Table 4.
Power calculations for main outcomes in the ADDITION-PRO study
| |
Expected CVD events (n) |
Expected incidence rate (per 1000 person years) |
Power |
| Difference in CVD incidence between: |
|
|
|
| NGT and stable IFG/IGT |
53 |
7.4 |
0.97 |
| NGT and incident DM |
100 |
13.8 |
0.99 |
| Stable IFG/IGT and incident diabetes |
132 |
18.3 |
0.59 |
| |
Detectable differences |
Expected mean (SD) in reference group (NGT) |
Power |
| Aortic stiffness (pulse wave velocity) |
0.4 m/s |
7.5 m/s (2.5) |
0.94 |
| Renal function (eGFR) |
5 ml/min/1.73 m2 |
100 ml/min/1.73 m2 (20) |
0.98 |
| AGE – (skin autofluorescence) | 0.2 AU | 2.0 AU (0.5) | 0.94 |
AGE = advanced glycation end-products; CVD = cardiovascular disease;
eGFR = estimated glomerular filtration rate; IFG = impaired fasting glucose;
IGT = impaired glucose tolerance; NGT = normal glucose tolerance.