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.
