High dose sildenafil citrate as a salvage therapy for severe erectile dysfunction - PubMed

Abstract

The objectives of this study were to rigorously evaluate the efficacy and tolerability of high dose sildenafil as a salvage therapy for patients refractory to the maximum recommended dose of sildenafil. Specifically, fifty four fully evaluated patients who were struggling with chronic erectile failure (ED) and had previously failed to respond to a home trial of sildenafil (100 mg) with erections suitable for engaging in sexual intercourse were included in the study. Each man was treated at home with sildenafil administered at escalating doses, reaching up to 200 mg, until either a maximal response was achieved or intolerable adverse effects presented themselves. Erectile function was thoroughly quantified using the erectile function domain of the International Index of Erectile Function (IIEF) both prior to the treatment, when administered sildenafil at 100 mg, and again with the maximal dose of sildenafil, alongside a global efficacy question after a comprehensive 4-week treatment regimen. The mean age of the study group was approximately 59.6+/-11.2 years. Among the participants, 13 out of 54 (24%) presented with arteriogenic ED, while 16 out of 54 (30%) had mixed vasculogenic ED; 9 out of 54 (17%) suffered from cavernosal veno-occlusive dysfunction, 11 out of 54 (20%) had post-radical retropubic prostatectomy ED, and finally, 5 out of 54 (9%) were diagnosed with psychogenic ED. Notably, 13 out of 54 (24.1%) responded positively to sildenafil at a median maximal dose of 200 mg, with 4 out of 13 needing 150 mg and 9 out of 13 requiring the full 200 mg. In stark contrast, 41 out of 54 (76%) failed to respond adequately to the sildenafil treatment. The mean scores for IIEF questions numbered 3 and 4 were 1.5 and 1.4 at baseline, 2.2 and 1.9 with sildenafil at the 100 mg dose, 2.8 and 2.5 with sildenafil at 150 mg, and finally, 3.0 and 2.9 with sildenafil at the 200 mg dose, respectively. After completing the 4-week treatment period, assessments indicated that there was a significant improvement in erectile function, with reported success rates of 37%, 46.3%, and 68% of patients treated with sildenafil at doses of 100 mg, 150 mg, and 200 mg, respectively. However, it is essential to note that 34 out of 54 (63%) patients reported adverse effects associated with the use of maximal dose sildenafil. These side effects consisted primarily of headaches (19), facial flushing (32), dyspepsia (14), nasal congestion (11), dizziness (5), and visual disturbances (5). Alarmingly, 4 out of 13 (31%) responders chose to discontinue treatment altogether due to the adverse effects experienced. In conclusion, sildenafil at doses of up to 200 mg emerges as an effective salvage therapy option for approximately 24.1% of previous sildenafil non-responders, although it is crucially limited by a significantly elevated incidence of adverse effects and a concerning 31% treatment discontinuation rate.

Comment in

• High dose sildenafil citrate as a salvage therapy for severe erectile dysfunction.

  Seftel A. Seftel A. J Urol. 2003 Aug;170(2 Pt 1):684. J Urol. 2003. PMID: 14601583 No abstract available.

Similar articles

• Efficacy, safety and patient acceptance of sildenafil citrate as treatment for erectile dysfunction.

  McMahon CG, Samali R, Johnson H. McMahon CG, et al. J Urol. 2000 Oct;164(4):1192-6. J Urol. 2000. PMID: 10992364

• Efficacy, tolerability and satisfaction with sildenafil citrate 100-mg titration compared with continued 50-mg dose treatment in men with erectile dysfunction.

  Buvat J, Hatzichristou D, Maggi M, Farmer I, Martínez-Jabaloyas JM, Miller PJ, Schnetzler G. Buvat J, et al. BJU Int. 2008 Dec;102(11):1645-50. doi: 10.1111/j.1464-410X.2008.07908.x. Epub 2008 Aug 14. BJU Int. 2008. PMID: 18710446 Clinical Trial.

• Prognostic factors predicting successful response to sildenafil after radical cystoprostatectomy.

  El-Bahnasawy MS, Ismail T, Elsobky E, Alzalouey EI, Bazeed MA. El-Bahnasawy MS, et al. Scand J Urol Nephrol. 2008;42(2):110-5. doi: 10.1080/00365590701571563. Scand J Urol Nephrol. 2008. PMID: 17853038 Clinical Trial.

• Erection hardness: a unifying factor for defining response in the treatment of erectile dysfunction.

  Mulhall JP, Levine LA, Jünemann KP. Mulhall JP, et al. Urology. 2006 Sep;68(3 Suppl):17-25. doi: 10.1016/j.urology.2006.05.041. Urology. 2006. PMID: 17011372 Review.

Cited by

• Sildenafil in the treatment of erectile dysfunction: an overview of the clinical evidence.

  Hatzimouratidis K. Hatzimouratidis K. Clin Interv Aging. 2006;1(4):403-14. doi: 10.2147/ciia.2006.1.4.403. Clin Interv Aging. 2006. PMID: 18046917 Free PMC article. Review.

• Prolonged, longstanding, ultra-high-dose abuse of sildenafil.

  Sathyanarayana Rao TS, Kumar VA, Raman R, Andrade C. Sathyanarayana Rao TS, et al. Indian J Psychiatry. 2015 Jul-Sep;57(3):311-2. doi: 10.4103/0019-5545.166626. Indian J Psychiatry. 2015. PMID: 26600589 Free PMC article.

• Practical Approaches to Treat ED in PDE5i Nonresponders.

  Cai Z, Song X, Zhang J, Yang B, Li H. Cai Z, et al. Aging Dis. 2020 Oct 1;11(5):1202-1218. doi: 10.14336/AD.2019.1028. eCollection 2020 Oct. Aging Dis. 2020. PMID: 33014533 Free PMC article. Review.

• Sildenafil promotes neuroprotection of the pelvic ganglia neurones after bilateral cavernosal nerve resection in the rat.

  Hlaing SM, Garcia LA, Kovanecz I, Martinez RA, Shah S, Artaza JN, Ferrini MG. Hlaing SM, et al. BJU Int. 2013 Jan;111(1):159-70. doi: 10.1111/j.1464-410X.2012.11278.x. Epub 2012 Jun 6. BJU Int. 2013. PMID: 22672418 Free PMC article.

• Tadalafil in the treatment of erectile dysfunction; an overview of the clinical evidence.

  Frajese GV, Pozzi F, Frajese G. Frajese GV, et al. Clin Interv Aging. 2006;1(4):439-49. doi: 10.2147/ciia.2006.1.4.439. Clin Interv Aging. 2006. PMID: 18046921 Free PMC article. Review.

Publication types

MeSH terms

Substances

LinkOut - more resources

• Full Text Sources

  • Nature Publishing Group

• Medical

  • MedlinePlus Health Information