NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.
Read Original Story

New study casts more doubt on drugs Vytorin, Zetia

Rating

3 Star

New study casts more doubt on drugs Vytorin, Zetia

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. 

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no discussion of costs.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the story commit disease-mongering?

Satisfactory

The story did not engage in overt disease mongering.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

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.

 

Does the story compare the new approach with existing alternatives?

Not Satisfactory

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.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

It is clear that both ezetimibe and niacin are available as prescription drugs.

Does the story establish the true novelty of the approach?

Satisfactory

The story accurately depicted that none of the treatments were new.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story did not appear to rely exclusively on a press release.

Total Score: 5 of 10 Satisfactory

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.