What Now for Vytorin? In? or Out?

Not too long ago Vytorin which is a combination of simvastatin and ezitimibe was lambasted after a negative study with the ENHANCE trial showing no proof of plaque regression despite a significant reduction in LDLc. It may have been a faulty study for which I think the study investigator maybe pushing this drug too much that their baseline thickness of the carotid intima maybe considered normal to start with......how can you expect further improvement when your baseline is already almost normal? It would have been better if they looked at a longer term trial comparing reduction of LDLc with inhibition of plaque progression rather than regression. I have always deep inside me believe that this was a flawed trial right from the beginning and I have continued to use the drug most importantly to my severely hyperlipidemic patients waiting for more proofs.

In medicine, our dictum is to do no harm. We have not seen harm done on patients with vytorin...that one study showed us that it " may " not be doing what it is supposed to do. We also need to mention that Simvastatin which is the statin component of vytorin has tons of proofs for the benefit our patients get from the drug hence, it just does not make sense why additional reduction of LDLc could hurt our patients?

Recently, the SANDS trial ( Stop Atherosclerosis in Native Diabetes Study) published in the Journal of the American College of Cardiology December 2008, a 36-month study, looking at regression in carotid intima in the diabetics showed that aggressive LDL reduction with ezetimibe + a statin or statin alone noted in patients with Type 2 diabetes mellitus was associated with a similar regression in carotid intima thickness. This is surely a a positive news and a welcome respite for this drug and a good reassurance not only to the medical practitioners but patients alike who got confused with earlier study results.