Distal upper and lower limb fractures associated with thiazolidinedione use.

OBJECTIVE

To determine if patients with diabetes mellitus taking a thiazolidinedione experienced higher proportions of distal upper and lower limb fractures compared with those not taking a thiazolidinedione, as recent US Food and Drug Administration safety alerts suggested.

STUDY

DESIGN

This 3-year cross-sectional study used medical and pharmacy claims from a large southeastern managed care organization for continuously enrolled members from January 1, 2004, through December 31, 2006.

METHODS

A total of 29,284 patients with type 2 diabetes mellitus aged 18 to 64 years were allocated to mutually exclusive study groups of thiazolidinedione users versus thiazolidinedione nonusers and thiazolidinedione type (pioglitazone hydrochloride, rosiglitazone maleate, or a combination). chi(2) Tests were used to determine if fracture proportions for thiazolidinedione users differed from those of thiazolidinedione nonusers and if thiazolidinedione type was significant. Multivariate logistic regression models and backward stepwise elimination algorithms were constructed to evaluate associations of fracture proportions with age, sex, and chronicity of drug use for 7462 members using a thiazolidinedione.

RESULTS

The mean (SE) fracture proportions were significantly higher for thiazolidinedione users (5.1% [0.5%]) versus nonusers (4.5% [0.3%]) (P = .03). Fracture proportions did not differ by thiazolidinedione type (P = .86). Overall, women experienced a higher mean (SE) proportion of fractures compared with men (6.0% [0.4%] vs 3.5% [0.3%]) (P <.001), regardless of thiazolidinedione use. On average, the odds of experiencing a fracture for women using a thiazolidinedione increased 2% for every year increase in age.

CONCLUSIONS

Patients with diabetes using thiazolidinediones, regardless of type, had higher proportions of distal upper and lower limb fractures compared with those not using thiazolidinediones. Fracture proportions were higher among women and increased with age.