title: Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies.
abstract: OBJECTIVE
  To assess the efficacy and safety of tadalafil, a phosphodiesterase 5 (PDE5) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH), in population subgroups, using pooled data from 4 international, randomized, placebo-controlled studies in men with LUTS/BPH.
  
  
  METHODS
  The safety database included 1500 men randomized to tadalafil 5 mg once daily or placebo for 12 weeks. Changes in total International Prostate Symptom Score (IPSS), IPSS-quality of life index, and BPH impact index were examined overall, and changes in IPSS or adverse events (AEs) were examined across subgroups of interest. Treatment-group differences were assessed using analysis of covariance.
  
  
  RESULTS
  Results of pooled data confirmed that tadalafil (N = 752) resulted in significant improvements from baseline vs placebo (N = 746) in IPSS (mean difference -2.3; P <.001), and also in BPH impact index and IPSS-quality of life index (both P <.001). Subgroup analyses demonstrated that IPSS improvements were significant regardless of baseline LUTS severity (IPSS <20/≥20), age (≤65/>65 years), recent previous use of α-blockers or PDE5 inhibitors, total testosterone level (<300/≥300 ng/dL), or prostate-specific antigen predicted prostate volume (<40/≥40 mL). [corrected] Rates of treatment emergent AEs were comparable between subgroups of baseline age (≤65/>65 years), previous PDE5 inhibitor use, and the presence or absence of pre-existing diabetes, hypertension, or cardiovascular disease (including hypertension), but somewhat higher for recent previous α-blocker use.
  
  
  CONCLUSIONS
  In these pooled data analyses, tadalafil 5 mg improved LUTS/BPH across subgroups of age, LUTS severity, testosterone levels, and prostate volume. Rates of AEs were similar across the subgroups assessed.
authors.affiliation: Department of Urology, Hannover Medical School, Hannover, Germany. Porst20354@aol.com
authors.forename: Hartmut
authors.initials: H
authors.lastname: Porst
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
authors.forename: Evan R
authors.initials: ER
authors.lastname: Goldfischer
authors.forename: David
authors.initials: D
authors.lastname: Cox
authors.forename: Steven
authors.initials: S
authors.lastname: Watts
authors.forename: Debashish
authors.initials: D
authors.lastname: Dey
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use; D000367:Age Factors; D000368:Aged; D001416:Back Pain / Q000139:chemically induced; D002243:Carbolines / Q000494:pharmacology / Q000627:therapeutic use*; D004415:Dyspepsia / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced; D009929:Organ Size / Q000187:drug effects; D058986:Phosphodiesterase 5 Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D011467:Prostate / Q000473:pathology*; D017430:Prostate-Specific Antigen / Q000097:blood; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D000068581:Tadalafil; D013739:Testosterone / Q000097:blood
chemical_list: D000317:Adrenergic alpha-Antagonists; D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D013739:Testosterone; D000068581:Tadalafil; D017430:Prostate-Specific Antigen