Safety and Efficacy of Oral Mirodenafil in Mexican with Erectile Dysfunction  

作　　者：Juan Gerardo Reyes-García Noemí Santos-Caballero Francisco Javier Flores-Murrieta Juan Gerardo Reyes-García;Noemí Santos-Caballero;Francisco Javier Flores-Murrieta(Sección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, Ciudad de México, Mexico;Landsteiner Scientific, S.A. de C.V., Ciudad de México, Mexico;Unidad de Investigación en Farmacología, Instituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas”, Ciudad de México, Mexico)

机构地区：[1]Sección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, Ciudad de México, Mexico [2]Landsteiner Scientific, S.A. de C.V., Ciudad de México, Mexico [3]Unidad de Investigación en Farmacología, Instituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas”, Ciudad de México, Mexico

出　　处：《International Journal of Clinical Medicine》2016年第9期628-638,共11页临床医学国际期刊（英文）

摘　　要：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.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.

关 键 词：EFFICACY Erectile Dysfunction MEXICANS Mirodenafil SAFETY 

分 类 号：R73[医药卫生—肿瘤]