68793
document
Time to onset of clinically meaningful improvement with tadalafil 5 mg once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia : analysis of data pooled from 4 pivotal , double-blind , placebo controlled studies . PURPOSE Tadalafil once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia consistently shows statistically significant I-PSS improvements . However , physicians and patients wish to know whether tadalafil provides rapid , clinically meaningful improvement in lower urinary tract symptoms . In this post hoc analysis we integrated results from 4 placebo controlled studies to determine the duration of tadalafil once daily required to achieve clinically meaningful improvement . MATERIALS AND METHODS We performed post hoc analysis of data integrated from 4 double-blind studies of tadalafil 5 mg and placebo once daily in 742 and 735 men , respectively , 45 years old or older with total I-PSS 13 or greater . Two clinically meaningful improvement categories were assessed , including 1 ) 3-point or greater baseline to end point total I-PSS improvement and 2 ) 25 % or greater baseline to end point total I-PSS improvement . I-PSS was assessed at weeks 4 , 8 and 12 in all studies , week 1 in 2 and week 2 in 1 . Results in men treated with tadalafil who showed clinically meaningful improvement ( responders ) were further examined to determine the earliest time to clinically meaningful improvement . RESULTS Of 742 tadalafil treated patients 513 ( 69.1 % ) and 444 ( 59.8 % ) demonstrated category 1 and 2 clinically meaningful improvement , respectively , at the study end point . Of 234 category 1 responders with week 1 assessments 140 ( 59.8 % ) achieved clinically meaningful improvement by week 1 and 407 of the total of 513 category 1 responders ( 79.3 % ) showed it by week 4 . Of the 205 category 2 responders with week 1 assessments 103 ( 50.2 % ) achieved clinically meaningful improvement by week 1 while 322 of the 444 category 2 responders ( 72.5 % ) did so by week 4 . CONCLUSIONS Tadalafil 5 mg once daily led to clinically meaningful improvement in approximately two-thirds of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia . More than half of this group of tadalafil treated responders achieved clinically meaningful improvement after 1 week of therapy and more than 70 % did so within 4 weeks .
68794
Intervention_Pharmacological
tadalafil
68795
Intervention_Control
placebo
68796
Intervention_Pharmacological
Tadalafil
68797
Intervention_Pharmacological
tadalafil
68798
Intervention_Control
placebo
68799
Intervention_Pharmacological
tadalafil
68800
Intervention_Pharmacological
tadalafil
68801
Intervention_Control
and placebo
68802
Intervention_Pharmacological
tadalafil
68803
Intervention_Pharmacological
tadalafil
68804
Intervention_Pharmacological
Tadalafil
68805
Intervention_Pharmacological
tadalafil