European trial data ‘reinforce’ safety profile and efficacy of Lixiana

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Daiichi Sankyo Europe has announced outcomes from an observational study in mainly caucasian atrial fibrillation (AF) patients being treated with the anti-coagulation drug edoxaban (Lixiana).

The results of the Danish observational cohort study, published in the European Heart Journal – Cardiovascular Pharmacotherapy, showed that rates of thromboembolism—ischaemic stroke and systemic embolism—were similar to those observed in the composite ‘stroke’ outcome in the ENGAGE AF-TIMI 48 clinical trial, a study comparing the long-term efficacy and safety of Lixiana with warfarin in AF patients.

In addition, primary (composite) bleeding outcomes requiring hospitalisation were approximately 50% lower than observed in ENGAGE AF-TIMI 48. The real-world findings reinforce Lixiana’s efficacy and safety profile in elderly AF patients in routine clinical practice, Daiichi Sankyo said in a press release.

Many patients were elderly with comorbidities and almost one-fourth (23.5%) had a hospital diagnosis of cancer.

Commenting on the study, lead author, Peter Brønnum Nielsen (Aalborg Thrombosis Research Unit, Aalborg University, Denmark), said: “These new data, reporting on outcomes in a European AF population seen in routine clinical practice, are reassuring as they reinforce previous evidence that edoxaban has a good safety profile and is an effective treatment for the prevention of stroke in a broad AF population.”

643 patients (28%) received Lixiana 30 mg dosage regimen and 1,642 (72%) Lixiana 60 mg which is similar to the split in ENGAGE AF-TIMI 48. The primary effectiveness endpoint of thromboembolism, comprised of a composite outcome of stroke and systemic embolism, occurred 41 times. In patients taking Lixiana 30 mg daily (dose reduced) the event rate was 2.07 per 100 person-years, and in those taking Lixiana 60 mg daily (full dose) the event rate was 1.62 per 100 person-years.

The safety outcomes, comprised of a composite of all bleedings, including intracranial, gastrointestinal and major bleeding in other anatomic sites, occurred 89 times. Safety outcome event rates were similar among the full dose and dose reduced groups, with rates of 3.87 and 3.85 per 100 person-years respectively.

Gastrointestinal bleeding occurred <10 times and intracranial bleeding occurred <12 times among the total cohort. The remaining bleeds (74 major) were in other anatomical locations. In addition, 40 of the total bleeds required hospitalisation (1.74 per 100 person-years in the dose reduced group and 1.69 in the full dose group).

“Real-world data, such as these, provide us with a greater understanding of AF treatment pathways and broaden our insight into the patient population,” said Wolfgang Zierhut, MD, executive director medical affairs and Head Thrombosis and Cardiovascular at Daiichi Sankyo Europe. “We are committed to adding to the growing body of evidence on the use of edoxaban through real-world data, particularly in the underserved elderly population.”


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