The manufacturer of rosiglitazone (Avandia® and Avandamet®) has written to healthcare professionals to highlight the increased risk of fractures identified in the ADOPT Study.
The ADOPT Study compared monotherapy with metformin, glibenclamide and rosiglitazone in achieving glycaemic control in over 4,000 patients with type 2 diabetes. Significantly more fractures of bones in the hands, feet and upper arm were seen in women taking rosiglitazone compared to the other two trial drugs.
Some interesting points to note are:
- The increase in risk was not observed in male patients
- The fractures were not typical of fragility fractures (e.g. spine and hip)
- Patients taking rosiglitazone were more likely to have gained weight compared to metformin
- Patients taking rosiglitazone were more likely to be prescribed statins and loop diuretics
However, an early analysis of an on-going study has reported observations that are consistent with these results. It is therefore recommended that the risk of fracture is considered, especially in female patients, who are being prescribed or being considered for initiation on treatment with rosiglitazone.
Action: Metformin remains the first line hypoglycaemic in type 2 diabetes. It is unknown if this increased fracture risk applies only to rosiglitazone or to all glitazones and therefore fracture risk should be considered before starting treatment with any glitazone and during medication reviews for patients already on treatment.
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