Patients with Multiple Sclerosis
Authors:Giuseppe Lombardi  Angelo Macchiarella  Giulio Del Popolo
Affiliation:1. Private Practice of Urology and Andrology, Hamburg, Germany;2. Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA;3. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA;4. StatisticsPharmaNet/i3IndianapolisINUSA
Abstract:IntroductionData are sparse concerning the effects of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction (ED) in subjects with multiple sclerosis (MS).AimTo evaluate the efficacy and safety of tadalafil use in subjects with ED because of MS.MethodsNinety-six MS patients with ED after a 4-week treatment-free period were given tadalafil 10 mg. All patients were re-evaluated after 4 weeks. Those with a score lower than 26 on the International Index of Erectile Function (IIEF-15) and with less than 75% of total successful sexual attempts assessed by the Sexual Encounter Profile Questions 2 and 3 (SEP2-3) had their dosage of tadalafil increased to 20 mg, whereas responding subjects continued with 10 mg. Subsequently, all patients had a final follow-up visit after 8 weeks.Main Outcome MeasuresSEP2-3, IIEF-15 questionnaire. The Life Satisfaction Checklist (LSC) questionnaire composed of eight questions was used prior to starting tadalafil and at the end of the 12-week treatment.ResultsNinety-two subjects completed the study. Seventy-two responded, 30 of whom used 10 mg. Two subjects discontinued the therapy because of moderate side effects: one suffered from headache and one from tachycardia. Responding patients reached a significant statistical improvement in all follow-ups compared with baseline on the erectile domain and overall sexual satisfaction scores of the IIEF-15 using the Wilcoxon test P < 0.01. Furthermore, they showed statistical improvement through the Wilcoxon test P < 0.01 on the sexual life, family life, and partner relationship questions of the LSC compared with baseline.ConclusionTadalafil is an effective and safe treatment for males with MS suffering from ED. Further studies are needed on MS patients to evaluate the efficacy and safety of long-term use, and to detect predictable parameters for the success of PDE5 inhibitors. Lombardi G, Macchiarella A, and Del Popolo G. Efficacy and safety of tadalafil for erectile dysfunction in patients with multiple sclerosis.
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