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document
Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia : pooled results of 2 phase 3 studies . PURPOSE We evaluated the efficacy and safety of silodosin for treatment of benign prostatic hyperplasia symptoms in 2 randomized , placebo controlled , phase 3 studies . MATERIALS AND METHODS Men 50 years or older with an International Prostate Symptom Score of 13 or greater and peak urinary flow rate of 4 to 15 ml per second received placebo or 8 mg silodosin daily with breakfast for 12 weeks . The primary end point was International Prostate Symptom Score change from baseline to last observation . Change in peak urinary flow rate was a secondary end point . Differences in treatment efficacy were assessed by ANCOVA . RESULTS Of 923 patients ( mean age 65 years ) 466 received silodosin and 457 placebo . After 0.5 week ( range 3 to 4 days ) of treatment patients receiving silodosin vs placebo achieved significant improvement in total International Prostate Symptom Score ( difference -1.9 , p < 0.0001 ) and irritative ( -0.5 , p = 0.0002 ) and obstructive ( -1.4 , p < 0.0001 ) subscores . The mean +/- SD change from baseline in total International Prostate Symptom Score was -4.2 +/- 5.3 for silodosin vs -2.3 +/- 4.4 for placebo . Differences ( silodosin vs placebo ) in International Prostate Symptom Score and subscores increased by week 12 ( p < 0.0001 ) . Mean change from baseline in peak urinary flow rate ( ml per second ) 2 to 6 hours after initial dose was greater ( p < 0.0001 ) with silodosin ( 2.8 +/- 3.4 ) than placebo ( 1.5 +/- 3.8 ) . Differences remained significant ( p < 0.001 ) through week 12 . The most common treatment emergent adverse event was ( mostly mild ) retrograde ejaculation ( silodosin 28.1 % of patients , placebo 0.9 % ) . Few patients receiving silodosin ( 2.8 % ) discontinued because of retrograde ejaculation . Proportions of patients with treatment emergent orthostatic hypotension were similar for silodosin ( 2.6 % ) and placebo ( 1.5 % ) . CONCLUSIONS Treatment with silodosin produced rapid improvement in urinary symptoms that was sustained for 12 weeks . Silodosin was well tolerated with a low incidence of orthostatic hypotension .
39988
Intervention_Pharmacological
silodosin
39989
Intervention_Pharmacological
silodosin
39990
Intervention_Control
placebo controlled
39991
Intervention_Control
placebo
39992
Intervention_Pharmacological
silodosin
39993
Intervention_Pharmacological
silodosin
39994
Intervention_Pharmacological
silodosin
39995
Outcome_Other
efficacy and safety
39996
Outcome_Physical
International Prostate Symptom Score
39997
Outcome_Physical
peak urinary flow rate
39998
Outcome_Other
Differences in treatment efficacy
39999
Outcome_Physical
total International Prostate Symptom Score
40000
Outcome_Physical
irritative
40001
Outcome_Physical
obstructive
40002
Outcome_Physical
International Prostate Symptom Score
40003
Outcome_Physical
International Prostate Symptom Score
40004
Outcome_Physical
peak urinary flow rate
40005
Outcome_Adverse-effects
adverse event
40006
Outcome_Adverse-effects
retrograde ejaculation
40007
Outcome_Adverse-effects
retrograde ejaculation
40008
Outcome_Physical
orthostatic hypotension
40009
Outcome_Physical
urinary symptoms
40010
Outcome_Physical
orthostatic hypotension
40011
Participant_Sex
men
40012
Participant_Condition
benign prostatic hyperplasia
40013
Participant_Sex
Men
40014
Participant_Age
50 years or older
40015
Participant_Condition
Prostate
40016
Participant_Sample-size
923
40017
Participant_Age
65
40018
Participant_Sample-size
466
40019
Participant_Sample-size
457