title: The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study.
abstract: OBJECTIVE
  • To assess the effects of combined therapy with dutasteride and tamsulosin on voiding and storage symptoms compared with those of dutasteride or tamsulosin alone, using 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study.
  
  
  METHODS
  • Men (n = 4844) aged ≥ 50 years with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH), a prostate volume of ≥ 30 mL, and a serum prostate-specific antigen level of 1.5-10 ng/mL. • CombAT was a multicentre, double-blind, parallel-group study. • Oral dutasteride (0.5 mg) or tamsulosin (0.4 mg) alone or in combination was taken daily for 4 years. • Mean changes from baseline in storage and voiding symptoms at 4 years were assessed using subscales of the International Prostate Symptom Score.
  
  
  RESULTS
  •  At 4 years, the mean reduction in the storage subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference -0.43) and tamsulosin (adjusted mean difference -0.96) monotherapy groups (P < 0.001). • Also at 4 years, the mean reduction in the voiding subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference -0.51) and tamsulosin (adjusted mean difference -1.60) monotherapy groups (P < 0.001). • The improvement in the storage subscore with combined therapy was significantly better (P < 0.001) than dutasteride and tamsulosin from 3 months and 12 months, respectively. Similarly, the improvement in the voiding subscore with combined therapy was significantly better than dutasteride (P < 0.001) and tamsulosin (P ≤ 0.006) from 3 months and 6 months, respectively. • Improvements in the storage and voiding symptom subscores with combined therapy were achieved irrespective of prostate volume, although in men with the highest baseline prostate volumes (≥ 58 mL), combined therapy was not better than dutasteride.
  
  
  CONCLUSIONS
  • In men with a prostate volume of ≥ 30 mL, combined therapy with dutasteride plus tamsulosin provided better long-term (up to 4 years) control of both storage and voiding LUTS compared with tamsulosin monotherapy. • Combined therapy was better than dutasteride monotherapy in men with prostate volumes of ≥ 30 to < 58 mL, but not in men with a prostate volume of ≥ 58 mL.
authors.affiliation: Universitá Vita Salute San Raffaele, Milan, Italy. montorsi.francesco@hsr.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Montorsi
authors.forename: Claus
authors.initials: C
authors.lastname: Roehrborn
authors.forename: Javier
authors.initials: J
authors.lastname: Garcia-Penit
authors.forename: Michael
authors.initials: M
authors.lastname: Borre
authors.forename: Ton A
authors.initials: TA
authors.lastname: Roeleveld
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Alimi
authors.forename: Paul
authors.initials: P
authors.lastname: Gagnier
authors.forename: Timothy H
authors.initials: TH
authors.lastname: Wilson
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000627:therapeutic use*; D000368:Aged; D001378:Azasteroids / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D000068538:Dutasteride; D004812:Epidemiologic Methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D053448:Prostatism / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D001378:Azasteroids; D013449:Sulfonamides; D000077409:Tamsulosin; D000068538:Dutasteride