title: Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: analyses of data pooled from three randomized, double-blind, placebo-controlled studies.
abstract: OBJECTIVE
  Assess the efficacy and safety of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms by pooling data from three clinical studies.
  
  
  METHODS
  Data on 1199 Japanese, Korean, and Taiwanese men given tadalafil 5 mg (n = 601) or placebo (n = 598) were pooled from three double-blind, placebo-controlled, 12-week studies. Efficacy measures included International Prostate Symptom Score, and Patient and Clinician Global Impressions of Improvement. These measures were also assessed for patient subgroups (age categories, baseline disease severity and/or prostate volume, prior alpha-blocker treatment). Safety measures included adverse events, including those in selected body systems. Efficacy measure changes throughout treatment were assessed by mixed-effect model repeated-measures analysis; baseline to end-point changes for the total population and subgroups were evaluated by analysis of covariance.
  
  
  RESULTS
  Tadalafil 5 mg led to significant improvement (vs placebo) in all International Prostate Symptom Scores at all time-points (week 4 P ≤ 0.013 for all measures; week 8 P ≤ 0.005, week 12 P < 0.001). End-point results for both global impressions scales also favored tadalafil (both P < 0.001 vs placebo). Tadalafil efficacy was similar between patient subgroups of varied disease severity (interaction P = 0.097), prior alpha-blocker use (P = 0.580), and prostate volume (P = 0.921). The drug was slightly less effective in older men (interaction P = 0.042). No unexpected adverse events were reported, and no meaningful adverse effects were observed in visual, auditory, or cardiovascular systems.
  
  
  CONCLUSIONS
  Tadalafil 5 mg once-daily for 12 weeks is efficacious and safe in Asian men with lower urinary tract symptoms. Tadalafil is also effective in men of different ages, disease severity, prior alpha-blocker exposure, and prostate volumes.
authors.affiliation: Department of Urology, Azumi General Hospital, Kita-Azumi-gun, Nagano.
authors.forename: Osamu
authors.initials: O
authors.lastname: Nishizawa
authors.forename: Masaki
authors.initials: M
authors.lastname: Yoshida
authors.forename: Masayuki
authors.initials: M
authors.lastname: Takeda
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokoyama
authors.forename: Yoji
authors.initials: Y
authors.lastname: Morisaki
authors.forename: Masahiro
authors.initials: M
authors.lastname: Murakami
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use; D000367:Age Factors; D000368:Aged; D044466:Asian People; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D011467:Prostate / Q000473:pathology*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D053448:Prostatism / Q000188:drug therapy* / Q000209:etiology; D012720:Severity of Illness Index; D000068581:Tadalafil / Q000008:administration & dosage* / Q000009:adverse effects; D013624:Taiwan; D064804:Urological Agents / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000317:Adrenergic alpha-Antagonists; D064804:Urological Agents; D000068581:Tadalafil
keywords: Asia; benign prostatic hyperplasia; lower urinary tract symptoms; prostate; tadalafil