Table 1.
Baseline characteristics | Unmatched | Propensity score matched | ||||
---|---|---|---|---|---|---|
Overall study population | Overall study population | |||||
Demographics |
DPP‐4 inhibitors (N = 170 841) |
Empagliflozin (N = 7089) |
St. Diff. |
DPP‐4 inhibitors (N = 6643) |
Empagliflozin (N = 6643) |
St. Diff. |
Age; mean (SD) | 67.25 (9.72) | 57.12 (8.85) | 1.09 | 57.36 (8.97) | 57.40 (8.89) | 0.00 |
Male; n (%) | 81 890 (47.9%) | 3761 (53.1%) | −0.01 | 3555 (53.5%) | 3529 (53.1%) | 0.00 |
White racea; n (%) | 70 390 (75.5%) | 70 390 (75.5%) | 0.24 | 70 390 (75.5%) | 70 390 (75.5%) | 0.02 |
Burden of comorbidities | ||||||
Combined comorbidity scoreb; mean (SD) | 0.44 (1.65) | 0.10 (1.22) | 0.23 | 0.61 (1.40) | 0.61 (1.39) | 0.00 |
Frailty scorec, mean (SD) | 0.15 (0.05) | 0.14 (0.04) | 0.22 | 0.14 (0.04) | 0.14 (0.04) | 0.00 |
Diabetes‐related complications | ||||||
Diabetic nephropathy; n (%) | 15 991 (9.4%) | 462 (6.5%) | 0.01 | 408 (6.1%) | 427 (6.4%) | 0.00 |
Diabetic retinopathy; n (%) | 13 854 (8.1%) | 496 (7.0%) | 0.00 | 474 (7.1%) | 456 (6.9%) | 0.00 |
Diabetic neuropathy; n (%) | 29 840 (17.5%) | 1102 (15.5%) | 0.00 | 1058 (15.9%) | 1010 (15.2%) | 0.00 |
Diabetes with peripheral circulatory disorders; n (%) | 11 325 (6.6%) | 265 (3.7%) | 0.01 | 232 (3.5%) | 244 (3.7%) | 0.00 |
Diabetic Foot; n (%) | 4443 (2.6%) | 142 (2.0%) | 0.00 | 136 (2.0%) | 130 (2.0%) | 0.00 |
Hypoglycaemia; n (%) | 10 511 (6.2%) | 379 (5.3%) | 0.00 | 335 (5.0%) | 354 (5.3%) | 0.00 |
Features of diabetes medication initiation and baseline diabetes therapy | ||||||
No. antidiabetic drugs at cohort entry; mean (SD) | 2.14 (0.78) | 2.31 (0.97) | −0.19 | 2.24 (0.84) | 2.26 (0.94) | −0.02 |
Naive new user; n (%) | 96 148 (56.3%) | 1683 (23.7%) | 0.05 | 1638 (24.6%) | 1661 (25.0%) | 0.00 |
Monotherapy; n (%) | 110 469 (64.7%) | 2291 (32.3%) | 0.05 | 2301 (34.6%) | 2265 (34.1%) | 0.00 |
Dual therapy with metformin; n (%) | 38 130 (22.3%) | 787 (11.1%) | 0.03 | 742 (11.2%) | 768 (11.6%) | 0.00 |
Concomitant initiation or current use of metformin; n (%) | 106 505 (62.3%) | 4209 (59.4%) | 0.00 | 3922 (59.0%) | 3954 (59.5%) | 0.00 |
Concomitant initiation or current use of sulfonylureas; n (%) | 56 152 (32.9%) | 1821 (25.7%) | 0.01 | 1675 (25.2%) | 1740 (26.2%) | 0.00 |
Concomitant initiation or current use of insulin; n (%) | 18 070 (10.6%) | 1600 (22.6%) | −0.03 | 1406 (21.2%) | 1402 (21.1%) | 0.00 |
Past use of metformin; n (%) | 24 742 (14.5%) | 1305 (18.4%) | −0.01 | 1236 (18.6%) | 1230 (18.5%) | 0.00 |
Past use of sulfonylureas; n (%) | 16 522 (9.7%) | 652 (9.2%) | 0.00 | 593 (8.9%) | 587 (8.8%) | 0.00 |
Past use of insulin; n (%) | 6638 (3.9%) | 658 (9.3%) | −0.02 | 580 (8.7%) | 554 (8.3%) | 0.00 |
Life style factors | ||||||
Obesity; n (%) | 38 579 (22.6%) | 2189 (30.9%) | −0.02 | 1994 (30.0%) | 2003 (30.1%) | 0.00 |
Overweight; n (%) | 7966 (4.7%) | 267 (3.8%) | 0.00 | 254 (3.8%) | 250 (3.8%) | 0.00 |
Smoking; n (%) | 23 880 (14.0%) | 675 (9.5%) | 0.01 | 625 (9.4%) | 644 (9.7%) | 0.00 |
Other comorbidities at baseline | ||||||
Ischaemic heart disease; n (%) | 44 534 (26.1%) | 1113 (15.7%) | 0.02 | 1026 (15.4%) | 1049 (15.8%) | 0.00 |
Previous coronary revascularization; n (%) | 13 246 (7.8%) | 253 (3.6%) | 0.02 | 219 (3.3%) | 243 (3.7%) | 0.00 |
Ischaemic or haemorrhagic stroke; n (%) | 17 419 (10.2%) | 329 (4.6%) | 0.02 | 315 (4.7%) | 313 (4.7%) | 0.00 |
Heart failure; n (%) | 18 653 (10.9%) | 302 (4.3%) | 0.02 | 280 (4.2%) | 292 (4.4%) | 0.00 |
Peripheral arterial disease or surgery; n (%) | 18 344 (10.7%) | 328 (4.6%) | 0.02 | 312 (4.7%) | 314 (4.7%) | 0.00 |
Hypertension; n (%) | 141 117 (82.6%) | 5291 (74.6%) | 0.01 | 4947 (74.4%) | 4941 (74.3%) | 0.00 |
Hyperlipidemia; n (%) | 139 697 (81.8%) | 5622 (79.3%) | 0.00 | 5249 (79.0%) | 5246 (78.9%) | 0.00 |
Oedema; n (%) | 18 375 (10.8%) | 449 (6.3%) | 0.02 | 450 (6.8%) | 431 (6.5%) | 0.00 |
Nondiabetic renal dysfunction; n (%) | 34 829 (20.4%) | 612 (8.6%) | 0.03 | 624 (9.4%) | 589 (8.9%) | 0.00 |
Chronic kidney disease; n (%) | 29 889 (17.5%) | 446 (6.3%) | 0.03 | 438 (6.6%) | 432 (6.5%) | 0.00 |
COPD; n (%) | 18 581 (10.9%) | 383 (5.4%) | 0.02 | 370 (5.6%) | 367 (5.5%) | 0.00 |
Obstructive sleep apnoea; n (%) | 17 053 (10.0%) | 1068 (15.1%) | −0.01 | 961 (14.5%) | 977 (14.7%) | 0.00 |
Pneumonia; n (%) | 7287 (4.3%) | 174 (2.5%) | 0.01 | 151 (2.3%) | 163 (2.5%) | 0.00 |
Liver disease; n (%) | 11 734 (6.9%) | 486 (6.9%) | 0.00 | 435 (6.5%) | 455 (6.8%) | 0.00 |
Osteoarthritis; n (%) | 40 824 (23.9%) | 1089 (15.4%) | 0.02 | 963 (14.5%) | 1033 (15.5%) | 0.00 |
Other Medications | ||||||
Angiotensin converting enzyme inhibitors; n (%) | 79 712 (46.7%) | 3293 (46.5%) | 0.00 | 3085 (46.4%) | 3082 (46.4%) | 0.00 |
Angiotensin II receptor blockers; n (%) | 52 655 (30.8%) | 2126 (30.0%) | 0.00 | 1925 (29.0%) | 1974 (29.7%) | 0.00 |
Beta‐blockers; n (%) | 71 567 (41.9%) | 2220 (31.3%) | 0.02 | 2057 (31.0%) | 2078 (31.3%) | 0.00 |
Calcium‐channel blockers; n (%) | 53 432 (31.3%) | 1562 (22.0%) | 0.02 | 1590 (23.9%) | 1467 (22.1%) | 0.00 |
Thiazide diuretics; n (%) | 24 190 (14.2%) | 808 (11.4%) | 0.01 | 805 (12.1%) | 759 (11.4%) | 0.00 |
Loop diuretics; n (%) | 28 161 (16.5%) | 668 (9.4%) | 0.02 | 586 (8.8%) | 622 (9.4%) | 0.00 |
Nitrates; n (%) | 13 163 (7.7%) | 310 (4.4%) | 0.01 | 293 (4.4%) | 291 (4.4%) | 0.00 |
Other hypertension drugs; n (%) | 13 648 (8.0%) | 320 (4.5%) | 0.01 | 321 (4.8%) | 306 (4.6%) | 0.00 |
Digoxin; n (%) | 4568 (2.7%) | 095 (1.3%) | 0.01 | 079 (1.2%) | 090 (1.4%) | 0.00 |
Statins; n (%) | 118 401 (69.3%) | 4631 (65.3%) | 0.00 | 4276 (64.3%) | 4301 (64.7%) | 0.00 |
Antiplatelet agents; n (%) | 24 496 (14.3%) | 668 (9.4%) | 0.01 | 605 (9.1%) | 634 (9.5%) | 0.00 |
Oral anticoagulants; n (%) | 13 447 (7.9%) | 295 (4.2%) | 0.02 | 283 (4.3%) | 284 (4.3%) | 0.00 |
