title: Proportion of tadalafil-treated patients with clinically meaningful improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia – integrated data from 1,499 study participants.
abstract: OBJECTIVE
  To evaluate the proportion of patients achieving clinically meaningful improvement of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) with tadalafil using two definitions of response.
  
  
  METHODS
  Post hoc integrated analysis of four placebo-controlled studies in men (aged ≥45 years; International Prostate Symptom Score [IPSS] of ≥13; maximum urinary flow rate [Q(max)] of ≥4 to ≤15 mL/s) with BPH-LUTS randomised to tadalafil 5 mg (752 patients) or placebo (747) for 12 weeks after a 4-week placebo run-in. Responders were defined as having a total IPSS improvement of ≥3 points or ≥25% from randomisation to endpoint (Week 12). Response status was calculated per patient, and relative benefit and odds ratio (OR) with 95% confidence interval (CI) of tadalafil vs placebo was calculated using a logistic Generalised Mixed Model for Repeated Measures.
  
  
  RESULTS
  Tadalafil 5 mg once daily resulted in a significantly greater proportion of patients achieving a ≥3-point IPSS improvement (71.1% and 56.0% for tadalafil and placebo patients, respectively [OR 1.9, 95% CI 1.5, 2.4; P < 0.001]) and achieving a ≥25% improvement in total IPSS randomisation to endpoint (61.7% and 45.5% for tadalafil and placebo patients, respectively [OR 2.0, 95% CI 1.6, 2.5; P < 0.001]).
  
  
  CONCLUSIONS
  About two-thirds of tadalafil-treated patients achieve a clinically meaningful improvement in BPH-LUTS symptoms, based on two different definitions of responder status.
authors.affiliation: Department of Urology, Queen's University, Kingston, UK.
authors.forename: John Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: Gerald B
authors.initials: GB
authors.lastname: Brock
authors.forename: Sender
authors.initials: S
authors.lastname: Herschorn
authors.forename: Ruth
authors.initials: R
authors.lastname: Dickson
authors.forename: Carsten
authors.initials: C
authors.lastname: Henneges
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D002243:Carbolines / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications; D012074:Remission Induction; D000068581:Tadalafil
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil
keywords: benign prostatic hyperplasia; meaningful improvement; tadalafil