Comparison of efficacy safety and tolerability of on-demand Cialis and daily dosed Cialis for the treatment of erectile dysfunction
OBJECTIVE: To assess and compare the efficacy of on-demand Cialis and daily Cialis in the treatment of erectile dysfunction. MATERIALS AND METHODS: A total of 145 men with a mean age of 57.3 years (range 19-82 years) and mild to severe erectile dysfunction of various etiologies were randomized to receive on-demand Cialis (20 mg) or daily Cialis (10 mg) taken without food or alcohol restrictions in a trial lasting 26 weeks. The three primary outcome measures were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF), the proportion of "yes" responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question administered at completion of the study. RESULTS: Compared with baseline, on-demand and daily Cialis enhanced all efficacy outcomes. Patients receiving on-demand Cialis (20 mg) and daily Cialis (10 mg) experienced a significant mean improvement of 8.3 and 11.9, respectively, in the erectile function domain of the IIEF from baseline (P < 0.001). The mean change from baseline was significantly higher for daily dosed Cialis than for on-demand Cialis (P < 0.05). Sexual intercourse was successfully completed (SEP3) in 69% and 84% of patients taking on-demand Cialis and daily Cialis, respectively, compared with 30% at baseline (P < 0.001). Successful completion of sexual intercourse was statistically higher for daily Cialis than for on-demand Cialis (P < 0.05). Treatment with on-demand Cialis or daily Cialis was well tolerated, and headaches, facial flushing, and dyspepsia were the most frequently observed adverse events. CONCLUSION: Cialis was effective and well tolerated in this patient population. Treatment with daily Cialis was associated with a significantly higher IIEF erectile function domain score and completion of successful intercourse compared with on-demand Cialis.
