By Chris Berrie
BRUSSELS, Belgium -- December 9, 2008 -- Tadalafil is slightly more effective than sildenafil and vardenafil in treating men with severe erectile dysfunction (ED), and more ED patients preferred tadalafil for erection quality, according to a prospective, randomised study presented at the Joint Congress of the European and International Societies for Sexual Medicine (ESSM-ISSM).
The aim of this open-label, fixed-dose, crossover study was to determine the effectiveness and side effects of, the differences between, and the patient preference for the 3 phosphodiesterase-5 (PDE5) inhibitors, sildenafil, vardenafil, and tadalafil. Jose Maria Cuadrado, MD, Hospital Universitario de Bellvitge, Barcelona, Spain, indicated that patient inclusion was specified as severe erectile dysfunction with an evolution of greater than 6 months and an International Index of Erectile Function (IIEF) score of 10 or less.
"Sildenafil 100 mg, vardenafil 20 mg, and tadalafil 20 mg were taken at least 4 times [by each patient] over a period of 30 to 45 days, with a washout period of 7 days," Dr. Cuadrado described, speaking here at a poster presentation on December 8.
The baseline characteristics of the 108 patients who completed the study were as follows: average age 55.9 years; average time of evolving ED 28.4 months; associated comorbidities 94%; average IIEF score 8.52.
As post-treatment comparisons were made with baseline values, the mean IIEF scores showed tadalafil (21.74) to be slightly, but significantly, more effective than both sildenafil (20.56; P = .003) and vardenafil (20.64; P = .001), which were not significantly different from each other.
Similarly, the patient (n = 108) and partner (n = 75) Erectile Dysfunction Inventory for Treatment Satisfaction scores generally demonstrated small but significant benefits for tadalafil (28.65 and 11.47, respectively) over both sildenafil (27.07, P = .027; 10.84, P = .158) and vardenafil (27.29, P = .027; 10.41, P = .013). Again, no differences were seen between sildenafil and vardenafil.
For the Sexual Encounter Profile (SEP), Dr. Cuadrado noted, "Questions SEP4 and SEP5 were significantly in favour of tadalafil over sildenafil and vardenafil [38.09 vs 31.20 vs 32.10, P = .025; 41.43 vs 33.42 vs 35.85, P = .025; respectively]".
Patient preference according to erection quality was also seen to favour tadalafil (39.8%) over both sildenafil (18.5%) and vardenafil (17.6%), although 24.1% of patients also expressed no specific preference.
[Presentation title: Effectiveness and Preference Study in Patients With Severe Erectile Dysfunction, After Taking the Three Phosphodiesterase-5 Inhibitors. Abstract MP-028]