Ezetimibe (Zetia) Shown to Reduce Heart Attack and Stroke After Thirty Billion Dollars in Sales

Important findings from the IMPROVE-IT trial were presented at the American Heart Association meeting yesterday. They demonstrate for the first time that the cholesterol lowering drug ezetimibe (brand name Zetia) lowers the risk of heart attack and stroke when added to a statin drug in high risk patients (those who have sustained a heart attack or had unstable angina) over a statin drug plus placebo.

That study showed

 The primary endpoint of CV death/MI/UA/coronary revascularization beyond 30 days/stroke was significantly lower in the ezetimibe/simvastatin arm compared with the simvastatin arm over the duration of follow-up (32.7% vs. 34.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.89-0.99; p = 0.016).

Prior to this study, Zetia had been prescribed to millions of patients since 2002 garnering Merck, its maker, profits of 30 billion dollars despite there being no evidence that it reduced heart attack or stroke.

Dr. Melissa Walton-Shirley wrote an excellent article on the status of Zetia at the beginning of 2014, summarizing thusly:

Perhaps the lesson to be learned is that starting in 2014, let’s not put compounds on the market for human ingestion without knowing if they help or hurt. Let’s make it unacceptable for a company to make tens of billion dollars from the sale of a compound without knowing if it lowers mortality or improves quality of life

I have previously bashed Zetia on this site and I only prescribe it in very rare cases. These new data may change my approach.

Before embracing Zetia, though, I want to see the full paper in published form and examine the data in detail. Many questions need to be answered. For example, the addition of the drug to simvastatin lowered heart attack and stroke compared to simvastatin alone but there was no difference in overall death rates or cardiovascular death rates. That raises a red flag.

In addition, this study does not support the use of Zetia in patients who have not had heart attacks or near heart attacks (primary prevention).

Science moves slowly but inexorably toward the truth if done properly. It’s important that public policy and drug prescribing not get in front of the science as it did with this drug.

 

2 thoughts on “Ezetimibe (Zetia) Shown to Reduce Heart Attack and Stroke After Thirty Billion Dollars in Sales”

    1. I agree that the composite endpoint should be viewed with suspicion because it includes “soft” outcomes like hospitalization and revascularization” however the hard endpoints of stroke and heart attack (MI) were reduced : MIs alone were reduced by 13 percent, and non-fatal stroke by 20 percent.
      Despite reducing MIS and strokes deaths from cardiovascular disease were statistically the same in both groups.
      The benefits in this high risk group are modest.
      I will still only use Zetia in high risk patients that cannot tolerate appropriate statin dosages but now I can at least tell the patients that there is some evidence supporting its efficacy in reducing cardiovascular disease.

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