|
Mean score reduction
|
Placebo (n=135)
|
Rupatadine (n= 131)
|
P-value
|
|---|
|
4TSS at 4 weeks
|
-2.4 (1.9)
|
-3.1 (2.1)
|
P < 0.01
|
|
4TSS at 6 weeks
|
-2.6( 2.0)
|
-3.4 (2.1)
|
P < 0.01
|
|
5TSS at 4 weeks
|
-2.7 (2.4)
|
-3.7 (2.5)
|
P < 0.01
|
|
5TSS at 6 weeks
|
-2.9 ( 2.5)
|
-4.0 (2.6)
|
P < 0.01
|
- PRQLQ overall score showed statistical significant differences between RUP and placebo at 4 weeks (p=0.01) and 6 weeks (p<0.05). Adverse events were scarce in both treatment groups throughout the study. Somnolence was reported with a very low incidence (1.4% RUP) and no serious adverse events were reported.
