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Pradaxa's link to heart attack under scrutiny again

Boehringer Ingelheim’s anticoagulant sees contrasting safety results in two different studies

Two studies of Boehringer Ingelheim's anticoagulant Pradaxa have drawn different conclusions about the drug's cardiovascular safety.

A meta-analysis of seven studies of Pradaxa (dabigatran) published in Archives of Internal Medicine has concluded that the drug increases the risk of myocardial infarction (MI) and acute coronary syndromes in patients receiving the drug.

Meanwhile, the investigators in the 18,000-patient in RE-LY study - which first provided a signal that Pradaxa could increase MI rates when used to prevent stroke in atrial fibrillation (AF) patients - have published a new analysis of their data in Circulation.

Data from this study concludes that the excess in heart attack rates is small and in a sizeable proportion of cases was probably unrelated to the medication.

Pradaxa is a major growth driver for Boehringer and is approved in the US for stroke prevention in patients suffering from AF, and in Europe to prevent venous thromboembolism (VTE) in patients who have undergone hip and knee replacements.

Safety concerns have dogged Pradaxa since its launch in 2008, with the US FDA launching a review of post-marketing data in December following reports of bleeding complications.

In Europe, the EMA carried out its own review of the topic earlier in 2011 and concluded that Pradaxa was safe when used in accordance with its labelling.

The MI issue is important because Boehringer's product is currently jostling for market share with two other new anticoagulants, namely Bayer/Johnson & Johnson's Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb's Eliquis (apixaban).

That said, all three products have been tipped for blockbuster status given the huge demand for anticoagulants that can replace warfarin.

New analyses
The Circulation study examined ischaemic events in RE-LY much more detail - including not only MI but also cardiac arrest, unstable angina, and the need for coronary artery surgery for example - and concluded that there was a net benefit in favour of Pradaxa over the comparator drug warfarin.

Crucially, it also showed that Pradaxa provided the same net benefit regardless of whether patients had ischemic heart disease.

Meanwhile, the AIM meta-analysis concluded that the increased risk of an MI was real when data from studies other than RE-LY was assessed, but also modest.

In AF patients the increased risk was counterbalanced by Pradaxa's clinical benefits compared to comparator drugs, say the authors, although they conclude that the picture is not so clear for VTE.

Both studies conclude that, overall, the benefits of Pradaxa use outweigh its risks in patients with AF, which is considered to be the most important therapeutic indication for the drug from a commercial viewpoint.

10th January 2012

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