FDA Adds Diabetes Warning to Statin Labels

The diabetes warning has been rumored as a possibility since the findings from the JUPITER trial of rosuvastatin revealed an unexpected 27% increase in new onset diabetes among patients randomized to the statin.That finding was especially perplexing because JUPITER was a study of statins in patients who had no history of cardiovascular disease, the so-called healthy patient trial. Moreover, based on the JUPITER results, the FDA approved rosuvastatin for primary prevention.The FDA said hyperglycemia was also observed among patients treated with 40-mg atorvastatin in a substudy of PROVE-IT TIMI 22, and a meta-analysis of data from 13 statin trials “reported that statin therapy was associated with a 9% increased risk for incident diabetes.”

via Medical News:FDA Adds Diabetes Warning to Statin Label – in Cardiovascular, Dyslipidemia from MedPage Today.

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