title: Erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) combined responders to tadalafil after 12 weeks of treatment.
abstract: OBJECTIVE
  To analyse the proportion of men taking tadalafil 5 mg once daily who experience a combined improvement in symptoms of both erectile dysfunction (ED) and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH).
  
  
  METHODS
  The data from men aged ≥45 years randomized to tadalafil 5 mg once daily or placebo enrolled in one of four randomized, placebo-controlled LUTS/BPH clinical trials were analysed (N = 927). A novel classification of 'combined responders' to ED and LUTS/BPH treatment was defined, based on published criteria for men who showed improvement in both International Index of Erectile Function - Erectile Function domain (IIEF-EF) score and total International Prostate Symptom Score (IPSS). Descriptive analyses assessed the covariate distribution by responder status. Unadjusted and adjusted logistic regressions provided odds ratios with 95% confidence intervals comparing combined responders with all others (partial and non-responders).
  
  
  RESULTS
  Among men randomized to tadalafil 5 mg, 40.5% were combined responders (n = 189). Among placebo randomized men, 18.3% were combined responders (n = 84). Combined responders, in the total population, had the highest baseline IPSS and lowest baseline IIEF-EF scores, corresponding to the highest level of dysfunction. The majority of men were aged ≤65 years, white, non-obese, non-smokers, and regular alcohol consumers. Only treatment, baseline IPSS, baseline IIEF-EF, obesity and psychoactive medication use were significantly associated with responder status (P ≤ 0.05). Tadalafil-treated men had 2.8 times significantly increased adjusted odds of being combined responders vs non-responders (P < 0.001). For each unit decrease in baseline IIEF-EF or alcoholic drink consumption per week there was a 4% significant increase in the adjusted odds of being a combined responder to tadalafil therapy.
  
  
  CONCLUSIONS
  This novel measure of combined response is useful in differentiating patients with clinically relevant symptom improvement for both ED and LUTS/BPH after treatment with tadalafil 5 mg once daily vs placebo. This combined responder measure may be useful in future assessment of treatment benefits across patient groups after various types of treatment intervention (e.g. surgical vs pharmacotherapy vs non-pharmacological intervention).
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.affiliation: New England Research Institutes, Inc., Watertown, MA, USA.
authors.forename: Kathryn B
authors.initials: KB
authors.lastname: Egan
authors.affiliation: Men's Health Center, The Miriam Hospital, Providence, RI, USA.
authors.forename: Martin M
authors.initials: MM
authors.lastname: Miner
authors.affiliation: Global Statistical Sciences and Advanced Analytics, USA.
authors.forename: Xiao
authors.initials: X
authors.lastname: Ni
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: David G
authors.initials: DG
authors.lastname: Wong
authors.affiliation: New England Research Institutes, Inc., Watertown, MA, USA.
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Rosen
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000188:drug therapy*; D000068581:Tadalafil / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000068581:Tadalafil
keywords: BPH; LUTS; erectile dysfunction; tadalafil