THE ANALYSIS STUDY OF EFFECTIVENESS AND SAFETY OF ORAL SILDENAFIL CITRATE FOR TREATMENT OF ERECTILE DYSFUNCTION: A COMPREHENSIVE SYSTEMATIC REVIEW
DOI:
https://doi.org/10.61841/qn44z039Keywords:
Erectile dysfunction, sildenafil citrate, efficacy, safetyAbstract
Background: Erectile dysfunction (ED) is a medical condition affecting men's sexual performance and well-being. Sildenafil citrate, a specific inhibitor of phosphodiesterase type 5, is approved for treating ED. The efficacy and safety of oral sildenafil citrate in treating ED are crucial for successful treatment procedures. Understanding the relationship between the efficacy and safety of oral sildenafil citrate can help develop successful treatment procedures for ED patients.
Methods: This systematic review adhered to the PRISMA 2020 guidelines and primarily examined entire English literature published between 2000 and 2024. Only editorials and review articles published in the same publication as the submission were accepted if they possessed a Digital Object Identifier (DOI). A variety of online platforms, including ScienceDirect, PubMed, and SagePub, were utilized to gather the relevant literature.
Result: The study analyzed more than 2000 papers from reputable sources such as Science Direct, SagePub, and PubMed. After deciding to subject eight publications to additional inspection, a thorough evaluation of the entire body of literature was carried out.
Conclusion: Sildenafil, a potent treatment for erectile dysfunction (ED), has been found to be effective in improving men's psychosocial aspects. It is an inhibitor of PDE5, a condition that affects men's emotional well-being. The study also found that the firmness of erections was linked to improvements in psychosocial aspects. Sildenafil can be used interchangeably with tablets, providing a convenient alternative for those with difficulty swallowing. However, followup for men with ED is often inadequate due to improper doses and lack of understanding.
References
1. NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. PMID: 8510302.
Ayta IA, McKinlay JB, Krane RJ. The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int. 1999 Jul;84(1):50-6. doi: 10.1046/j.1464-410x.1999.00142.x. PMID: 10444124.
Corona G, Lee DM, Forti G, O'Connor DB, Maggi M, O'Neill TW, Pendleton N, Bartfai G, Boonen S, Casanueva FF, Finn JD, Giwercman A, Han TS, Huhtaniemi IT, Kula K, Lean ME, Punab M, Silman AJ, Vanderschueren D, Wu FC; EMAS Study Group. Age-related changes in general and sexual health in middle-aged and older men: results from the European Male Ageing Study (EMAS). J Sex Med. 2010 Apr;7(4 Pt 1):1362-80. doi:
1111/j.1743-6109.2009.01601.x. Epub 2009 Nov 19. PMID: 19929914.
Zhang X, Yang B, Li N, Li H. Prevalence and Risk Factors for Erectile Dysfunction in Chinese Adult Males. J Sex Med. 2017 Oct;14(10):1201-1208. doi: 10.1016/j.jsxm.2017.08.009. Epub 2017 Sep 2. PMID: 28874333.
Chou PS, Chou WP, Chen MC, Lai CL, Wen YC, Yeh KC, Chang WP, Chou YH. Newly diagnosed erectile dysfunction and risk of depression: a population-based 5-year follow-up study in Taiwan. J Sex Med. 2015 Mar;12(3):804-12. doi: 10.1111/jsm.12792. Epub 2014 Dec 5. PMID: 25475605.
Latini DM, Penson DF, Colwell HH, Lubeck DP, Mehta SS, Henning JM, Lue TF. Psychological impact of erectile dysfunction: validation of a new health related quality of life measure for patients with erectile dysfunction. J Urol. 2002 Nov;168(5):2086-91. doi: 10.1016/S0022-5347(05)64302-9. PMID: 12394715.
Chevret M, Jaudinot E, Sullivan K, Marrel A, De Gendre AS. Impact of erectile dysfunction (ED) on sexual life of female partners: assessment with the Index of Sexual Life (ISL) questionnaire. J Sex Marital Ther. 2004 MayJun;30(3):157-72. doi: 10.1080/00926230490262366. PMID: 15205072.
Althof SE. Quality of life and erectile dysfunction. Urology. 2002 Jun;59(6):803-10. doi: 10.1016/s00904295(02)01606-0. PMID: 12031357.
Scaglione F, Donde S, Hassan TA, Jannini EA. Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction: Pharmacology and Clinical Impact of the Sildenafil Citrate Orodispersible Tablet Formulation. Clin Ther. 2017 Feb;39(2):370-377. doi: 10.1016/j.clinthera.2017.01.001. Epub 2017 Jan 28. PMID: 28139291.
Hackett G, Kell P, Ralph D, Dean J, Price D, Speakman M, Wylie K; British Society for Sexual Medicine. British Society for Sexual Medicine guidelines on the management of erectile dysfunction. J Sex Med. 2008 Aug;5(8):1841-65. doi: 10.1111/j.1743-6109.2008.00773.x. Epub 2008 Feb 21. PMID: 18298470.
Nichols DJ, Muirhead GJ, Harness JA. Pharmacokinetics of sildenafil after single oral doses in healthy male subjects: absolute bioavailability, food effects and dose proportionality. Br J Clin Pharmacol. 2002;53 Suppl 1(Suppl 1):5S-12S. doi: 10.1046/j.0306-5251.2001.00027.x. PMID: 11879254; PMCID: PMC1874258.
Lv Y, Luo BY, LaBadie RR, Zhu H, Feng Y, Ernst C, Crownover PH, Liang Y, Zhao Q. Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects. Clin Pharmacol Drug Dev. 2020 Jul;9(5):573-581. doi: 10.1002/cpdd.806. Epub 2020 May 28. PMID: 32463593; PMCID: PMC7384059.
