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Is Zetia a Safe Medicine For Lowering Cholesterol

April 28th, 2008 | by David Reiner, M.D. |

                                       

There has been considerable press recently on the cholesterol lowering medicine Zetia, also known as Ezetimibe, since the release of a recent study known as the ENHANCE study.  This study compared the cholesterol medication simvastatin, also known as Zocor, to the combination of Zocor and Zetia used together.  It looked out how effective each drug was in lowering cholesterol, how safe each drug combination was, and also measured the difference in the thickness of cholesterol blockages in arteries in the neck arteries during the study.  The aim was to see if the additional cholesterol lowering achieved by the addition of Zetia to Zocor could cause shrinking of the amount of cholesterol blockages as measured by ultrasound of these neck arteries.  The end result of the study was that the thickness of these blockages was not statistically different with either of these two drug treatments. 

However, this study looked at a very rare patient population who have a genetic disease where they have extremely high cholesterol levels that exist from a very young age.  This study lowered cholesterol to levels that are higher than most patients have prior to getting started on cholesterol medication.  Most patients with this disorder are on multiple drugs to lower there cholesterol, whereas the patients in this study were taken off their previous medications prior to being enrolled, and placed on only one drug.  Therefore, it is not at all clear what this study tells us, since most patients in this study acheived cholesterol levels that were still extremely higher than standard treatment targets.  What we can learn from this study is that the addition of Zetia to treatment with the statin Zocor lowered cholesterol an additional 17%.  Additionally, the rate of side effects was no different, and the rate of heart attack or stroke was similar in both groups.

Since no study ever done to date has ever shown that having higher cholesterol levels is more favorable, we cannot accept the conclusion being touted by the press.   In this case, they have been reporting that Zetia is not an effective drug and doctors are overprescribing it.  However, the applicability of this study to the general population is very limited, and the design of this trial has too many limitations to make any meaningful conclusions.   Future studies are needed to determine if the addition of Zetia to other therapy for high cholesterol can result in less heart attacks and strokes.

This is another crucial example of the need for patients to be getting medical advice from their physicians, rather than from the newspapers. 

Kastelstein et al: New England Journal of Medicine April 3, 2008

Tags: cholesterol, Heart Attack, simavastatin, statin, stroke, vytorin, zetia