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


Authors: Müller, A.; Smith, L.; Parker, M.; Mulhall, J. P.
Article Title: Analysis of the efficacy and safety of sildenafil citrate in the geriatric population
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 ≥ 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 © 2007 The Authors.
Keywords: controlled study; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; major clinical study; drug tolerability; drug efficacy; drug safety; hypertension; side effect; outcome assessment; demography; risk factors; reference database; risk factor; questionnaires; flushing; drug induced headache; diabetes mellitus; comorbidity; scoring system; vision; aging; therapy effect; purines; dyslipidemia; disease duration; safety; heartburn; piperazines; analysis of variance; erectile dysfunction; coronary artery disease; life expectancy; geriatric patient; penile erection; sildenafil; phosphodiesterase inhibitors; impotence; sulfones; efficacy; sildenafil citrate; lower urinary tract symptom; nose congestion; databases; phosphodiesterase inhibitor; geriatric population; cardiovascular symptom
Journal Title: BJU International
Volume: 100
Issue: 1
ISSN: 1464-4096
Publisher: Wiley Blackwell  
Date Published: 2007-07-01
Start Page: 117
End Page: 121
Language: English
DOI: 10.1111/j.1464-410X.2007.06915.x
PUBMED: 17552959
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 9" - "Export Date: 17 November 2011" - "CODEN: BJINF" - "Source: Scopus"
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  1. John P Mulhall
    601 Mulhall