1. ¹Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
2. ²Seoul National University College of Medicine, Seoul, Republic of Korea
3. ³Cheon's Family Medicine Clinic, Kangleung, Republic of Korea
4. ⁴National Cancer Center, Goyang, Republic of Korea
5. ⁵Rho's Family Medicine Clinic, Seoul, Republic of Korea
6. ⁶College of Medicine, Denkook University, Cheonan, Republic of Korea
7. ⁷College of Medicine, Korea University, Seoul, Republic of Korea
8. ⁸Kangdong Sungshin Clinic, Seoul, Republic of Korea
9. ⁹College of Medicine, Keimyung University, Daegu, Republic of Korea

Correspondence: YS Kim, Family Medicine, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Pungnap-dong, Songpa-gu, Seoul, Republic of Korea. E-mail: youngkim@amc.seoul.kr

Received 20 February 2004; Revised 12 July 2004; Accepted 3 September 2004; Published online 14 October 2004.

Abstract

In order to investigate the safety and efficacy of sildenafil prescribed in primary care, a post-marketing surveillance study was undertaken. A total of 651 men with erectile dysfunction (ED) were enrolled from 31 family physicians in Korea from December 1999 to July 2002. Patients were regularly followed up to ascertain the safety and efficacy of sildenafil. Of the 651 patients enrolled, 572 (87.9%) returned for safety evaluation and efficacy assessment. In all, 458 (80.1%) of 572 patients reported improved erectile function with sildenafil. Hypertension, diabetes and low-dose sildenafil were associated with poor efficacy. A total of 71 adverse events were reported among 56 patients (8.6%), with the most frequent being hot flushes (5.6%), followed by headache (2.6%), palpitation (1.0%), anxiety (0.5%) and elevated ALT (0.5%). Only six patients (1.0%) discontinued sildenafil as a direct result of adverse events. These results suggest that sildenafil prescribed by primary care physicians was well tolerated and improved erectile function in patients with ED.