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New study casts more doubt on drugs Vytorin, Zetia
November 16, 2009
Didn't make clear whether findings are clinically significant. Also no mention of trial dropout rates, costs, or frequency of harms.
Our Review Summary
This was a story reporting on the results of a recent clinical trial in which individuals at elevated risk of heart attack were given either niacin or ezetimbe in addition to the cholesterol lowering medication they were already taking. What the study showed was that the niacin containing drug appeared better at reducing the size of the plaque present in the carotid artery compared to ezetimbe in these patients. Whether this observation is clinically significant still remains to be seen. This last point was nowhere to be found in the story. It‘s also important to report on dropout rates as one sign of how treatments are tolerated – and that information was also missing from the story. No information on costs nor estimates of how frequently harms occurred.
Click on Criteria for definitions.
It is clear that both ezetimibe and niacin are available as prescription drugs.
There was no discussion of costs.
The story did not engage in overt disease mongering.
The story did not provide a clear explanation of the study - who was studied, what was the goal, what end points were used and what does it all mean in terms of real health outcomes.
The evidence from the study was provided in a somewhat confusing and incomplete fashion. The primary endpoint of the study was carotid intima changes and the study was stopped early based on pre-established stopping rules. A composite endpoint of major cardiovascular events (heart attack, revascularization etc) was used as a secondary endpoint. The story notes a numeric advantage in the niacin group and quotes the senior author. However, the actual article notes that there was in fact a statistically significant difference in major cardiovascular events with the advatage going to niacin. Importantly, the number (and percentage) of subjects who did not complete the study (a measure of real world tolerability of the treatments) was not provided.
The side effects of niacin, itching and flushing, were presented in this story as making niacin difficult to take. However there was no information in this piece about how many people were affected nor the severity of their symptoms. And, as already noted, no mention is made of the overall drop out rate in both arms of the study related to adverse drug events.
The story accurately depicted that none of the treatments were new.
The story did not do an adequate job of reporting quantitative benefit of treatment. The difference reported was in the size of the plaque in the carotid artery. What does this mean in terms of the health of the individuals studied? The story should have been clear that this is a surrogate endpoint and while it may be suggestive that there will be a clinical difference, is not the same as demonstrating one. A couple of sentences explaining this would have added to the value of this story for the average reader.
The story did not appear to rely exclusively on a press release.
Quotes from the lead author of the study reported on and the author of the editorial written about the study were included in this story.
The story does not place the study results into a context beyond a previously published study looking at ezetimibe. Millions of people in the US are taking drugs to reduce their cholesterol and presumably reduce their risk of a cardiovascular event. There are a number of options available for drug treatment that should have been mentioned. It also would have been valuable to note that ezetimibe does not work in the same way to lower cholesterol as do the statins.
Total Score: 5 of 10 Satisfactory
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