• Presented at the American Heart Association’s Scientific Sessions 2013, results from the large-scale phase III trial ENGAGE AF-TIMI 48 demonstrate non-inferiority of edoxaban compared with warfarin for prevention of stroke in patients with non-valvular atrial fibrillation (AF)1,2
• With data now available from all four trials of novel oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation,1-6 Pradaxa® (dabigatran etexilate) 150mg bid continues to be the only NOAC, study of which showed a significant reduction of both ischaemic and haemorrhagic strokes compared to warfarin in its pivotal trial RE-LY®3,4
• RE-LY® was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) design trial comparing two fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.3,4,7 Pradaxa® 110mg bid, which is indicated for certain patients,8 showed non-inferior efficacy versus warfarin for reducing risk of stroke3,4
INGELHEIM, Germany I November 25, 2013 I Prevention of ischaemic stroke (a stroke caused by a blood clot)9 is the reason to treat patients with atrial fibrillation (AF) with an anticoagulant treatment.10 Examining all phase III trial analyses now available (RE-LY®3,4 [Pradaxa® (dabigatran etexilate)], ROCKET-AF5 [rivaroxaban], ARISTOTLE6 [apixaban]) as well as ENGAGE-AF-TIMI 481,2 [edoxaban], for which new data were presented on 19 November at the American Heart Association’s Scientific Sessions), Pradaxa® 150mg bid continues to be the only NOAC to offer a statistically significant superior reduction in the risk of ischaemic stroke versus well controlled warfarin.3,4 In all of the trials, ischaemic stroke was included as part of the composite of stroke (ischaemic and haemorrhagic or systemic embolism), the primary study outcome.1-6
In the RE-LY® (Randomized Evaluation of Long term anticoagulant therapY) trial, Pradaxa® 150mg bid demonstrated a 25% reduction in the risk of ischaemic strokes and a 74% reduction in the risk of haemorrhagic strokes versus warfarin. Furthermore, rates of total bleeds and life threatening bleeds were significantly reduced versus warfarin.3,4 Pradaxa® 110mg bid, which is indicated for certain AF patients,8 showed non-inferior efficacy versus warfarin for reducing risk of stroke with significantly reduced rates of total and major bleeds.3,4
“With its positive efficacy and safety profile which is well established worldwide, Pradaxa® offers substantial advantages over warfarin for AF patients requiring anticoagulant treatment,” stated Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The breakthrough results of the RE-LY® trial as well as numerous additional data support the breadth of benefit that Pradaxa® offers to AF patients, including superior protection against ischaemic stroke compared to warfarin.”
With over 9 out of 10 strokes suffered by patients with AF being of ischaemic type,11 protection against ischaemic stroke is the key clinical benefit that should be achieved by anticoagulant treatment.12 Ischaemic strokes associated with AF are often fatal, and those patients who survive are on average left more disabled by their stroke and have a higher likelihood of stroke recurrence than patients with other causes of stroke.12
“Trying to prevent ischaemic stroke, so the stroke caused by the blood clot that can form in the hearts of patients with atrial fibrillation, is the reason why we treat these patients with oral anticoagulants,” commented Professor Hans-Christoph Diener, Professor of Neurology and Chairman of the Department of Neurology, University of Essen, Germany.
