In the 7 years since sildenafil citrate (VIAGRA) was introduced as the first oral phosphodiesterase type 5 inhibitor therapy for erectile dysfunction, it has been used to treat nearly 27 million men with erectile dysfunction worldwide. Patient populations with erectile dysfunction of varying etiologies and with diverse comorbidities have benefited from sildenafil treatment. This update focuses on relatively recent research that further defines the response and effectiveness profiles of sildenafil and provides additional insight into optimizing treatment. In addition to providing recent data on sildenafil efficacy and safety/tolerability, the update provides data on assessments of erection hardness, measures of psychosocial outcomes (e.g., emotional well-being and treatment satisfaction), and treatment approaches to maximize response and effectiveness (e.g., by titrating to the maximum tolerated dose). Increased understanding of the sildenafil response and effectiveness profiles and optimal sildenafil treatment are central to the appropriate management of erectile dysfunction using sildenafil.
This is a preview of subscription content, access via your institution
Open Access articles citing this article.
Oxytocin receptor antagonists as a novel pharmacological agent for reducing smooth muscle tone in the human prostate
Scientific Reports Open Access 18 March 2021
Subscribe to Journal
Get full journal access for 1 year
only $14.88 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Tax calculation will be finalised during checkout.
Get time limited or full article access on ReadCube.
All prices are NET prices.
Aytac IA, McKinley J, Krane RJ . The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999; 84: 50–56.
Data on File. Pfizer Inc: New York, NY, 2005.
Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA . Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med 1998; 338: 1397–1404.
Dinsmore WW, Hodges M, Hargreaves C, Osterloh IH, Smith MD, Rosen RC . Sildenafil citrate (VIAGRA) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects. Urology 1999; 53: 800–805.
Becher E, Tejada Noriega A, Gomez R, Decia R . Sildenafil citrate (Viagra) in the treatment of men with erectile dysfunction in southern Latin America: a double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible-dose escalation study. Int J Impot Res 2002; 14 (Suppl 2): S33–S41.
Glina S, Bertero E, Claro J, Damiao R, Faria G, Fregonesi A et al. Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction in Brazilian and Mexican men. Int J Impot Res 2002; 14 (Suppl 2): S27–S32.
Gomez F, Davila H, Costa A, Acuna A, Wadskier LA, Plua P . Efficacy and safety of oral sildenafil citrate (Viagra) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study. Int J Impot Res 2002; 14 (Suppl 2): S42–S47.
Levinson IP, Khalaf IM, Shaeer KZ, Smart DO . Efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in Egypt and South Africa. Int J Impot Res 2003; 15 (Suppl 1): S25–S29.
Osegbe DN, Shittu OB, Aghaji AE, Onyemelukwe GC, Dogo D, Dikko AA . Sildenafil citrate (Viagra) for the treatment of erectile dysfunction in Nigerian men. Int J Impot Res 2003; 15 (Suppl 1): S15–S18.
Tan HM, Moh CL, Mendoza JB, Gana T, Albano GJ, de la Cruz R et al. Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. The Assess-1 Study Group. Urology 2000; 56: 635–640.
Chen KK, Hsieh JT, Huang ST, Jiaan DB, Lin JS, Wang CJ . ASSESS-3: a randomised, double-blind, flexible-dose clinical trial of the efficacy and safety of oral sildenafil in the treatment of men with erectile dysfunction in Taiwan. Int J Impot Res 2001; 13: 221–229.
Stuckey BG, Jadzinsky MN, Murphy LJ, Montorsi F, Kadioglu A, Fraige F et al. Sildenafil citrate for treatment of erectile dysfunction in men with type 1 diabetes: results of a randomized controlled trial. Diabet Care 2003; 26: 279–284.
Carson CC, Burnett AL, Levine LA, Nehra A . The efficacy of sildenafil citrate (Viagra®) in clinical populations: an update. Urology 2002; 60 (Suppl 2B): 12–27.
Padma-Nathan H, Eardley I, Kloner RA, Laties AM, Montorsi F . A 4-year update on the safety of sildenafil citrate (Viagra®). Urology 2002; 60 (Suppl 2B): 67–90.
Carson C, Siegel R, Orazem J . Sildenafil citrate treatment for erectile dysfunction: rate of adverse events decreases over time. J Urol 2002; 167 (Suppl): 179.
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A . The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997; 49: 822–830.
Boolell M, Gepi-Attee S, Gingell JC, Allen MJ . Sildenafil, a novel effective oral therapy for male erectile dysfunction. Br J Urol 1996; 78: 257–261.
Levinson IP . Viagra® (sildenafil citrate) improves erectile function and quality in men with erectile dysfunction. J Sex Med 2005; 2 (Suppl 1): 59.
