Table 1

Patients with bone fracture AEs in placebo-controlled trials

Empagliflozin 10 mg group (n = 4,221)Empagliflozin 25 mg group (n = 4,196)Placebo group (n = 4,203)
n (%)Rate/100 patient-yearsn (%)Rate/100 patient-yearsn (%)Rate/100 patient-years
Any bone fracture AE119 (2.8)1.55105 (2.5)1.36123 (2.9)1.69
Pathological fracturea10 (0.2)0.136 (0.1)0.089 (0.2)0.12
Serious bone fracture AEb30 (0.7)0.3837 (0.9)0.4744 (1.0)0.59
Bone fracture AE leading to treatment discontinuation6 (0.1)0.088 (0.2)0.1017 (0.4)0.23
Bone fracture site
 Lower limb30 (0.7)0.3841 (1.0)0.5345 (1.1)0.61
  Hip3 (0.1)0.049 (0.2)0.125 (0.1)0.07
 Upper limb41 (1.0)0.5325 (0.6)0.3223 (0.5)0.31
 Thoracic cage22 (0.5)0.2816 (0.4)0.2017 (0.4)0.23
 Spinal1 (<0.1)0.019 (0.2)0.1212 (0.3)0.16
 Skull and facial7 (0.2)0.093 (0.1)0.045 (0.1)0.07
 Pelvic4 (0.1)0.052 (<0.1)0.033 (0.1)0.04
 Other20 (0.5)0.2617 (0.4)0.2226 (0.6)0.35
  • Patients treated with one or more doses of study drug.

  • aMedDRA preferred terms “pathological fracture” and “osteoporotic fracture.”

  • bAE reported as serious AE by investigator.