Efficacy and Safety of Sildenafil in Asian Males with Erectile Dysfunction and Cardiovascular Risk(cid:31),(cid:31)(cid:31)
Peera Buranakitjaroen MD*, Ampica Mangklabruks MD**, Somboon Leungwattanakij MD***, Weerapatn Ngaothamatasn MD****, Charan Malhotra MD*****, Christopher Chee MD******, Sahabudin Raja Mohamed MD*******, Rohan Malek Dato’Johan MD********
Affiliation : (cid:31) This study was funded by a grant from Pfizer (Thailand) Limited (cid:31)(cid:31) The Thai-Malaysian-Singapore Erectile dysfunction Study Group (THAMES Group) * Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand ** Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand *** Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand **** Division of Medicine, Hadyai Hospital, Songkla, Thailand ***** Department of Medicine, BNH Hospital, Bangkok, Thailand ****** Department of Urology, Singapore General Hospital, Outram Road, Singapore ******* Institute of Urology, Kuala Lumpur Hospital, Jalan Pahang, Kuala Lumpur, Malaysia ******** Department of Urology, Selayang Hospital, Lebuh Raya Selayang – Kepong, Batu Caves, Selangor Darul Ehsan, Malaysia
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.
Materials and 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 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
Keywords : Sildenafil, Erectile dysfunction, Randomized controlled trial,Cardiovascular risk, Diabetes mellitus
