New data analyses show consistent efficacy and safety profile of Pradaxa® in broad range of patients with acute deep vein thrombosis or pulmonary embolism

The efficacy and safety profile of Pradaxa® (dabigatran etexilate) was maintained regardless of patient characteristics^1,2,3,4

• Pooled safety data favour Pradaxa® treatment over warfarin and provide further reassurance^1-4
• The analysed patient characteristics included age, renal function, simultaneous use of anti-inflammatory drugs (NSAIDs) or low-dose acetylsalicylic acid (ASA) and the presence of cancer^1-4
• Data also showed that taking commonly used NSAIDs or low-dose ASA with Pradaxa® did not increase the risk of bleeding¹
  

New data analyses show that the positive treatment effect (efficacy and safety profile) of Pradaxa® (dabigatran etexilate) 150mg twice daily was consistent in a wide range of patients with acute deep vein thrombosis (DVT), a blood clot in the leg veins, or pulmonary embolism (PE), a blood clot in the lung, regardless of age, renal function, simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose acetylsalicylic acid (ASA), or the presence of cancer.^1-4 These new findings from the pooled safety analysis of the RE-COVER™ and RE-COVER™ II phase III clinical trials were presented this week during the American Society of Hematology Annual Meeting, New Orleans, USA.^1-4

“Knowing that the positive efficacy and safety profile of dabigatran is consistent regardless of patient characteristics in the treatment of acute DVT and PE is important as there is an ongoing need to improve treatment outcomes,” said Professor Sam Schulman, Principal Investigator, Division of Hematology and Thromboembolism, Department of Medicine, McMaster University, Canada. “The pooled data from these analyses favour dabigatran treatment over warfarin and provide further reassurance to both physicians and patients especially regarding the safety of the treatment.”

Previous data from the RE-COVER™ and RE-COVER™ II phase III clinical trials showed that in the acute treatment of DVT and PE, Pradaxa® 150 mg twice daily was an effective and well-tolerated treatment.^5,6

• Comparable efficacy for Pradaxa® 150 mg and warfarin: 2.7% vs. 2.4% (non-inferiority for primary endpoint of venous thromboembolism (VTE) or related death in trial period plus 6 month follow-up)

The rapid and full effect of Pradaxa® in less than two hours allows for an easy transition from initial heparin treatment with no overlap required.⁷ Due to one fixed-dose treatment with Pradaxa® from the beginning, patient management is simplified, as there is no need to titrate or adjust once prescribed.

Pooled data from RE-COVER™ and RE-COVER™ II show that, after the end of treatment with heparin, once patients are only treated with Pradaxa® compared to warfarin, they had significant safety benefits:⁶

• 40% lower risk of major bleeding events (Pradaxa® 150mg vs. warfarin, HR 0.60, CI 0.36-0.99)
• 44% lower risk of major or clinically relevant bleeding (Pradaxa® 150mg vs. warfarin, HR 0.56, CI 0.45-0.71)
• 33% lower risk of total bleeding events (Pradaxa® 150mg vs. warfarin, HR 0.67, CI 0.59-0.77)

“The presented data from the different RE-COVER trials sub-analyses show that the efficacy and safety profile of Pradaxa® 150 mg in the treatment of acute DVT or PE is very consistent, without a need for dose adjustments,” commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The data confirm the potential of Pradaxa® as an effective treatment with safety benefits for a wide range of patients, including older patients and patients with a moderately impaired renal function.”

Pradaxa® is already widely approved for stroke prevention in atrial fibrillation and for primary prevention of venous thromboembolism following total hip replacement or total knee replacement surgery.7 Collective clinical experience across all licensed indications exceeds five years, with two million patient-years placing Pradaxa® first among the novel oral anticoagulants.^8,9

References

1. Schulman S, et al. Influence Of Concomitant NSAID Or ASA On The Efficacy and Safety Of Dabigatran Versus Warfarin For The Treatment Of Acute Venous Thromboembolism: A Pooled Analysis From RE-Cover and RE-Cover II. Poster presentation #1136 on Saturday 7 December 2013 at American Society of Hematology Annual Meeting and Exposition, New Orleans, Louisiana, USA.
2. Schulman S, et al. Influence Of Active Cancer On The Efficacy and Safety Of Dabigatran Versus Warfarin For The Treatment Of Acute Venous Thromboembolism: A Pooled Analysis From RE-Cover and RE-Cover II. Poster presentation #582 on Monday 9 December 2013 at American Society of Hematology Annual Meeting and Exposition, New Orleans, Louisiana, USA.
3. Schulman S, et al. Influence Of Renal Function On The Efficacy and Safety Of Dabigatran Versus Warfarin For The Treatment Of Acute Venous Thromboembolism: A Pooled Analysis From RE-Cover and RE-Cover II. Poster presentation #212 on Monday 9 December 2013 at American Society of Hematology Annual Meeting and Exposition, New Orleans, Louisiana, USA.
4. Schulman S, et al. Influence Of Age On The Efficacy and Safety Of Dabigatran Versus Warfarin For The Treatment Of Acute Venous Thromboembolism: A Pooled Analysis Of RE-Cover and RE-Cover II. Poster presentation #2375 on Sunday 8 December 2013 at American Society of Hematology Annual Meeting and Exposition, New Orleans, Louisiana, USA.
5. Schulman S. et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
6. Schulman S, et al. Safety of dabigatran versus warfarin for acute venous thromboembolism: pooled analyses of RE-COVER and RE-COVER II. Oral presentation. Presented on July 3, 2013 at the 2013 Congress of the International Society on Thrombosis and Haemostasis.
7. Pradaxa European Summary of Product Characteristics, 2013
8. Ezekowitz M, et al. RE-LY and RELY-ABLE: Long-term Follow-up of Patients With Nonvalvular. 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.
9. Boehringer Ingelheim data on file.