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document
Long-term evaluation of tamsulosin in benign prostatic hyperplasia : placebo-controlled , double-blind extension of phase III trial . Tamsulosin Investigator Group . OBJECTIVES To evaluate the long-term efficacy and safety of once-daily tamsulosin ( 0.4 and 0.8 mg ) , a unique selective alpha1A-adrenoceptor antagonist in patients with benign prostatic hyperplasia ( BPH ) . METHODS This trial extended a 13-week , Phase III multicenter placebo-controlled , double-blind outpatient trial for an additional 40 weeks . Of 618 patients , 418 ( 68 % ) continued into the extension phase on the same double-blind medication and dose . The primary efficacy parameters were total American Urological Association ( AUA ) symptom score and maximum urinary flow ( Qmax ) . RESULTS The mean changes in AUA symptom score from baseline to end point were statistically significant in all groups ( P < 0.001 ) . Significant improvements were observed in Qmax for both tamsulosin groups but not for the placebo group . The statistically significant improvements from baseline in efficacy parameters observed for each tamsulosin group at the end of the 13-week Phase III trial were maintained during the long-term extension phase . Tamsulosin at both dosages was well tolerated as maintenance therapy . Clinically significant orthostatic hypotension was not observed . Vital sign changes in either hypertensive or normotensive patients were not clinically significantly different across the three groups . CONCLUSIONS Tamsulosin once-daily at 0.4 or 0.8 mg was shown to be effective , safe , and well tolerated in the target BPH population during long-term use .
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Intervention_Pharmacological
tamsulosin
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
tamsulosin
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Intervention_Pharmacological
tamsulosin
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Intervention_Control
placebo
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Intervention_Pharmacological
tamsulosin
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Intervention_Pharmacological
Tamsulosin
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Outcome_Physical
total American Urological Association ( AUA ) symptom score
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Outcome_Physical
maximum urinary flow ( Qmax )
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Outcome_Physical
AUA symptom score
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Outcome_Physical
Qmax
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Outcome_Other
significant improvements
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Outcome_Other
tolerated
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Outcome_Physical
orthostatic hypotension
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Outcome_Physical
Vital sign changes
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Participant_Condition
benign prostatic hyperplasia :
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Participant_Condition
target BPH population