Padma-Nathan H, Stecher VJ, Sweeney M, Orazem J, Tseng LJ, deRiesthal H . Minimal time to successful intercourse after sildenafil citrate: results of a randomized, double-blind, placebo-controlled trial. Urology 2003; 62: 400–403.
Gingell C, Sultana S, Hodgson G, Wulff M, Gepi-Attee S . Duration of action of sildenafil citrate in men with erectile dysfunction. J Sex Med 2004; 1: 179–184.
Levinson IP . Erectile function is associated with sexual and relationship satisfaction: a pooled analysis of 26 randomized, double-blind, placebo-controlled trials. J Sex Med 2005; 2 (Suppl 1): 59.
Boulton AJ, Selam JL, Sweeney M, Ziegler D . Sildenafil citrate for the treatment of erectile dysfunction in men with type II diabetes mellitus. Diabetologia 2001; 44: 1296–1301.
Arruda-Olson AM, Mahoney DW, Nehra A, Leckel M, Pellikka PA . Cardiovascular effects of sildenafil during exercise in men with known or probable coronary artery disease: a randomized crossover trial. JAMA 2002; 287: 719–725.
DeBusk RF, Pepine CJ, Glasser DB, Shpilsky A, deRiesthal H, Sweeney M . Efficacy and safety of sildenafil citrate in men with erectile dysfunction and stable coronary artery disease. Am J Cardiol 2004; 93: 147–153.
Pickering TG, Shepherd AM, Puddey IB, Glasser DB, Orazem J, Sherman N et al. Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: a randomized controlled trial. Am J Hypertens 2004; 17: 1135–1142.
Webster LJ, Michelakis ED, Davis T, Archer SL . Use of sildenafil for safe improvement of erectile function and quality of life in men with New York Heart Association classes II and III congestive heart failure: a prospective, placebo-controlled, double-blind crossover trial. Arch Intern Med 2004; 164: 514–520.
Aranda P, Ruilope LM, Calvo C, Luque M, Coca A, Gil de Miguel A . Erectile dysfunction in essential arterial hypertension and effects of sildenafil: results of a Spanish national study. Am J Hypertens 2004; 17: 139–145.
Seidman SN, Roose SP, Menza MA, Shabsigh R, Rosen RC . Treatment of erectile dysfunction in men with depressive symptoms: results of a placebo-controlled trial with sildenafil citrate. Am J Psychiatry 2001; 158: 1623–1630.
Nurnberg HG, Hensley PL, Gelenberg AJ, Fava M, Lauriello J, Paine S . Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial. JAMA 2003; 289: 56–64.
Tignol J, Furlan PM, Gomez-Beneyto M, Opsomer R, Schreiber W, Sweeney M et al. Efficacy of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in remission from depression. Int Clin Psychopharmacol 2004; 19: 191–199.
Sahin Y, Aygun C, Peskircioglu CL, Kut A, Tekin MI, Ozdemir FN et al. Efficacy and safety of sildenafil citrate in hemodialysis patients. Transplant Proc 2004; 36: 56–58.
YenicerioGlu Y, Kefi A, Aslan G, Cavdar C, Esen AA, Camsari T et al. Efficacy and safety of sildenafil for treating erectile dysfunction in patients on dialysis. BJU Int 2002; 90: 442–445.
Seibel I, Poli De Figueiredo CE, Teloken C, Moraes JF . Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction. J Am Soc Nephrol 2002; 13: 2770–2775.
Russo D, Musone D, Alteri V, Cindolo L, Lanzillo B, Federico S et al. Erectile dysfunction in kidney transplanted patients: efficacy of sildenafil. J Nephrol 2004; 17: 291–295.
Espinoza R, Melchor JS, Gracida C . Sildenafil (Viagra) in kidney transplant recipients with erectile dysfunction. Transplantation Proc 2002; 34: 408–409.
Barrou B, Cuzin B, Malavaud B, Petit J, Pariente JL, Buchler M et al. Early experience with sildenafil for the treatment of erectile dysfunction in renal transplant recipients. Nephrol Dial Transplant 2003; 18: 411–417.
Christ B, Brockmeier D, Hauck EW, Kamali-Ernst S . Investigation on interaction between tacrolimus and sildenafil in kidney-transplanted patients with erectile dysfunction. Int J Clin Pharmacol Ther 2004; 42: 149–156.
Zippe CD, Jhaveri FM, Klein EA, Kedia S, Pasqualotto FF, Kedia A et al. Role of Viagra after radical prostatectomy. Urology 2000; 55: 241–245.
Zagaja GP, Mhoon DA, Aikens JE, Brendler CB . Sildenafil in the treatment of erectile dysfunction after radical prostatectomy. Urology 2000; 56: 631–634.
Raina R, Lakin MM, Agarwal A, Sharma R, Goyal KK, Montague DK et al. Long-term effect of sildenafil citrate on erectile dysfunction after radical prostatectomy: 3-year follow-up. Urology 2003; 62: 110–115.
Padma-Nathan H, McCullough AR, Giuliano F, Toler SM, Wohlhuter C, Shpilsky AB . Postoperative nightly administration of sildenafil citrate significantly improves the return of normal spontaneous erectile function after bilateral nerve-sparing radical prostatectomy. J Urol 2003; 169 (Suppl): 375–376.
Merrick GS, Butler WM, Galbreath RW, Stipetich RL, Abel LJ, Lief JH . Erectile function after permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys 2002; 52: 893–902.
Raina R, Agarwal A, Goyal KK, Jackson C, Ulchaker J, Angermeier K et al. Long-term potency after iodine-125 radiotherapy for prostate cancer and role of sildenafil citrate. Urology 2003; 62: 1103–1108.
Zelefsky MJ, McKee AB, Lee H, Leibel SA . Efficacy of oral sildenafil in patients with erectile dysfunction after radiotherapy for carcinoma of the prostate. Urology 1999; 53: 775–778.
Kedia S, Zippe CD, Agarwal A, Nelson DR, Lakin MM . Treatment of erectile dysfunction with sildenafil citrate (Viagra) after radiation therapy for prostate cancer. Urology 1999; 54: 308–312.
Incrocci L, Hop WC, Slob AK . Efficacy of sildenafil in an open-label study as a continuation of a double-blind study in the treatment of erectile dysfunction after radiotherapy for prostate cancer. Urology 2003; 62: 116–120.
Morales A, Gingell C, Collins M, Wicker PA, Osterloh IH . Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Int J Impot Res 1998; 10: 69–74.
Mittleman MA, Maclure M, Glasser DB . Evaluation of acute risk for myocardial infarction in men treated with sildenafil citrate. Am J Cardiol 2005; 96: 443–446.
Mittleman MA, Glasser DB, Orazem J . Clinical trials of sildenafil citrate (Viagra) demonstrate no increase in risk of myocardial infarction and cardiovascular death compared with placebo. Int J Clin Pract 2003; 57: 597–600.
Fox KM, Thadani U, Ma PTS, Nash SD, Keltai M, Keating Z et al. Sildenafil citrate does not reduce exercise tolerance in men with erectile dysfunction and chronic stable angina. On behalf of the CAESAR I investigators (Clinical American and European Studies of Angina and Revascularization). Eur Heart J 2003; 24: 2206–2212.
Galie N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med 2005; 353: 2148–2157.
DeBusk R, Drory Y, Goldstein I, Jackson G, Kaul S, Kimmel SE et al. Management of sexual dysfunction in patients with cardiovascular disease: recommendations of the Princeton consensus panel. Am J Cardiol 2000; 86: 175–181.
Cheitlin MD, Hutter Jr AM, Brindis RG, Ganz P, Kaul S, Russell Jr RO et al. ACC/AHA expert consensus document. Use of sildenafil (Viagra) in patients with cardiovascular disease. American College of Cardiology/American Heart Association. J Am Coll Cardiol 1999; 33: 273–282.
Jackson G, Betteridge J, Dean J, Hall R, Holdright D, Holmes S et al. A systematic approach to erectile dysfunction in the cardiovascular patient: a consensus statement. Int J Clin Pract 1999; 53: 445–451.
Jackson G, Betteridge J, Dean J, Eardley I, Hall R, Holdright D et al. A systematic approach to erectile dysfunction in the cardiovascular patient: a consensus statement – update 2002. Int J Clin Pract 2002; 56: 663–671.
Kostis JB, Jackson G, Rosen R, Barrett-Connor E, Billups K, Burnett AL et al. Sexual dysfunction and cardiac risk: The 2nd Princeton Consensus Conference. Am J Cardiol 2005; 96: 313–321.
Laties AM, Sharlip I . Ocular safety in patients using sildenafil citrate therapy for erectile dysfunction. J Sex Med 2006; 3: 12–27.
Johnson LN, Arnold AC . Incidence of nonarteritic and arteritic anterior ischemic optic neuropathy. Population-based study in the state of Missouri and Los Angeles County, California. J Neuroophthalmol 1994; 14: 38–44.
Hattenhauer MG, Leavitt JA, Hodge DO, Grill R, Gray DT . Incidence of nonarteritic anterior ischemic optic neuropathy. Am J Ophthalmol 1997; 123: 103–107.
