FDA supports use of ezetimibe (Zetia/Vytorin) after review of ENHANCE findings
As regular readers will remember, I am a user of ezetimibe (Zetia, Schering-Plough & Merck) for LDL-C reduction beyond that provided from the statin I also take. Before and after ENHANCE preliminary results were released and again after they were published, I wrote editorials outlining my opinion that appropriately selected users of ezitimibe should in most cases remain on the drug if it were working.
Now, FDA has completed its review of ENHANCE and has entered the public debate–prescribe now or not. The Agency reviewers and I appear to be in complete agreement:
The results from ENHANCE do not change FDA’s position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease….An ongoing trial known as IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) is examining whether treatment with Vytorin reduces the risk for cardiovascular events (composite endpoint of CV death, major coronary events, and stroke) compared with simvastatin alone. This trial of 18,000 patients is scheduled to be completed in 2012. IMPROVE-IT will provide additional data regarding Vytorin’s effect on the risk for cardiovascular disease.
Whether this pronouncement will have any effect on ezetimibe prescribing seems unlikely to me. I don’t think FDA opinion holds much sway in this type of prescribing decision. Quite a large number (around 35% between January and October 2008) of ezetimibe users stopped therapy after ENHANCE. It’s unknown what proportion of those who stopped were appropriately prescribed it to begin with. For the folks who need the drug to keep their LDL-C at or near goal, like me, IMPROVE-IT should provide the evidence we need to make a rational decision for or against its continued use.
