Too Good to Be True?

From the annual congress of the European Society of Cardiology in Barcelona.

How do you react to smashing success in a drug trial?

That was the dilemma, and seemingly the only problem facing the results from a study with the new antithrombic drug dabigatran, which rang up stunning numbers against its entrenched comparator, warfarin, for preventing stroke or systemic embolism in patients with atrial fibrillation.

Dr. Stuart J. Connolly/photo Mitchel Zoler

Dr. Stuart J. Connolly/photo Mitchel Zoler

Dr. Stuart J. Connolly from McMaster University in Hamilton, Canada, reported the remarkable results of the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) here on Aug. 30. The two dosages of dabigatran tested either significantly cut the event rate with safety equal to warfarin, or had comparable efficacy with significantly better safety in a study with 18,000 patients (full results were simultaneously published in the New England Journal of Medicine). This double win for dabigatran came for a drug that’s also far easier to use than warfarin.

The immediate reaction by cardiologists on the scene was generally unmitigated euphoria. “A paradigm change” said one, a “revolution” said another, a “breakthough” said a third, a “real winner” said a fourth. 

At a time of intensified skepticism, when the watchword is that what’s too good to be true probably is, what’s to be made of a result that’s too good but may well be just that?

–Mitchel Zoler at 10:45 AM, Aug 31, in Barcelona (on twitter @mitchelzoler)

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