A draft guideline from the European Medicines Agency, which is currently undergoing public consultation, further highlights the importance of ischaemic stroke prevention. The draft guideline recommends that Phase III trials of anticoagulant treatments for patients with AF should be designed to include a primary composite efficacy endpoint that shows a treatment’s ability to reduce the number of thromboembolic events, including ischaemic strokes, undefined strokes and systemic embolic events (SEE).12
The efficacy and safety profile of Pradaxa® in its licensed indications is well documented in the extensive RE-VOLUTION® clinical trial programme which will include over 55,000 patients worldwide3,4,13-23 and has led to regulatory approvals in over 100 countries to date.22 The favourable benefit-risk profile of Pradaxa® is supported by assessments from regulatory authorities including the European Medicines Agency and the U.S. Food and Drug Administration (FDA).24,25 Clinical experience with Pradaxa® continues to grow and equates to over 2 million patient-years in all licensed indications to date supporting Pradaxa® as the leading novel oral anticoagulant.22
NOTES TO THE EDITORS
About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) exceeds that of all other novel oral anticoagulants, equating to over 2 million patient-years in all licensed indications worldwide.22 Pradaxa® has already been in the market for more than 5 years and is approved in over 100 countries.8,22 Currently approved indications for Pradaxa® are:8
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and a risk factor for stroke
Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery
Primary prevention of venous thromboembolic events in patients undergoing elective total knee replacement surgery
In June 2013 Boehringer Ingelheim started submitting new applications to regulatory authorities for Pradaxa® for the following indications:22
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death
Important Notice: Pradaxa® is currently not approved for the acute treatment or prevention of recurrent DVT and/or PE8
Pradaxa®, a direct reversible thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.8,26 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.27 In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa® provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.26,28
About Pradaxa® and Stroke Prevention in Atrial Fibrillation (AF)
Pradaxa® 150mg bid is the only novel oral anticoagulant, for which its pivotal trial vs. warfarin has shown a statistically significant reduction in both ischaemic strokes and haemorrhagic when compared to warfarin.3,4 Pradaxa® 110mg bid was as effective as warfarin in overall stroke risk reduction.3,4 These results were shown in RE-LY®, a phase III PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial.3,4,7 Additionally, treatment with Pradaxa® at both doses was associated with significant reductions in intracranial haemorrhage, one of the most devastating complications of anticoagulation therapy.29
Stroke Prevention in Atrial Fibrillation (AF)
AF is the most common sustained heart rhythm condition, with one in four adults over the age of 40 developing the condition in their lifetime.30 People with AF are more likely to experience blood clots, which increases the risk of stroke by five-fold.31 Ischaemic strokes are the most common type of AF-related stroke, accounting for 92% of strokes and frequently leading to severe debilitation.11,32
Appropriate anticoagulation therapy has been proven to be highly effective in preventing AF-related strokes and saving patients from its consequences.33
For further information on the prevalence, medical background and societal burden of AF please visit: http://www.newshome.com/af-stroke.aspx
About the Pradaxa® (dabigatran etexilate) clinical trial programme
Since its discovery, Pradaxa® has been evaluated through the extensive RE-VOLUTION® clinical trial programme, which will involve more than 55,000 patients in over 100 countries globally, encompassing studies in:3,4,13-23
Stroke prevention in non-valvular AF
Primary prevention of VTE in patients undergoing elective total hip replacement surgery
Primary prevention of VTE in patients undergoing elective total knee replacement surgery
Treatment of acute DVT or PE
Prevention of recurrent DVT or PE
Planned investigation – Prevention of recurrent strokes following embolic stroke of undetermined source (ESUS)
Planned investigation – Prevention of clinically relevant bleeding and thrombotic events in non-valvular AF patients who have undergone percutaneous coronary intervention (PCI) with stenting
In line with Boehringer Ingelheim’s commitment to research and scientific development the clinical trial programme for Pradaxa® is ongoing.
About RE-LY®
The pivotal RE-LY® trial was designed to investigate the efficacy and safety of Pradaxa® in stroke prevention in patients with non-valvular atrial fibrillation. RE-LY® (Randomized Evaluation of Long term anticoagulant therapY) was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial of 18,113 patients enrolled in over 900 centres in 44 countries designed to compare two fixed doses of the oral direct thrombin inhibitor Pradaxa® (dabigatran etexilate 110mg and 150mg bid) each administered in a blinded manner, with open label warfarin (INR 2.0-3.0, median TTR 67%8).3,4,7
For further information on study design, objectives and endpoints please visit: http://www.newshome.com/af-stroke/atrial-fibrillation-stroke/rely-relyable-backgrounder.aspx
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim’s culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
Related link:
www.newshome.com
www.youtube.com/cvtv
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S., the UK or Canada.
References
1Giugliano R.P. ENGAGE AF-TIMI 48 Primary Results. Late breaker within session LBCT.05-New Strategies for Atrial Fibrillation Patients: Rhythm and Thrombosis. Presented on Tuesday 19th November at the American Heart Association’s Scientific Sessions, Dallas, USA.
2Giugliano R.P. et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2013. DOI: 10.1056/NEJMoa1310907
3Connolly S.J. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
4Connolly S.J. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
5Patel M.R. et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med. 2011;365:883-91.
