title: Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial.
abstract: OBJECTIVE
  To investigate the effect of dutasteride and tamsulosin as combined therapy compared with each monotherapy for improving patient-reported health outcomes in men with moderate-to-severe urinary symptoms and prostate enlargement, reporting the pre-planned 2-year analyses from the CombAT trial.
  
  
  METHODS
  The CombAT study is an ongoing, international, double-blind, randomized, parallel-group trial. Men aged >or=50 years with a clinical diagnosis of benign prostatic hyperplasia (BPH), an International Prostate Symptom Score (IPSS) of >or=12 units, a prostate volume of >or=30 mL, a total serum prostate-specific antigen level of 1.5-10 ng/mL and a peak urinary flow of >5 and <or=15 mL/s, with a minimum voided volume of >or=125 mL, were randomized to receive 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months. The primary endpoint at 2 years was the change in IPSS from baseline. Secondary endpoints included various measures of health outcomes, which included the BPH Impact Index (BII), IPSS Question 8 (Q8), and the Patient Perception of Study Medication (PPSM) questionnaire.
  
  
  RESULTS
  Combined therapy resulted in significantly greater improvements in BII and IPSS Q8 from baseline than did dutasteride from 3 months and compared with tamsulosin from 9 months (BII) or 12 months (IPSS Q8). Assessments using the PPSM questionnaire showed that a significantly higher proportion of patients were satisfied with and would request dutasteride and tamsulosin combined therapy than with each monotherapy at 24 months.
  
  
  CONCLUSIONS
  Dutasteride and tamsulosin combined therapy provides significantly greater improvements in patient-reported quality of life and treatment satisfaction than both monotherapies at 2 years, following the trends for clinical improvements in symptom scores and peak urinary flow rates, in men with moderate-to-severe BPH symptoms.
authors.affiliation: Department of Urology, University of Toronto, Toronto, Canada. j.barkin@rogers.com
authors.forename: Jack
authors.initials: J
authors.lastname: Barkin
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.forename: Paul
authors.initials: P
authors.lastname: Siami
authors.forename: Olivier
authors.initials: O
authors.lastname: Haillot
authors.forename: Betsy
authors.initials: B
authors.lastname: Morrill
authors.forename: Libby
authors.initials: L
authors.lastname: Black
authors.forename: Francesco
authors.initials: F
authors.lastname: Montorsi
mesh_terms: D000368:Aged; D001378:Azasteroids / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068538:Dutasteride; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D053448:Prostatism / Q000188:drug therapy* / Q000209:etiology; D011788:Quality of Life; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D000077409:Tamsulosin; D016896:Treatment Outcome; D014563:Urodynamics
chemical_list: D001378:Azasteroids; D013449:Sulfonamides; D000077409:Tamsulosin; D000068538:Dutasteride