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In comparison of clot-busting drugs, HealthDay gets props for being clear on costs and harms

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A Better Clot-Buster Drug for Strokes?

Our Review Summary

This story reported on a study that compared a newer clot-buster to treat strokes involving a blocked artery — the most common kind — to the current standard drug, alteplase (also known as tPA).

The story included cost data on the two drugs, mentioned the frequency of an important harm, and let readers know that the newer drug isn’t yet approved to treat stroke in the U.S. On the flipside, it missed significant limitations to the evidence, the most significant one being that there is no evidence that clot-busters save lives in stroke patients, as we have written.

 

Why This Matters

An editorial accompanying this study says tenecteplase has the potential to provide an alternative for some stroke patients to alteplase, possibly lowering costs and reducing the number of surgeries to remove blood clots. However, it says, changes to practice would require further evidence that the drug works as well or better than alteplase and is also convenient, accessible, affordable and practical.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story explained that tenecteplase costs about $5,800 in the U.S. compared with about $8,000 for alteplase.

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

Satisfactory

The story reported that 22% of patients treated with tenecteplase had more than 50% of blood flow return to the brain, compared with 10% of those treated with alteplase. That was the primary outcome.

It also said that patients treated with tenecteplase also had better functional outcomes after 90 days than those given alteplase, but doesn’t give data on the size of the difference.

The story didn’t mention that there were no significant differences between the two groups in two secondary outcomes: The proportion of patients who had minimal or no deficit after 90 days or the proportion of patients whose condition improved within three days.

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

Satisfactory

The story mentioned a feared complication of clot-busting stroke drugs: often-fatal brain bleeds, which it said occurred in 1% of patients regardless of which drugs they received. It did not say that one of the two patients in the study who had a brain bleed died from it.

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

Not Satisfactory

Several limitations of this study go unmentioned.

  • The story doesn’t explain that the primary outcome measured in the trial — restoration of blood flow to the affected artery — is a surrogate outcome that doesn’t necessarily mean better recovery after the stroke.
  • There was no mention of whether the standard drug — alteplase — has been proven to offer a benefit compared with a placebo.
  • There is little to no evidence that clot-busters save lives in stroke patients, as we have written.

Also, the results of the trial apply only to about 13% of ischemic stroke patients who have large-vessel blockages, according to the study. Such patients disproportionately become disabled due to stroke.

Does the story commit disease-mongering?

Satisfactory

No disease-mongering here.

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

Not Satisfactory

The story has one independent source.

It also says the study didn’t receive drug company funding, which is good to know.

However, some of the researchers or their institutions have accepted financial support from companies that make stroke drugs and devices as well as Stryker, a company that makes vehicles designed to quickly deliver thrombotic therapies to stroke patients.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story said tenecteplase is “easier to give, requiring only a single injection, while alteplase requires an injection and an IV drip.”

That’s sufficient but the story would have been stronger had it mentioned the option of simply proceeding with surgical removal of a clot, called a thrombectomy, without first giving either medication. All patients in this trial went on to receive mechanical thrombectomy regardless of which medication they received.

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

Satisfactory

The story said tenecteplase is not approved for stroke in the United States, though it used for other purposes like heart attacks and blood clots in the lungs.

It also notes that “for either drug to be most effective, it needs to be given as soon as possible after a stroke occurs,” and in this study patients were given the drug within 4.5 hours of the onset of a stroke.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story didn’t establish what was novel about this study. This was the first study to examine the performance of these drugs in patients who went on to have blood clot removal surgery. A previous trial comparing these two drugs differed slightly than this one because the patients didn’t have surgery in that trial. The study found that tenecteplase was shown to be not superior to alteplase and similar in safety in treating patients with mild stroke.

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

Satisfactory

The story does not appear to rely on a news release.

Total Score: 7 of 10 Satisfactory

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