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Onglyza risk neutral for fracture in adults with type 2 diabetes
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The DPP-IV inhibitor Onglyza does not increase or decrease fracture risk in adults with type 2 diabetes, according to research in Diabetes Care.
As part of the randomized, double blind, placebo-controlled SAVOR-TIMI 53 cohort study, in which fractures were considered one of 10 adverse events of special interest, researchers also found a strong, independent association between longer diabetes duration, older age, major hypoglycemic events and the risk for fracture in patients.
Ofri Mosenzon
“This is a significant factor for clinicians to consider, especially because [bone mineral density] underestimates the risk for fractures among patients with type 2 diabetes,” the researchers wrote. “Further data collected through ongoing large outcome studies, as well as by observational studies, may further shed light on this important overlap between two of the largest epidemics of our time: type 2 diabetes and osteoporosis.”
Ofri Mosenzon, MD, of the diabetes unit at Hadassah Hebrew University Hospital in Jerusalem, and colleagues analyzed data from 16,492 adults (mean age, 65.1 years) with type 2 diabetes and an established history of cardiovascular disease participating in the SAVOR-TIMI 53 trial. Within the cohort, 8,280 adults were randomly assigned Onglyza (saxagliptin, AstraZeneca) 5 mg daily; researchers compared their incidence of fracture with 8,212 adults randomly assigned a matching placebo. Researchers also analyzed all participants’ fracture risk.
In the saxagliptin group, 241 adults (2.9%) experienced a fracture during a median follow-up of 2.1 years; 240 adults in the placebo group (2.9%) also experienced a fracture (HR = 1; 95% CI, 0.83-1.19). Both groups developed 14.7 fractures per 1,000 patient-years. After adjusting for race, CV risk and renal function, fracture risk remained similar in both patient groups, according to researchers.
Incidence of serious fractures requiring hospitalization, as well as occurrences of multiple fractures in the same participant, was similar in both groups.
“This is especially important considering some of the high-risk groups that were included in the study: sizeable female population of 5,455, large elderly population of 8,561 aged 65 years old and 2,330 aged 75 years old, and a large population with renal dysfunction,” the researchers wrote.
“There was also no difference in major osteoporotic fracture as classified according to the [WHO] definition,” the researchers wrote. “Therefore ... saxagliptin therapy does not influence the risk of fractures among patients with type 2 diabetes.” – by Regina Schaffer
Disclosure: The study was funded by AstraZeneca and Bristol-Myers Squibb. Mosenzon reports advisory board/speaker fee/grant support relationships with AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck, Novartis, Novo Nordisk and Sanofi. Please see the full study for a list of all authors’ relevant financial disclosures.
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