Table 5.
Selected baseline characteristics of cohorts to assess severe complications of urinary tract infection, full sample before propensity score trimming, by sex
| CPRD | HIRD | Medicare | ||||
|---|---|---|---|---|---|---|
| Dapagliflozin | Comparator GLD | Dapagliflozin | Comparator GLD | Dapagliflozin | Comparator GLD | |
| Females | n = 5508 | n = 20,807 | n = 10,544 | n = 124,755 | n = 12,561 | n = 188,415 |
| Age, mean (SD),a years | 57.0 (11.1) | 59.3 (11.7) | 51.7 (8.8) | 51.6 (9.1) | 71.8 (5.8) | 71.9 (5.9) |
| Race/ethnicity,b n (%) | ||||||
| Asian | NA | NA | NA | NA | 877 (7.0) | 9602 (5.1) |
| Black | NA | NA | NA | NA | 1086 (8.6) | 20,268 (10.8) |
| Hispanic | NA | NA | NA | NA | 676 (5.4) | 8599 (4.6) |
| White | NA | NA | NA | NA | 9,377 (74.7) | 141,452 (75.1) |
| Otherc | NA | NA | NA | NA | 333 (2.7) | 5731 (3.0) |
| Unknown | NA | NA | NA | NA | 212 (1.7) | 2763 (1.5) |
| Insulin use at the index date, n (%) | 838 (15.2) | 1414 (6.8) | 1584 (15.0) | 14,960 (12.0) | 2488 (19.8) | 29,397 (15.6) |
| Kidney diseases, all types, acute and chronic, n (%) | 487 (8.8) | 3614 (17.4) | 468 (4.4) | 7312 (5.9) | 2293 (18.3) | 47,402 (25.2) |
| Urinary infections (chronic or recurring), n (%) | 242 (4.4) | 1029 (4.9) | 1206 (11.4) | 15,996 (12.8) | 3320 (26.4) | 51,343 (27.2) |
| Indicators of diabetes severity, n (%) | ||||||
| Diabetic nephropathy or renal insufficiency | 40 (0.7) | 149 (0.7) | 196 (1.9) | 2927 (2.3) | 1215 (9.7) | 24,203 (12.8) |
| Retinopathy | 1438 (26.1) | 4827 (23.2) | 2650 (25.1) | 27,545 (22.1) | 5309 (42.3) | 70,520 (37.4) |
| Peripheral neuropathy | 173 (3.1) | 608 (2.9) | 244 (2.3) | 2646 (2.1) | 966 (7.7) | 15,013 (8.0) |
| Peripheral vascular diseased | 112 (2.0) | 693 (3.3) | 2469 (23.4) | 26,434 (21.2) | 5305 (42.2) | 74,660 (39.6) |
| Coronary heart disease | 420 (7.6) | 2127 (10.2) | 765 (7.3) | 9774 (7.8) | 3896 (31.0) | 57,850 (30.7) |
| Cerebrovascular disease | 235 (4.3) | 1300 (6.2) | 194 (1.8) | 3132 (2.5) | 2078 (16.5) | 31,838 (16.9) |
| Amputation | 15 (0.3) | 113 (0.5) | 16 (0.2) | 329 (0.3) | 52 (0.4) | 1,484 (0.8) |
| Body mass index (kg/m2),e n (%) | ||||||
| < 20 (underweight) | 14 (0.3) | 156 (0.7) | NA | NA | NA | NA |
| 20 to < 25 (normal) | 177 (3.2) | 1531 (7.4) | NA | NA | NA | NA |
| 25 to < 30 (overweight) | 910 (16.5) | 4393 (21.1) | NA | NA | NA | NA |
| 30 to < 40 (obese) | 2842 (51.6) | 9822 (47.2) | NA | NA | NA | NA |
| ≥ 40 (severely obese) | 1487 (27.0) | 4139 (19.9) | NA | NA | NA | NA |
| Unknown | 78 (1.4) | 766 (3.7) | NA | NA | NA | NA |
| Healthcare utilization in the 180 days before the index date | ||||||
| No. of outpatient visits, f n (%) | ||||||
| 0 | 210 (3.8) | 645 (3.1) | 137 (1.3) | 3221 (2.6) | 539 (4.3) | 10,091 (5.4) |
| 1 | 337 (6.1) | 1260 (6.1) | 272 (2.6) | 3662 (2.9) | 636 (5.1) | 11,222 (6.0) |
| 2 or more | 4961 (90.1) | 18,902 (90.8) | 10,135 (96.1) | 117,872 (94.5) | 11,386 (90.6) | 167,102 (88.7) |
| No. of hospitalizations, n (%) | ||||||
| 0 | 4935 (89.6) | 17,938 (86.2) | 10,175 (96.5) | 117,447 (94.1) | 11,717 (93.3) | 164,178 (87.1) |
| 1 | 410 (7.4) | 1721 (8.3) | 321 (3.0) | 6185 (5.0) | 557 (4.4) | 13,533 (7.2) |
| 2 or more | 163 (3.0) | 1148 (5.5) | 48 (0.5) | 1123 (0.9) | 287 (2.3) | 10,704 (5.7) |
