Table 1.
Effect of semaglutide 2.4 mg on continuous kidney endpoints
| Outcome | Semaglutide 2.4 mg (N = 8,803) | Placebo (N = 8,801) | ETD (95% CI); P value |
|---|---|---|---|
| Change in eGFR at week 104, mL min−1 1.73 m−2 | −0.86 | −1.61 | 0.75 (0.43, 1.06); P < 0.001 |
| By baseline eGFR | |||
| <60 ml min−1 m−2 | 5.28 | 3.09 | 2.19 (1.00, 3.38); P < 0.001 |
| ≥60 ml min−1 m−2 | −1.62 | −2.20 | 0.57 (0.26, 0.89); P < 0.001 |
| Total eGFR slope, ml min−1 m−2 per year | −0.78 | −1.17 | 0.39 (0.30, 0.48); P < 0.001 |
| Chronic eGFR slope, ml min−1 m−2 per year | −0.98 | −1.28 | 0.29 (0.18, 0.40); P < 0.001 |
| Acute eGFR slope, ml min−1 m−2 per year | −2.41 | −1.08 | −1.33 (−2.68, 0.02); P = 0.05 |
| Change in UACR at week 104, log-transformed, % | 0.3 | 12.3 | −10.7 (−13.2, −8.2); P < 0.001 |
| By baseline UACR | |||
| <30 mg g−1 | 14.2 | 24.3 | −8.1 (−10.6, −5.6); P < 0.001 |
| 30 to <300 mg g−1 | −53.4 | −36.0 | −27.2 (−35.3, −18.1); P < 0.001 |
| ≥300 mg g−1 | −75.0 | −63.5 | −31.4 (−54.9, 4.3); P = 0.08 |
| By baseline eGFR | |||
| <60 ml min−1 m−2 | 4.0 | 19.7 | −13.1 (−22.1, −3.1); P = 0.01 |
| ≥60 ml min−1 m−2 | −0.3 | 11.9 | −10.9 (−13.5, −8.4); P < 0.001 |
For changes in eGFR and UACR, data are the estimated mean changes from the estimated baseline value to week 104 and ETD, analyzed using MMRM. Changes in UACR were analyzed as estimated mean ratio to baseline at week 104 and estimated treatment ratio; for ease of interpretation, these ratios were converted to relative percentage changes from baseline and relative percentage treatment differences using the formula (estimated ratio − 1) × 100. The eGFR slope (that is, the annualized rate of change in eGFR) and ETD were analyzed using a linear random regression model. The chronic period included data from week 20 to end of trial (that is, any data before week 20 were excluded). Total refers to the eGFR change from baseline to end of trial. The acute period included data from baseline to week 16 and was evaluable only in European patients in whom there were additional early measures. P values (from top to bottom of the table) are 2.6895 × 10−6, 0.0003, 0.0004, 1.9939 × 10−16, 1.3273 × 10−7, 0.0535, 3.5231 × 10−15, 1.2913 × 10−9, 1.4054 × 10−7, 0.0777, 0.0119 and 2.3245 × 10−15. P values are two-sided using a t-test in the models and were not adjusted for multiplicity. ETD, estimated treatment difference.