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A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea.
Choi, H K; Ahn, T Y; Kim, J J; Kim, S C; Paick, J S; Suh, J K; Kim, H S; Kim, Y K; Lee, W H; Oh, B H; Park, C H; Ryu, W S; Chung, T G; Kim, S W; Lee, W H; Moon, D G; Ryu, D S; Seo, K K; Kim, D K; Lee, D S.
Afiliação
  • Choi HK; Department of Urology, Yonsei University Hospital, Korea. ssclinic@yumc.yonsei.ac.kr
Int J Impot Res ; 15(2): 80-6, 2003 Apr.
Article em En | MEDLINE | ID: mdl-12789384
The efficacy and safety of sildenafil was evaluated in a randomiSed, double-blind, placebo-controlled, flexible-dose study in Korean men aged 28-78 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months duration. A total of 133 patients were randomised at six centres in Korea to receive either sildenafil (50 mg initially, increased if necessary to l00 mg or decreased to 25 mg depending on efficacy and tolerance) (n=66) or matching placebo (n=67) taken on an 'as needed' basis l h prior to anticipated sexual activity for a period of 8 weeks. At the end of this time, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the International Index of Erectile Function (IIEF) scale, (2) the percentage of successful intercourse attempts, and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P&<0.0001). Treatment-related adverse events occurred in 56.1% of patients receiving sildenafil and 20.9% receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache and abnormalities in colour vision (31.8, 22.7 and 6.1% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western populations.
Assuntos
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Piperazinas / Vasodilatadores / Disfunção Erétil Tipo de estudo: Clinical_trials Limite: Adult / Aged / Humans / Male / Middle aged País/Região como assunto: Asia Idioma: En Revista: Int J Impot Res Assunto da revista: MEDICINA REPRODUTIVA / UROLOGIA Ano de publicação: 2003 Tipo de documento: Article País de publicação: Reino Unido
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Piperazinas / Vasodilatadores / Disfunção Erétil Tipo de estudo: Clinical_trials Limite: Adult / Aged / Humans / Male / Middle aged País/Região como assunto: Asia Idioma: En Revista: Int J Impot Res Assunto da revista: MEDICINA REPRODUTIVA / UROLOGIA Ano de publicação: 2003 Tipo de documento: Article País de publicação: Reino Unido