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"Approval of new drug heralds 'momentous' advance in stroke prevention"

Montreal Gazette

Source: Montreal Gazette

Published: 28 Oct 2021

Category: Pharmaceutical

Rating: (3 stars)

Keywords: stroke blood clot warfarin dabigatrin atrial fibrillation

what they said (Hover the mouse cursor over underlined words for more info)

In what Canadian doctors are calling a "momentous" advance, Health Canada has approved the first anti-clotting drug for stroke prevention since the introduction of warfarin more than half a century ago....

The original article can be found at:

how did it rate? (more information)

Criteria Rating
Total Score 6 of 11
Availability of Treatment Satisfactory (?)
Novelty of Treatment Satisfactory (?)
Disease Mongering Not Satisfactory (?)
Treatment Options Satisfactory (?)
Costs of Treatment Satisfactory (?)
Evidence Not Satisfactory (?)
Quantification of Benefits of Treatment Not Satisfactory (?)
Harms of Treatment Satisfactory (?)
Sources of Information Not Satisfactory (?)
Relies on Press Release Satisfactory (?)
Quantification of Harms of Treatment Not Satisfactory (?)

what we said (Hover the mouse cursor over underlined words for more info)

This was a poor quality article reporting on a major drug trial for a product that may potentially be used by vast numbers of Canadians. While the article did include some useful information for the readers (e.g. treatment cost, availability, treatment options), the lack of quality evidence should ring a few alarm bells. The article did not provide sufficient details about the trial design and only included the relative risk reduction values.

This article committed a common "sin" in that it failed to mention absolute differences in side effects between the two therapies (Pradax versus warfarin). Without this information it is impossible to tell whether (or by how much) the benefits of the new therapy outweigh the risks. In the clinical trial, Pradax was associated with a higher rate of treatment discontinuation (5%), a higher rate of major gastrointestinal reactions (11%) and a higher rate of 'major bleeding'. While we may want to replace warfarin with a safer and easier-to-take drug, the question we must ask is whether the reduction in stroke risk achieved by this new product is worth a higher risk of these seemingly major side effects (gastric bleeds and reactions)?

It is important to remember that the drug has only been approved for patients who have undergone total hip or knee replacement therapy. With articles like this one, you can be sure that patients will clamor for it. We need to await the careful considered assessment of the Common Drug Review before we get excited about this new drug approval.

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