Saxagliptin Not Linked to Increased Fracture Risk in T2DM
Risk of fracture linked to female gender, older age, diabetes duration, major hypoglycemic events
THURSDAY, Sept. 24, 2015 (HealthDay News) -- For patients with type 2 diabetes, treatment with saxagliptin is not associated with increased fracture risk, according to a study published online Sept. 10 in Diabetes Care.
Ofri Mosenzon, M.D., from the Hadassah Hebrew University Hospital in Jerusalem, and colleagues compared the incidence of fractures among the 8,280 patients assigned to saxagliptin treatment and the 8,212 patients assigned to placebo from the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR-TIMI 53) trial. Patients were followed for a median of 2.1 years.
The researchers found that 2.9 percent of the saxagliptin and placebo groups experienced a fracture during follow-up (hazard ratio, 1.00; 95 percent confidence interval, 0.83 to 1.19). In both treatment arms, event rates for fractures were the same (14.7 and 14.0 per 1,000 patient-years in the entire population and on-treatment population, respectively). For saxagliptin and placebo groups, fracture risk was similar across different subgroups defined by race, cardiovascular risk, and renal function. The risk of fracture correlated with female gender, longer diabetes duration, older age, major hypoglycemic events, noncompliance with study drugs, and treatment with thiazolidinediones, in multivariable analysis.
"In a large population of older patients with type 2 diabetes, treatment with saxagliptin was not associated with an increased risk of fractures," the authors write.
Several authors disclosed financial ties to the pharmaceutical industry. The SAVOR-TIMI 53 trial was funded by AstraZeneca and Bristol-Myers Squibb, both of whom market saxagliptin.