Rs. Kirby et al., MORNING VS EVENING DOSING WITH DOXAZOSIN IN BENIGN PROSTATIC HYPERPLASIA - EFFICACY AND SAFETY, PROSTATE CANCER AND PROSTATIC DISEASES, 1(3), 1998, pp. 163-171
Three hundred and fifty-three patients with symptomatic benign prostat
ic hyperplasia were randomized to doxazosin or placebo, with morning o
r evening dosing, to compare the effect of dosing time on the efficacy
and safety of doxazosin treatment. After 24 weeks of treatment, the m
ean International Prostate Symptom Score had decreased by 6.8 units in
the doxazosin group compared with 4.5 units in the placebo group (P =
0.003). Improvements in Q(max) of 2.03 ml/s and 0.30 ml/s were seen f
or the doxazosin and the placebo groups, respectively (P < 0.001). No
differences in efficacy or safety between the morning- and evening-dos
ed subgroups were observed. Doxazosin was significantly more effective
than placebo at improving symptoms of BPH and urinary flow rates at e
ndpoint, and was well tolerated. The time of dosing did not appear to
influence the efficacy or safety of doxazosin, suggesting that there i
s no need to restrict administration of doxazosin to the evening in BP
H patients.