Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Paper
  • Published:

Assessment of the efficacy and safety of Viagra® (sildenafil citrate) in men with erectile dysfunction during long-term treatment

Abstract

Long-term efficacy and safety of sildenafil was assessed in 1008 patients with erectile dysfunction (ED) enrolled in four flexible-dose (25–100 mg), open-label, 36- or 52-week extension studies. After 36 and 52 weeks, 92% and 89% of patients felt that treatment with sildenafil had improved their erections. Responses to a Sexual Function Questionnaire indicated that 52 weeks of sildenafil treatment resulted in clinically significant improvements in the duration and firmness of erections, overall satisfaction with sex life, and the frequency of stimulated erections. Commonly reported adverse events (AEs) were headache, flushing, dyspepsia, and rhinitis, which were generally mild to moderate. Reports of abnormal vision were consistent with previous clinical trials. The occurrence of treatment-related cardiovascular AEs, such as hypertension, tachycardia, and palpitation, was <1%. Discontinuations due to treatment-related AEs were low (2%). Long-term therapy does not diminish the efficacy of sildenafil in patients with ED and remains well tolerated.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

Similar content being viewed by others

References

  1. NIH Consensus Development Panel on Impotence . Impotence. JAMA 1993 270, 83–90

    Article  Google Scholar 

  2. Spector KR, Boyle M . The prevalence and perceived aetiology of male sexual problems in a non-clinical sample. Br J Med Psychol 1986 59, 351–358

    Article  Google Scholar 

  3. Giuliano FA, Knelleson S, Paturaud JP . Epidemiologic study of erectile dysfunction in France. Eur Urol 1996 30, (Suppl 2): 250 (abstract)

    Google Scholar 

  4. Feldman HA et al.. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994 151, 54–61

    Article  CAS  Google Scholar 

  5. Burnett AL . Role of nitric oxide in the physiology of erection. Biol Reprod 1995 52, 485–489

    Article  CAS  Google Scholar 

  6. Burnett AL . Nitric oxide in the penis: physiology and pathology. J Urol 1997 157, 320–324

    Article  CAS  Google Scholar 

  7. Ignarro LJ et al.. Mechanism of vascular smooth muscle relaxation by organic nitrates, nitritcs, nitroprusside and nitric oxide: evidence for the involvement of S-nitrosothiols as active intermediates. J Pharmacol Exp Ther 1981 218, 739–749

    CAS  PubMed  Google Scholar 

  8. Beavo JA . Cyclic nucleotide phosphodiesterases: functional implications of multiple isoforms. Physiol Rev 1995 75, 725–748

    Article  CAS  Google Scholar 

  9. Boolell M et al.. Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Int J Impot Res 1996 8, 47–52

    CAS  Google Scholar 

  10. Jeremy JY et al.. Effects of sildenafil, a type-5 cGMP phosphodiesterase inhibitor, and papaverine on cyclic GMP and cyclic AMP levels in the rabbit corpus cavernosum in vitro Br J Urol 1997 79, 958–963

    Article  CAS  Google Scholar 

  11. Ballard SA et al.. Effects of sildenafil on the relaxation of human corpus cavernosum tissue in vitro and on the activities of cyclic nucleotide phosphodiesterase isozymes. J Urol 1998 159, 2164–2171

    Article  CAS  Google Scholar 

  12. Goldstein I et al.. Oral sildenafil in the treatment of erectile dysfunction. New Engl J Med 1998 338, 1397–1404

    Article  CAS  Google Scholar 

  13. Morales A et al.. Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Int J Impot Res 1998 10, 69–74

    Article  CAS  Google Scholar 

  14. Ballard S et al.. In vitro profile of UK-92,480, an inhibitor of cyclic GMP-specific phosphodiesterase 5 for the treatment of male erectile dysfunction. J Urol 1996 155, 676A

    Google Scholar 

  15. Padma-Nathan H, Steers WD, Wicker PA, for the Sildenafil Study Group . Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction: a double-blind, placebo-controlled study of 329 patients. Int J Clin Pract 1998 52, 375–380

    CAS  PubMed  Google Scholar 

  16. Muller JE et al.. Triggering myocardial infarction by sexual activity. Low absolute risk and prevention by regular physical exertion. JAMA 1996 275, 1405–1409

    Article  CAS  Google Scholar 

  17. Parker JD, Parker JO . Nitrate therapy for stable angina pectoris. New Engl J Med 1998 338, 520–531

    Article  CAS  Google Scholar 

  18. Jackson G et al.. Effects of sildenafil citrate on human hemodynamics. Am J Cardiol 1999 83, (Suppl 5A): 13C–20C

    Article  Google Scholar 

  19. Webb DJ et al.. Sildenafil citrate and blood-pressure-lowering drugs: results of drug interaction studies with an organic nitrate and a calcium antagonist. Am J Cardiol 1999 83, (Suppl 5A): 21C–28C

    Google Scholar 

  20. Pfizer Inc, New York, NY . Viagra (sildenafil citrate) prescribing information.

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Steers, W., Guay, A., Leriche, A. et al. Assessment of the efficacy and safety of Viagra® (sildenafil citrate) in men with erectile dysfunction during long-term treatment. Int J Impot Res 13, 261–267 (2001). https://doi.org/10.1038/sj.ijir.3900714

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/sj.ijir.3900714

Keywords

This article is cited by

Search

Quick links