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document
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 . 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 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 % ) . 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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Intervention_Pharmacological
sildenafil
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Intervention_Pharmacological
sildenafil
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
sildenafil
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Intervention_Control
placebo
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Intervention_Pharmacological
Sildenafil
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Intervention_Pharmacological
sildenafil-treated
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Intervention_Pharmacological
sildenafil-treated
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Outcome_Other
Efficacy and safety
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Outcome_Physical
International Index of Erectile Function ( IIEF ) questions 3 and 4
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Outcome_Physical
intercourse success rate
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Outcome_Adverse-effects
dizziness
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Outcome_Adverse-effects
tinnitus
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Participant_Condition
Asian
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Participant_Sex
males
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Participant_Condition
erectile dysfunction
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Participant_Condition
cardiovascular risk
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Participant_Sex
males
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Participant_Condition
erectile dysfunction
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Participant_Condition
ED
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Participant_Condition
hypertension
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Participant_Condition
dyslipidemia
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Participant_Condition
diabetes
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Participant_Sample-size
One hundred and fifty five male