title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Urology, Hannover Medical School, Hannover, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
authors.affiliation: Department of Urology, Palo Alto Medical Foundation, Palo Alto, California.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Shinghal
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.
authors.forename: Angelina
authors.initials: A
authors.lastname: Sontag
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.
authors.forename: Simin K
authors.initials: SK
authors.lastname: Baygani
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana. Electronic address: donatucci_craig_f@lilly.com.
authors.forename: Craig F
authors.initials: CF
authors.lastname: Donatucci
mesh_terms: D002243:Carbolines / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D011470:Prostatic Hyperplasia / Q000150:complications; D012074:Remission Induction; D000068581:Tadalafil; D013997:Time Factors
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil
keywords: lower urinary tract symptoms; prostate; questionnaires; tadalafil; treatment outcome