Introduction
Methods
Study design and participants
Biomarker measurement
Statistical analysis
Model derivation and validation
Individual baseline risk and treatment effect estimation
Numbers needed to treat, and events prevented
Results
Baseline characteristics and clinical outcomes
Description | Canagliflozin (N = 2472) | Placebo (N = 1241) | Total (N = 3713) |
---|---|---|---|
Age (years) | 62.8 (7.9) | 62.6 (7.8) | 62.7 (7.9) |
Males, N (%) | 1653 (66.9) | 833 (67.1) | 2486 (67.0) |
Race, N (%) | |||
Caucasian | 1992 (80.6) | 997 (80.3) | 2989 (80.5) |
Black | 60 (2.4) | 32 (2.6) | 92 (2.5) |
Asian | 257 (10.4) | 134 (10.8) | 391 (10.5) |
Others | 163 (6.6) | 78 (6.3) | 241 (6.5) |
Smoker (yes) | 429 (17.4) | 250 (20.1) | 679 (18.3) |
Previous CVD history (yes) | 1474 (59.6) | 730 (58.8) | 2204 (59.4) |
eGFR (ml/min/1.73m2) | 79.6 (17.4) | 79.4 (17.3) | 79.5 (17.3) |
Glycated hemoglobin (%) | 8.2 (0.9) | 8.2 (0.9) | 8.2 (0.9) |
Systolic BP (mmHg) | 136.3 (15.9) | 137.2 (15.8) | 136.6 (15.9) |
UACR (mg/g) | 11.7 [6.5 to 35.0] | 11.6 [6.3 to 36.5] | 11.7 [6.4 to 35.7] |
Weight (kg) | 93.6 (20.9) | 92.9 (20.7) | 93.4 (20.8) |
Hemoglobin (g/L) | 140.6 (14.5) | 140.0 (14.4) | 140.4 (14.5) |
Albumin (g/L) | 41.0 (3.3) | 41.0 (3.2) | 41.0 (3.2) |
HDL-cholesterol (mmol/L) | 1.2 (0.3) | 1.2 (0.3) | 1.2 (0.3) |
LDL-cholesterol (mmol/L) | 2.3 (0.9) | 2.3 (0.9) | 2.3 (0.9) |
Uric acid (umol/L) | 351.5 (91.8) | 350.5 (98.5) | 351.2 (94.1) |
Potassium (mmol/L) | 4.4 (0.5) | 4.4 (0.4) | 4.4 (0.5) |
TNFR-1 (ng/ml) | 2.6 [2.1 to 3.2] | 2.6 [2.1 to 3.1] | 2.6 [2.1 to 3.2] |
TNFR-2 (ng/ml) | 9.7 [7.8 to 12.0] | 9.6 [7.9 to 12.1] | 9.7 [7.9 to 12.0] |
KIM-1 (ng/ml) | 0.1 [0.1 to 0.2] | 0.1 [0.1 to 0.2] | 0.1 [0.1 to 0.2] |
GDF-15 (ng/ml) | 1.8 [1.2 to 2.5] | 1.8 [1.2 to 2.5] | 1.8 [1.2 to 2.5] |
MMP-7 (ng/ml) | 6.1 [4.7 to 8.4] | 6.2 [4.7 to 8.4] | 6.2 [4.7 to 8.4] |
IL-6 (pg/ml) | 1.6 [1.2 to 2.4] | 1.6 [1.2 to 2.3] | 1.6 [1.2 to 2.4] |
uMCP-1 (ng/ml) | 0.2 [0.1 to 0.3] | 0.2 [0.1 to 0.3] | 0.2 [0.1 to 0.3] |
uEGF (ng/ml) | 4.6 [2.6 to 7.8] | 4.6 [2.6 to 7.9] | 4.6 [2.6 to 7.8] |
uMCP-1/Cr (ng/g) | 191.0 [121.8 to 312.7] | 193.0 [123.0 to 344.1] | 191.7 [122.6 to 321.1] |
uEGF/Cr (ng/g) | 5063.3 [3345.4 to 7865.9] | 5198.9 [3450.0 to 7658.5] | 5097.4 [3365.7 to 7811.7] |