Efficacy and safety of sildenafil in Asian males with erectile dysfunction and cardiovascular risk.
OBJECTIVE
Assess the effectiveness of sildenafil in Asian males with erectile dysfunction (ED) and one or more of the co-morbidities, mild-to-moderate hypertension, dyslipidemia, and diabetes.


METHODS
A six-week, double-blind, randomized, placebo-controlled, multicenter study was carried out in Thailand, Malaysia and Singapore. One hundred and fifty five male subjects were randomized (2:1) to sildenafil (n = 104) or placebo (n = 51). Sildenafil was started at 50 mg and increased (100 mg) or decreased (25 mg) at week 2 if necessary.


RESULTS
On the primary efficacy endpoint, sildenafil-treated subjects had significantly better scores on the International Index of Erectile Function (IIEF) questions 3 and 4 than placebo (p < 0.001, both questions). When accumulated into IIEF domains, all five domains were significant in favor of sildenafil. In addition, sildenafil-treated subjects were more satisfied with treatment and had a higher intercourse success rate. The majority of adverse events were mild in severity; the most commonly reported treatment-related events were dizziness (7.7%) and tinnitus (2.9%).


CONCLUSIONS
Sildenafil (25, 50, and 100 mg) was found to be an effective, safe, and well-tolerated treatment for ED in the present study population of Thai, Malaysian, and Singaporean males who also had increased cardiovascular risk
Buranakitjaroen
Peera
P
Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Prannok Rd, Bangkoknoi, Bangkok 10700, Thailand. sipbn@mahidol.ac.th
Mangklabruks
Ampica
A
Leungwattanakij
Somboon
S
Ngaothamatasn
Weerapatn
W
Malhotra
Charan
C
Chee
Christopher
C
Mohamed
Sahabudin Raja
SR
Dato'Johan
Rohan Malek
RM
D044466:Asian People; D002318:Cardiovascular Diseases / Q000139:chemically induced / Q000209:etiology; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D050171:Dyslipidemias / Q000150:complications*; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D006973:Hypertension / Q000150:complications*; D008296:Malaysia; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011687:Purines / Q000009:adverse effects / Q000627:therapeutic use; D018570:Risk Assessment; D012307:Risk Factors; D000068677:Sildenafil Citrate; D012846:Singapore; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use*; D013785:Thailand; D016896:Treatment Outcome
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate