Incidence rates and HRs of outcomes, by data source
| Saxagliptin initiators | Other OAD initiators | ||||||||
| Outcome, by data source | Users (n) | Person-years | Events (n) | Rate of events per 1000 person-years (95% CI) | Users (n) | Person-years | Events (n) | Rate of events per 1000 person-years (95% CI) | Adjusted HR* (95% CI) |
| Major cardiovascular event | |||||||||
| Medicare | 70 271 | 39 300.8 | 1030 | 26.2 (24.6 to 27.9) | 562 159 | 308 101.7 | 8945 | 29.0 (28.4 to 29.6) | 0.92 (0.86 to 0.98) |
| HIRD | 9219 | 5988.1 | 45 | 7.5 (5.5 to 10.1) | 89 538 | 41 694.0 | 362 | 8.7 (7.8 to 9.6) | 0.86 (0.62 to 1.20) |
| CPRD | 3769 | 2551.4 | 13 | 5.1 (2.7 to 8.7) | 35 916 | 20 245.3 | 145 | 7.2 (6.0 to 8.4) | 0.63 (0.35 to 1.16) |
| THIN (excluding CPRD) | 785 | 524.3 | 5 | 9.5 (3.1 to 22.3) | 4873 | 2850.8 | 21 | 7.4 (4.6 to 11.3) | 0.99 (0.34 to 2.87) |
| Acute liver failure | |||||||||
| Medicare† | 72 831 | 41 011.4 | 28 | 0.7 (0.5 to 1.0) | 72 831 | 37 260.1 | 40 | 1.1 (0.8 to 1.5) | 0.72 (0.42 to 1.25) |
| HIRD† | 9265 | 6059.8 | 2 | 0.3 (0.04 to 1.2) | 90 174 | 42 230.7 | 6 | 0.1 (0.05 to 0.3) | 2.97 (0.49 to 18.11)‡ |
| CPRD† | 3794 | 2581.4 | 0 | 0.0 (0.0 to 1.2) | 36 196 | 20 549.8 | 0 | 0.0 (0.0 to 0.1) | – |
| THIN (excluding CPRD)† | 791 | 531.0 | 0 | 0.0 (0.0 to 5.6) | 4913 | 2879.5 | 0 | 0.0 (0.0 to 1.0) | – |
| Acute kidney injury | |||||||||
| Medicare | 61 888 | 34 597.7 | 334 | 9.7 (8.6 to 10.7) | 519 259 | 289 326.5 | 2708 | 9.4 (9.0 to 9.7) | 0.99 (0.88 to 1.11) |
| HIRD | 8894 | 5819.5 | 4 | 0.7 (0.2 to 1.8) | 87 770 | 40 979.4 | 26 | 0.6 (0.4 to 0.9) | 0.88 (0.29 to 2.74) |
| CPRD† | 2972 | 1947.4 | 0 | 0.0 (0.0 to 1.5) | 32 798 | 18 369.1 | 7 | 0.4 (0.2 to 0.8) | – |
| THIN (excluding CPRD)† | 602 | 412.8 | 0 | 0.0 (0.0 to 7.3) | 4327 | 2522.3 | 2 | 0.8 (0.10 to 2.9) | – |
| Infection | |||||||||
| Medicare | 74 263 | 41 012.6 | 2280 | 55.6 (53.3 to 57.9) | 577 572 | 314 496.9 | 17 840 | 56.7 (55.9 to 57.6) | 0.97 (0.92 to 1.01) |
| HIRD | 9300 | 6047.8 | 84 | 13.9 (11.1 to 17.2) | 89 485 | 41 773.4 | 552 | 13.2 (12.1 to 14.4) | 1.07 (0.83 to 1.37) |
| CPRD† | 3714 | 2456.9 | 74 | 30.1 (23.7 to 37.8) | 35 417 | 19 687.2 | 661 | 33.6 (31.1 to 36.2) | 0.81 (0.63 to 1.06) |
| THIN (excluding CPRD) | 780 | 508.9 | 2 | 3.9 (0.5 to 14.2) | 4834 | 2785.5 | 18 | 6.5 (3.8 to 10.2) | 0.64 (0.13 to 3.16) |
| Hypersensitivity | |||||||||
| Medicare† | 77 857 | 43 764.4 | 75 | 1.7 (1.3 to 2.1) | 624 074 | 342 886.0 | 702 | 2.0 (1.9 to 2.2) | 0.80 (0.62 to 1.02) |
| HIRD† | 9439 | 6162.2 | 4 | 0.6 (0.2 to 1.7) | 91 814 | 42 887.8 | 72 | 1.7 (1.3 to 2.1) | 0.48 (0.17 to 1.38) |
| CPRD† | 3795 | 2581.5 | 2 | 0.8 (0.09 to 2.8) | 36 245 | 20 558.8 | 13 | 0.6 (0.3 to 1.1) | 1.80 (0.31 to 10.28)‡ |
| THIN (excluding CPRD)† | 792 | 531.6 | 0 | 0.0 (0.0 to 5.6) | 4921 | 2884.2 | 0 | 0.0 (0.0 to 1.0) | – |
↵*Adjusted for prior OAD therapy, quarter of observation, and geographic region unless otherwise noted.
↵†A validated algorithm was unable to be determined, so, conservatively, we included all electronically identified outcomes that were either confirmed by medical record review or had unobtained charts as events.
↵‡Since there were not enough events to run the fully adjusted model, the propensity score-adjusted HR is presented.
CPRD, Clinical Practice Research Datalink; HIRD, HealthCore Integrated Research Database; OAD, oral antidiabetic drug; THIN, The Health Improvement Network.