Fink HA, Mac Donald R, Rutks IR, Nelson DB, Wilt TJ. Sildenafil for male erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med. 2002 Jun 24;162(12):1349-60. doi: 10.1001/archinte.162.12.1349. PMID: 12076233.
Gómez F, Davila H, Costa A, Acuña A, Wadskier LA, Plua P; Andean Group of Erectile Dysfunction Study. 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 Aug;14 Suppl 2:S42-7. doi: 10.1038/sj.ijir.3900897. PMID: 12161767.
Blonde L. Sildenafil citrate for erectile dysfunction in men with diabetes and cardiovascular risk factors: a retrospective analysis of pooled data from placebo-controlled trials. Curr Med Res Opin. 2006 Nov;22(11):211120. doi: 10.1185/030079906X148256. PMID: 17076971.
King R, Juenemann KP, Levinson IP, Stecher VJ, Creanga DL. Correlations between increased erection hardness and improvements in emotional well-being and satisfaction outcomes in men treated with sildenafil citrate for erectile dysfunction. Int J Impot Res. 2007 Jul-Aug;19(4):398-406. doi: 10.1038/sj.ijir.3901549. Epub 2007 Mar 15. PMID: 17361232.
Buvat J, Hatzichristou D, Maggi M, Farmer I, Martínez-Jabaloyas JM, Miller PJ, Schnetzler G. Efficacy, tolerability and satisfaction with sildenafil citrate 100-mg titration compared with continued 50-mg dose treatment in men with erectile dysfunction. BJU Int. 2008 Dec;102(11):1645-50. doi: 10.1111/j.1464410X.2008.07908.x. Epub 2008 Aug 14. PMID: 18710446.
Giuliano F, Jackson G, Montorsi F, Martin-Morales A, Raillard P. Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database. Int J Clin Pract. 2010 Jan;64(2):240-55. doi: 10.1111/j.1742-1241.2009.02254.x. Epub 2009 Nov 9. PMID: 19900167; PMCID: PMC2810448.
Yuan J, Zhang R, Yang Z, Lee J, Liu Y, Tian J, Qin X, Ren Z, Ding H, Chen Q, Mao C, Tang J. Comparative effectiveness and safety of oral phosphodiesterase type 5 inhibitors for erectile dysfunction: a systematic review and network meta-analysis. Eur Urol. 2013 May;63(5):902-12. doi: 10.1016/j.eururo.2013.01.012. Epub 2013 Jan 31. PMID: 23395275.
Jannini EA, Isidori AM, Gravina GL, Aversa A, Balercia G, Bocchio M, Boscaro M, Carani C, Corona G, Fabbri A, Foresta C, Forti G, Francavilla S, Granata AR, Maggi M, Mansani R, Palego P, Spera G, Vetri M, Lenzi A; Endotrial Study Group. The ENDOTRIAL study: a spontaneous, open-label, randomized, multicenter, crossover study on the efficacy of sildenafil, tadalafil, and vardenafil in the treatment of erectile dysfunction. J Sex Med. 2009 Sep;6(9):2547-60. doi: 10.1111/j.1743-6109.2009.01375.x. Epub 2009 Jun 29. PMID: 19570039.
Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18. PMID: 24447534.
Carson C, Siegel R, Orazem J. Sildenafil citrate treatment for erec- tile dysfunction: rate of adverse events decreases over time. J Urol 2002; 167(Suppl.): 179.
McCullough AR, Barada JH, Fawzy A, Guay AT, Hatzichristou D. Achieving treatment optimization with sildenafil citrate (Viagra) in patients with erectile dysfunction. Urology. 2002 Sep;60(2 Suppl 2):28-38. doi: 10.1016/s0090-4295(02)01688-6. PMID: 12414331.
McCullough AR, Carson CC, Hatzichristou D. A prospective study of the beneficial effects of dose optimization and customized instructions on patient satisfaction with sildenafil citrate (Viagra) for erectile dysfunction. Urology. 2006 Sep;68(3 Suppl):38-46. doi: 10.1016/j.urology.2006.04.040. PMID: 17011374.
Hatzichristou D, Moysidis K, Apostolidis A, Bekos A, Tzortzis V, Hatzimouratidis K, Ioannidis E. Sildenafil failures may be due to inadequate patient instructions and follow-up: a study on 100 non-responders. Eur Urol. 2005 Apr;47(4):518-22; discussion 522-3. doi: 10.1016/j.eururo.2004.12.005. Epub 2005 Jan 20. PMID: 15774252.
Steidle CP, McCullough AR, Kaminetsky JC, Crowley AR, Siegel RL, Deriesthal H, Tseng LJ. Early sildenafil dose optimization and personalized instruction improves the frequency, flexibility, and success of sexual intercourse in men with erectile dysfunction. Int J Impot Res. 2007 Mar-Apr;19(2):154-60. doi: 10.1038/sj.ijir.3901498. Epub 2006 Jul 20. PMID: 16858367.
Fava M, Nurnberg HG, Seidman SN, Holloway W, Nicholas S, Tseng LJ, Stecher VJ. Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2006 Feb;67(2):240-6. doi: 10.4088/jcp.v67n0210. PMID: 16566619.
Montorsi F, Padma-Nathan H, Glina S. Erectile function and assessments of erection hardness correlate positively with measures of emotional well-being, sexual satisfaction, and treatment satisfaction in men with erectile dysfunction treated with sildenafil citrate (Viagra). Urology. 2006 Sep;68(3 Suppl):26-37. doi: 10.1016/j.urology.2006.06.027. PMID: 17011373.
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