Abstract
The objectives of this study were to evaluate the efficacy and tolerability of high dose sildenafil as a salvage therapy for patients refractory to the maximum recommended dose of sildenafil. Fifty four fully evaluated patients with chronic erectile failure (ED) who had previously failed to respond to a home trial of sildenafil (100 mg) with erections suitable for sexual intercourse were studied. Each man was treated at home with sildenafil at escalating doses of up to 200 mg until either maximal response or intolerable adverse effects occurred. Erectile function was quantified using the erectile function domain of the International Index of Erectile Function (IIEF) before treatment, with sildenafil 100 mg and with maximal dose of sildenafil and a global efficacy question after 4 weeks of treatment.
The mean age of the study group was 59.6±11.2 y. 13/54 (24%) had arteriogenic ED, 16/54 (30%) had mixed vasculogenic ED, 9/54 (17%) had cavernosal veno-occlusive dysfunction, 11/54 (20%) had post radical retropubic prostatectomy ED and 5/54 (9%) had psychogenic ED. 13/54 (24.1%) responded to sildenafil at a median maximal dose of 200 mg, 4/13 required 150 mg and 9/13 required 200 mg. 41/54 (76%) failed to respond to sildenafil. Mean IIEF question 3 and 4 scores were 1.5 and 1.4 at baseline, 2.2 and 1.9 with sildenafil 100 mg, 2.8 and 2.5 with sildenafil 150 mg and 3.0 and 2.9 with sildenafil 200 mg, respectively. After 4 weeks, treatment was regarded as having improved their erections by 37%, 46.3% and 68% of patients with sildenafil 100 mg, 150 mg and 200 mg, respectively. 34/54 (63%) reported adverse effects with maximal dose sildenafil comprising headache (19), facial flushing (32), dyspepsia (14), nasal congestion (11), dizziness (5) and visual disturbances (5). 4/13 (31%) responders refused to continue treatment due to adverse effects.
In conclusion, sildenafil at doses of up to 200 mg is an effective salvage therapy for 24.1% of previous sildenafil non-responders but is limited by a significantly higher incidence of adverse effects and a 31% treatment discontinuation rate.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 8 print issues and online access
$259.00 per year
only $32.38 per issue
Rent or buy this article
Prices vary by article type
from$1.95
to$39.95
Prices may be subject to local taxes which are calculated during checkout



Similar content being viewed by others
References
NIH Consensus Conference. Impotence, NIH Consensus Development Panel on Impotence JAMA 1983; 270: 83–90.
Laumann EO, Paik A, Rosen RC . Sexual dysfunction in the United States: prevalence and predictors JAMA 1999; 281: 537–544.
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.
Bortolotti A, Parazzini F, Colli E, Landoni M . The epidemiology of erectile dysfunction and its risk factors Int J Androl 1997; 20: 323–334.
Jonler M, Moon T, Brannan W, Stone NN, Heisey D, Bruskewitz RC . The effect of age, ethnicity and geographical location on impotence and quality of life Br J Urol 1995; 75: 651–655.
Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA . Oral sildenafil in the treatment of erectile dysfunction New Engl J Med 1998; 338: 1397–1404.
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.
Dinsmore WW, Hodges M, Hargreaves C, Osterloh JH, 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.
Jarow JP, Burnett AL, Geringer AM . Clinical efficacy of sildenafil citrate based on etiology and response to prior treatment J Urol 1999; 162: 722–725.
Virag R . Indications and early results of sildenafil (Viagra) in erectile dysfunction Urology 1999; 54: 1073–1077.
McMahon CG, Samali R, Johnson H . Efficacy, safety and patient acceptance of sildenafil citrate as a treatment for erectile dysfunction J Urol 2000; 164: 1192–1196.
Hanash KA . Comparative results of goal oriented therapy for erectile dysfunction J Urol 1997; 157: 2135–2138.
Steers WD et al. Sildenafil (Viagra) is effective in the treatment of severe erectile dysfunction In: Proceedings of the Second Meeting of the European Society for Impotence Research, Madrid Int J Impot Res 1998; 10: S49.
McMahon CG, Samali R, Johnston HM . Treatment of intracorporal injection non-responders with sildenafil alone or in combination with polyagent intracorporal injections J Urol 1999; 162: (6) 1992–1997.
Shabsigh R . Efficacy of sildenafil (ViagraTM) is not affected by etiology of erectile dysfunction Int J Impot Res 1998; 10: S32.
Shabsigh R, Padma-Nathan H, Gittleman M, McMurray J, Kaufman J, Goldstein I . Intracavernous alprostadil alfadex (EDEXTM/VIRIDALTM) is effective and safe in patients with erectile dysfunction after failing sildenafil (Viagra) Urology 2000; 55: (4) 477–480.
Joint Clinical Review for NDA-20-985 — Sildenafil for male impotence. Study 148–106 22 January, 1999 pp 126–130.
Lowentritt BH et al. Sildenafil citrate after radical retropubic prostatectomy J Urol 1999; 162: (5) 1614–1617.
Hong EK, Lepor H, McCullough AR . Time dependent patient satisfaction with sildenafil for erectile dysfunction (ED) after nerve-sparing radical retropubic prostatectomy (RRP) Int J Impot Res 1999; 11: (Suppl 1) S15–S22.
Morales A, Gingell C, Collins M, Wicker PA, Osterloh IH . Clinical safety of oral sildenafil citrate in the treatment of erectile dysfunction Int J Impot Res 1998; 10: 69–74.
Porst HJ . The rationale for prostaglandin E1 in erectile failure: A survey of worldwide experience Urol 1996; 155: 802–815.
Anderson KM, Odell PM, Wilson PW, Kannel WB . Cardiovascular disease risk profiles Am Heart J 1991; 121: 293–298.
Anderson M, Nicholson B, Louie E, Mulhall JP . An analysis of vasculogenic erectile dysfunction as a predictor of occult cardiac disease: J Urol 1998; 159: 30.
Matsuzawa I, Kondo Y, Horiuchi K, Akimoto M, Yokohama H . Cardiac evaluation using treadmill test for ED patients before treatment with sildenafil citrate Int J Impot Res 2001; 13: (Suppl 1) S72.
Kawanishi Y et al. Ischaemic heart disease in patients with erectile dysfunction Int J Impot Res 2001; 13: (Suppl 1) S76.
O'Kane PD, Jackson G . Erectile dysfunction: is there silent obstructive coronary artery disease? Int J Clin Pract 2001; 55: 219–220.
Cheitlin MD, Hutter AM Jr, Brindis RG, Ganz P, Kaul S, Russell RO Jr, Zusman RM . ACC/AHA expert consensus document. Use of sildenafil (Viagra) in patients with cardiovascular disease J Am Coll Cardiol 1999; 33: 273–282.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
McMahon, C. High dose sildenafil citrate as a salvage therapy for severe erectile dysfunction. Int J Impot Res 14, 533–538 (2002). https://doi.org/10.1038/sj.ijir.3900936
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/sj.ijir.3900936
Keywords
This article is cited by
-
Non-invasive Management Options for Erectile Dysfunction When a Phosphodiesterase Type 5 Inhibitor Fails
Drugs & Aging (2018)
-
Additional non-invasive options can be considered for erectile dysfunction when phosphodiesterase type 5 inhibitors fail
Drugs & Therapy Perspectives (2018)
-
Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?
International Journal of Impotence Research (2007)
-
Repeated intracorporeal self-injection: effect on peak systolic velocity and cavernosal artery diameter
International Journal of Impotence Research (2007)
-
Optimizing response to phosphodiesterase type 5 inhibitors
Current Sexual Health Reports (2007)