Analysis of the efficacy and safety of sildenafil citrate in the geriatric population

Abstract

To define the efficacy and tolerability of sildenafil in elderly men, as epidemiological data show an increasing life-expectancy of the population, and age is not only correlated with increasing morbidity but also an increase in the prevalence of erectile dysfunction (ED), for which sildenafil, available for >8 years, is effective and safe across a wide variety of medical comorbidities, severity and causes of ED. A database was generated from all sildenafil users in one sexual medicine practice, and data were extracted for men aged >60 years. The database included data on patient demographics, comorbidities, International Index of Erectile Function (IIEF) scores and adverse events (AEs). The patients were subdivided into those aged 60-69 (group 1), 70-79 (group 2), and > or = 80 years (group 3). Analysis of variance was used to assess differences among the three groups for several variables of demographics and erectile response. In all, 167 patients were analysed; there were no significant differences in the duration of ED (5 +/- 3 years) or presence of comorbidities among the three groups. With a mean of two risk factors, the overall incidence of comorbidities was hypertension in 37%, dyslipidaemia in 28%, diabetes in 26%, coronary artery disease in 18% and lower urinary tract symptoms in 46%. The efficacy data showed that overall, 54% of men responded to sildenafil, with a mean increase in IIEF EF domain score of 5.7. Within the three groups there was a significant age-related decrease in response rate and IIEF EF domain score with age. However, there was no difference in AE incidence among the three groups, with an overall profile of 18% headache, 8% flushing, 8% dyspepsia, 5% nasal congestion and 2% visual changes. No overt cardiovascular events were reported. From these data, sildenafil is an effective agent in elderly men, but had a lower efficacy rate with increasing age, especially in men aged >80 years. The incidence of side-effects was similar to that in the general population taking sildenafil, with no difference in AEs among the different age groups.