GSK reports lack of CV AEs in Avandia study

UK drug major GlaxoSmithKline says it is encouraged by findings from the APPROACH study which demonstrated that treatment with Avandia (rosiglitazone maleate) may stall the progression of coronary atherosclerosis, although the type 2 diabetes drug missed the primary endpoint.

According to a statement issued at the American Heart Association's annual meeting in New Orleans, Louisiana, treatment with the agent was associated with reduced atherosclerotic plaque volume compared to the sulfonylurea glipizide, however, the difference between groups for the main study endpoint did not achieve significance.

Also, there were no unexpected differences between Avandia and glipizide. The overall incidence of cardiovascular events was comparable between groups, although this study was not powered to evaluate clinical outcomes.