Back
 IJCM  Vol.7 No.9 , September 2016
Safety and Efficacy of Oral Mirodenafil in Mexican with Erectile Dysfunction
Abstract: Erectile dysfunction is treated with 5-phospodiesterase inhibitors as Mirodenafil, which has shown its efficacy and safety in Koreans, however; no information in other populations is available. An open clinical trial study was designed to evaluate the efficacy and safety in real life of a fixed-dose of Mirodenafil in Mexican patients with erectile dysfunction. Forty-seven male patients received a 100 mg tablet of Mirodenafil, during 12 weeks. Primary outcome efficacy measure was the percentage of male patients with successful intercourse. Secondary outcomes measures included patient satisfaction, mood and self-esteem level. Safety assessments included laboratory tests, vital signs, physical examination, 12-lead electrocardiogram recordings, and incidence of adverse events by patients. Oral administration of Mirodenafil improved in an 80% - 90% the number of successful intercourses from 7 to 84 days of treatment. Moreover, patients reported a significant increment in their sexual satisfaction, mood and self-esteem. Mirodenafil treatment did not modify vital signs nor anthropometric parameters during 84 days. Mild headache was the most frequent adverse event (17.0%) and there were no severe adverse events during pharmacological treatment. Data suggest that oral Mirodenafil is safety, well tolerated and effective in the Mexican population with erectile dysfunction.
Cite this paper: Reyes-García, J. , Santos-Caballero, N. and Flores-Murrieta, F. (2016) Safety and Efficacy of Oral Mirodenafil in Mexican with Erectile Dysfunction. International Journal of Clinical Medicine, 7, 628-638. doi: 10.4236/ijcm.2016.79069.
References

[1]   Park, K., Hwang, E.C. and Kim, S.O. (2011) Prevalence and Medical Management of Erectile Dysfunction in Asia. Asian Journal of Andrology, 13, 543-549.
http://dx.doi.org/10.1038/aja.2010.131

[2]   Feldman, H.A., Goldstein, I., Hatzichristou, D.G., et al. (1994) Impotence and Its Medical and Psychosocial Correlates: Results of the Massachusetts Male Aging Study. The Journal of Urology, 151, 54-61.

[3]   Mola, J.R. (2015) Erectile Dysfunction in the Older Adult Male. Urologic Nursing, 35, 87-93.

[4]   Ugarte y Romano, F. and Barroso-Aguirre, J. (2001) Prevalencia de disfunción eréctil en México y factores de riesgo asociados. Revista Mexicana de Urología, 61, 63-76.

[5]   Chitaley, K., Kupelian, V., Subak, L., et al. (2009) Diabetes, Obesity and Erectile Dysfunction: Field Overview and Research Priorities. The Journal of Urology, 182, S45-S50.
http://dx.doi.org/10.1016/j.juro.2009.07.089

[6]   Maas, R., Schwedhelm, E., Albsmeier, J., et al. (2002) The Pathophysiology of Erectile Dysfunction Related to Endothelial Dysfunction and Mediators of Vascular Function. Vascular Medicine, 7, 213-225.
http://dx.doi.org/10.1191/1358863x02vm429ra

[7]   Feldman, H.A., Johannes, C.B., Derby, C.A., et al. (2000) Erectile Dysfunction and Coronary Risk Factors: Prospective Results from the Massachusetts Male Aging Study. Preventive Medicine, 30, 328-338.
http://dx.doi.org/10.1006/pmed.2000.0643

[8]   Park, H.J., Moon, K.H., Lee, S.W., et al. (2014) Mirodenafil for the Treatment of Erectile Dysfunction: A Systematic Review of the Literature. The World Journal of Men’s Health, 32, 18-27.
http://dx.doi.org/10.5534/wjmh.2014.32.1.18

[9]   Cho, M.C. and Paick, J.S. (2016) A Review of the Efficacy and Safety of Mirodenafil in the Management of Erectile Dysfunction. Therapeutic Advances in Urology, 8, 100-117.
http://dx.doi.org/10.1177/1756287215625408

[10]   Kim, H., Sohn, D.W., Kim, S.D., et al. (2010) The Effect of Mirodenafil on the Penile Erection and Corpus Cavernosum in the Rat Model of Cavernosal Nerve Injury. International Journal of Impotence Research, 22, 291-297.
http://dx.doi.org/10.1038/ijir.2010.19

