Initiation of dapagliflozin and treatment-emergent fractures

Konstantinos A Toulis1,2, John P Bilezikian3, G Neil Thomas1

  • 1Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Insights

This study found no increased fracture risk in type 2 diabetes patients starting dapagliflozin. The sodium-glucose co-transporter-2 (SGLT2) inhibitor class was investigated for fracture risk, with dapagliflozin showing no significant difference compared to standard treatment.

Area of Science:

  • Endocrinology
  • Pharmacology
  • Epidemiology

Background:

  • Fracture risk is a concern in type 2 diabetes mellitus (T2DM).
  • Canagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, has been linked to increased fracture risk.
  • The fracture risk associated with dapagliflozin initiation in T2DM patients remains unclear.

Purpose of the Study:

  • To investigate the association between dapagliflozin initiation and fracture risk in patients with T2DM.
  • To compare the risk of fragility fractures and any fractures in T2DM patients treated with dapagliflozin versus standard antidiabetic treatment.

Main Methods:

  • Population-based, open cohort study using The Health Improvement Network (THIN) database (January 2013-January 2016).
  • Included 22,618 T2DM patients (4,548 exposed to dapagliflozin, 18,070 controls), matched for age, sex, BMI, and diabetes duration.
  • Used Cox regression to calculate adjusted hazard rate ratios (HRs) for fragility fractures and any fractures.

Main Results:

  • No significant difference in the risk of fragility fractures between dapagliflozin users and controls (adjusted HR 0.87, 95% CI 0.56-1.35).
  • No significant difference in the risk of any fracture between the groups (adjusted HR 0.89, 95% CI 0.66-1.20).
  • Sensitivity analyses in high-risk populations yielded similar results, indicating no increased fracture risk.

Conclusions:

  • Initiation of dapagliflozin in patients with T2DM is not associated with an increased risk of treatment-emergent fractures.
  • Findings suggest dapagliflozin may have a different fracture risk profile compared to other SGLT2 inhibitors.
  • Further research may be warranted to fully elucidate the fracture risk across the SGLT2 inhibitor class.

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