title: Efficacy and safety of sildenafil in Asian males with erectile dysfunction and cardiovascular risk.
abstract: 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
authors.affiliation: Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Prannok Rd, Bangkoknoi, Bangkok 10700, Thailand. sipbn@mahidol.ac.th
authors.forename: Peera
authors.initials: P
authors.lastname: Buranakitjaroen
authors.forename: Ampica
authors.initials: A
authors.lastname: Mangklabruks
authors.forename: Somboon
authors.initials: S
authors.lastname: Leungwattanakij
authors.forename: Weerapatn
authors.initials: W
authors.lastname: Ngaothamatasn
authors.forename: Charan
authors.initials: C
authors.lastname: Malhotra
authors.forename: Christopher
authors.initials: C
authors.lastname: Chee
authors.forename: Sahabudin Raja
authors.initials: SR
authors.lastname: Mohamed
authors.forename: Rohan Malek
authors.initials: RM
authors.lastname: Dato'Johan
mesh_terms: 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
chemical_list: D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate