1. ¹Department of Urology, Yonsei University Hospital, Korea
2. ²Department of Urology, Ulsan University Hospital, Korea
3. ³Department of Urology, Korea University Hospital, Korea
4. ⁴Department of Urology, Chung-ang University Hospital, Korea
5. ⁵Department of Urology, Seoul University Hospital, Korea
6. ⁶Department of Urology, Inha University Hospital, Korea
7. ⁷Department of Medicine, Yonsei University Hospital, Korea
8. ⁸Department of Medicine, Korea University Hospital, Korea
9. ⁹Department of Medicine, Inha University Hospital, Korea
10. ¹⁰Department of Medicine, Seoul University Hospital, Korea
11. ¹¹Department of Medicine, Ulsan University Hospital, Korea
12. ¹²Department of Medicine, Chung-ang University Hospital, Korea
13. ¹³Department of Biostatistics, Yonsei University, College of Medicine, Korea
14. ¹⁴Pfizer Pharmaceuticals Korea Ltd., Korea

Correspondence: HK Choi, Department of Urology, Yonsei University College of Medicine, Yong-Dong Severance Hospital, 146-92 Dogok-Dong, Kangnam-Ku, Seoul 135-270, Korea. E-mail: ssclinic@yumc.yonsei.ac.kr

Received 10 January 2002; Revised 19 July 2002; Accepted 15 August 2002.

Abstract

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.