Table 1. Demographics and Baseline Participant Characteristics.
| Characteristics | Cohort 1 (PRA ≤1.0 ng/mL/h) | Exploratory cohort 2 (PRA >1.0 ng/mL/h) | ||||||
|---|---|---|---|---|---|---|---|---|
| Lorundrostat | Placebo (n = 30) | Lorundrostat, 100 mg once daily (n = 31) | Placebo (n = 6) | |||||
| 100 mg once daily (n = 30) | 50 mg once daily (n = 28) | 25 mg twice daily (n = 30) | 12.5 mg twice daily (n = 22)a | 12.5 mg once daily (n = 23)a | ||||
| Age, mean (SD), y | 68.7 (8.9) | 64.7 (9.5) | 64.8 (9.7) | 68.1 (10.1) | 65.2 (11.3) | 62.6 (10.7) | 66.6 (10.6) | 62.7 (12.3) |
| Sex, No. (%) | ||||||||
| Female | 18 (60.0) | 15 (53.6) | 19 (63.3) | 14 (63.6) | 12 (52.2) | 17 (56.7) | 21 (67.7) | 4 (66.7) |
| Male | 12 (40.0) | 13 (46.4) | 11 (36.7) | 8 (36.4) | 11 (47.8) | 13 (43.3) | 10 (32.3) | 2 (33.3) |
| Race, No. (%)b | ||||||||
| Asian | 1 (3.3) | 0 | 0 | 0 | 1 (4.3) | 1 (3.3) | 0 | 0 |
| Black or African American | 15 (50.0) | 8 (28.6) | 7 (23.3) | 7 (31.8) | 11 (47.8) | 16 (53.3) | 6 (19.4) | 2 (33.3) |
| White | 14 (46.7) | 19 (67.9) | 23 (76.7) | 15 (68.2) | 11 (47.8) | 13 (43.3) | 25 (80.6) | 4 (66.7) |
| Hispanic or Latino ethnicity, No. (%)b | 16 (53.3) | 14 (50.0) | 17 (56.7) | 7 (31.8) | 10 (43.5) | 12 (40.0) | 17 (54.8) | 2 (33.3) |
| Body mass index, mean (SD)c | 30.4 (5.5) | 32.0 (5.0) | 30.6 (5.5) | 32.0 (5.2) | 30.6 (4.9) | 31.9 (5.0) | 30.5 (4.4) | 32.0 (3.9) |
| Automated office BP at randomization, mean (SD), mm Hg | ||||||||
| Systolic | 142.2 (13.4) | 140.0 (12.1) | 142.8 (13.1) | 142.6 (13.3) | 142.9 (13.7) | 142.9 (10.7) | 139.8 (9.1) | 135.3 (5.5) |
| Diastolic | 78.5 (10.0) | 84.7 (7.0) | 80.1 (9.3) | 81.6 (9.4) | 80.3 (12.0) | 83.8 (9.5) | 78.6 (10.0) | 81.5 (7.9) |
| eGFR, mean (SD), mL/min/1.73 m2 | 77.4 (14.0) | 77.2 (14.1) | 80.9 (12.4) | 81.7 (16.3) | 77.9 (18.7) | 81.6 (17.3) | 79.9 (13.1) | 83.9 (18.6) |
| Comorbidities, No. (%) | ||||||||
| Diabetes | 8 (26.7) | 8 (28.6) | 11 (36.7) | 9 (40.9) | 11 (47.8) | 14 (46.7) | 16 (51.6) | 2 (33.3) |
| Heart failure | 1 (3.3) | 1 (3.6) | 1 (3.3) | 1 (4.5) | 1 (4.3) | 0 | 0 | 0 |
| Medications, No. (%) | ||||||||
| 2 Background BP medications | 14 (46.7) | 20 (71.4) | 14 (46.7) | 7 (31.8) | 14 (60.9) | 17 (56.7) | 20 (64.5) | 4 (66.7) |
| ≥3 Background BP medications | 16 (53.3) | 8 (28.6) | 16 (53.3) | 15 (68.2) | 9 (39.1) | 13 (43.3) | 11 (35.5) | 2 (33.3) |
| Thiazide-type diuretic use | 17 (56.7) | 16 (57.1) | 18 (60.0) | 13 (59.1) | 12 (52.2) | 16 (53.3) | 19 (61.3) | 5 (83.3) |
| ACE inhibitor or ARB use | 23 (76.7) | 20 (71.4) | 27 (90.0) | 17 (77.3) | 18 (78.3) | 22 (73.3) | 30 (96.8) | 5 (83.3) |
Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; BP, blood pressure; eGFR, estimated glomerular filtration rate; PRA, plasma renin activity.
a
Following an interim analysis, randomization to the lowest doses was discontinued.
b
Self-reported race and ethnicity. There was 1 participant in the 50-mg once-daily lorundrostat group whose race was not reported.
c
Calculated as weight in kilograms divided by height in meters squared.