Opioids; n (%) | 56 179 (32.9%) | 2331 (32.9%) | 0.00 | 2177 (32.8%) | 2188 (32.9%) | 0.00 |
Measures of healthcare utilization | ||||||
Previous hospitalization; n (%) | 24 336 (14.2%) | 549 (7.7%) | 0.02 | 488 (7.3%) | 519 (7.8%) | 0.00 |
Hospitalization within prior 30 d; n (%) | 7601 (4.4%) | 063 (0.9%) | 0.02 | 055 (0.8%) | 063 (0.9%) | 0.00 |
No. emergency department visits; mean (sd) | 0.73 (2.02) | 0.31 (1.40) | 0.24 | 0.31 (1.44) | 0.30 (1.17) | 0.01 |
No. office visits; mean (SD) | 9.49 (7.26) | 8.76 (6.36) | 0.11 | 8.63 (6.62) | 8.68 (6.33) | −0.01 |
Endocrinologist visit within prior 30 d; n (%) | 13 066 (7.6%) | 1401 (19.8%) | −0.03 | 1117 (16.8%) | 1118 (16.8%) | 0.00 |
Internal medicine visit within prior 30 d; n (%) | 111 623 (65.3%) | 4171 (58.8%) | 0.01 | 4074 (61.3%) | 4003 (60.2%) | 0.00 |
Cardiologist visit within prior 30 d; n (%) | 18 618 (10.9%) | 394 (5.6%) | 0.02 | 366 (5.5%) | 378 (5.7%) | 0.00 |
No. distinct medication prescriptions; mean (SD) | 12.16 (6.06) | 12.42 (6.08) | −0.04 | 12.19 (6.23) | 12.25 (6.05) | −0.01 |
Laboratory test resultsd | ||||||
HbA1c (%); mean (SD) | 8.41 (1.82) | 8.49 (1.76) | −0.04 | 8.62 (1.84) | 8.48 (1.76) | 0.08 |
Patients with HbA1c results available; n (%) | 15 768 (20.3%) | 943 (16.2%) | 0.01 | 1002 (18.6%) | 864 (16.0%) | 0.01 |
Creatinine (mg/dL); mean (SD) | 0.96 (0.34) | 0.89 (0.23) | 0.24 | 0.91 (0.27) | 0.89 (0.23) | 0.08 |
Patients with creatinine results available; n (%) | 16 248 (20.9%) | 1044 (18.0%) | 0.01 | 1046 (19.4%) | 952 (17.7%) | 0.00 |
Total cholesterol (mg/dL); mean (SD) | 179.38 (47.09) | 177.44 (47.46) | 0.04 | 177.75 (45.04) | 177.92 (48.05) | 0.00 |
Patients with total cholesterol results available; n (%) | 14 494 (18.7%) | 944 (16.2%) | 0.01 | 955 (17.7%) | 863 (16.0%) | 0.00 |
LDL level (mg/dL); mean (sd) | 90.82 (40.13) | 87.09 (38.55) | 0.09 | 88.92 (39.42) | 87.47 (38.91) | 0.04 |
Patients with LDL results available; n (%) | 14 984 (19.3%) | 943 (16.2%) | 0.01 | 976 (18.1%) | 864 (16.0%) | 0.01 |
HDL level (mg/dL); mean (SD) | 45.74 (21.76) | 44.44 (13.04) | 0.07 | 43.96 (12.59) | 44.39 (13.04) | −0.03 |
Patients with HDL results available; n (%) | 14 325 (18.5%) | 926 (15.9%) | 0.01 | 942 (17.5%) | 846 (15.7%) | 0.00 |
Abbreviations: DPP‐4: dipeptidyl peptidase‐4; St. Diff: standardized differences, that is, the difference in means or proportions divided by the pooled standard deviation [Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity‐score matched samples. Statistics in medicine 2009;28:3083‐107]; SD: standard deviation; Q: quarter; GLP‐1 RA: glucagon‐like peptide‐1 receptor agonists; COPD: chronic obstructive pulmonary disease; BUN: blood urea nitrogen; HbA1c: haemoglobin A1c; LDL: low‐density lipoprotein; HDL: high‐density lipoproteins.
Only available in Medicare fee‐for‐service.
Gagne et al.42
Kim et al.56
Only available in Optum Clinformatics and Truven MarketScan.