Table 2

Patients with bone fracture AEs in the EMPA-REG H2H-SU trial

Empagliflozin 25 mg (n = 765)Glimepiride 1–4 mg (n = 780)
n (%)Rate/100 patient-yearsn (%)Rate/100 patient-years
Total with bone fracture AEs31 (4.1)1.2833 (4.2)1.40
Serious bone fracture AEsa11 (1.4)0.454 (0.5)0.17
Bone fracture AEs leading to treatment discontinuation0000
Bone fracture site
 Upper limb11 (1.4)0.4515 (1.9)0.63
 Lower limb9 (1.2)0.375 (0.6)0.21
 Thoracic cage1 (0.1)0.046 (0.8)0.25
 Spinal002 (0.3)0.08
 Skull and facial1 (0.1)0.041 (0.1)0.04
 Pelvic001 (0.1)0.04
 Other10 (1.3)0.413 (0.4)0.12
  • Patients treated with one or more doses of study drug.

  • aAEs reported as serious AEs by investigator.