Thursday, November 21, 2013

New long-term treatment data confirms consistent benefit and safety profile of Pradaxa beyond 6 years

ME Newswire / Businesswire

INGELHEIM, Germany - Tuesday, November 19th 2013

    Pradaxa® (dabigatran etexilate) is the only novel oral

anticoagulant with more than 6 years of long-term data supporting its

beneficial role for stroke prevention in atrial fibrillation1
    The efficacy and safety profiles of both doses of Pradaxa® during

up to 6.7 years of extended treatment remain consistent with the

pivotal results seen in the registration trial RE-LY®1,2,3
    Presented during the American Heart Association's Scientific

Sessions, new data add to the body of evidence for Pradaxa®

For media outside of the US, the UK & Canada only

Results from a new combined analysis of the pivotal Phase III RE-LY®

trial and its extension study RELY-ABLE® show that, in long-term

treatment, the efficacy and safety profiles of both doses of Pradaxa®

(dabigatran etexilate, 150mg bid and 110mg bid) remain consistent with

the results seen in the 18,000 patient-strong RE-LY® registration

trial.1,2,3 The new data were presented during the American Heart

Association’s Scientific Sessions 2013.

“This is important news for physicians and patients who use either dose

of dabigatran etexilate to reduce the lifetime risk of stroke

associated with atrial fibrillation,” said Prof. Michael D. Ezekowitz,

Thomas Jefferson Medical College, Philadelphia, USA. “They can feel

reassured that dabigatran etexilate will provide sustained stroke

prevention and a favourable long-term safety profile.”

The combined analysis includes all patients from RE-LY® and RELY-ABLE®

who were treated with either Pradaxa® 150mg bid or Pradaxa® 110mg bid.

Median follow-up lasted an average of 4.6 years, with maximum follow-up

extending to 6.7 years in several hundred patients. The new findings

show that for Pradaxa®:1

    The rates of stroke or systemic embolism were 1.25 and 1.54 percent

/ year on dabigatran 150mg bid and 110mg bid respectively
        The rates of ischaemic stroke were 1.03 and 1.29 percent / year

on dabigatran 150mg bid and 110mg bid respectively
        The rates of haemorrhagic stroke were 0.11 and 0.13 percent /

year on dabigatran 150mg bid and 110mg bid respectively
    The rates of major haemorrhage were 3.34 and 2.76 percent / year on

dabigatran 150mg bid and 110mg bid respectively

    The safety profile was consistent over time, with no new safety

issues identified compared to the original RE-LY® results

“These unique long-term treatment results presented during the AHA

Scientific Sessions show consistent safety and efficacy profiles for

both doses of Pradaxa® over more than 6 years of clinical follow-up,”

said Professor Klaus Dugi, Corporate Senior Vice President Medicine,

Boehringer Ingelheim. “Among the novel oral anticoagulants, such long-

term data are only available for Pradaxa®. Especially for a chronic

condition that requires life-long treatment like stroke prevention in

atrial fibrillation, results such as these provide key insights for

physicians and patients.”

The favourable efficacy-safety profile of Pradaxa® is supported by

safety assessments from regulatory authorities including the European

Medicines Agency and the U.S. Food and Drug Administration (FDA).4,5

Clinical experience with Pradaxa® continues to grow and equates to over

two million patient-years in all licensed indications to date.6

Pradaxa® is the longest studied novel oral anticoagulant.6

Pradaxa® is currently approved in over 100 countries worldwide for the

prevention of stroke and systemic embolism in patients with non-

valvular atrial fibrillation and for the primary prevention of venous

thromboembolism following total hip replacement or total knee

replacement surgery.6,7


Please click on the link for ‘Notes to Editors’ and ‘References’:



Boehringer Ingelheim Corporate Communications Media + PR

Sara McClelland

Phone: +49 6132 – 77 8271

Fax: +49 6132 – 77 6601



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