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.
BACKGROUND
Erectile dysfunction (ED) is common among men taking antihypertensive agents to control blood pressure.


OBJECTIVE
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.


METHODS
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
Hyun Jun
HJ
Department of Urology, Pusan National University School of Medicine, Busan, Korea.
Park
Nam Cheol
NC
Shim
Hong Bang
HB
Park
Jong Kwan
JK
Lee
Sung Won
SW
Park
Kwangsung
K
Kim
Sae Woong
SW
Moon
Ki Hak
KH
Lee
Dong Hyeon
DH
Yoon
Sang Jin
SJ
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology; D007723:Korea; D008297:Male; D008875:Middle Aged; D010413:Penis / Q000098:blood supply / Q000187:drug effects; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011687:Purines / Q000627:therapeutic use; D012307:Risk Factors; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
D000959:Antihypertensive Agents; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate