CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

April 14th, 2011

FDA Officials Offer Explanation for Absence of Low-Dose Dabigatran

Following the approval last October of dabigatran, some observers criticized the FDA’s decision not to approve the lower 110 mg dose of the drug in addition to the higher 150 mg dose. Now, in a perspective in the New England Journal of Medicine, 3 FDA officials — B. Nhi Beasley, Ellis Unger, and Robert Temple — explain that their decision “was based on our inability to identify any subgroup in which use of the lower dose would not represent a substantial disadvantage.”

The FDA officials acknowledge that there were several good reasons for approving the lower dose, including the finding of safety and efficacy and the ability to individualize treatment. However, the FDA review team was unable to identify a patient population in which the lower dose might be superior to the higher dose, including older patients, patients with renal function, and patients with previous bleeding episodes.

The authors also express concern about physicians and patients who fear the bleeding risk of warfarin and dabigatran: “we concluded that encouraging the ‘play it safe’ option for patients and physicians represented an undesirable stimulus to use a less-effective regimen and would lead to unnecessary strokes and disability.”

Categories: Anticoagulation, Electrophysiology, Vascular
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One Response to “FDA Officials Offer Explanation for Absence of Low-Dose Dabigatran”

  1. David Powell , MD, FACC says:
    April 15, 2011 at 5:54 pm

    Despite the paternalism embedded in the above statement, I generally agree. The problem with dosing dabi arises with borderline GFRs around 30. Same issue for other drugs with dichotomous GFR cutoffs. A particular concern is a GFR (by C-G formula, as done in trial) in 30 to 40 range and concomitant use of a glycoprotein inhibitor known to increase AUC. On occasion, I may check trough PTT. If over 3x ULN, my reading indicates that the dose is too high.

    Competing interests pertaining specifically to this post, comment, or both:
    BI speaker