| No. of GLD classesg used within 12 monthsh before the index date, n (%) | ||||||
| 0 | 69 (1.3) | 942 (4.5) | 1524 (14.5) | 25,562 (20.5) | 720 (5.7) | 15,134 (8.0) |
| 1–2 | 3538 (64.2) | 17,260 (83.0) | 7170 (68.0) | 89,075 (71.4) | 7372 (58.7) | 140,167 (74.4) |
| 3–4 | 1875 (34.0) | 2578 (12.4) | 1833 (17.4) | 10,067 (8.1) | 4285 (34.1) | 32,316 (17.2) |
| 5-8 | 26 (0.5) | 27 (0.1) | 17 (0.2) | 51 (0.0) | 184 (1.5) | 798 (0.4) |
| Type of index therapy,i n (%) | ||||||
| Index monotherapy with no prior treatment | 148 (2.7) | 761 (3.7) | 987 (9.4) | 17,374 (13.9) | 1224 (9.7) | 16,522 (8.8) |
| Combined index therapy with no prior treatment | 69 (1.3) | 885 (4.3) | 699 (6.6) | 10,017 (8.0) | 601 (4.8) | 15,436 (8.2) |
| Add-on index therapy | 3211 (58.3) | 13,380 (64.3) | 6986 (66.3) | 73,272 (58.7) | 6901 (54.9) | 90,357 (48.0) |
| Switched-to index therapy | 290 (5.3) | 1949 (9.4) | 284 (2.7) | 3196 (2.6) | 1102 (8.8) | 27,585 (14.6) |
| Add-on and switched-to index therapy | 1605 (29.1) | 3079 (14.8) | 911 (8.6) | 7656 (6.1) | 2016 (16.0) | 28,009 (14.9) |
| Non-evaluablej | 185 (3.4) | 753 (3.6) | 677 (6.4) | 13,240 (10.6) | 717 (5.7) | 10,506 (5.6) |
| Males | n = 7610 | n = 29,195 | n = 13,091 | n = 147,737 | n = 12,783 | n = 191,736 |
| Age, mean (SD),a years | 57.9 (10.0) | 59.5 (10.6) | 52.2 (8.2) | 52.4 (8.3) | 71.4 (5.3) | 71.5 (5.4) |
| Race/ethnicity,b n (%) | ||||||
| Asian | NA | NA | NA | NA | 657 (5.1) | 7660 (4.0) |
| Black | NA | NA | NA | NA | 609 (4.8) | 13,374 (7.0) |
| Hispanic | NA | NA | NA | NA | 381 (3.0) | 5627 (2.9) |
| White | NA | NA | NA | NA | 10,364 (81.1) | 153,069 (79.8) |
| Otherc | NA | NA | NA | NA | 398 (3.1) | 6383 (3.3) |
| Unknown | NA | NA | NA | NA | 374 (2.9) | 5623 (2.9) |
| Insulin use at the index date, n (%) | 1009 (13.3) | 1694 (5.8) | 1900 (14.5) | 17,245 (11.7) | 2393 (18.7) | 27,418 (14.3) |
| Kidney diseases, all types, acute and chronic, n (%) | 517 (6.8) | 4005 (13.7) | 703 (5.4) | 11,494 (7.8) | 2549 (19.9) | 53,343 (27.8) |
| Urinary infections (chronic or recurring), n (%) | 97 (1.3) | 454 (1.6) | 353 (2.7) | 4489 (3.0) | 1382 (10.8) | 20,713 (10.8) |
| Indicators of diabetes severity, n (%) | ||||||
| Diabetic nephropathy or renal insufficiency | 95 (1.2) | 378 (1.3) | 303 (2.3) | 4726 (3.2) | 1348 (10.5) | 27,507 (14.3) |
| Retinopathy | 2333 (30.7) | 7607 (26.1) | 3276 (25.0) | 34,705 (23.5) | 4878 (38.2) | 65,539 (34.2) |
| Peripheral neuropathy | 292 (3.8) | 941 (3.2) | 249 (1.9) | 3065 (2.1) | 931 (7.3) | 13,581 (7.1) |
| Peripheral vascular diseased | 330 (4.3) | 1423 (4.9) | 3144 (24.0) | 34,735 (23.5) | 5164 (40.4) | 74,241 (38.7) |
| Coronary heart disease | 1231 (16.2) | 5155 (17.7) | 1635 (12.5) | 20,248 (13.7) | 5328 (41.7) | 80,694 (42.1) |
| Cerebrovascular disease | 368 (4.8) | 1950 (6.7) | 256 (2.0) | 3845 (2.6) | 2004 (15.7) | 32,065 (16.7) |
| Amputation | 81 (1.1) | 381 (1.3) | 59 (0.5) | 1082 (0.7) | 136 (1.1) | 3,018 (1.6) |
| Body mass index (kg/m2),e n (%) | ||||||
| < 20 (underweight) | 10 (0.1) | 132 (0.5) | NA | NA | NA | NA |
| 20 to < 25 (normal) | 292 (3.8) | 2380 (8.2) | NA | NA | NA | NA |
| 25 to < 30 (overweight) | 1691 (22.2) | 8651 (29.6) | NA | NA | NA | NA |
