Apidra Increased CV Events Likely Due To Baseline Imbalance, FDA Concludes
This article was originally published in The Pink Sheet Daily
Executive Summary
While a nine-fold increase in CV events was seen in type 1 diabetics, other studies with Sanofi-Aventis’ Apidra (insulin glulisine), including type 2 diabetes trials, did not replicate the effect. Labeling for the short-acting insulin analog does not report the data.
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