Introduction
Methods
Model overview
Clinical parameters
Parameters | Metformin (versus placebo) | Dapagliflozin (versus placebo) | Sourcea | ||
---|---|---|---|---|---|
Expected value | Range | Expected value | Range | ||
Decrease in HbA1c | 1.13 | 0.9–1.37 | 0.50 | 0.21–0.78 | [20] |
Decrease in SBP (mmHg) | 2.00 | − 7.26 to 11.21 | 8.11 | 1.48–14.74 | |
Decrease in total-C (mg/dL) | 11.93 | − 0.79 to 24.07 | 2.80 | − 5.92 to 11.63 | |
Increase in HDL-C (mg/dL) | 2.01 | − 7.67 to 11.53 | 8.10 | 1.24–15.14 |
Costs and utilities
Parameters | Expected value | Range | Source |
---|---|---|---|
Costs ($) | |||
Metformin 1500 mg per day | 0.7 | 0.1–0.7 | [8] |
Dapagliflozin 10 mg per day | 2.5 | 1.3–2.5 | [8] |
Anti-diabetic therapy per day (disease duration ≤ 3 year) | 0.5 | 0.2–1.3 | [26] |
Anti-diabetic therapy per day (3 < disease duration ≤ 5 year) | 0.8 | 0.2–1.7 | [26] |
Anti-diabetic therapy per day (6 ≤ disease duration < 10 year) | 1.2 | 0.3–2.5 | [26] |
Anti-diabetic therapy per day (disease duration ≥ 10 year) | 2.0 | 0.7–3.2 | [26] |
MI hospitalization per event | 7383.0 | 6505.2–8260.9 | |
Care after MI per year | 455.4 | 288.6–622.2 | |
Stroke hospitalization per event | 2875.2 | 2184.6–4738.3 | |
Care after stroke per year | 506.9 | 445.9–828 | |
CHF per year | 1507.7 | 1254.6–2632.3 | |
ESRD per year | 13,803.2 | 13,153.8–14,569.2 | [29] |
Blindness per year | 1642.0 | 1430.4–1853.5 | |
Clinical neuropathy per month | 60.9 | 26.2–101.4 | [28] |
Uncomplicated DFU per event | 76.2 | 0–226.2 | [28] |
Complicated DFU per event | 2293.3 | 1228.5–2880.8 | [28] |
Minor amputation per event | 3316.9 | 2165.2–5038.9 | [28] |
Major amputation per event | 5019.2 | 2981.1–7738.2 | [28] |
Care after major amputation per month | 338.1 | 0–600.7 | [28] |
Hypoglycemia per event | 70.0 | 0–855.5 | Local charge |
Utility values | |||
T2DM without complications | 0.876 | 0.736–1 | [30] |
Utility decrements | |||
MI hospitalization for 1 month | 1.000 | 0.236–1 | [31] |
MI after discharge | 0.236 | 0.026–0.446 | [30] |
Stroke hospitalization for 1 month | 1.000 | 0.326–1 | [31] |
Stroke after discharge | 0.326 | 0.036–0.616 | [30] |
CHF | 0.236 | 0.026–0.446 | [30] |
ESRD | 0.400 | 0.19–0.61 | [33] |
Blindness | 0.157 | 0.007–0.307 | [33] |
Clinical neuropathy | 0.185 | 0.015–0.355 | [30] |
Uncomplicated DFU | 0.250 | 0.213–0.287 | [32] |
Complicated DFU | 0.300 | 0.165–0.435 | [32] |
Minor amputation | 0.320 | 0.204–0.436 | [32] |
Major amputation | 0.380 | 0.264–0.496 | [32] |
Sensitivity analyses
Results
Base-case analysis
Outcomes | Metformin | Dapagliflozin | Differencea |
---|---|---|---|
Events | |||
MI | 10.90% | 11.01% | 0.11% |
Stroke | 24.57% | 25.40% | 0.83% |
CHF | 15.56% | 15.60% | 0.03% |
ESRD | 4.748% | 4.846% | 0.097% |
Blindness | 5.17% | 5.15% | − 0.02% |
Clinical neuropathy | 15.96% | 16.00% | 0.04% |
Minor amputation | 13.959% | 13.963% | 0.004% |
Major amputation | 10.501% | 10.504% | 0.003% |
Total QALY | 11.12 | 11.03 | − 0.10 |
Total LY | 24.86 | 24.71 | − 0.15 |
Total cost (US $) | 15,262 | 17,450 | 2188 |
ICER (US $/QALY) | NA | Dominated |