Table 5.

Analysis of change in blood pressure and heart rate from baseline: ‘SV plus vericiguat’ versus ‘SV plus placebo’ treatment groups (PD analysis set)

Parameter	n	Mean change from baseline	Minimum	Maximum
SBP, mmHg
Vericiguat (day 1)	15	4.83	−13.10	40.45
Placebo (day 1)	15	1.44	−17.59	22.04
SV plus vericiguat (day 41)	14	0.05	13.51	26.04
SV plus placebo (day 41)	15	5.35	−19.49	41.04
DBP, mmHg
Vericiguat (day 1)	15	7.93	−4.63	25.98
Placebo (day 1)	15	6.27	−17.72	31.65
SV plus vericiguat (day 41)	14	3.29	−7.33	19.41
SV plus placebo (day 41)	15	7.76	−6.33	23.00
HR, beats/min
Vericiguat (day 1)	15	−8.63	−26.85	8.93
Placebo (day 1)	15	−10.20	−32.67	7.83
SV plus vericiguat (day 41)	14	0.74	−20.04	29.50
SV plus placebo (day 41)	15	1.00	−16.96	19.54

Parameter	n	Difference between treatments	90% confidence limits, lower/upper		p value of the t statistic
Difference between SV plus vericiguat (day 41) vs. SV alone (day 27)
SBP, mmHg	15	−0.09	−1.15	0.97	0.8849
DBP, mmHg	15	0.06	−0.83	0.94	0.9106
HR, beats/min	14	0.19	−0.60	0.99	0.6726
Difference between SV plus vericiguat (day 41) vs. SV plus placebo (day 41)
SBP, mmHg	29	−1.66	−4.22	0.90	0.2779
DBP, mmHg	29	−1.80	−3.24	−0.36	0.0429
HR, beats/min	29	−0.33	−2.25	1.58	0.7682

One subject in the vericiguat group was not included in the statistical evaluation, as valid PD data for day 40 were not available. Baseline was calculated as the arithmetic mean of all (four) measurements taken in the seated position within 20 min prior to dose or reference time point, respectively. Data were analyzed using analysis of covariance, including administration (SV alone or in combination with vericiguat), time (within the hemodynamic profile), and administration*time effects with baseline SBP, DBP, or HR as a covariate

DBP diastolic blood pressure, HR heart rate, PD pharmacodynamic, SBP systolic blood pressure, SV sacubitril/valsartan