The story reports no additional cardiovascular protection with the cholesterol lowering drug ezetimibe (Zetia) alone, or in combination with the statin simvastatin (trade name Zocor).
The report is unfortunately yet another example of an attempt to explain a very complicated story in a short TV chat. The study design, patient population, methodology and support for the surrogate endpoint are absent from the discussion. So, the context of "failure" is totally lost on the audience. This failure to provide any context is especially unfortunate because the report was accompanied by two excellent editorials. The editorial by Brown and Taylor in the NEJM highlights the study design, patient cohort studied and puts the results into an objective context. This report does little to inform its listeners and a wonderful opportunity was lost in the process.
The story does not note the cost of a typical statin regimen, Zetia or the combination treatment, Vytorin. This is an important oversight as many people who are prescribed these medications take them for life. The story does mention that these new drugs "raked in 5 billion dollars last year". The failure of the combination product to be better than simvastatin alone has significant financial implications. Simvastatin (the generic name for Merck’s Zocor) is available for about $1.25 a day. Vytorin costs about $3.35 a day. Most clinicians assumed that the combined product was an advantage if you could not get a patient to a LDL goal with just the statin alone or side effects with the simvastatin prevented an adequate dose. The price for the combination is less than the cost of the components.
Also, stating that taking more statins is the answer is incomplete at best. Lifestyle changes along with other drugs may be options as well. Interestingly however, this study raises questions about the simple notion that lowering total cholesterol, and LDL are important to lowering cardiovascular risk. People who are not able to lower their cholesterol enough with statins alone (or cannot tolerate the dose of statins needed to lower it) may wish to discuss with their doctor whether other medications (i.e., rather than ezetimibe) may be appropriate. These include niacin, fibrates, and bile acid resins. When added to statins, they can effectively lower cardiovascular risk.
There are no interviews with the study authors or with practicing clinicians. The story reported on data presented at a recent American College of Cardiology Meeting, so there were several thousand cardiologists and other specialists available who could have been interviewed for clinical perspective on the results of this study.
The story does not note the cost of a typical statin regimen, Zetia or the combination treatment, Vytorin. This is an important oversight as many people who are prescribed these medications take them for life. The story does mention that these new drugs "raked in 5 billion dollars last year". The failure of the combination product to be better than simvastatin alone has significant financial implications. Simvastatin (the generic name for Merck’s Zocor) is available for about $1.25 a day. Vytorin costs about $3.35 a day. Most clinicians assumed that the combined product was an advantage if you could not get a patient to an LDL goal with just the statin alone or side effects with the simvastatin prevented an adequate dose. The price for the combination is less than the cost of the components.
The story provides no quantitative data and no information on the number needed to treat to show benefit (i.e. prevention of a heart attack or stroke through lowered LDLs) in one patient with the newer medications, with traditional statins or with combination treatment.
The story says that there are no real dangers to continuing the drugs Zetia and Vytorin based on the lower drop-out rate and reported side effects in the study. The comments from both parties cast an extraordinarily negative shadow on the study drug and on the company sponsors. Without an appropriate description of the study design, the results cannot be fairly discussed to the public. While the primary endpoint was not obtained with the combination, it did lower LDL and inflammatory markers in excess of that achieved with simvastatin alone. Suggesting the drug did not "work" is a bit of a mis-statement.
The story encourages patients to keep taking these drugs. The story also does not mention the potential harm of taking statins long-term, especially in high does. Some of these harms are very rare, however, they include: muscle pain and kidney or liver problems.
The story provides no real discussion of the data presented at the American College of Cardiology meeting and published in the peer-reviewed New England Journal of Medicine. And the story didn’t assess the quality of the evidence.
The study followed people (average age mid-40s) who had an inherited condition (called familial hypercholesterolemia) that is associated with very high cholesterol levels and greatly increased risk of early coronary artery disease. Many of them had been taking statins and other cholesterol-lowering medicines for years. All were randomly assigned to take either a statin (simvastatin, trade name Zocor) alone or a statin combined with another cholesterol-lowering medication, ezetimibe.
The study was designed to find out if the combination of the two drugs could slow the growth of plaque in carotid arteries supplying the brain more than the statin alone. Plaque in these arteries is associated with an increased risk of stroke and heart attack. The two drugs together were more effective at lowering cholesterol than simvastatin alone, but adding ezetimibe did not change plaque measurements in the carotid arteries. The story does mention that lowering cholesterol may have other benefits, but we are not sure how those translate to fewer cardiovascular events or increased survival from these events.
There are no interviews with the study authors or with practicing clinicians. The story reported on data presented at a recent American College of Cardiology Meeting, so there were several thousand cardiologists and other specialists available who could have been interviewed for clinical perspective on the results of this study. There was also no mention of the two accompanying editorials in the NEJM. The editorial by Brown and Tayor nicely identifies the issues related to the study and helps put the results into perspective. Unfortunately, this editorial was ignored by both parties involved in the story.
Stating that taking more statins is the answer is incomplete at best. Lifestyle changes along with other drugs may be options as well. Interestingly however, this study raises questions about the simple notion that lowering total cholesterol, and LDL are important to lowering cardiovascular risk.
People who are not able to lower their cholesterol enough with statins alone (or cannot tolerate the dose of statins needed to lower it) may wish to discuss with their doctor whether other medications (i.e., rather than ezetimibe) may be appropriate. These include niacin, fibrates, and bile acid resins. When added to statins, they can effectively lower cardiovascular risk.
It’s clear from the story that the drugs in question are still available to patients, though they should not be considered first-line therapy.
The story focuses on new information that there is little to no benefit of newer cholestrol-lowering medications on the prevention of arterial plaque, which translate to little benefit for prevention of heart disease, stroke and cardiovascular-related death.
We can’t be sure if the story relied solely or largely on a news release. No researcher or cardiologist is interviewed. Quantified data from the American College of Cardiology presentation or from the New England Journal of Medicine article are not directly cited.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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