Table 2.
Summary of primary and secondary efficacy endpoints (full analysis set)
| Endpoints | Placebo, n=227 | Esaxerenone 1.25–2.5 mg/d, n=222 | Treatment difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Patients with remission at the end of treatment, n (%)a | 9 (4) | 49 (22) | 18 (12 to 25) | <0.001 | |
| Patients with UACR <30 mg/g creatinine, n (%) | 9 (4) | 49 (22) | 18 (12 to 25) | <0.001 | |
| Patients with ≥30% reduction in UACR, n (%) | 45 (20) | 154 (69) | 50 (41 to 57) | <0.001 | |
| Geometric mean of UACR at baseline, mg/g creatinine | 110 (103 to 117) | 117 (109 to 124) | — | — | |
| Geometric mean of UACR at end of treatment, mg/g creatinine | 120 (107 to 134) | 48 (43 to 55) | — | — | |
| Geometric least-square mean ratio from baseline to end of treatment in UACRb | 1.08 (0.98, 1.20) | 0.42 (0.38, 0.46) | 0.38c (0.33 to 0.44) | <0.001 | |
Data are shown as n (%) or as geometric means, geometric and least-square mean changes, or treatment differences (all shown with 95% confidence intervals in parentheses); P values are also indicated. UACR, urinary albumin-to-creatinine ratio.
Remission was defined as two consecutive UACR <30 mg/g creatinine values and ≥30% reduction in UACR from baseline.
Least-squares means of the change from baseline log-transformed values at the end of treatment, on the basis of the analysis of covariance (ANCOVA) model with treatment group as a factor and log-transformed baseline values as covariates. The estimates are back transformed, and expressed as the ratio in the original scale.
Least-squares means of the between-treatment difference of the change log-transformed values (esaxerenone–placebo), on the basis of the same ANCOVA model. The estimates are back transformed, and expressed as the ratio in the original scale.