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Clinical and observational studies suggest that use of thiazolidinediones (TZDs) is associated with an increased fracture risk. In addition, type 2 diabetes mellitus (T2DM) is a risk factor for osteoporotic fracture. Our aim was to estimate fracture risks in TZD users and users of other antidiabetic drugs, classified according to proxies of disease severity.We conducted a population-based cohort study utilizing the Dutch PHARMO database (1998-2008). PHARMO links pharmacy-dispensing data to the National Hospital Registry. Oral antidiabetic users (n = 123,452) were matched 1:4 by year of birth and sex to non-users. Cox proportional hazards models were used to estimate hazard ratios (HRs) of fracture in TZD users. We created a proxy indicator for disease severity. The first stage was defined as current use of either a biguanide or a sulfonylureum, the second stage as current use of a biguanide and a sulfonylureum at the same time, the third stage was assigned to patients using TZDs and the fourth stage to patients using insulin.The risk of osteoporotic fracture was increased 1.5-fold (HR 1.49, 95%CI 1.28-1.73) in patients who currently used TZDs (stage 3), and for patients using insulin (stage 4), the risk was increased 1.2-fold (HR 1.24, 1.14-1.36), as compared with controls. In the first and second stages, risks were lower: HR 1.11 (1.06-1.17) for stage 1 and HR 1.03 (0.96-1.11) for stage 2.When observational studies assess risk of fracture in patients with TZDs, the severity of T2DM should be taken into account.

Original publication

DOI

10.1002/pds.3234

Type

Journal article

Journal

Pharmacoepidemiology and drug safety

Publication Date

05/2012

Volume

21

Pages

507 - 514

Addresses

Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. m.t.bazelier@uu.nl

Keywords

Humans, Diabetes Mellitus, Type 2, Thiazolidinediones, Hypoglycemic Agents, Administration, Oral, Severity of Illness Index, Registries, Proportional Hazards Models, Risk Factors, Case-Control Studies, Cohort Studies, Follow-Up Studies, Databases, Factual, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Netherlands, Female, Male, Young Adult, Osteoporotic Fractures