The influence of age on treatment outcomes in men with erectile dysfunction treated with two regimens of tadalafil: results of the SURE study.

Objective: To evaluate whether patterns of sexual activity and efficacy over time to two dosing regimens of tadalafil differ with ageing in men with erectile dysfunction (ED).

Patients And Methods: The SURE study was a multicentre, crossover, open-label study. In all, 4262 men with ED were randomly assigned to treatment with tadalafil 20 mg on-demand before sexual activity, or three times per week for 5-6 weeks. After a 1-week washout period, patients were crossed over to the alternative regimen for 5-6 weeks. This post hoc analysis evaluated the pattern of sexual attempts, efficacy and safety of these two regimens of tadalafil across several age groups.

Results: The mean number of sexual attempts per week decreased from a range of 2.6-2.8 at age < or = 40 years to 1.9 at age >70 years. Age did not significantly influence the time of sexual activity after dosing. A high percentage of attempts occurred >4 h after dosing for all age groups ( approximately 70% for men taking tadalafil three times per week and approximately 50% for men taking tadalafil on-demand). For all age groups, most attempts took place in the late evening. The mean per-patient rate of successful attempts was similar for each interval up to 36 h after dosing and decreased with increasing age (> or =75% at age < or = 60 years, > or = 68% at age >60 to < or = 70 years, and > or = 60% at age >70 years). Tadalafil was well tolerated at all ages.

Conclusions: Patterns of sexual activity with tadalafil 20 mg, taken on-demand or three times per week, were similar in the different age groups. Tadalafil was effective up to 36 h after dosing for all age groups.