title: Nocturia improvement in the combination of Avodart(®) and tamsulosin (CombAT) study.
abstract: OBJECTIVE
  The purpose of the study was to assess the impact of dutasteride plus tamsulosin combination therapy, compared with dutasteride or tamsulosin monotherapy, on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) using data from the 4-year CombAT study.
  
  
  METHODS
  Nocturia was assessed using Question 7 of the International Prostate Symptom Score questionnaire. Efficacy measures included as follows: mean change in nocturia at 3-month intervals up to 48 months; proportion of patients with improvement/worsening in nocturia; nocturnal voiding frequency at baseline and study end, overall and by baseline subgroups; and nocturnal voiding frequency <2 at study end in patients with a baseline score ≥ 2.
  
  
  RESULTS
  In total, 4,722 patients with a mean age of 66 years were included. Mean nocturia improvements were significantly superior (p ≤ 0.01) with combination therapy than with either monotherapy (adjusted mean change from baseline in IPSS Question 7 score at month 48: combination therapy -0.5, dutasteride -0.4, tamsulosin -0.3). Reduction in nocturia score with combination therapy was significantly (p ≤ 0.01) better than tamsulosin monotherapy across all baseline subgroups tested, except for men with previous 5ARI use. Among those with a baseline IPSS Q7 score ≥ 2, more patients with combination therapy had a score <2 at month 48 (34 %) compared with dutasteride (30 %, p = 0.018) or tamsulosin (26 %, p < 0.0001).
  
  
  CONCLUSIONS
  Combination therapy provided greater improvements and less worsening of nocturia compared with both dutasteride and tamsulosin monotherapies. These analyses are the first to show greater improvement with a 5ARI/α-blocker combination versus either agent alone for the management of nocturia in patients with LUTS/BPH.
authors.affiliation: Department of Urology, OE 6240, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany, oelke.matthias@mh-hannover.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.forename: Carlos
authors.initials: C
authors.lastname: D'Ancona
authors.forename: Timothy H
authors.initials: TH
authors.lastname: Wilson
authors.forename: Ramiro
authors.initials: R
authors.lastname: Castro
authors.forename: Michael
authors.initials: M
authors.lastname: Manyak
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000008:administration & dosage*; D058668:Adrenergic alpha-1 Receptor Antagonists / Q000008:administration & dosage*; D000368:Aged; D001378:Azasteroids / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D000068538:Dutasteride; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000150:complications; D008297:Male; D008875:Middle Aged; D053158:Nocturia / Q000188:drug therapy* / Q000209:etiology; D011470:Prostatic Hyperplasia / Q000150:complications; D013449:Sulfonamides / Q000008:administration & dosage*; D000077409:Tamsulosin
chemical_list: D058891:5-alpha Reductase Inhibitors; D058668:Adrenergic alpha-1 Receptor Antagonists; D001378:Azasteroids; D004338:Drug Combinations; D013449:Sulfonamides; D000077409:Tamsulosin; D000068538:Dutasteride