Clinical Efficacy and Safety of Sildenafil in the Men with Erectile Dysfunction in Korea

Lee, Uk; Lee, Min ho; Kim, Sang Yon; Ji, Young Hwan; Hong, Jun Hyuk; Ahn, Tai Young

Abstract

PURPOSE: Erectile dysfunction has variety of etiologic factors and it has been a common medical disorder with an estimated prevalence of about 50%. It has been confirmed that sildenafil improved impaired erectile responses in men. We evaluated the efficacy and safety of oral sildenafil for the patients with erectile dysfunction in Korea. MATERIALS AND METHODS: 583 patients were administered sildenafil for erectile dysfunction and 256 of them have been followed up over one month. The initial usual dosage was 50mg and the dosage was titrated based on efficacy and tolerance at every visit. Sexual function was measured before and during the therapy using International Index of Erectile Function (IIEF). RESULTS: Mean IIEF score changed significantly from 27.93+/-18.52 at baseline to 44.57+/-16.56 after treatment with sildenafil (p<0.001) and the mean scores of each IIEF domain (erectile function, orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction) also improved (p<0.001). Q3 (penetration ability) and Q4 (maintenance ability) scores changed from 2.08+/-1.69 to 3.21+/-1.50 (p<0.001) and from 1.77+/-1.50 to 2.96+/-1.44 (p<0.001), respectively. In response to the global efficacy question, 73.4% of patients reported that treatment had improved their erections. With respect to the etiology, IIEF was changed significantly in DM group and no specific underlying disease group (p<0.001), but in radical prostatectomy or cystectomy group no significant change was observed. Side effects were reported in 56 patients (21.9%), including facial flushing (11.7%), headache (7.0%), dyspepsia (2.0%), altered vision (1.6%), nasal congestion (1.6%), conjunctival injection (1.2%), dyspnea (0.8%), dizziness (0.8%), and palpitation (0.8%). Only 4 patients (1.6%) discontinued treatment due to the side effects. CONCLUSIONS: Sildenafil citrate is a highly effective and well-tolerated oral agent for the treatment of erectile dysfunction in Korean men.