Per pooled data from placebo-controlled trials and data from a head-to-head study with glimepiride
FRIDAY, July 20, 2018 (HealthDay News) — Empagliflozin does not increase the risk of bone fracture in patients with type 2 diabetes, according to a study published online June 15 in Diabetes Care.
Sven Kohler, M.D., from Boehringer Ingelheim International in Germany, and colleagues assessed the effect of empagliflozin on bone fracture adverse events (AEs) and bone mineral density in patients with type 2 diabetes. Data came from pooled placebo-controlled trial data (1:1:1; empagliflozin 10 mg, empagliflozin 25 mg, or placebo in phase I to III clinical trials) and a head-to-head study versus glimepiride.
The researchers found that in the pooled analysis, bone fracture AEs were reported in 119 of 4,221 patients (2.8 percent) randomized to empagliflozin 10 mg, 105 of 4,196 patients (2.5 percent) randomized to empagliflozin 25 mg, and 123 of 4,203 patients (2.9 percent) randomized to the placebo group. In the head-to-head trial, bone fracture AEs were reported in 31 of 765 patients (4.1 percent) receiving empagliflozin 25 mg and in 33 of 780 patients (4.2 percent) receiving glimepiride.
“Empagliflozin did not increase the risk of bone fracture compared with placebo in a pooled analysis of >12,000 patients or compared with glimepiride in a four-year head-to-head study,” the authors write.
Boehringer Ingelheim and Eli Lilly and Company, which together manufacture empagliflozin, funded the study.
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