Table 5.
Change from baseline to day 28 in ambulatory SBP, DBP and HR by preexisting hypertension status
| Ambulatory BP parameter, mean (SD) | With preexisting hypertensiona | Without preexisting hypertension | ||
|---|---|---|---|---|
| Placebo (N = 31) | Vibegron (N = 38) | Placebo (N = 70) | Vibegron (N = 58) | |
| Daytime SBP, mmHg | ||||
| Baseline | 132.8 (10.5) | 131.2 (10.2) | 123.8 (9.3) | 122.3 (10.3) |
| Change from baseline at day 28 | –0.9 (8.0) | –0.1 (10.6) | 0.0 (6.0) | 1.1 (5.8) |
| Daytime DBP, mmHg | ||||
| Baseline | 78.5 (8.0) | 77.2 (9.7) | 74.4 (8.2) | 75.1 (6.5) |
| Change from baseline at day 28 | –0.4 (5.3) | 0.0 (7.2) | 0.5 (4.3) | 0.2 (3.7) |
| Daytime HR, bpm | ||||
| Baseline | 75.3 (9.5) | 76.1 (9.5) | 76.7 (8.4) | 77.5 (7.5) |
| Change from baseline at day 28 | 0.2 (4.7) | 1.2 (5.2) | 0.4 (5.0) | 1.3 (4.8) |
| 24-h SBP, mmHg | ||||
| Baseline | 129.1 (9.6) | 127.6 (10.2) | 120.3 (9.0) | 118.5 (10.1) |
| Change from baseline at day 28 | –0.8 (7.5) | –0.6 (9.5) | 0.1 (5.3) | 1.3 (5.6) |
| 24-h DBP, mmHg | ||||
| Baseline | 75.4 (7.4) | 74.4 (9.2) | 71.4 (7.9) | 71.8 (6.2) |
| Change from baseline at day 28 | –0.1 (4.9) | –0.2 (6.8) | 0.8 (3.5) | 0.5 (3.4) |
| 24-h HR, bpm | ||||
| Baseline | 73.8 (9.0) | 73.9 (8.5) | 74.2 (8.0) | 74.8 (7.1) |
| Change from baseline at day 28 | –0.1 (4.5) | 0.9 (4.7) | 0.1 (4.7) | 1.1 (4.3) |
| Maximum (0.5–6.5 h) SBP, mmHgb | ||||
| Baseline | 142.4 (13.0) | 141.5 (12.8) | 133.3 (11.6) | 130.6 (12.9) |
| Change from baseline at day 28c | –1.1 (10.7) | 1.8 (15.3) | 0.0 (9.6) | 1.7 (8.8) |
| Maximum (0.5–6.5 h) DBP, mmHgb | ||||
| Baseline | 86.7 (10.2) | 84.3 (11.4) | 83.1 (9.1) | 82.4 (7.4) |
| Change from baseline at day 28c | –1.7 (7.6) | 1.5 (8.5) | –0.9 (6.6) | –0.4 (6.2) |
| Maximum (0.5–6.5 h) HR, bpmb | ||||
| Baseline | 83.1 (12.7) | 85.3 (15.0) | 86.2 (13.7) | 86.8 (10.8) |
| Change from baseline at day 28c | –0.2 (9.7) | 2.1 (10.4) | 0.5 (12.0) | 0.9 (12.5) |
BP, blood pressure; DBP, diastolic BP; HR, heart rate; SBP, systolic BP.
a
Defined as baseline SBP ≥140 mmHg and/or DBP ≥90 mmHg (based on clinical visit measurements) or as SBP <140 mmHg and/or DBP <90 mmHg in patients taking antihypertensives.
b
Defined as the maximum of the hourly means between 0.5 and 6.5 h post cuff fitting, corresponding to the time to maximum concentration of vibegron.
c
With preexisting hypertension: placebo, N = 30; vibegron, N = 36; without preexisting hypertension: placebo, N = 66; vibegron, N = 56.