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.

October 20th, 2010

FDA Approves Dabigatran for Stroke Prevention in Atrial Fibrillation

The FDA announced on Tuesday that it has approved Pradaxa (dabigatran, Boehringer Ingelheim) for the prevention of stroke and blood clots in patients with atrial fibrillation. The drug will be available in 75-mg and 150-mg capsules.

“Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” said Norman Stockbridge, the director of the FDA’s Division of Cardiovascular and Renal Products, in an FDA press release.

Comments are closed on this post, but please join the conversation at our Dabigatran Resource Round-Up.

Categories: Electrophysiology, General, Prevention
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6 Responses to “FDA Approves Dabigatran for Stroke Prevention in Atrial Fibrillation”

  1. William DeMedio, MD says:
    October 20, 2010 at 10:35 pm

    Does anyone know the recommended starting dose? I know 150 mg was the study dose.

  2. David Hinchman, MD says:
    October 21, 2010 at 12:29 am

    The dabigatran doses in the RE-LY trial were 110mg BID or 150mg BID. Rates of the primary outcome were 1.69 percent per year in the warfarin group, compared with 1.53 percent per year in the group that received 110 mg of dabigatran, and 1.11 percent per year in the group that received 150 mg of dabigatran.

    The rate of major bleeding was 3.36 percent annually in the warfarin group, compared with 2.71 percent per year in the group receiving 110 mg of dabigatran, and 3.11 percent per year in the group receiving 150 mg of dabigatran. The rate of hemorrhagic stroke was 0.38 percent per year in the warfarin group, compared with 0.12 percent per year with 110 mg of dabigatran and 0.1 percent per year with 150 mg of dabigatran.

    The mortality rate was 4.13 percent per year in the warfarin group, compared with 3.75 percent per year with 110 mg of dabigatran and 3.64 percent per year with 150 mg of dabigatran, Connolly and colleagues reported.

    However, the authors reported that the rate of MI was higher with both doses of dabigatran than with warfarin. They said an “explanation might be that warfarin provides better protection against coronary ischemic events than dabigatran, and warfarin is known to reduce the risk of MI. However, rates of MI were similar between patients with atrial fibrillation who were receiving warfarin and those who were receiving ximelagatran [Exanta from the London-based AstraZeneca], another direct thrombin inhibitor. The explanation for this finding is therefore uncertain.”

    Perhaps patients at high risk (CHADS2>2) should take the higher dose and others the lower dose, although this concept was not specifically tested in the trial.

    P-glycoprotein inhibitors—including verapamil, amiodarone and especially quinidine—raise dabigatran serum concentrations considerably.

    Competing interests pertaining specifically to this post, comment, or both:
    None.

  3. Giuseppe Marino Benvenuto, MD says:
    October 21, 2010 at 2:27 am

    I think that D. – for its high price – should be used only for those pts where W. is no clinically safe beacuse of the wide variability of INR in some pts during time, for several well-known reasons. This is true expecially for a National Public organization of Health as in Italy where there are about 1,5 millions of pts (3% of population)and the difference of price for a month-therapy between D. and W. is 80 Euros…!

    Competing interests pertaining specifically to this post, comment, or both:
    I have no conflict of interest

  4. John Dodson, MD says:
    October 21, 2010 at 8:53 am

    Another niche for this drug may be in very elderly patients who (1) have difficulty getting frequent INR checks and (2) are at increased bleeding risk secondary to advanced age and existing dual antiplatelet therapy. The lower-dose dabigatran strategy may make a lot of sense in these cases. It is interesting that for all the subgroups (figure 2) in the original paper, age was not analyzed – I would be interested to see the trend for patients >80.

  5. Jesus Antonio Gonzalez-Hermosillo, MD says:
    October 21, 2010 at 10:35 am

    This is a major milestone in the search of more effective and safe oral anticoagulants. Dabigatran seems to be an alternative to vitamine K antagonists in the managemente of patients with atrial fibrillation and moderate to high risk for stroke. We will be waiting for new trials testing its value in patients with valvular atrial fibrillation or patients with AF plus prosthetic valves.

  6. Paul Young-Hyman, MD says:
    October 21, 2010 at 12:27 pm

    I agree with Dr Benvenuto The cost will be a major role in choosing the drug. It is not a blockbuster and along with the better efficacy at the higher dose is the cost of more bleeding, which particularly in the elderly is a major problem.
    The lower dose seems more favorable with noniferiority and lower bleeding risk. I like that. I would not try to extrapolate its benefit in patients on anti platelet drugs.
    It will be very interesting to see how the insurers and medicare position themselves. There was no economic analysis reported in the study That will be important to payers.

    Competing interests pertaining specifically to this post, comment, or both:
    none