te to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value 13) received silodosin 8 mg once daily in two Phase III placebocontrolled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe. In all studies, patients who did not respond to placebo during a 4-week placebo run-in phase were randomised to receive the study treatment. In all studies, patients treated with silodosin had a greater decrease in both storage (irritative) and voiding (obstructive) symptoms of BPH as compared to placebo as assessed after 12 weeks of treatment. Data observed in the Intent-to-treat populations of each study are shown below:
|
Study
|
Treatment arm
|
No. of patients
|
IPSS
Total Score
|
IPSS
Irritative symptoms
|
IPSS
Obstructive symptoms
|
|
Baseline Value (±SD)
|
Change from baseline
|
Difference (95 % CI) vs placebo
|
Change from baseline
|
Difference (95 % CI) vs placebo
|
Change from baseline
|
Difference (95 % CI) vs placebo
|
|
US-1
|
Silodosin
Placebo
|
233
228
|
22 ± 5
21± 5
|
 6.5
3.6
|
-2.8*
(-3.9, -1.7)
|
2.3
1.4
|
-0.9*
(-1.4, -0.4)
|
4.2
2.2
|
-1.9*
(-2.6, -1.2)
|
|
US-2
|
Silodosin
Placebo
|
233
229
|
21 ± 5
21 ± 5
|
6.3
3.4
|
-2.9*
(-4.0, -1.8)
|
2.4
1.3
|
-1.0*
(-1.5, -0.6)
|
3.9
2.1
|
-1.8*
(-2.5, -1.1)
|
|
Europe
|
Silodosin
Tamsulosin
Placebo
|
371
376
185
|
19 ± 4
19 ± 4
19 ± 4
|
7.0
|
|