6Granger C.B. et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2011;365:981-92.
7Ezekowitz M.D. et al. Rationale and design of RE-LY®: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009;157(5):805-10.
8Pradaxa® European Summary of Product Characteristics 2013.
9National Heart, Lung, and Blood Institute. Types of Strokes. http://www.nhlbi.nih.gov/health/health-topics/topics/stroke/types.html Last accessed 21 November 2013.
10Marini C. et al. Contribution of Atrial Fibrillation to Incidence and Outcome of Ischemic Stroke: Results: From a Population-Based Study. Stroke. 2005;36:1115-9.
11Andersen K.K. et al. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068-72.
12European Medicines Agency – Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation. EMA/CHMP/623942/20131. Draft as of 24 October 2013. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154227.pdf Last accessed 21 November 2013.
13Eriksson BI. et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949–56.
14Eriksson BI. et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, doubleblind, non-inferiority trial. Thromb Haemost. 2011;105(4):721-9.
15Eriksson BI. et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost. 2007;5:2178–85.
16Ginsberg JS. et al. Oral thrombin inhibitor dabigatran etexilate vs. North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthoplasty. 2009;24(1)1–9.
17Schulman S. et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
18Schulman S. et al. A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism (RE-COVER II). Oral presentation from Session 332: Antithrombotic Therapy: New Anticoagulants. Presented on 12 December at the American Society of Hematology (ASH) Annual Meeting 2011.
19Schulman S. et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709–18.
20Oldgren J. et al. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J. 2011;32:2781-9.
21Ezekowitz 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.
22Boehringer Ingelheim data on file.
23Boehringer Ingelheim press release – Boehringer Ingelheim planning two new Global Clinical Trials for Pradaxa® (dabigatran etexilate) in expanded patient populations. Distributed on 19 November 2013.
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/19_november_2013_dabigatranetexilate1.html Last accessed 21 November 2013.
24European 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 20 November 2013.
25FDA 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 21 November 2013.
26Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
27Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
28Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabagitran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63.
29Hart R.G. et al. Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with Warfarin or Dabigatran: The RE-LY® Trial. Stroke. 2012;43(6):1511-7.
30Lloyd-Jones D.M. et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110(9):1042-46.
31Camm A.J. et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2012;33(21):2719-47.
32Gladstone D.J. et al. Potentially Preventable Strokes in High-Risk Patients With Atrial Fibrillation Who Are Not Adequately Anticoagulated. Stroke. 2009;40:235-240.
33Aguilar M.I., Hart R. Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. Cochrane Database of Syst Rev. 2005;(3):CD001927.
SOURCE: Boehringer Ingelheim
Post Views: 133
• Presented at the American Heart Association’s Scientific Sessions 2013, results from the large-scale phase III trial ENGAGE AF-TIMI 48 demonstrate non-inferiority of edoxaban compared with warfarin for prevention of stroke in patients with non-valvular atrial fibrillation (AF)1,2
• With data now available from all four trials of novel oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation,1-6 Pradaxa® (dabigatran etexilate) 150mg bid continues to be the only NOAC, study of which showed a significant reduction of both ischaemic and haemorrhagic strokes compared to warfarin in its pivotal trial RE-LY®3,4
• RE-LY® was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) design trial comparing two fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.3,4,7 Pradaxa® 110mg bid, which is indicated for certain patients,8 showed non-inferior efficacy versus warfarin for reducing risk of stroke3,4
INGELHEIM, Germany I November 25, 2013 I Prevention of ischaemic stroke (a stroke caused by a blood clot)9 is the reason to treat patients with atrial fibrillation (AF) with an anticoagulant treatment.10 Examining all phase III trial analyses now available (RE-LY®3,4 [Pradaxa® (dabigatran etexilate)], ROCKET-AF5 [rivaroxaban], ARISTOTLE6 [apixaban]) as well as ENGAGE-AF-TIMI 481,2 [edoxaban], for which new data were presented on 19 November at the American Heart Association’s Scientific Sessions), Pradaxa® 150mg bid continues to be the only NOAC to offer a statistically significant superior reduction in the risk of ischaemic stroke versus well controlled warfarin.3,4 In all of the trials, ischaemic stroke was included as part of the composite of stroke (ischaemic and haemorrhagic or systemic embolism), the primary study outcome.1-6
In the RE-LY® (Randomized Evaluation of Long term anticoagulant therapY) trial, Pradaxa® 150mg bid demonstrated a 25% reduction in the risk of ischaemic strokes and a 74% reduction in the risk of haemorrhagic strokes versus warfarin. Furthermore, rates of total bleeds and life threatening bleeds were significantly reduced versus warfarin.3,4 Pradaxa® 110mg bid, which is indicated for certain AF patients,8 showed non-inferior efficacy versus warfarin for reducing risk of stroke with significantly reduced rates of total and major bleeds.3,4
“With its positive efficacy and safety profile which is well established worldwide, Pradaxa® offers substantial advantages over warfarin for AF patients requiring anticoagulant treatment,” stated Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The breakthrough results of the RE-LY® trial as well as numerous additional data support the breadth of benefit that Pradaxa® offers to AF patients, including superior protection against ischaemic stroke compared to warfarin.”
