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Trial Shows Blockbuster Potential for Blood Clot Pill

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4 Star

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Trial Shows Blockbuster Potential for Blood Clot Pill

Our Review Summary

This is a story about a large clinical trial that found a new medication to be more effective though more expensive than the current medication used to reduce the chance of blood clot formation in individuals with atrial fibrillation.  The story did a good job of detailing the study reported on as well as the financial ramifications for the drug maker.  It remains to be seen whether the adherence seen in the trial will be as good in the real world.  And Eliquis, the drug reported, still needs to undergo review by the FDA for safety and efficacy. But it appears that at least some clinicians and market analysts are enthused about the impact of this medication.

A drawback of this story is that it fails to provide information about the absolute reduction in risks that may be possible with this medication.  In the absence of this information, it is impossible to assess the true scope of how valuable a treatment this might be.

 

Why This Matters

The risk of hemorrhagic stroke is a concern to those who use warfarin as part of their treatment for atrial fibrillation.  The availability of a medication that reduces that risk and is a more effective treatment for their condition will be of interest to those who can afford the added costs.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story mentioned that it was expected that the drug reported on would cost $8/day as compared with <$1/day for warfarin.

One aspect of costs that were not considered in this story is the difference in monitoring, which would be less with patients using Eliquis. The competing HealthDay story did a better job on this latter point.

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

Not Satisfactory

The story provided only relative risk reduction figures – “prevented 21 percent more strokes…31 percent fewer incidents of major bleeding…reduced total deaths by 11 percent” – but neglected to present the absolute decrease in adverse events.

21% of what?
31% of what?
11% of what?

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

Not Satisfactory

The story mentioned some of the disadvantages associated with this use of the medication reported on.  It did not specifically detail whether there were any harms associated with this medication or how well people in the study were able to stick with the dosing schedule.

On this issue, this story was not as complete as its HealthDay competition, which reported:

“The new trial comes on the heels of another study on apixaban that was stopped early due to safety concerns. In that trial, published in July in the New England Journal of Medicine, apixaban’s use was associated with raised odds for bleeding — without providing patients with any reduction in heart attack risk.However, “in that case, apixaban was given to patients with coronary artery disease who were also taking two other blood thinners,” Ansell noted. “The three of them together showed that the risk of bleeding was just too high and there was no real benefit in that population. But, that’s an entirely different problem, compared with atrial fibrillation,” he said.”

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

Satisfactory

The story included a lot of information about the study it reported on – where the results were presented and published, its design, the number of clinical sites, countries involved, the number of people studied and the length of time they were studied..

Does the story commit disease-mongering?

Satisfactory

No overt disease mongering.

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

Satisfactory

The story mentioned that the study reported on had been funded by the drug maker.  It included comments from a clinician who had no ties to the study reported on.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story compared the study drug with the long time treatment, warfarin, as well as mentioning a newly approved medication and another medication in the approval process.

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

Satisfactory

The story opened by indicating that Eliquis (apixabane) was experimental and closed by indicating the expectation of submission to the FDA for approval.

Does the story establish the true novelty of the approach?

Satisfactory

The story was clear that this was a new medication, though there are two other medications (warfarin and Pradax) that are currently available.

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

Satisfactory

Did not appear to rely solely on a news release.

Total Score: 8 of 10 Satisfactory

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