title: The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.
abstract: BACKGROUND
  Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists (alpha-blockers) or 5alpha-reductase inhibitors. The long-term effect of these drugs, singly or combined, on the risk of clinical progression is unknown.
  
  
  METHODS
  We conducted a long-term, double-blind trial (mean follow-up, 4.5 years) involving 3047 men to compare the effects of placebo, doxazosin, finasteride, and combination therapy on measures of the clinical progression of benign prostatic hyperplasia.
  
  
  RESULTS
  The risk of overall clinical progression--defined as an increase above base line of at least 4 points in the American Urological Association symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection--was significantly reduced by doxazosin (39 percent risk reduction, P<0.001) and finasteride (34 percent risk reduction, P=0.002), as compared with placebo. The reduction in risk associated with combination therapy (66 percent for the comparison with placebo, P<0.001) was significantly greater than that associated with doxazosin (P<0.001) or finasteride (P<0.001) alone. The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy (P<0.001) and finasteride (P<0.001) but not by doxazosin. Doxazosin (P<0.001), finasteride (P=0.001), and combination therapy (P<0.001) each resulted in significant improvement in symptom scores, with combination therapy being superior to both doxazosin (P=0.006) and finasteride (P<0.001) alone.
  
  
  CONCLUSIONS
  Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy.
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, TX 75390-9110, USA.
authors.forename: John D
authors.initials: JD
authors.lastname: McConnell
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.forename: Oliver M
authors.initials: OM
authors.lastname: Bautista
authors.forename: Gerald L
authors.initials: GL
authors.lastname: Andriole
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Dixon
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.forename: Herbert
authors.initials: H
authors.lastname: Lepor
authors.forename: Kevin T
authors.initials: KT
authors.lastname: McVary
authors.forename: Leroy M
authors.initials: LM
authors.lastname: Nyberg
authors.forename: Harry S
authors.initials: HS
authors.lastname: Clarke
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
authors.forename: Ananias
authors.initials: A
authors.lastname: Diokno
authors.forename: John P
authors.initials: JP
authors.lastname: Foley
authors.forename: Harris E
authors.initials: HE
authors.lastname: Foster
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Jacobs
authors.forename: Steven A
authors.initials: SA
authors.lastname: Kaplan
authors.forename: Karl J
authors.initials: KJ
authors.lastname: Kreder
authors.forename: Michael M
authors.initials: MM
authors.lastname: Lieber
authors.forename: M Scott
authors.initials: MS
authors.lastname: Lucia
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Miller
authors.forename: Mani
authors.initials: M
authors.lastname: Menon
authors.forename: Douglas F
authors.initials: DF
authors.lastname: Milam
authors.forename: Joe W
authors.initials: JW
authors.lastname: Ramsdell
authors.forename: Noah S
authors.initials: NS
authors.lastname: Schenkman
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Slawin
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Smith
mesh_terms: D058891:5-alpha Reductase Inhibitors; D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000704:Analysis of Variance; D018450:Disease Progression; D004311:Double-Blind Method; D017292:Doxazosin / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D018120:Finasteride / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000145:classification / Q000188:drug therapy* / Q000601:surgery; D012720:Severity of Illness Index
chemical_list: D058891:5-alpha Reductase Inhibitors; D000317:Adrenergic alpha-Antagonists; D004791:Enzyme Inhibitors; D018120:Finasteride; D017292:Doxazosin