GSK responds to rosiglitazone review

GlaxoSmithKline (GSK) has issued a response to a review of rosiglitazone by the Cochrane Collaboration recently published online.

The company claims that the review – Rosiglitazone for type two diabetes mellitus – is a meta-analysis of existing data, while the limited number of studies assessed by the collaboration has resulted in the drawing of misleading conclusions based on no new evidence.

It adds that while collating 18 existing studies, the review does not include all the existing information available on the clinical trial register of GSK, while the compound has been tested in 52,000 patients – the largest ever programme for an orally-administered treatment for diabetes.

“Furthermore, the studies included in the review primarily measured differences in blood glucose control over the short term, not mortality or morbidity outcomes,” GSK states.

“It is therefore not surprising that positive conclusions were not drawn on this outcome.”

The firm adds that safety concerns regarding rosiglitazone should be addressed through assessments of the full available body of data, with a focus on long-term prospective studies of the compound.

In May 2007, GSK similarly responded to claims relating to adverse cardiovascular effects occurring as a result of administration of Avandia (rosiglitazone maleate) published in the New England Journal of Medicine.