| Incidence of DKA in Index Period by GLD Status—Dual Treatment | |||
|
| Empagliflozin (N = 343) | DPP-4 Inhibitors (N = 393) | Rate Ratio |
| Patients with events in the period, n(%) | 0 | 1 (0.3) |
|
| Crude incidence rate | 0 | 0.003 | 0 |
| (95% confidence interval) | (0, 0.011) | (0, 0.014) |
|
| Treatment-adjusted incidence rate |
|
|
|
| (crude per 1000 patient-years) | 0 | 1.407 | 0 |
| (95% confidence interval) | (0, 5.092) | (0.036, 7.842) |
|
| Incidence of DKA in Index Period by GLD Status—Quadruple Treatment | |||
|
| Empagliflozin (N = 43) | DPP-4 Inhibitors (N = 29) | Rate Ratio |
| Patients with events in the period, n (%) | 1 (2.3) | 0 |
|
| Crude incidence rate | 0.023 | 0 |
|
| (95% confidence interval) | (0.001, 0.123) | (0.000, 0.119) |
|
| Treatment-adjusted incidence rate |
|
|
|
| (crude per 1000 patient-years) | 1.380 | 0.000 |
|
| (95% confidence interval) | (0.035, 7.690) | (0, 5.192) |
|
| Incidence of Volume Depletion in Index Period by GLD Status—Dual Treatment | |||
|
| Empagliflozin N = 343 | DPP-4 Inhibitors N = 393 | Rate Ratio |
| Patients with events in the period, n (%) | 2 (0.6) | 5 (1.3) |
|
| Patients without event, n (%) | 341 (99.4) | 388 (98.7) |
|
| Crude incidence rate | 0.006 | 0.013 | 0.462 |
| (95% confidence interval) | (0.001, 0.021) | (0.004, 0.029) |
|
| Treatment-adjusted incidence rate |
|
|
|
| (crude per 1000 patient-years) | 2.761 | 7.037 | 0.392 |
| (95% confidence interval) | (0.334, 9.972) | (2.285, 16.423) |
|
| Time from start of period to first occurrence in period (days) | 229 ± 190.9 | 287 ± 75.6 |
|
| Incidence of Volume Depletion in Index Period by GLD Status—Triple Treatment | |||
|
| Empagliflozin N = 231 | DPP-4 Inhibitors N = 209 | Rate Ratio |
| Patients with events in the period, n (%) | 2 (0.9) | 1 (0.5) |
|
| Patients without event, n (%) | 229 (99.1) | 208 (99.5) |
|
| Crude incidence rate | 0.009 | 0.005 | 1.800 |
| (95% confidence interval) | (0.001, 0.031) | (0.000, 0.026) |
|
| Treatment-adjusted incidence rate |
|
|
|
| (crude per 1000 patient-years) | 2.761 | 1.407 | 1.962 |
| (95% confidence interval) | (0.334, 9.972) | (0.036, 7.842) |
|
| Time from start of period to first occurrence in period (days) | 187 ± 168.3 | 309 |
|
| Incidence of Volume Depletion in Index Period by GLD Status— Quadruple Treatment | |||
|
| Empagliflozin N = 43 | DPP-4 Inhibitors N = 29 | Rate Ratio |
| Patients with events in the period, n (%) | 0 | 1 (3.4) |
|
| Crude incidence rate | 0 | 0.034 | 0 |
| (95% confidence interval) | (0, 0.082) | (0.001, 0.178) |
|
| Treatment-adjusted incidence rate |
|
|
|
| (crude per 1000 patient-years) | 0 | 1.407 | 0 |
| (95% confidence interval) | (0, 5.092) | (0.036, 7.842) |
|
| Incidence of Volume Depletion in Index Period by GLD Status— Quintuple Treatment | |||
|
| Empagliflozin N = 12 | DPP-4 Inhibitors N = 6 | Rate Ratio |
| Patients with events in the period, n (%) | 2 (16.7) | 0 |
|
| Patients without event, n (%) | 10 (83.3) | 6 (100) |
|
| Crude incidence rate | 0.167 | 0 |
|
| (95% confidence interval) | (0.021, 0.484) | (0, 0.459) |
|
| Treatment-adjusted incidence rate |
|
|
|
| (crude per 1000 patient-years) | 2.761 | 0 |
|
| (95% confidence interval) | (0.334, 9.972) | (0, 5.192) |
|
| Time from start of period to first occurrence in period (days) | 91 ± 32.5 |
|
|