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

BJU Int. 2007 Jul;100(1):117-21. doi: 10.1111/j.1464-410X.2007.06915.x.

Abstract

Objective: 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.

Patients and methods: 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.

Results: 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.

Conclusions: 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.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aging / physiology*
  • Analysis of Variance
  • Databases as Topic
  • Erectile Dysfunction / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Penile Erection / drug effects
  • Penile Erection / physiology
  • Phosphodiesterase Inhibitors / adverse effects
  • Phosphodiesterase Inhibitors / therapeutic use*
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Purines / adverse effects
  • Purines / therapeutic use
  • Risk Factors
  • Sildenafil Citrate
  • Sulfones / adverse effects
  • Sulfones / therapeutic use*
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Phosphodiesterase Inhibitors
  • Piperazines
  • Purines
  • Sulfones
  • Sildenafil Citrate