With over 9 out of 10 strokes suffered by patients with AF being of ischaemic type,11 protection against ischaemic stroke is the key clinical benefit that should be achieved by anticoagulant treatment.12 Ischaemic strokes associated with AF are often fatal, and those patients who survive are on average left more disabled by their stroke and have a higher likelihood of stroke recurrence than patients with other causes of stroke.12
“Trying to prevent ischaemic stroke, so the stroke caused by the blood clot that can form in the hearts of patients with atrial fibrillation, is the reason why we treat these patients with oral anticoagulants,” commented Professor Hans-Christoph Diener, Professor of Neurology and Chairman of the Department of Neurology, University of Essen, Germany.
A draft guideline from the European Medicines Agency, which is currently undergoing public consultation, further highlights the importance of ischaemic stroke prevention. The draft guideline recommends that Phase III trials of anticoagulant treatments for patients with AF should be designed to include a primary composite efficacy endpoint that shows a treatment’s ability to reduce the number of thromboembolic events, including ischaemic strokes, undefined strokes and systemic embolic events (SEE).12
The efficacy and safety profile of Pradaxa® in its licensed indications is well documented in the extensive RE-VOLUTION® clinical trial programme which will include over 55,000 patients worldwide3,4,13-23 and has led to regulatory approvals in over 100 countries to date.22 The favourable benefit-risk profile of Pradaxa® is supported by assessments from regulatory authorities including the European Medicines Agency and the U.S. Food and Drug Administration (FDA).24,25 Clinical experience with Pradaxa® continues to grow and equates to over 2 million patient-years in all licensed indications to date supporting Pradaxa® as the leading novel oral anticoagulant.22
NOTES TO THE EDITORS
About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) exceeds that of all other novel oral anticoagulants, equating to over 2 million patient-years in all licensed indications worldwide.22 Pradaxa® has already been in the market for more than 5 years and is approved in over 100 countries.8,22 Currently approved indications for Pradaxa® are:8
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and a risk factor for stroke
Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery
Primary prevention of venous thromboembolic events in patients undergoing elective total knee replacement surgery
In June 2013 Boehringer Ingelheim started submitting new applications to regulatory authorities for Pradaxa® for the following indications:22
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death
Important Notice: Pradaxa® is currently not approved for the acute treatment or prevention of recurrent DVT and/or PE8
Pradaxa®, a direct reversible thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.8,26 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.27 In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa® provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.26,28
About Pradaxa® and Stroke Prevention in Atrial Fibrillation (AF)
Pradaxa® 150mg bid is the only novel oral anticoagulant, for which its pivotal trial vs. warfarin has shown a statistically significant reduction in both ischaemic strokes and haemorrhagic when compared to warfarin.3,4 Pradaxa® 110mg bid was as effective as warfarin in overall stroke risk reduction.3,4 These results were shown in RE-LY®, a phase III PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial.3,4,7 Additionally, treatment with Pradaxa® at both doses was associated with significant reductions in intracranial haemorrhage, one of the most devastating complications of anticoagulation therapy.29
Stroke Prevention in Atrial Fibrillation (AF)
AF is the most common sustained heart rhythm condition, with one in four adults over the age of 40 developing the condition in their lifetime.30 People with AF are more likely to experience blood clots, which increases the risk of stroke by five-fold.31 Ischaemic strokes are the most common type of AF-related stroke, accounting for 92% of strokes and frequently leading to severe debilitation.11,32
Appropriate anticoagulation therapy has been proven to be highly effective in preventing AF-related strokes and saving patients from its consequences.33
For further information on the prevalence, medical background and societal burden of AF please visit: http://www.newshome.com/af-stroke.aspx
About the Pradaxa® (dabigatran etexilate) clinical trial programme
Since its discovery, Pradaxa® has been evaluated through the extensive RE-VOLUTION® clinical trial programme, which will involve more than 55,000 patients in over 100 countries globally, encompassing studies in:3,4,13-23
Stroke prevention in non-valvular AF
Primary prevention of VTE in patients undergoing elective total hip replacement surgery
Primary prevention of VTE in patients undergoing elective total knee replacement surgery
Treatment of acute DVT or PE
Prevention of recurrent DVT or PE
Planned investigation – Prevention of recurrent strokes following embolic stroke of undetermined source (ESUS)
Planned investigation – Prevention of clinically relevant bleeding and thrombotic events in non-valvular AF patients who have undergone percutaneous coronary intervention (PCI) with stenting
In line with Boehringer Ingelheim’s commitment to research and scientific development the clinical trial programme for Pradaxa® is ongoing.
