Researchers conducting a large, population-based cohort study have concluded that new-use sitagliptin (Januvia, Merck & Co) was not associated with an increased risk for major osteoporotic fractures in patients with type 2 diabetes.
However, the results showed that treatment with insulin, sulfonylureas, and thiazolidinediones (TZDs) were all significantly associated with increased risk.
“These differential effects on bone health and fracture risk should be considered when making treatment decisions in patients with type 2 diabetes who might be at particularly high risk of osteoporosis-related fractures,” the researchers wrote.
Researchers enrolled 72 738 patients with type 2 diabetes who received a new prescription for any antidiabetic medication from January 1, 2004, to December 31, 2009. Patients were followed until an outcome or death occurred, insurance was terminated, or the study ended on December 31, 2010.
Median age was 52 years, 54% of participants were men, 61% had 2
additional comorbidities, and their diabetes was well-controlled. The cohort accrued 181 139 person years of follow-up.
New sitagliptin users made up 12% of the study population, and they tended to be younger, had fewer comorbidities, were less likely to use insulin, and had better glycemic control.
There were 741 major osteoporotic fractures over a median of 2 years of follow-up for an overall incidence rate of 4.1 fractures per 1000 person-years. There were 53 fractures (4.8 per 1000 person-years) among new users of sitagliptin vs 688 fractures (4.0 per 1000 person-years) among nonusers (P=.3). Propensity adjusted time-varying multivariable analyses showed no independent association between use of sitagliptin and the risk for fracture (hazard ratio [HR]=1.1; 95% CI, 0.8- 1.4).
However, researchers did find that insulin (HR=2.1; 95% CI,
1.6-1.8) was significantly associated with a large increased risk for fracture, and that both sulfonylureas (P=.001) and TZDs (P=.019) were independently associated with increased risk. Older age, female sex, and a history of osteoporosis were also independently associated with increased risk of fracture.