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e692 THE JOURNAL OF UROLOGY Vol. 183, No. 4, Supplement, Tuesday, June 1, 2010
provement relative to placebo in urinary symptoms and BPH progres- Table 1. Efficacy and tolerability measures after 4 years of treatment
sion in LUTS patients with baseline PV 30 mL compared to those with with combination therapy or either monotherapy.
baseline PV 30 mL. In addition, this data set represents the longest Previously treated Previously untreated
DT D T DT D T
follow up of any 5-ARI compared to placebo with respect to both n836 n836 n839 n746 n757 n747
efficacy as well as BPH progression. AUR or BPH-related
Year 4 Results (ITT analysis population) surgery
Baseline PV30 mL Baseline PV30 mL Crude incidence rate 4.7% 6.0% 12.6% 3.6% 4.5% 10.8%
PBO FIN PBO FIN p value vs. — 0.23 0.001 — 0.39 0.001
Mean Change in AUA SS -5.2 -5.3 -4.6 -5.8 combination
Mean Change in PV (mL) 7.3 0.3 8.8 -5.8 BPH clinical
Mean Change in PVR (mL) -6.6 -7.5 7.3 -7.6 progression‡
Crude incidence rate 13.0% 18.5% 23.1% 11.9% 16.9% 19.9%
Mean
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