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“Safe and effective”? Overzealous claim for blood thinner study with no control group

Blood thinners on 'as needed' basis is safe and effective for lowering stroke risk as compared to long-term use

Our Review Summary

Doctor measuring pulse rateThis news release reports on a small observational study presented at a medical conference on the novel use of “as-needed” anticoagulants and routine pulse monitoring by patients with atrial fibrillation (AF). While the release as a whole doesn’t exaggerate the study’s impact (it was a small observational study, of short duration, with a unique ‘highly motivated’ patient population), important details were omitted from the release, such as the particular anticoagulant drug(s) being tested, or any mention of warfarin, the current standard of care. Contrary to the release headline, the study in no way established effectiveness.

 

Why This Matters

Atrial fibrillation is a common condition that increases with age. For some it is always there and for others, they alternate between a normal heart rhythm and AF. For many patients it causes no symptoms and is picked up incidentally when checking the pulse and finding it irregular. For some patients it causes symptoms that require treatment.

This study could be an important avenue of research in trying to optimize the use of anticoagulants in preventing heart attacks and strokes in patients with atrial fibrillation. As one co-author noted:  “It is extremely common for patients with AF to seek treatment that does not involve the use of chronic oral anticoagulants therapy, as there are other risks associated with their long term use.”  The implications of the research, ie: shorter, safer periods of anticoagulant use, could be an important public health advance, but as the news release noted, “more research is required.”

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Since we don’t know which drugs were used in the study we don’t really have an idea what the costs, or costs savings would have been. Obviously if patients start taking their novel anticoagulants on an ‘as needed’ basis then a lot of money could be saved. These drugs, it should be noted, are typically a lot more expensive than warfarin, the current standard of care in AF.

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

Not Satisfactory

We are told that 100 participants were followed for 23 months and of those hundred, 28 “started taking the blood thinner at least once for a suspected or detected AF episode, and only 10 patients transitioned back to chronic oral anticoagulation therapy for recurrent AF.”  What is missing from this is any detail on what kind of stroke or ischemic attack that could have been present in a control group. In other words, we have no idea if this is a meaningful result or not.  Interesting, yes. Meaningful?  Not so much.

The headline claim, “Blood thinners on ‘as needed’ basis is safe and effective for lowering stroke risk as compared to long-term use,” isn’t borne out by the reported research results.

To get credit here, one would need information on what one would have expected if they had not received this treatment. The goal of anticoagulation is to prevent stroke. Would we have expected strokes in this population if it hadn’t been treated this way? While the results are reassuring, the risk of stroke in AF is small and accrues over time.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The release mentions the bleeding harms that come with taking anticoagulants, a harm that increases with chronic use. However, the release suggests that the therapy was proven safe when that wasn’t clearly established.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The researchers didn’t exaggerate the value of the study or extrapolate it to other patients over longer periods of time.  We also give them credit for mentioning at the end of the release that this was an observational study with a small sample size and that these results need to be verified. However, there isn’t much description about what was done which leaves readers with unanswered questions. Which drugs were used? How accurate was the patient’s monitoring? Are we sure that the 28 episodes were AF?  What did they do when they identified an episode? How long were they supposed to take the medicine for when they had an episode? How compliant were they? Was there any attempt to verify compliance?

Does the news release commit disease-mongering?

Satisfactory

There was no obvious disease mongering here. Atrial fibrillation is a real and important health issue for which better use of effective drugs is warranted. We’d remind readers that patients who’ve had an ablation (the surgical removal of body tissue) and aren’t in AF may not need anti-coagulation.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

It seems that the funding sources are very transparent as is the involvement of the researchers.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The news release presents “as-needed anticoagulation” drug therapy as an alternative to “long-term, daily oral anticoagulation medications.” The problem is that we’re not sure what to do – take no medicine, daily medicine or this “as needed” medicine. We aren’t told if the comparator is a daily anti-coagulation (such as warfarin, the standard treatment) or no anti-coagulation. It isn’t clear and it is important.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

It seems obvious that the drugs being studied are on the market and fully available, but it is hard to definitively know this. The news release tells us the drugs are “novel” but doesn’t name them.

Does the news release establish the true novelty of the approach?

Satisfactory

The ‘novelty’ here is in approach and the researchers were fair in describing what is authentic novelty.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

There was no exaggerating language in the news release. However, the headline went overboard stating that the study proved that this therapy is safe or effective.

Total Score: 6 of 10 Satisfactory

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