Table 2. Change From Baseline to Month 3 or 6 in 24-Hour Mean Ambulatory and Office Systolic Blood Pressure (SBP) Among the Full Analysis Seta.
| Outcome | Zilebesiran | Placebo (n = 75) | ||||
|---|---|---|---|---|---|---|
| 150 mg every 6 mo (n = 78) | 300 mg every 6 mo (n = 73) | 300 mg every 3 mo (n = 75) | 300 mg every 3 mo or every 6 mo (n = 148) | 600 mg every 6 mo (n = 76) | ||
| Ambulatory SBP at baseline, patients with data, mean (SD), mm Hg | 140.6 (8.5) | 142.5 (8.8) | 141.6 (7.7) | 142.0 (8.3) | 143.1 (9.0) | 141.1 (7.9) |
| Office SBP at baseline, mean (SD), mm Hg | 142.0 (10.9) | 143.0 (11.3) | 140.0 (11.0) [n = 74] | 141.5 (11.2) [n = 147] | 140.8 (10.6) | 143.1 (13.3) |
| Primary end point | ||||||
| Ambulatory SBP at month 3, mean (SD), mm Hg | 133.2 (14.7) [n = 68] | 131.8 (12.8) [n = 137] | 133.1 (14.9) [n = 65] | 147.3 (15.2) [n = 60] | ||
| LSM change from baseline (95% CI), mm Hg | −7.3 (−10.3 to −4.4) | −10.0 (−12.0 to −7.9) | −8.9 (−11.9 to −6.0) | 6.8 (3.6 to 9.9) | ||
| LSM difference vs placebo (95% CI), mm Hgb | −14.1 (−19.2 to −9.0) | −16.7 (−21.2 to −12.3) | −15.7 (−20.8 to −10.6) | |||
| P valueb | <.001 | <.001 | <.001 | |||
| Secondary end point | ||||||
| Office SBP at month 3, mean (SD), mm Hg | 131.8 (13.6) [n = 68] | 129.1 (13.8) [n = 134] | 131.3 (15.9) [n = 64] | 141.4 (12.6) [n = 60] | ||
| LSM change from baseline (95% CI), mm Hg | −9.7 (−12.6 to −6.8) | −12.1 (−14.2 to −10.0) [n = 133] | −9.2 (−12.1 to −6.2) | −0.1 (−3.2 to 3.0) | ||
| LSM difference vs placebo (95% CI), mm Hgb | −9.6 (−13.8 to −5.3) | −12.0 (−15.7 to −8.3) [n = 133] | −9.1 (−13.4 to −4.8) | |||
| P value | <.001 | <.001 | <.001 | |||
| Ambulatory SBP at month 6, mean (SD), mm Hg | 134.4 (15.0) [n = 62] | 132.2 (13.8) [n = 68] | 131.6 (12.2) [n = 60] | 131.7 (16.8) [n = 63] | 144.6 (15.0) [n = 54] | |
| LSM change from baseline (95% CI), mm Hg | −6.5 (−9.7 to −3.3) | −9.9 (−13.0 to −6.8) | −9.5 (−12.8 to −6.3) | −9.6 (−12.8 to −6.4) | 4.6 (1.2 to 8.0) | |
| LSM difference vs placebo (95% CI), mm Hgb | −11.1 (−15.8 to −6.4) | −14.5 (−19.1 to −9.9) | −14.1 (−18.9 to −9.4) | −14.2 (−18.9 to −9.5) | ||
| P value | <.001 | <.001 | <.001 | <.001 | ||
| Office SBP at month 6, mean (SD), mm Hg | 133.7 (13.6) [n = 65] | 131.2 (16.1) [n = 68] | 127.4 (14.5) [n = 58] | 128.9 (15.6) [n = 62] | 140.6 (12.4) [n = 57] | |
| LSM change from baseline (95% CI), mm Hg | −8.2 (−11.5 to −4.8) | −11.1 (−14.4 to −7.8) | −12.8 (−16.3 to −9.2)[n = 57] | −10.8 (−14.2 to −7.4) | −0.6 (−4.2 to 2.9) | |
| LSM difference vs placebo (95% CI), mm Hgb | −7.5 (−12.4 to −2.7) | −10.5 (−15.3 to −5.7) | −12.1 (−17.2 to −7.1) [n = 57] | −10.2 (−15.1 to −5.3) | ||
| P value | .003 | <.001 | <.001 | <.001 | ||
Abbreviations: LSM, least-squares mean; SBP, systolic blood pressure.
a
All randomized patients who received any amount of study drug, analyzed according to randomized treatment.
b
Mixed model for repeated measures adjusted for race and corresponding baseline SBP. P values and 95% CIs for the primary end point are adjusted based on the Dunnett test.