title: Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Tadalafil is being investigated for the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH-LUTS).
  
  
  OBJECTIVE
  To assess efficacy, including onset, and safety of tadalafil on BPH-LUTS and the subject's and clinician's perception of changes in urinary symptoms.
  
  
  METHODS
  This randomized, double-blind, placebo-controlled, 12-week trial enrolled men ≥45 yr of age with BPH-LUTS for >6 mo, International Prostate Symptom Score (IPSS) ≥13, and maximum urine flow rate (Q(max)) ≥4 to ≤15 ml/s.
  
  
  METHODS
  Tadalafil 5mg (n=161) or placebo (n=164), once daily.
  
  
  METHODS
  Analysis of covariance (ANCOVA) modeling evaluated change from baseline in continuous efficacy variables. Categoric efficacy variables were analyzed with the Cochran-Mantel-Haenszel test, and between-group differences in treatment-emergent adverse events (TEAEs) were assessed using the Fisher exact test. RESULTS AND LIMITATION: Tadalafil significantly improved IPSS results, from baseline to endpoint, compared to placebo (-5.6 vs -3.6; p=0.004). Reduction in IPSS results was apparent after 1 wk and significant after 4 wk (tadalafil -5.3 vs placebo -3.5; p=0.003). The BPH Impact Index (BII) was not assessed at week 1; however, BII improvement was apparent at 4 wk (tadalafil -1.8 vs placebo -1.2; p=0.029) and continued at 12 wk (tadalafil -1.8 vs placebo -1.3; p=0.057). Tadalafil significantly improved the International Index of Erectile Function-Erectile Function score in sexually active men with erectile dysfunction (ED; 6.7 vs 2.0; p<0.001) at 12 wk (not assessed at week 1). Few subjects reported one TEAE or more (p=0.44). For tadalafil, the most common TEAEs were headache (3.7%) and back pain (3.1%). Tadalafil did not significantly improve Q(max) or reduce postvoid residual volume.
  
  
  CONCLUSIONS
  Tadalafil 5mg once daily for 12 wk resulted in a clinically meaningful reduction in total IPSS results as early as 1 wk and achieved statistical significance at 4 wk in men with BPH-LUTS. The adverse event profile was consistent with that previously reported in men with ED.
  
  
  BACKGROUND
  This clinical trial is registered on the clinicaltrials.gov website (http://www.clinicaltrials.gov). The registration number is NCT00827242.
authors.affiliation: porst20354@aol.com
authors.forename: Hartmut
authors.initials: H
authors.lastname: Porst
authors.forename: Edward D
authors.initials: ED
authors.lastname: Kim
authors.forename: Adolfo R
authors.initials: AR
authors.lastname: Casabé
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Mirone
authors.forename: Roberta J
authors.initials: RJ
authors.lastname: Secrest
authors.forename: Lei
authors.initials: L
authors.lastname: Xu
authors.forename: David P
authors.initials: DP
authors.lastname: Sundin
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D001118:Argentina; D002243:Carbolines / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D008297:Male; D008800:Mexico; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D000068581:Tadalafil; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014554:Urination / Q000187:drug effects; D014563:Urodynamics / Q000187:drug effects
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D010919:Placebos; D000068581:Tadalafil