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

• 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®

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

References

1. Ezekowitz M, et al. RE-LY and RELY-ABLE: Long-term Follow-up of Patients With Non-valvular Atrial Fibrillation Receiving Dabigatran Etexilate for Up to 6.7 Years. Oral presentation #10684 on Monday 18 November 2013 at the American Heart Association’s Scientific Sessions, Dallas, Texas, USA.
2. Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
3. Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
4. FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran) – 2 November 2012 http://www.fda.gov/Drugs/drugsafety/ucm326580.htm Last accessed 11 November 2013.
5. European Medicines Agency Press release – 25 May 2012: EMA/337406/2012. European Medicines Agency updates patient and prescriber information for Pradaxa. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/05/news_detail_001518.jsp&mid=WC0b01ac058004d5c1 Last accessed 11 November 2013.
6. Boehringer Ingelheim data on file.
7. Pradaxa® European Summary of Product Characteristics 2013.