About RE-LY®
The pivotal RE-LY® trial was designed to investigate the efficacy and safety of Pradaxa® in stroke prevention in patients with non-valvular atrial fibrillation. RE-LY® (Randomized Evaluation of Long term anticoagulant therapY) was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial of 18,113 patients enrolled in over 900 centres in 44 countries designed to compare two fixed doses of the oral direct thrombin inhibitor Pradaxa® (dabigatran etexilate 110mg and 150mg bid) each administered in a blinded manner, with open label warfarin (INR 2.0-3.0, median TTR 67%8).3,4,7
For further information on study design, objectives and endpoints please visit: http://www.newshome.com/af-stroke/atrial-fibrillation-stroke/rely-relyable-backgrounder.aspx
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim’s culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
Related link:
www.newshome.com
www.youtube.com/cvtv
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S., the UK or Canada.
References
1Giugliano R.P. ENGAGE AF-TIMI 48 Primary Results. Late breaker within session LBCT.05-New Strategies for Atrial Fibrillation Patients: Rhythm and Thrombosis. Presented on Tuesday 19th November at the American Heart Association’s Scientific Sessions, Dallas, USA.
2Giugliano R.P. et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2013. DOI: 10.1056/NEJMoa1310907
3Connolly S.J. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
4Connolly S.J. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
5Patel M.R. et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med. 2011;365:883-91.
6Granger C.B. et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2011;365:981-92.
7Ezekowitz M.D. et al. Rationale and design of RE-LY®: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009;157(5):805-10.
8Pradaxa® European Summary of Product Characteristics 2013.
9National Heart, Lung, and Blood Institute. Types of Strokes. http://www.nhlbi.nih.gov/health/health-topics/topics/stroke/types.html Last accessed 21 November 2013.
10Marini C. et al. Contribution of Atrial Fibrillation to Incidence and Outcome of Ischemic Stroke: Results: From a Population-Based Study. Stroke. 2005;36:1115-9.
11Andersen K.K. et al. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068-72.
12European Medicines Agency – Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation. EMA/CHMP/623942/20131. Draft as of 24 October 2013. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154227.pdf Last accessed 21 November 2013.
13Eriksson BI. et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949–56.
14Eriksson BI. et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, doubleblind, non-inferiority trial. Thromb Haemost. 2011;105(4):721-9.
15Eriksson BI. et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost. 2007;5:2178–85.
16Ginsberg JS. et al. Oral thrombin inhibitor dabigatran etexilate vs. North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthoplasty. 2009;24(1)1–9.
17Schulman S. et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
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22Boehringer Ingelheim data on file.
23Boehringer Ingelheim press release – Boehringer Ingelheim planning two new Global Clinical Trials for Pradaxa® (dabigatran etexilate) in expanded patient populations. Distributed on 19 November 2013.
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/19_november_2013_dabigatranetexilate1.html Last accessed 21 November 2013.
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25FDA 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 21 November 2013.
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SOURCE: Boehringer Ingelheim
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