Monday, March 5, 2012

FDA: Atorvastatin/ezetimibe combo needs more data

This from The Heart.org

Vytorin has been plagued by controversy in recent years, particularly given the lack of benefit with the drug in the Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. In addition, many in the clinical community have criticized the company, as well as the FDA, for the delays in reporting hard clinical outcomes data with the ezetimibe/simvastatin combination. The Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) study is currently expected to be completed in June 2013.

Read the full article here.

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