The effect of doxazosin, finasteride and combination therapy on nocturia in men with benign prostatic hyperplasia.
OBJECTIVE
We evaluated the effectiveness of single or combination drug therapy on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.


METHODS
A total of 3,047 men with lower urinary tract symptoms/benign prostatic hyperplasia enrolled in the Medical Therapy of Prostatic Symptoms trial were randomly assigned to receive doxazosin alone, finasteride alone, combination therapy or placebo. Treatment effectiveness was assessed according to intent to treat by mean reduction in self-reported nightly nocturia at 1 and 4 years. A subgroup analysis by age (younger than 70 vs 70 years old or older) was also performed.


RESULTS
Of the men 2,583 reported 1 or more episodes of nocturia and finished 12 or more months of the trial. Mean nocturia was similar in all groups at baseline. Mean nocturia was reduced at 1 year by 0.35, 0.40, 0.54 and 0.58 in the placebo, finasteride, doxazosin and combination groups, respectively. Reductions with doxazosin and combination therapy were statistically greater than with placebo (p <0.05). At 4 years nocturia was also significantly reduced in patients treated with doxazosin and combination therapy (p <0.05 vs placebo). In men older than 70 years (495) all drugs significantly reduced nocturia at 1 year (finasteride 0.29, doxazosin 0.46 and combination 0.42) compared to placebo (0.11, p <0.05).


CONCLUSIONS
Doxazosin and combination therapy reduced nocturia more than placebo, but the net benefit of active drug compared to placebo was often modest with a net difference of less than 0.20 fewer nightly nocturia episodes at 1 and 4 years. Findings in men 70 years old or older were similar, with an even smaller effect observed for finasteride.
Johnson
Theodore M
TM
Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Atlanta Veterans Affairs Medical Center, Decatur, Georgia 30033, USA.
Burrows
Pamela K
PK
Kusek
John W
JW
Nyberg
Leroy M
LM
Tenover
J Lisa
JL
Lepor
Herbert
H
Roehrborn
Claus G
CG
D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D017292:Doxazosin / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D018120:Finasteride / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D053158:Nocturia / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D010865:Pilot Projects; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000188:drug therapy / Q000503:physiopathology; D016896:Treatment Outcome; D014563:Urodynamics / Q000187:drug effects
D000317:Adrenergic alpha-Antagonists; D004791:Enzyme Inhibitors; D018120:Finasteride; D017292:Doxazosin