Canagliflozin increases the fracture risk in patients with type 2 diabetes mellitus, according to findings of a pooled analysis of data from clinical trials published in the Journal of Clinical Endocrinology and Metabolism.

The incidence of fracture was assessed in 10 194 patients treated with canaglifozin in nine controlled studies, including 4327 patients in the CANVAS study, and in 5867 patients in non-CANVAS studies.

In the non-CANVAS Studies, the fracture rate was similar in patients receiving canagliflozin compared with no canagliflozin (1.7% and 1.5%, respectively). However, in the CANVAS study, the risk of fracture was significantly higher in canagliflozin- than placebo-treated patients (4.0% vs 2.6%); most fractures were in upper or lower limbs. The overall incidence of fracture was 2.7% in canagliflozin recipients versus 1.9% in patients not receiving canagliflozin.

"Fracture risk was increased with canagliflozin treatment, driven by CANVAS patients, who were older, with prior history/risk of cardiovascular disease, and with lower baseline eGFR and higher baseline diuretic use," said the authors. "The increase in fractures may be mediated by falls; however, the cause of increased fracture risk with canagliflozin is unknown," they said.