[11]   Choi, Y.H., Lee, Y.S., Bae, S.H., et al. (2009) Dose-Dependent Pharmacokinetics and First-Pass Effects of Mirodenafil, a New Erectogenic, in Rats. Biopharmaceutics & Drug Disposition, 30, 305-317.
http://dx.doi.org/10.1002/bdd.669

[12]   Choi, Y.H., Lee, Y.S., Lee, M.G., et al. (2010) Pharmacokinetics of Mirodenafil, a New Erectogenic, and Its Metabolite, SK3541, in Rats: Involvement of CYP1A1/2, 2B1/2, 2D Subfamily, and 3A1/2 for the Metabolism of Both Mirodenafil and SK3541. Journal of Pharmaceutical Sciences, 13, 93-106.
http://dx.doi.org/10.18433/J3688M

[13]   Lee, S.K., Kim, Y., Kim, T.K., et al. (2009) Determination of Mirodenafil and Sildenafil in the Plasma and Corpus Cavernous of SD Male Rats. Journal of Pharmaceutical and Biomedical Analysis, 49, 513-518.
http://dx.doi.org/10.1016/j.jpba.2008.11.004

[14]   Paick, J.S., Ahn, T.Y., Choi, H.K., et al. (2008) Efficacy and Safety of Mirodenafil, a New Oral Phosphodiesterase Type 5 Inhibitor, for Treatment of Erectile Dysfunction. The Journal of Sexual Medicine, 5, 2672-2680.
http://dx.doi.org/10.1111/j.1743-6109.2008.00945.x

[15]   Du, W., Li, J., Fan, N., et al. (2014) Efficacy and Safety of Mirodenafil for Patients with Erectile Dysfunction: A Meta-Analysis of Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trials. Aging Male, 17, 107-111.
http://dx.doi.org/10.3109/13685538.2013.858114

[16]   Park, H.J., Choi, H.K., Ahn, T.Y., et al. (2010) Efficacy and Safety of Oral Mirodenafil in the Treatment of Erectile Dysfunction in Diabetic Men in Korea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. The Journal of Sexual Medicine, 7, 2842-2850.
http://dx.doi.org/10.1111/j.1743-6109.2010.01888.x

[17]   Paick, J.S., Kim, J.J., Kim, S.C., et al. (2010) Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications. The Journal of Sexual Medicine, 7, 3143-3152.
http://dx.doi.org/10.1111/j.1743-6109.2010.01926.x

[18]   Lee, J.Y., Cho, S.Y., Oh, C.Y., et al. (2011) Efficacy and Safety of Combination Therapy with Mirodenafil and α1-Blocker for Benign Prostatic Hyperplasia-Induced Lower Urinary Tract Symptoms Accompanied by Erectile Dysfunction: A Multicenter, Open-Label, Prospective Study. International Journal of Impotence Research, 23, 249-256.
http://dx.doi.org/10.1038/ijir.2011.34

[19]   Preissner, S.C., Hoffmann, M.F., Preissner, R., et al. (2013) Polymorphic Cytochrome P450 Enzymes (CYPs) and Their Role in Personalized Therapy. PLoS One, 8, Article ID: e82562.
http://dx.doi.org/10.1371/journal.pone.0082562

[20]   Yasuda, S.U., Zhang, L. and Huang, S.M. (2008) The Role of Ethnicity in Variability in Response to Drugs: Focus on Clinical Pharmacology Studies. Clinical Pharmacology & Therapeutics, 84, 417-423.
http://dx.doi.org/10.1038/clpt.2008.141

[21]   Flores-Murrieta, F.J., Castañeda-Hernández, G., Granados-Soto, V., et al. (2000) Increased Bioavailability of Sildenafil in Mexican Men. JAMA, 283, 1826-1826.
http://dx.doi.org/10.1001/jama.283.14.1825

[22]   World Medical Association Inc. (2013) Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects.
http://www.wma.net/en/30publications/10policies/b3/

[23]   Chung, J.H., Kang, D.H., Oh, C.Y., et al. (2013) Safety and Efficacy of Once Daily Administration of 50 mg Mirodenafil in Patients with Erectile Dysfunction: A Multicenter, Double-Blind, Placebo Controlled Trial. The Journal of Urology, 189, 1006-1013.
http://dx.doi.org/10.1016/j.juro.2012.08.243

[24]   McCabe, M.P., Sharlip, I.D., Lewis, R., et al. (2016) Risk Factors for Sexual Dysfunction among Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015. The Journal of Sexual Medicine, 13, 153-167.
http://dx.doi.org/10.1016/j.jsxm.2015.12.015

 
 
Top