Table 2.
Clinical characteristics of patients with fracture sourced from the US Food and Drug Administration’s Adverse Event Reporting System database (2004q1 to 2019q4)
| Characteristics | Reports, n (%) |
|---|---|
| Reporting region | |
| Europe | 54 (17.04%) |
| North America | 196 (61.83%) |
| South America | 8 (2.52%) |
| Asia | 55 (17.35%) |
| Oceania | 4 (1.26%) |
| Reporters | |
| Consumer | 127 (40.06%) |
| Other health professional | 38 (11.99%) |
| Pharmacist | 21 (6.62%) |
| Physician | 115 (36.28%) |
| Unknown or missing | 16 (5.05%) |
| Reporting year | |
| 2019 | 66 (20.82%) |
| 2018 | 95 (29.97%) |
| 2017 | 52 (16.40%) |
| 2016 | 65 (20.50%) |
| 2015 | 28 (8.83%) |
| 2014 | 8 (2.52%) |
| 2013 | 2 (0.63%) |
| Unknown or missing | 1 (0.32%) |
| Sex of patients | |
| Male | 184 (58.04%) |
| Female | 108 (34.07%) |
| Unknown or missing | 25 (7.89%) |
| Age groups (years) | |
| <18 | 1 (0.32%) |
| 18–44 | 8 (2.52%) |
| 45–64 | 105 (33.12%) |
| 65–74 | 65 (20.50%) |
| >75 | 48 (15.14%) |
| Unknown or missing | 90 (28.39%) |
| SGLT2is | |
| Canagliflozin | 162 (51.10%) |
| Dapagliflozin | 78 (24.60%) |
| Empagliflozin | 75 (23.66%) |
| Ertugliflozin | 2 (0.63%) |
| Ipragliflozin | 0 (0%) |
| Luseogliflozin | 0 (0%) |
| Remogliflozin | 0 (0%) |
| Tofogliflozin | 0 (0%) |
| Indications | |
| Cardiac disorder | 5 (1.64) |
| Chronic kidney disease | 2 (0.65) |
| Diabetes mellitus | 46 (15.04) |
| Glycosylated hemoglobin increased | 4 (1.31) |
| Obesity | 1 (0.33) |
| Type 1 diabetes mellitus | 3 (0.98) |
| Type 2 diabetes mellitus | 175 (57.19) |
| Unknown | 70 (22.88) |
SGLT2is, sodium–glucose cotransporter 2 inhibitors.