title: Treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: Secondary results from a 6-month, randomized, double-blind study comparing finasteride plus tadalafil with finasteride plus placebo.
abstract: OBJECTIVE
  To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5 mg with finasteride 5 mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia.
  
  
  METHODS
  An international, randomized, double-blind, parallel study was carried out in men aged ≥45 years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30 mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26 weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization.
  
  
  RESULTS
  Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week 4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week 12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week 26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81-1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21-2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87-1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89-1.70). Treatment satisfaction at week 26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P = 0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P ≥ 0.371).
  
  
  CONCLUSIONS
  Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/finasteride.
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.affiliation: Instituto Médico Especializado, Buenos Aires, Argentina.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Casabé
authors.affiliation: Instituto H. Ellis and Department of Urology, Ipiranga Hospital, Sao Paolo, Brazil.
authors.forename: Sidney
authors.initials: S
authors.lastname: Glina
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sorsaburu
authors.affiliation: Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Henneges
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000627:therapeutic use*; D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D018120:Finasteride / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D017060:Patient Satisfaction; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D011471:Prostatic Neoplasms / Q000473:pathology; D053448:Prostatism / Q000188:drug therapy* / Q000209:etiology; D012720:Severity of Illness Index; D000068581:Tadalafil / Q000627:therapeutic use*
chemical_list: D058891:5-alpha Reductase Inhibitors; D058986:Phosphodiesterase 5 Inhibitors; D018120:Finasteride; D000068581:Tadalafil
keywords: benign prostatic hyperplasia; finasteride; lower urinary tract symptoms; tadalafil; treatment satisfaction