An Open-Label, Multicenter, Flexible Dose Study to Evaluate the Efficacy and Safety of Viagra ® (Sildenafil Citrate) in Korean Men with Erectile Dysfunction and Arterial Hypertension who are Taking Antihypertensive Agents Hyun Jun Park, MD, PhD,* Nam Cheol Park, MD, PhD,* Hong Bang Shim, MD, PhD, † Jong Kwan Park, MD, PhD, ‡ Sung Won Lee, MD, PhD, § Kwangsung Park, MD, PhD, ¶ Sae Woong Kim, MD, PhD,** Ki Hak Moon, MD, PhD, †† Dong Hyeon Lee, MD, PhD, ‡‡ and Sang Jin Yoon, MD, PhD §§ *Department of Urology, Pusan National University School of Medicine, Busan, Korea; † Department of Urology, Veterans Hospital, Seoul, Korea; ‡ Department of Urology, Chonbuk National University School of Medicine, Jeonju, Korea; § Department of Urology, College of Medicine, Sungkyunkwan University, Seoul, Korea; ¶ Department of Urology, College of Medicine, Chonnam National University, Gwangju, Korea; **Department of Urology, College of Medicine, Catholic University, Seoul, Korea; †† Department of Urology, College of Medicine, Yeungnam University, Daegu, Korea; ‡‡ Department of Urology, Ewha Womans University School of Medicine, Seoul, Korea; §§ Gachon University Gil Medical Center, Incheon, Korea DOI: 10.1111/j.1743-6109.2008.00864.x ABSTRACT Introduction. Erectile dysfunction (ED) is common among men taking antihypertensive agents to control blood pressure. Aim. We evaluated the efficacy and safety of sildenafil citrate in men with ED taking antihypertensive agents. Methods. A total of 198 male subjects, aged 20 years and older were enrolled. This study was conducted for 10 weeks as an open-label, multicenter and flexible dose trial with a 2-week screening period and an 8-week treatment phase. Main Outcome Measures. Subjects were asked to complete Event Log Worksheets, as well as the International Index of Erectile Function (IIEF) and the Global Efficacy Assessment Questions (GEAQ) questionnaires during the study period. Results. The average age among the 167 subjects who completed the study was 55.8 (31.7 to 77.1). The scores for questions 3 and 4 of IIEF improved from 2.3 and 1.8 at baseline to 3.7 and 3.4 at week 4 and 3.8 and 3.4 at week 8, respectively. There were 86.3% of the patients reported improved erectile function at week 8; 88.3% of the patients reported improved ability to achieve sexual intercourse at week 8. There were no significant differences observed in the responses to questions 3 and 4 of IIEF and GEAQ by the number of antihypertensive agents taken. The adverse events were facial flushing (20.1%), headache (11.7%), palpitation (5.0%), rhinitis (2.8%), URI (2.8%), dizziness (2.2%), dyspnea (2.2%), and nausea (1.7%). Conclusions. Sildenafil citrate is an effective treatment for ED; it is safe and well tolerated by patients with ED taking multiple antihypertensive agents for arterial hypertension. Park HJ, Park NC, Shim HB, Park JK, Lee SW, Park K, Kim SW, Moon KH, Lee DH, and Yoon SJ. An open-label, multicenter, flexible dose study to evaluate the efficacy and safety of Viagra ® (sildenafil citrate) in Korean men with erectile dysfunction and arterial hypertension who are taking antihypertensive agents. J Sex Med 2008;5:2405–2413. Key Words. Sildenafil; Erectile Dysfunction; Hypertension; Antihypertensive Agents 2405 © 2008 International Society for Sexual Medicine J Sex Med 2008;5:2405–2413