Efficacy and safety of sildenafil in Asian males with erectile dysfunction and cardiovascular risk
Buranakitjaroen, P.; Mangklabruks, A.; Leungwattanakij, S.; Ngaothamatasn, W.; Malhotra, C.; Chee, C.; Mohamed, S.Raja.; Dato'Johan, R.Malek.
Journal of the Medical Association of Thailand 90(6): 1100-1108
2007
ISSN/ISBN: 0125-2208 PMID: 17624203 Document Number: 2846
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.Material and Method. 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 50mg and increased (100 mg) or decreased (25mg) 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%).Conclusion: 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.
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