Table 5.
Parameter (unit) | Vericiguat trough concentration | Vericiguat peak concentration | ||||
---|---|---|---|---|---|---|
Vericiguat dose (study day) | Difference “vericiguat‐placebo” (90% CI) | P value of t statistic | Vericiguat dose (study day) | Difference “vericiguat‐placebo” (90% CI) | P value of t statistic | |
SBP (mmHg) | 2.5 mg (Day 12) | 2.47 (−2.23, 7.17) | 0.3802 | 2.5 mg (Day 13) | −0.15 (–5.10, 4.80) | 0.96 |
5 mg (Day 26) | 2.42 (−1.15, 6.00) | 0.2594 | 5 mg (Day 27) | 1.59 (−3.36, 6.53) | 0.59 | |
10 mg (Day 40) | –2.57 (−7.12, 1.98) | 0.3455 | 10 mg (Day 41) | −4.44 (−9.80, 0.91) | 0.17 | |
DBP (mmHg) | 2.5 mg (Day 12) | 2.09 (−0.61, 4.78) | 0.1987 | 2.5 mg (Day 13) | 0.60 (−2.02, 3.22) | 0.70 |
5 mg (Day 26) | 1.89 (−0.39, 4.18) | 0.1699 | 5 mg (Day 27) | 3.20 (−0.10, 6.51) | 0.11 | |
10 mg (Day 40) | –0.89 (−3.85, 2.07) | 0.6124 | 10 mg (Day 41) | –0.70 (−3.73, 2.34) | 0.70 | |
HR (bpm) | 2.5 mg (Day 12) | 1.33 (−1.07, 3.74) | 0.3548 | 2.5 mg (Day 13) | 2.31 (0.07, 4.54) | 0.09 |
5 mg (Day 26) | 2.35 (−0.39, 5.08) | 0.1565 | 5 mg (Day 27) | 0.52 (−1.58, 2.63) | 0.68 | |
10 mg (Day 40) | −0.31 (−2.67, 2.05) | 0.8233 | 10 mg (Day 41) | 1.31 (−0.28, 2.90) | 0.17 |
The change in seated SBP, DBP, and HR after the nitroglycerin dose, with pretreatment of vericiguat in the steady state, was analyzed using an analysis of covariance model including treatment, time, and treatment‐by‐time effects, with the baseline variable (SBP, DBP, or HR) as a covariate. These analyses were restricted to measurements that were planned to be taken in the seated position and patients who received nitroglycerin. One patient was excluded from the Day 12 statistical analysis at vericiguat trough concentration because the administration of placebo and nitroglycerin was not done within the window specified in the protocol.
bpm, beats per minute; CI, confidence interval; DBP, diastolic blood pressure, HR, heart rate; SBP, systolic blood pressure.