Table 6. Pharmacodynamic assessments in study 1 (CTT116415).
| Parameters | Change from baseline in weighted mean (0 – 4 hours) | Treatment comparison (test vs. reference) | ||
|---|---|---|---|---|
| FF/UMEC/VI vs. UMEC/VI | FF/UMEC/VI vs. FF/VI | FF/UMEC/VI vs. FF/UMEC | ||
| Maximum change from baseline in heart rate (bpm) | Test | 18.9 | 18.9 | 18.9 |
| Reference | 19.1 | 17.5 | 5.2 | |
| Difference (95% CI) | –0.2 (–2.6 – 2.1) | 1.4 (–0.9 – 3.7) | 13.6 (11.3 – 15.9) | |
| Derived heart rate (bpm) | Test | 6.18 | 6.18 | 6.18 |
| Reference | 6.08 | 5.97 | 0.69 | |
| Difference (95% CI) | 0.10 (–1.16 – 1.35) | 0.20 (–1.05 – 1.46) | 5.49 (4.25 – 6.73) | |
| Minimum change from baseline in serum potassium (mmol/L) | Test | –0.30 | –0.30 | –0.30 |
| Reference | –0.37 | –0.36 | –0.24 | |
| Difference (95% CI) | 0.06 (–0.01 – 0.14) | 0.05 (–0.02 – 0.13) | –0.06 (–0.13 – 0.01) | |
| Derived serum potassium (mmol/L) | Test | –0.123 | –0.123 | –0.123 |
| Reference | –0.174 | –0.185 | –0.062 | |
| Difference (95% CI) | 0.051 (–0.022 – 0.124) | 0.063 (–0.010 – 0.136) | –0.061 (–0.133 – 0.012) | |
| Maximum change from baseline in blood glucose (mmol/L) | Test | 0.544 | 0.544 | 0.544 |
| Reference | 0.507 | 0.452 | 0.061 | |
| Difference (95% CI) | 0.037 (–0.044 – 0.110 0.117) | 0.092 (0.011 – 0.172) | 0.482 (0.403 – 0.562) | |
| Derived blood glucose (mmol/L) | Test | –0.0211 | –0.0211 | –0.0211 |
| Reference | –0.0478 | –0.0294 | –0.1698 | |
| Difference (95% CI) | 0.0267 (–0.0354 – 0.0889) | 0.0083 (–0.0539 – 0.0705) | 0.1486 (0.0871 – 0.2102) | |