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

Clinical Trial

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

C G McMahon. Int J Impot Res. 2002 Dec.

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. In this investigation, fifty-four fully evaluated patients suffering from chronic erectile dysfunction (ED), who had previously failed to respond adequately to a home trial of sildenafil at a dosage of 100 mg and were unable to achieve erections suitable for sexual intercourse, were meticulously studied. Each participant was treated in the comfort of their own homes with sildenafil, with doses escalating gradually up to 200 mg, until either maximum therapeutic response was obtained or intolerable adverse effects were reported. The erectile function of the patients was assessed using the erectile function domain of the International Index of Erectile Function (IIEF) both prior to treatment and after administration of sildenafil at 100 mg and the maximal dose of sildenafil, along with a global efficacy question after a treatment period of four weeks. The mean age of participants in the study cohort was found to be 59.6 ± 11.2 years, and a breakdown of the causes of ED among the patients indicated that 13 out of 54 (24%) had arteriogenic ED, while 16 out of 54 (30%) presented with mixed vasculogenic ED. Additionally, 9 out of 54 (17%) suffered from cavernosal veno-occlusive dysfunction, 11 out of 54 (20%) had experienced post-radical retropubic prostatectomy ED, and 5 out of 54 (9%) had psychogenic ED. Out of the total, 13 out of 54 patients (24.1%) responded positively to sildenafil at a median maximal dose of 200 mg, with 4 out of 13 requiring 150 mg, and 9 out of 13 requiring the full 200 mg dosage. Conversely, a significant proportion, 41 out of 54 (76%), failed to exhibit a meaningful response to sildenafil therapy. The mean scores for IIEF questions 3 and 4 were 1.5 and 1.4 at baseline, improving to 2.2 and 1.9 with sildenafil 100 mg, further increasing to 2.8 and 2.5 with sildenafil 150 mg, and ultimately reaching 3.0 and 2.9 with sildenafil 200 mg, respectively. After the four-week treatment period, evaluations indicated that there was a perception of improvement in erectile function, reported by 37%, 46.3%, and 68% of patients taking sildenafil at doses of 100 mg, 150 mg, and 200 mg respectively. However, it is noteworthy that 34 out of 54 patients (63%) reported experiencing adverse effects when taking the maximal dose of sildenafil, with headache (19 occurrences), facial flushing (32 occurrences), dyspepsia (14 occurrences), nasal congestion (11 occurrences), dizziness (5 occurrences), and visual disturbances (5 occurrences) being recorded. Of those who responded to treatment, 4 out of 13 (31%) declined to continue the treatment regimen due to these adverse effects. In conclusion, the data suggests that sildenafil, administered at dosages up to 200 mg, can serve as an effective salvage therapy for approximately 24.1% of individuals who previously did not respond to sildenafil, although this approach is tempered by a notably higher incidence of adverse side effects along with a 31% rate of treatment discontinuation due to these effects.

PubMed Disclaimer

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.

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.

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

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

Abstract

Comment in

Similar articles

Cited by

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical