Overall | Raloxifene subgroup | |||||||
---|---|---|---|---|---|---|---|---|
Characteristic | All (N = 15,559) | T2DM (N = 7580) | Non-DM (N = 7979) | P value | All (N = 1367) | T2DM (N = 668) | Non-DM (N = 699) | P value |
Age in years, mean (SD) | 73.1 (9.10) | 73.4 (8.99) | 72.9 (9.19) | <0.001 | 73.7 (9.08) | 74.9 (8.45) | 72.6 (9.53) | <0.001 |
Age, n (%) | <0.001 | <0.001 | ||||||
50–54 years | 439 (2.8) | 203 (2.7) | 236 (3.0) | 35 (2.6) | 8 (1.2) | 27 (3.9) | ||
55–59 years | 896 (5.8) | 413 (5.4) | 483 (6.1) | 62 (4.5) | 22 (3.3) | 40 (5.7) | ||
60–64 years | 1515 (9.7) | 679 (9.0) | 836 (10.5) | 114 (8.3) | 40 (6.0) | 74 (10.6) | ||
65–69 years | 2309 (14.8) | 1064 (14.0) | 1245 (15.6) | 229 (16.8) | 103 (15.4) | 126 (18.0) | ||
70–74 years | 2967 (19.1) | 1504 (19.8) | 1463 (18.3) | 264 (19.3) | 144 (21.6) | 120 (17.2) | ||
75–79 years | 3406 (21.9) | 1695 (22.4) | 1711 (21.4) | 280 (20.5) | 145 (21.7) | 135 (19.3) | ||
80 years and older | 4027 (25.9) | 2022 (26.7) | 2005 (25.1) | 383 (28.0) | 206 (30.8) | 177 (25.3) | ||
Fractures, n (%) | ||||||||
Patients with clinical fracturesa | 810 (5.2) | 405 (5.3) | 405 (5.1) | 0.453 | 76 (5.6) | 45 (6.7) | 31 (4.4) | 0.063 |
Patients with non-vertebral fractures | 542 (3.5) | 275 (3.6) | 267 (3.3) | 0.338 | 62 (4.5) | 33 (4.9) | 29 (4.1) | 0.482 |
Charlson Comorbidity Index, mean (SD) | 2.15 (2.28) | 2.76 (2.37) | 1.58 (2.03) | <0.001 | 1.70 (1.87) | 2.30 (1.99) | 1.13 (1.55) | <0.001 |
Comorbidities, n (%) | ||||||||
Dyslipidemia | 5329 (34.3) | 3671 (48.4) | 1658 (20.8) | <0.001 | 429 (31.4) | 323 (48.4) | 106 (15.2) | <0.001 |
Arteriosclerosis | 1487 (9.6) | 935 (12.3) | 552 (6.9) | <0.001 | 112 (8.2) | 75 (11.2) | 37 (5.3) | <0.001 |
Peripheral vascular disease | 1926 (12.4) | 1178 (15.5) | 748 (9.4) | <0.001 | 164 (12.0) | 96 (14.4) | 68 (9.7) | 0.008 |
Thyroid disease | 1702 (10.9) | 1120 (14.8) | 582 (7.3) | <0.001 | 138 (10.1) | 93 (13.9) | 45 (6.4) | <0.001 |
Liver disease | 2817 (18.1) | 1914 (25.3) | 903 (11.3) | <0.001 | 212 (15.5) | 155 (23.2) | 57 (8.2) | <0.001 |
Chronic kidney disease | 823 (5.3) | 647 (8.5) | 176 (2.2) | <0.001 | 57 (4.2) | 49 (7.3) | 8 (1.1) | <0.001 |
Type 2 diabetes | 4580 (29.4) | 4580 (60.4) | - | <0.001 | 357 (26.1) | 357 (53.4) | - | <0.001 |
Osteoporosis medications initiated, n (%) | ||||||||
Bisphosphonates | 8913 (57.3) | 4140 (54.6) | 4773 (59.8) | <0.001 | 47 (3.4) | 18 (2.7) | 29 (4.1) | 0.140 |
SERMs | 1373 (8.8) | 670 (8.8) | 703 (8.8) | 0.950 | 1367 (100.0) | 668 (100.0) | 699 (100.0) | - |
Active vitamin Db | 6155 (39.6) | 3101 (40.9) | 3054 (38.3) | <0.001 | 385 (28.2) | 167 (25.0) | 218 (31.2) | 0.011 |
Calcitonin | 4 (0.0) | 1 (0.0) | 3 (0.0) | 0.343c | - | - | - | |
Raloxifene without alendronate | 1339 (8.6) | 660 (8.7) | 679 (8.5) | 0.661 | 1339 (98.0) | 660 (98.8) | 679 (97.1) | 0.030 |
Raloxifene and alendronate in combination | 28 (0.2) | 8 (0.1) | 20 (0.3) | 0.033 | 28 (2.0) | 8 (1.2) | 20 (2.9) | 0.030 |
