title: The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study.
abstract: OBJECTIVE
  We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement (30 cc or greater). We report preplanned 2-year analyses.
  
  
  METHODS
  The CombAT study is an ongoing, multicenter, randomized, double-blind, parallel group study. Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia, International Prostate Symptom Score 12 points or greater, prostate volume 30 cc or greater, total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were randomized to 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months. The primary end point at 2 years was the change in International Prostate Symptom Score from baseline.
  
  
  RESULTS
  Combination therapy resulted in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9, and in benign prostatic hyperplasia related health status from months 3 and 12, respectively. There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6. There was a significant increase in drug related adverse events with combination therapy vs monotherapies, although most did not result in the cessation of therapy.
  
  
  CONCLUSIONS
  In men with moderate to severe lower urinary tract symptoms and prostate enlargement (30 cc or greater) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy.
authors: Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors: Claus G
authors: CG
authors: Roehrborn
authors: Paul
authors: P
authors: Siami
authors: Jack
authors: J
authors: Barkin
authors: Ronaldo
authors: R
authors: Damião
authors: Kim
authors: K
authors: Major-Walker
authors: Betsy
authors: B
authors: Morrill
authors: Francesco
authors: F
authors: Montorsi
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage*; D000368:Aged; D001378:Azasteroids / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000473:pathology / Q000503:physiopathology; D013449:Sulfonamides / Q000008:administration & dosage*; D000077409:Tamsulosin; D013997:Time Factors; D016896:Treatment Outcome; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology
chemical_list: D000317:Adrenergic alpha-Antagonists; D001378:Azasteroids; D004791:Enzyme Inhibitors; D013449:Sulfonamides; D000077409:Tamsulosin; D000068538:Dutasteride