| 30 to < 40 (obese) | 4330 (56.9) | 13,987 (47.9) | NA | NA | NA | NA |
| ≥ 40 (severely obese) | 1151 (15.1) | 3014 (10.3) | NA | NA | NA | NA |
| Unknown | 136 (1.8) | 1031 (3.5) | NA | NA | NA | NA |
| Healthcare utilization in the 180 days before the index date | ||||||
| No. of outpatient visits,f n (%) | ||||||
| 0 | 351 (4.6) | 1225 (4.2) | 309 (2.4) | 6754 (4.6) | 505 (4.0) | 9413 (4.9) |
| 1 | 722 (9.5) | 2,639 (9.0) | 560 (4.3) | 7475 (5.1) | 700 (5.5) | 11,547 (6.0) |
| 2 or more | 6537 (85.9) | 25,331 (86.8) | 12,222 (93.4) | 133,508 (90.4) | 11,578 (90.6) | 170,776 (89.1) |
| No. of hospitalizations, n (%) | ||||||
| 0 | 6940 (91.2) | 25,337 (86.8) | 12,598 (96.2) | 137,935 (93.4) | 11,906 (93.1) | 167,013 (87.1) |
| 1 | 478 (6.3) | 2380 (8.2) | 437 (3.3) | 8323 (5.6) | 611 (4.8) | 15,257 (8.0) |
| 2 or more | 192 (2.5) | 1478 (5.1) | 56 (0.4) | 1479 (1.0) | 266 (2.1) | 9466 (4.9) |
| No. of GLD classesg used within 12 monthsh before the index date, n (%) | ||||||
| 0 | 87 (1.1) | 1272 (4.4) | 1633 (12.5) | 25,127 (17.0) | 716 (5.6) | 16,106 (8.4) |
| 1–2 | 4427 (58.2) | 24,150 (82.7) | 8494 (64.9) | 108,278 (73.3) | 7129 (55.8) | 140,542 (73.3) |
| 3–4 | 3055 (40.1) | 3731 (12.8) | 2913 (22.3) | 14,227 (9.6) | 4695 (36.7) | 34,139 (17.8) |
| 5–8 | 41 (0.5) | 42 (0.1) | 51 (0.4) | 105 (0.1) | 243 (1.9) | 949 (0.5) |
| Type of index therapy,i n (%) | ||||||
| Index monotherapy with no prior treatment | 139 (1.8) | 784 (2.7) | 855 (6.5) | 9001 (6.1) | 1112 (8.7) | 14,575 (7.6) |
| Combined index therapy with no prior treatment | 113 (1.5) | 1389 (4.8) | 968 (7.4) | 17,868 (12.1) | 589 (4.6) | 17,780 (9.3) |
| Add-on index therapy | 4561 (59.9) | 19,661 (67.3) | 9098 (69.5) | 93,651 (63.4) | 7343 (57.4) | 95,709 (49.9) |
| Switched-to index therapy | 221 (2.9) | 1994 (6.8) | 220 (1.7) | 2085 (1.4) | 936 (7.3) | 24,754 (12.9) |
| Add-on and switched-to index therapy | 2326 (30.6) | 4260 (14.6) | 1010 (7.7) | 8137 (5.5) | 2106 (16.5) | 28,457 (14.8) |
| Non-evaluablej | 250 (3.3) | 1107 (3.8) | 940 (7.2) | 16,995 (11.5) | 697 (5.5) | 10,461 (5.5) |
CPRD Clinical Practice Research Datalink, GLD glucose-lowering drug, HIRD HealthCore Integrated Research Database, NA not applicable, SD standard deviation
aPatients were aged 18 years or older in CPRD, 18–64 years in the HIRD, and 65 years or older in Medicare
bData on race/ethnicity were available only in Medicare
cIncludes patients categorized as Other or North American Native in Medicare
dIncludes peripheral artery disease
eData on body mass index were available only in CPRD
fOutpatient visits included general practitioner and outpatient hospital visits
gGlucose-lowering drug classes that were considered were insulin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, biguanides (metformin), alpha glucosidase inhibitors, and meglitinides
hThose with at least 180 days of available lookback data before the index date were eligible for inclusion in the study, and therefore some patients had less than 12 months of available lookback data
iDetailed definitions for the index therapy type categories are provided in Online Resource 1
jPatients who did not have sufficient follow-up time to assess the 90-day add-on/switch requirement