Alendronate without raloxifene | 5363 (34.5) | 2476 (32.7) | 2887 (36.2) | <0.001 | - | - | - | - |
Other medications, n (%) | ||||||||
Corticosteroid | 3020 (19.4) | 1910 (25.2) | 1110 (13.9) | <0.001 | 157 (11.5) | 94 (14.1) | 63 (9.0) | 0.003 |
Proton-pump inhibitor | 3035 (19.5) | 2018 (26.6) | 1017 (12.7) | <0.001 | 245 (17.9) | 168 (25.1) | 77 (11.0) | <0.001 |
Thyroid hormone | 712 (4.6) | 429 (5.7) | 283 (3.5) | <0.001 | 41 (3.0) | 25 (3.7) | 16 (2.3) | 0.115 |
Anticonvulsants | 289 (1.9) | 181 (2.4) | 108 (1.4) | <0.001 | 21 (1.5) | 15 (2.2) | 6 (0.9) | 0.037 |
Immunosuppressants | 953 (6.1) | 587 (7.7) | 366 (4.6) | <0.001 | 51 (3.7) | 29 (4.3) | 22 (3.1) | 0.244 |
Diabetes medications, n (%) | ||||||||
Insulin | 365 (2.3) | 365 (4.8) | - | <0.001 | 29 (2.1) | 29 (4.3) | - | <0.001 |
Metformin | 249 (1.6) | 249 (3.3) | - | <0.001 | 32 (2.3) | 32 (4.8) | - | <0.001 |
Sulfonylurea | 467 (3.0) | 467 (6.2) | - | <0.001 | 50 (3.7) | 50 (7.5) | - | <0.001 |
Alpha-glucosidase inhibitor | 472 (3.0) | 472 (6.2) | - | <0.001 | 48 (3.5) | 48 (7.2) | - | <0.001 |
Thiazolidinedione | 219 (1.4) | 219 (2.9) | - | <0.001 | 25 (1.8) | 25 (3.7) | - | <0.001 |
Resource utilization | ||||||||
BMD test, n (%) | 2251 (14.5) | 913 (12.0) | 1338 (16.8) | <0.001 | 203 (14.9) | 71 (10.6) | 132 (18.9) | <0.001 |
Bone formation test, n (%) | 112 (0.7) | 61 (0.8) | 51 (0.6) | 0.222 | 8 (0.6) | 5 (0.7) | 3 (0.4) | 0.439c |
Bone resorption test, n (%) | 484 (3.1) | 223 (2.9) | 261 (3.3) | 0.237 | 58 (4.2) | 25 (3.7) | 33 (4.7) | 0.370 |
Osteoporosis-related testsd (baseline), n (%) | 3738 (24.0) | 1752 (23.1) | 1986 (24.9) | 0.010 | 323 (23.6) | 133 (19.9) | 190 (27.2) | 0.002 |
Osteoporosis-related testsd (baseline), mean per patient (SD) | 0.421 (0.980) | 0.434 (1.041) | 0.408 (0.918) | 0.098 | 0.358 (0.823) | 0.34 (0.859) | 0.375 (0.788) | 0.433 |
Laboratory tests, n (%) | 1975 (12.7) | 1199 (15.8) | 776 (9.7) | <0.001 | 179 (13.1) | 120 (18.0) | 59 (8.4) | <0.001 |
Laboratory tests, mean per patient (SD) | 8.983 (41.74) | 13.02 (51.36) | 5.144 (29.35) | <0.001 | 7.734 (34.43) | 11.66 (41.1) | 3.986 (26) | <0.001 |
Hospital admissions, n (%) | 1410 (9.1) | 872 (11.5) | 538 (6.7) | <0.001 | 81 (5.9) | 54 (8.1) | 27 (3.9) | <0.001 |
Hospital admissions, mean per patient (SD) | 0.117 (0.47) | 0.147 (0.488) | 0.088 (0.45) | <0.001 | 0.071 (0.313) | 0.099 (0.378) | 0.044 (0.232) | 0.001 |
Days in hospital, mean (SD) | 3.282 (21.65) | 4.33 (27.37) | 2.286 (14.15) | <0.001 | 1.688 (9.911) | 2.147 (11.16) | 1.25 (8.537) | 0.097 |
Outpatient visits, n (%) | 15,297 (98.3) | 7437 (98.1) | 7860 (98.5) | 0.056 | 1353 (99.0) | 660 (98.8) | 693 (99.1) | 0.533 |
Outpatient visits, mean per patient (SD) | 3.567 (8.038) | 4.216 (8.932) | 2.95 (7.03) | <0.001 | 2.52 (3.836) | 2.91 (4.524) | 2.147 (2.992) | <0.001 |
Total cost in JPY, mean (SD) | 122,000 (456,000) | 160,000 (535,000) | 85,215 (361,000) | <0.001 | 60,494 (261,000) | 81,248 (325,000) | 40,661 (178,000) | 0.005 |
Total cost in JPY, median | 13,983 | 18,675 | 10,783 | 9,565 | 13,066 | 6,654 |