The efficacy and safety of sildenafil was evaluated in a randomiSed, double-blind, placebocontrolled, flexible-dose study in Korean men aged 28-78 y with erectile dysfunction (ED) of broadspectrum 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 ¼ 66) or matching placebo (n ¼ 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 (Po0.0001). 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.

This open-label, dose-escalation study investigated the ef®cacy and safety of alprostadil (PGE 1 , prostaglandin E 1 ) Sterile Powder (S.Po.) (Caverject # ) for treatment of erectile dysfunction (ED) in 84 men with ED of various etiologies lasting ! 4 months. Doses started with 2.5 mg, then 5 mg, 10, 15, 20, 30, up to a 40 mg maximum. Eligible patients received single alprostadil injections in the physician's of®ce until an erection occurred. Ten minutes after injection, the patient's erection was clinically evaluated. Optimal response was de®ned as erection suf®cient to permit vaginal penetration and lasting 30±60 min. The patient also reported his own evaluation of response and any side effects. Patients were 24±65 y old (mean: 43.7 y), had ED of psychogenic, vascular, or neurogenic origin lasting 4 months±30 y (mean: 3.75 y). Of 84 patients enrolled, 82 completed the study. In the 82 patients who completed the study 78 (92.9%) achieved an optimal response; 18/78 patients (23.1%) had an optimal response at 2.5 mg, 9/78 (11.5%) at 5 mg, 21/78 (26.9%) at 10 mg, 12/ 78 (15.4%) at 15 mg, and 11/78 (14.1%) at 20 mg. Only 5/78 (6.4%) at 30 mg and 2/78 (2.6%) at 40 mg achieved an optimal response. Mean optimal alprostadil dose was 11.9 mg, and the mean minimal effective dose was 9.9 mg. Mean onset of erection was 11.2 min; mean duration of erection was 50.5 min. Penile pain in ®ve patients (6%) was the only reported side effect.