Table 1.
Baseline characteristics of ospemifene initiators and comparators.
| Characteristic | Ospemifene Cohort (N = 8977) | Comparator SERM Cohort (N = 12,621) | Untreated VVA Cohort (N = 242,488) |
|---|---|---|---|
| Age at index datea, years | |||
| Mean (SD) | 59.0 (4.1) | 63.7 (8.0) | 62.3 (7.5) |
| Median (IQR) | 58 (56–61) | 62 (58–67) | 60 (57–65) |
| Age categories, years | |||
| 54–59 | 5435 (60.5) | 4328 (34.3) | 105,544 (43.5) |
| 60–65 | 3113 (34.7) | 4675 (37.0) | 78,901 (32.5) |
| 66–72 | 333 (3.7) | 1785 (14.1) | 32,514 (13.4) |
| ⩾73 | 96 (1.1) | 1833 (14.5) | 25,529 (10.5) |
| Geographic region | |||
| Northeast | 1514 (16.9) | 2593 (20.5) | 66,639 (27.5) |
| North Central | 1665 (18.5) | 3120 (24.7) | 48,116 (19.8) |
| South | 4937 (55.0) | 5091 (40.3) | 87,189 (36.0) |
| West | 793 (8.8) | 1670 (13.2) | 38,062 (15.7) |
| Unknown | 68 (0.8) | 147 (1.2) | 2482 (1.0) |
| Index date, year | |||
| 2013 | 663 (7.4) | 2931 (23.2) | 52,976 (21.8) |
| 2014 | 2865 (31.9) | 3623 (28.7) | 69,896 (28.8) |
| 2015 | 2185 (24.3) | 2395 (19.0) | 47,345 (19.5) |
| 2016 | 1720 (19.2) | 1917 (15.2) | 31,514 (13.0) |
| 2017 | 961 (10.7) | 1176 (9.3) | 24,899 (10.3) |
| 2018 | 583 (6.5) | 579 (4.6) | 15,858 (6.5) |
| Index SERM | |||
| Ospemifene | 8977 (100.0) | 0 (0.0) | 0 (0.0) |
| Raloxifene | 0 (0.0) | 11,639 (92.2) | 0 (0.0) |
| Bazedoxifene | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Tamoxifen | 0 (0.0) | 982 (7.8) | 0 (0.0) |
| Measures of healthcare utilizationb | |||
| Number of physician visits, Median (IQR) | 6 (4–11) | 7 (4–13) | 7 (4–12) |
| Any emergency room visit | 759 (8.5) | 1,197 (9.5) | 26,606 (11.0) |
| Any hospitalization | 177 (2.0) | 369 (2.9) | 7026 (2.9) |
| Baseline conditions associated with an increased incidence of VTEc | |||
| Atrial fibrillation | 78 (0.9) | 246 (1.9) | 6,165 (2.5) |
| Transient ischemic attack | 35 (0.4) | 65 (0.5) | 1552 (0.6) |
| Hypertension | 3020 (33.6) | 4960 (39.3) | 106,774 (44.0) |
| Diabetes mellitus | 942 (10.5) | 1416 (11.2) | 40,427 (16.7) |
| Atherosclerosis | 213 (2.4) | 548 (4.3) | 13,637 (5.6) |
| Trauma (within 90 days before index date) | 743 (8.3) | 1221 (9.7) | 20,487 (8.4) |
| Surgery (within 90 days before index date) | 42 (0.5) | 86 (0.7) | 1488 (0.6) |
| Immobility | 176 (2.0) | 283 (2.2) | 5188 (2.1) |
| Congestive heart failure | 38 (0.4) | 164 (1.3) | 3671 (1.5) |
| Obesity | 678 (7.6) | 814 (6.4) | 25,984 (10.7) |
| Chronic obstructive pulmonary disease | 216 (2.4) | 599 (4.7) | 9585 (4.0) |
| Rheumatic disease | 338 (3.8) | 467 (3.7) | 8752 (3.6) |
| Chronic kidney disease | 173 (1.9) | 387 (3.1) | 7650 (3.2) |
| Inflammatory bowel disease | 103 (1.1) | 145 (1.1) | 2343 (1.0) |
| Inherited or acquired thrombophilia | 6 (0.07) | 13 (0.1) | 449 (0.2) |
| Baseline dispensing of medications that potentially modify the incidence of VTEc | |||
| Antihypertensives | 3144 (35.0) | 5146 (40.8) | 102,194 (42.1) |
| Glucose-lowering agents | 775 (8.6) | 1009 (8.0) | 29,605 (12.2) |
| Anticoagulants or anti-thrombolytic therapy | 169 (1.9) | 397 (3.1) | 9140 (3.8) |
| Antiarrhythmic therapy | 34 (0.4) | 82 (0.6) | 1596 (0.7) |
| Lipid-lowering therapy | 2730 (30.4) | 4605 (36.5) | 80,002 (33.0) |
| Progesterone therapy | 120 (1.3) | 42 (0.3) | 1780 (0.7) |
Note. Cell entries are n (%) unless otherwise specified.
IQR, interquartile range; SD, standard deviation; SERM, selective estrogen receptor modulator; VTE, venous thromboembolism; VVA, vulvar and vaginal atrophy.
a
Index date: first dispensing of ospemifene, first dispensing of comparator SERM, or first diagnosis of VVA
b
183 days prior to and including index date
c
365 days prior to and including index date