1. ¹Department of Family Medicine, Catholic U niversity College of Medicine, Uijeongbu, Korea
2. ²Department of Family Medicine, University of Ulsan College of Medicine, Seoul, Korea
3. ³Department of Family Medicine, Seoul National University College of Medicine, Seoul, Korea
4. ⁴Dr Rho's Family Medicine Clinic, Seoul, Korea
5. ⁵Inje Institute of Advanced Studies, Seoul, Korea
6. ⁶Department of Family Medicine, Medical College of Inje University, Goyang, Korea
7. ⁷Department of Family Medicine, College of Medicine, Sungkyunkwan University, Seoul, Korea
8. ⁸Department of Family Medicine, College of Medicine, Pusan National University, Pusan, Korea
9. ⁹Department of Family Medicine, College of Medicine, Keimyung University, Daegu, Korea

Correspondence: Dr YS Kim, Department of Family Medicine, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Pungnap-2dong, Songpa-gu, Seoul 138-736, Korea. E-mail: youngkim@amc.seoul.kr

Received 2 August 2006; Revised 2 January 2007; Accepted 3 January 2007; Published online 8 February 2007.

Abstract

To evaluate the safety and efficacy of vardenafil in primary care, we undertook a post-marketing surveillance study in 384 men with erectile dysfunction (ED), enrolled by 22 family physicians in Korea, from July 2004 to August 2005. Of the 384 patients enrolled, 343 (89.3%) returned for efficacy assessment and safety evaluation. Among the latter, 279 patients (81.3%) reported that their erectile function improved, 292 (92.1%) showed enhanced IIEF (International Index of Erectile Function)-5 scores and 265 (77.9%) responded that they were 'very satisfied' or 'satisfied' with vardenafil treatment. The most frequent reason for patient satisfaction with vardenafil was erectile potency (62.4%), followed by safety (42.4%), rapid onset (35.3%), adequate duration of efficacy (28.5%) and easy administration (25.9%). A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3.2%), followed by headache (1.2%), nasal congestion (0.6%), color vision disturbance (0.3%), dizziness (0.3%), dry mouth (0.3%), dyspepsia (0.3%), nausea (0.3%) and diarrhea (0.3%). Only one patient discontinued vardenafil as a direct result of an adverse event. These results suggest that vardenafil prescribed by primary care physicians improved erectile function and was well tolerated by patients with ED.