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The Relationship of Onglyza (Saxagliptin) and Fracture Risk in Type 2 Diabetes

It is known that type 2 diabetics have an increased risk of bone fractures for idiopathic factors. Thiazolidinediones (TZDs) have also shown to be associated with a greater incidence of osteoporotic fractures. In a randomized, double blind, placebo-controlled trial named SAVOR-TIMI 53, the use of saxagliptin and fractures were of special interest due to the adverse event of fractures.

Researchers were interested in comparing the incidence of fractures that were treated with saxagliptin versus placebo. Researchers also discovered a significant relation between longer duration of diabetes, greater age, major hypoglycemia events and risk for fracture. Researchers claim that bone mineral density underestimates the risk for fractures among type 2 diabetics; therefore, it is a significant factor for all clinicians to consider. Furthermore, ongoing studies will give some insight to the overlapping epidemic conditions of type 2 diabetes and osteoporosis.

Researcher Ofri Mosenzon, MD, and his partners analyzed data from the SAVOR-TIMI 53 trial. Within the cohort study, 8,280 adults were randomly allocated to Onglyza 5 mg daily. This was compared with incidence of fractures with 8,212 adults randomly allocated to placebo.

In the Onglyza treatment and placebo group, roughly 3% developed a fracture. This correlated to 241 and 240 patients, respectively (HR = 1; 95% CI, 0.83-1.19).

Furthermore, both groups experienced roughly 15 fractures per 1,000 patient-years. Researchers claim that upon adjustment for race, CV risk and renal function, the risk for fractures was consistent in both arms. The incidence of more than one fracture and major fractures requiring hospitalization were also consistent in both groups.

Authors conclude that treatment with Onglyza for type 2 diabetes in older patients was not related with an increased risk of fractures as this was shown by a study encompassing a large population sample. However, an interesting finding between the duration of diabetes and increased risk of bone fracture was discovered, which requires further studies to determine contributing factors.

Practice Pearls:

  • Bone mineral density underestimates the risk for fractures among type 2 diabetics
  • Researchers claim that treatment with Onglyza has a neutral risk for fractures among type 2 diabetics
  • There is a significant correlation between longer duration of diabetes, older age, major hypoglycemia events and risk for fractures; however, further studies need to be performed to identify the relationship between the epidemic conditions of diabetes and osteoporosis.

Mosenzon, Ofri, et al. “Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial.” Diabetes Care (2015): dc151068.