Table 2.
Summary of pharmacodynamic results.
| Efficacy variable | Treatment | n | Baseline Mean | Adjusted⋆⋆ mean change from baseline (s.e. mean) | 95% CI vs placebo | One-sided P value vs placebo | 95% CI for ebastin vs terfenadine | Two-sided P value vs terfenadine |
|---|---|---|---|---|---|---|---|---|
| Placebo | 25 | 383.8 | 1.4 (2.5) | |||||
| Mean QTcB | Ebastine 60 mg | 24 | 384.8 | 3.7 (2.5) | [−2.86, 7.46] | 0.2427 | [−19.46, −9.14] | 0.0000⋆ |
| (ms) | Ebastine 100 mg | 25 | 380.9 | 10.3 (2.5) | [3.75, 14.05] | 0.0034⋆ | [−12.86, −2.54] | 0.0195⋆ |
| Terfenadine | 24 | 382.7 | 18.0 (2.5) | [11.44, 21.76] | 0.0000⋆ | |||
| Placebo | 25 | 381.7 | −2.1 (2.1) | |||||
| Mean QTcF | Ebastine 60 mg | 24 | 383.2 | −3.2 (2.1) | [−5.43, 3.23] | 0.2765 | [−21.63, −12.97] | 0.0001⋆ |
| (ms) | Ebastine 100 mg | 25 | 379.8 | 1.5 (2.1) | [−0.73, 7.93] | 0.1490 | [−16.93, −8.27] | 0.0001⋆ |
| Terfenadine | 24 | 381.3 | 14.1 (2.1) | [11.87, 20.53] | 0.0001⋆ | |||
| Placebo | 25 | 378.3 | −8.9 (2.4) | |||||
| Mean QT | Ebastine 60 mg | 24 | 380.5 | −17.0 (2.5) | [−13.16, −3.04] | 0.9877 | [−28.16, −17.84] | 0.0000⋆ |
| (ms) | Ebastine 100 mg | 25 | 378.3 | −15.2 (2.4) | [−11.24, −1.36] | 0.9630 | [−26.26, −16.14] | 0.0000⋆ |
| Terfenadine | 24 | 379.0 | 6.0 (2.5) | [9.84, 19.96] | 0.0000⋆ | |||
| Placebo | 25 | 62.5 | 3.5 (1.0) | |||||
| Mean HR | Ebastine 60 mg | 24 | 62.0 | 7.6 (1.0) | [2.04, 6.16] | 0.0020⋆ | [1.5, 44.56] | 0.0128⋆ |
| (ms) | Ebastine 100 mg | 25 | 61.5 | 9.3 (1.0) | [3.74, 7.86] | 0.0000⋆ | [3.7, 14.26] | 0.0003⋆ |
| Terfenadine | 24 | 61.9 | 4.1 (1.0) | [−1.46, 2.66] | 0.3367 |
P values < 0.05.
Adjusted for imbalance of primary population in each treatment.