New Published Data from Lilly ICOS Describe Efficacy of Cialis in Difficult-to-Treat Prostatectomy P

Newly published clinical data on Cialis(R) (tadalafil) published in the September issue of the Journal of Urology show that 62 percent of men who underwent bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP), a surgery for prostate cancer, reported improved erections after taking the drug. Experts have said that more than half of men report erectiledys function (ED) 18 months or more after this form of radical prostatectomy(1), a cause of ED that is among the most difficult to treat.

"After the difficult journey of prostate cancer, to also be faced with erectile dysfunction can be both daunting and discouraging to a man and his partner," said Francesco Montorsi, M.D., from the Department of Urology, Universita Vita Salute San Raffaele, Milan, Italy. "These data offer hope that by using Cialis, men may regain an important part of their lives that might have otherwise been lost following their prostate surgery."

The study, conducted in 2002, demonstrated that 62 percent of men who developed ED following BNSRRP reported improved erections after taking 20 mg Cialis, compared with 23 percent with placebo, based on the question of whether the treatment they were taking improved their erections.

- Patients recorded that a majority of sexual attempts (54 percent) by men who took Cialis resulted in successful vaginal penetration as compared with 32 percent on placebo (p < 0.001).

- In a subgroup of men (N=201) who were able to experience some erection following this type of radical prostatectomy, 71 percent experienced an improved erection compared with 24 percent on placebo (p < 0.001).

- The most commonly reported (>/= 5 percent) treatment-emergent side effects with Cialis in the study were headache, upset stomach and muscle ache.

This Phase III multicenter study consisted of a four-week treatment-free period followed by 12 weeks of treatment with 20 mg Cialis or placebo. In the study, 303 men who had undergone bilateral nerve sparing radical prostatectomy 12-48 months before the study were randomized (2:1) to 20 mg or placebo. The study included a subgroup of 201 men who still retained the ability to have some erection following this type of surgery.