Table 4.
Vital sign ECG, and PVR volume results
| Variable | MIRA + SOLI (n = 166) | MIRA + PRO (n = 161) | MIRA + IMI (n = 161) | MIRA + TOL (n = 159) |
|---|---|---|---|---|
| Vital signs | ||||
| Pulse rate in b.p.m. on awakening, mean (SD) [n] | ||||
| Baseline | 70.07 (8.15) [166] | 69.15 (8.19) [161] | 69.17 (7.25) [160] | 68.51 (8.15) [159] |
| EoT | 70.68 (7.55) [159] | 72.35 (9.68) [155] | 69.26 (6.76) [157] | 70.64 (8.39) [156] |
| Change from baseline to EoT | 0.68 (4.95) [159] | 3.19 (6.54) [155] | 0.09 (5.74) [156] | 2.11 (5.20) [156] |
| Pulse rate in b.p.m. 6 h post‐dose, mean (SD) [n] | ||||
| Baseline | 74.91 (8.80) [166] | 73.87 (9.16) [160] | 74.56 (8.08) [161] | 74.09 (8.68) [159] |
| EoT | 74.93 (7.99) [159] | 76.74 (10.09) [155] | 73.22 (7.94) [157] | 77.55 (9.25) [156] |
| Change from baseline to EoT | 0.17 (6.25) [159] | 2.86 (6.62) [154] | −1.27 (6.67) [157] | 3.40 (6.86) [156] |
| SBP in mmHg on awakening, mean (SD) [n] | ||||
| Baseline | 128.91 (16.03) [166] | 129.75 (17.22) [161] | 127.21 (16.34) [160] | 129.22 (16.41) [159] |
| EoT | 126.91 (15.02) [159] | 126.86 (15.87) [155] | 126.28 (15.24) [157] | 126.65 (14.62) [156] |
| Change from baseline to EoT | −1.60 (11.56) [159] | −2.88 (9.08) [155] | −0.86 (9.64) [156] | −2.31 (10.14) [156] |
| SBP in mmHg 6 h post‐dose, mean (SD) [n] | ||||
| Baseline | 125.45 (13.52) [166] | 125.44 (13.99) [160] | 125.20 (14.35) [161] | 127.15 (13.74) [159] |
| EoT | 125.06 (13.24) [159] | 123.78 (13.11) [155] | 123.45 (14.03) [157] | 124.66 (13.40) [156] |
| Change from baseline to EoT | −0.46 (10.53) [159] | −1.55 (9.27) [154] | −1.64 (9.23) [157] | −2.35 (9.86) [156] |
| DBP in mmHg on awakening, mean (SD) [n] | ||||
| Baseline | 80.65 (9.14) [166] | 80.45 (10.36) [161] | 79.08 (10.04) [160] | 79.40 (9.82) [159] |
| EoT | 79.40 (8.83) [159] | 79.46 (9.96) [155] | 78.52 (9.45) [157] | 78.72 (9.52) [156] |
| Change from baseline to EoT | −0.90 (6.48) [159] | −1.00 (6.07) [155] | −0.64 (6.31) [156] | −0.54 (6.81) [156] |
| DBP in mmHg 6 h post‐dose, mean (SD) [n] | ||||
| Baseline | 78.03 (8.38) [166] | 77.67 (9.23) [160] | 77.30 (9.32) [161] | 77.85 (8.76) [159] |
| EoT | 77.33 (8.40) [159] | 77.12 (9.24) [155] | 75.55 (9.13) [157] | 78.12 (8.89) [156] |
| Change from baseline to EoT | −0.54 (6.48) [159] | −0.56 (6.25) [154] | −1.79 (5.92) [157] | 0.33 (7.17) [156] |
| ECGs | ||||
| QTcF in ms, mean (SD) [n] | ||||
| Baseline | 418.5 (17.4) [164] | 419.2 (16.9) [161] | 416.4 (17.3) [160] | 415.4 (15.6) [158] |
| EoT | 420.5 (16.6) [164] | 418.0 (16.7) [160] | 416.0 (17.5) [160] | 418.5 (15.9) [159] |
| Change from baseline to EoT | 1.8 (11.6) [162] | −1.2 (10.8) [160] | −0.4 (12.8) [159] | 3.0 (10.6) [158] |
| Absolute QTcF at EoT, n (%) | ||||
| ≤450 ms | 158 (96.3) | 157 (98.1) | 158 (98.8) | 155 (97.5) |
| >450 to ≤480 ms | 6 (3.7) | 2 (1.3) | 2 (1.3) | 4 (2.5) |
| >480 to ≤500 ms | 0 | 1 (0.6) | 0 | 0 |
| Change in QTcF from baseline to EoT, n (%) | ||||
| <0 ms | 70 (43.2) | 86 (53.8) | 77 (48.4) | 54 (34.2) |
| >0 to ≤30 ms | 91 (56.2) | 73 (45.6) | 80 (50.3) | 104 (65.8) |
| >30 to ≤60 ms | 1 (0.6) | 1 (0.6) | 2 (1.3) | 0 |
| PVR volume | ||||
| PVR volume in mL, mean (SD) [n] | ||||
| Baseline | 11.02 (15.43) [166] | 10.43 (17.07) [161] | 9.74 (14.35) [161] | 9.10 (14.41) [159] |
| EoT | 19.31 (43.18) [164] | 17.27 (34.86) [160] | 14.26 (26.04) [161] | 15.04 (36.68) [159] |
| Change from baseline to EoT | 8.17 (39.42) [164] | 6.83 (32.20) [160] | 4.52 (23.51) [161] | 5.94 (35.83) [159] |
Data shown for the SAF (patients who received at least one dose of study drug).