title: Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a randomized placebo- and tamsulosin-controlled 12-week study in Asian men.
abstract: OBJECTIVE
  To examine the efficacy and safety of tadalafil in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
  
  
  METHODS
  Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily placebo (n=154), tadalafil 2.5 mg (n=151), tadalafil 5.0 mg (n=155) or tamsulosin 0.2 mg (active control, n=152) for 12 weeks.
  
  
  RESULTS
  Total International Prostate Symptom Score least-squares mean changes from baseline to end-point significantly improved with tadalafil 2.5 mg (-4.8, P=0.003) and 5 mg (-4.7, P=0.004) versus placebo (-3.0). Significant improvement in the International Prostate Symptom Score versus placebo was observed earlier (week 2) for tadalafil 5.0 mg than for tadalafil 2.5 mg (week 8). Significant improvements (P<0.05) in both tadalafil groups versus placebo were observed for the International Prostate Symptom Score voiding subscore, International Prostate Symptom Score Quality of Life, and for Patient and Clinician Global Impressions of Improvement. Significant improvements versus placebo were observed in the International Prostate Symptom Score storage subscore for tadalafil 5.0 mg (-1.7, P=0.021), but not tadalafil 2.5 mg (-1.5, P=0.072). No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with tadalafil 2.5 mg or 5.0 mg versus placebo. Tamsulosin treatment resulted in significant improvements versus placebo across all efficacy parameters, except for peak urinary flow rates. Safety results were consistent with the known tadalafil and tamsulosin safety profiles.
  
  
  CONCLUSIONS
  Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
authors.affiliation: Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokoyama
authors.forename: Masaki
authors.initials: M
authors.lastname: Yoshida
authors.forename: Sae Chul
authors.initials: SC
authors.lastname: Kim
authors.forename: Chii-Jye
authors.initials: CJ
authors.lastname: Wang
authors.forename: Takeshi
authors.initials: T
authors.lastname: Imaoka
authors.forename: Yoji
authors.initials: Y
authors.lastname: Morisaki
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000704:Analysis of Variance; D002243:Carbolines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000175:diagnosis / Q000188:drug therapy*; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000627:therapeutic use*; D000068581:Tadalafil; D000077409:Tamsulosin; D016896:Treatment Outcome; D014554:Urination / Q000187:drug effects; D014563:Urodynamics
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D013449:Sulfonamides; D000068581:Tadalafil; D000077409:Tamsulosin