Webb DJ, Freestone S, Allen MJ, Muirhead GJ . 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: 21C–28C.
Webb DJ, Muirhead GJ, Wulff M, Sutton JA, Levi R, Dinsmore WW . Sildenafil citrate potentiates the hypotensive effects of nitric oxide donor drugs in male patients with stable angina. J Am Coll Cardiol 2000; 36: 25–31.
VIAGRA® Full prescribing information. Sildenafil Citrate. Pfizer Inc: New York, NY, 2005.
Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB . Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994; 151: 54–61.
Althof SE . Quality of life and erectile dysfunction. Urology 2002; 59: 803–810.
Althof SE, Cappelleri JC, Shpilsky A, Stecher V, Diuguid C, Sweeney M et al. Treatment responsiveness of the Self-Esteem And Relationship questionnaire in erectile dysfunction. Urology 2003; 61: 888–892.
Cappelleri JC, Althof SE, Siegel RL, Shpilsky A, Bell SS, Duttagupta S . Development and validation of the Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction. Int J Impot Res 2004; 16: 30–38.
O’Leary MP, Althof SE, Cappelleri JC, Crowley A, Sherman N, Duttagupta S et al. Self-esteem, confidence, and relationship satisfaction in men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel-group, double-blind, placebo-controlled study in the United States. J Urol 2006; 175: 1058–1062.
Takei M, Takamoto H, Glina S, Cappelleri JC, Duttagupta S, Sherman N et al. Relationship between erectile functioning and psychosocial functioning following treatment with Viagra® (sildenafil citrate): results from an international trial. Qual Life Res 2004; 13: 1558.
Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology 1999; 53: 793–799.
Lewis R, Bennett CJ, Borkon WD, Boykin WH, Althof SE, Stecher VJ et al. Patient and partner satisfaction with VIAGRA (sildenafil citrate) treatment as determined by the erectile dysfunction inventory of treatment satisfaction questionnaire. Urology 2001; 57: 960–965.
Montorsi F, Althof SE . Partner responses to sildenafil citrate (Viagra) treatment of erectile dysfunction. Urology 2004; 63: 762–767.
Gil A, Martinez E, Oyaguez I, Palacios G, Rejas J . Erectile dysfunction in a primary care setting: results of an observational, no-control-group, prospective study with sildenafil under routine conditions of use. Int J Impot Res 2001; 13: 338–347.
McMurray J, Feldman R, Auerbach S, deReisthal H, Wilson N . Long-term effectiveness and tolerability of Viagra (sildenafil citrate) in men with erectile dysfunction. Int J Impot Res 2002; 14 (Suppl 3): S104.
Sairam K, Kulinskaya E, Hanbury D, Boustead G, McNicholas T . Oral sildenafil (Viagra) in male erectile dysfunction: use, efficacy and safety profile in an unselected cohort presenting to a British district general hospital. BMC Urol 2002; 2: 4.
Jiann BP, Yu CC, Tsai JY, Wu TT, Lee YH, Huang JK . What to learn about sildenafil in the treatment of erectile dysfunction from 3-year clinical experience. Int J Impot Res 2003; 15: 412–417.
McCullough AR, Barada JH, Fawzy A, Guay AT, Hatzichristou D . Achieving treatment optimization with sildenafil citrate (Viagra®) in patients with erectile dysfunction. Urology 2002; 60: 28–38.
Atiemo H, Szostak M, Sklar G . Salvage of sildenafil failures referred from primary care physicians. J Urol 2003; 170 (6 Part 1): 2356–2358.
Jiann BP, Yu CC, Su CC, Huang JK . Rechallenge prior sildenafil nonresponders. Int J Impot Res 2004; 16: 64–68.
Steidle C, Crowley A, DeRiesthal H, Tseng L-J . Effects of early dose optimization and customized instructions on Viagra (sildenafil citrate) treatment satisfaction and nonresponder rescue. J Gen Intern Med 2005; 20 (Suppl 1): 97.
About this article
Cite this article
Padma-Nathan, H. Sildenafil citrate (Viagra) treatment for erectile dysfunction: an updated profile of response and effectiveness. Int J Impot Res 18, 423–431 (2006). https://doi.org/10.1038/sj.ijir.3901492
- erectile dysfunction
This article is cited by
Oxytocin receptor antagonists as a novel pharmacological agent for reducing smooth muscle tone in the human prostate
Scientific Reports (2021)
Current Epidemiology Reports (2016)
Effects of sildenafil and vardenafil treatments on sleep quality and depression in hemodialysis patients with erectile dysfunction
International Journal of Impotence Research (2011)