Rosiglitazone and increased risk of fracture
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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[...] fria em um dos tipos de drogas mais promissoras no tratamento de diabetes tipo 2, as glitazonas. A rosiglitazona mostrou nesse estudo ter uma ação significativa na diminuição da formação óssea em mulheres [...]
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Cheryl,
The heart risks posed by rosiglitazone are only a recent development comared to the additional fracture risk. The cardia risks surfaced in May 2007 when the first of several analyses were published as discussed in this post.
Comment by Matthew Robinson — November 2, 2007 #
Re Roziglitazone. I think the risk of fractures is minimal in comparison to the risk of fatal illness ie, heart and lung failure, it should be withdrawn from the market to prevent anyone else succumbing to it's fate.
Comment by Cheryl Morrissey — November 2, 2007 #
[…] have been concerns raised recently regarding fractures in women taking rosiglitazone and […]
Pingback by Study confirms glitazone bone problems | Prescribing Advice for GPs — May 2, 2007 #