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EMA committee issues positive opinion for an update of SmPC for Pradaxa

Ingelheim, Germany
Wednesday, September 20, 2017, 12:00 Hrs  [IST]

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for an update to the European Summary of Product Characteristics (SmPC) of Pradaxa (dabigatran etexilate) for the treatment of patients with atrial fibrillation (AF). The CHMP recommends to include recent RE-CIRCUIT data, which showed lower rates of major bleeding for uninterrupted Pradaxa 150 mg twice daily compared to warfarin in AF patients undergoing catheter ablation. The updated SmPC, if approved by the European Commission, will state that AF patients undergoing catheter ablation who take Pradaxa 150 mg twice daily will not need to stop taking their Pradaxa medication.

The results from RE-CIRCUIT showed that uninterrupted Pradaxa was associated with a significant reduction in major bleeding event (MBE) rate compared with INR-adjusted warfarin in the setting of ablation. The data were originally presented earlier this year in a late-breaking session at the American College of Cardiology 66th Annual Scientific Session in Washington and simultaneously published in the New England Journal of Medicine.

In addition, an Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation3 was published by leading professional organisations including the European Heart Rhythm Association (EHRA) this week in the Heart Rhythm journal; the consensus from ablation experts around the world is that the data and worldwide experience regarding dabigatran now support a recommendation for performing AF ablation with uninterrupted Pradaxa with the highest possible evidence level, a Class 1A recommendation.

“Optimal anticoagulation treatment during an AF ablation procedure is critically important as patients are at increased risk of complications for both bleeding and stroke. In the RE-CIRCUIT trial, uninterrupted Pradaxa was shown to be a much safer treatment choice with respect to major bleeding than warfarin,” commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “The data recommended for inclusion in the Pradaxa® SmPC are a great piece of evidence on the benefits Pradaxa® can offer patients with atrial fibrillation and their treating physicians. We are pleased that both the CHMP as well as international professional bodies recognise the significance of these data in their recommendations to physicians.”

The RE-CIRCUIT study (Randomised Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of different peri-proCedUral antIcoagulation sTrategies) is an exploratory prospective, randomised, open-label, blinded endpoint, multicentre, active controlled trial. Patients with paroxysmal or persistent NVAF scheduled for catheter ablation and eligible for dabigatran 150 mg twice daily were included in the trial. Patients were randomly assigned to dabigatran etexilate 150 mg twice daily or warfarin (target INR 2.0–3.0) in a 1:1 ratio and remained on this treatment for the duration of the trial.

The study enrolled 704 patients across 104 sites, with 635 patients undergoing ablation with uninterrupted anticoagulation treatment. All patients were screened with a transoesophageal echocardiogram before their ablation procedure to determine whether any blood clots were present in the upper left heart chamber (left atrium). The safety and efficacy of the therapies were assessed during the 3-4 month treatment period and follow-up visit 1 week after treatment end.

The primary endpoint of the RE-CIRCUIT study was the incidence of major bleeding events, as defined by the International Society on Thrombosis and Haemostasis (ISTH), during the ablation procedure and up to two months post-ablation. Secondary endpoints included thromboembolic events (stroke / systemic embolism / transient ischaemic attack), minor bleeding events or a composite of both the efficacy and safety endpoints during ablation and up to two months after the procedure.


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