ACCORD Trial Complicates “Treating To New Targets” Theory In Diabetes
The large government-sponsored ACCORD trial in type 2 diabetes has stumbled in trying to show that driving down blood glucose to normal levels can improve cardiovascular outcomes in high-risk patients
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FDA has unveiled the much-anticipated labeling change for GlaxoSmithKline's type 2 diabetes therapy Avandia, but is deeming the information about rosiglitzone's cardiovascular risk "inconclusive" and is asking the sponsor to undertake a long-term outcomes study to address outstanding safety questions
FDA is resoundingly rejecting the suggestion that clinical outcomes be used as the standard of evidence for demonstrating efficacy for anti-diabetic agents, rather than the standard surrogate measure of glycemic control currently used
Lipitor (atorvastatin) has gained approval for five new indications based on the Treating to New Targets and Incremental Decrease in Endpoints Through Aggressive Lipid Lowering studies, but the updated labeling includes mixed statements about the benefits of treatment with higher doses of atorvastatin