GSK responds to JAMA Avandia articles

GlaxoSmithKline (GSK) has issued a response to the recent articles published in the Journal of the American Medical Association (JAMA) regarding the safety profile of Avandia (rosiglitazone).

The firm claims that the conclusions from the meta-analyses published in the journal do not confirm a variation in the safety profile of Avandia when compared to Actos (pioglitazone).

GSK notes that the analyses from Drs Nissen et al and Furberg et al in the journal reflect the limitations inherent in all such meta-analyses – as confirmed by the authors, adding that when comparisons involve different studies with varying patient populations and endpoints, these limitations are even more pronounced.

“The pioglitazone meta-analysis is based on a small number of studies provided directly by Takeda, and is heavily biased by data from the PROactive study which contributed 80 per cent of the endpoint data,” GSK notes.

“The patient population in the PROactive study was at high risk of cardiovascular disease.”

Consequently, GSK has described as “inappropriate” the advice from the author for physicians to ignore advice from the US Food and Drug Administration to keep patients controlling their diabetes on rosiglitazone.

Last month, GSK received approval from the regulator to update its prescribing information for Avandia to increase the visibility of an existing warning relating to the risk of contracting congestive heart failure as a result of using thiazolidinediones.