ESC Congress 2016 Late Breaking Science Registry
First results from GLORIA™-AF Registry Program: Low incidences of stroke, major and life-threatening bleeding seen in non-valvular atrial fibrillation (NVAF) patients taking dabigatran etexilate1
GLORIA™-AF is one of the largest ongoing global registry programs examining the use of oral antithrombotics in real-world clinical practice2
INGELHEIM, Germany I August 29, 2016 I First outcome results from the GLORIA™-AF Registry show that treatment with dabigatran etexilate was associated with low incidences of stroke, major bleeding and life-threatening bleeding. The results from approximately 3,000 patients with non-valvular atrial fibrillation (NVAF) were presented in a late breaking science registry session at the ESC Congress 2016 in Rome, Italy.1 These data from GLORIATM-AF add to the extensive body of data supporting the safety and effectiveness profile of dabigatran for stroke risk reduction and are consistent with data seen in recently published studies assessing anticoagulant use in everyday clinical practice.3-19
The data presented are from Phase II of the GLORIA™-AF registry, and describe outcomes in 2,932 patients newly diagnosed with NVAF who were followed for two years.1 The findings show:
Low incidence of safety outcomes for dabigatran-treated patients in real-world clinical practice: only 1.12% of dabigatran-treated patients experienced a major bleed, and only 0.54% experienced a life-threatening bleed1
Dabigatran effectively reduced the risk of stroke for NVAF patients: less than 1% of dabigatran-treated patients experienced a stroke (0.63%)1,20
The safety and effectiveness of dabigatran was maintained over two years of follow up in routine clinical care1
“Real-world studies such as the GLORIA™-AF Registry complement knowledge gained from randomised controlled clinical trials and offer insights from larger, more diverse and co-morbid patient populations in varied medical settings,” said Professor Gregory Lip, Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, UK. “The findings from GLORIA™-AF show once again that the favourable risk-benefit profile of dabigatran established in the pivotal Phase III RE-LY® clinical trial is also observed in routine clinical care. This is consistent with findings from previous large real-world analyses including the US FDA Medicare analysis and the recently published results from Danish nationwide health databases, which were both independently conducted.”
GLORIA™-AF is one of the largest ongoing registry programs examining antithrombotic use in routine clinical care around the world. Up to 56,000 NVAF patients will be enrolled, with results expected to support physician decision-making regarding the use of antithrombotics for stroke prevention. To date, more than 34 500 patients have been included in the GLORIATM-AF Registry Program.2,21
Boehringer Ingelheim conducts a number of other studies investigating the use of its products in routine clinical care in anticoagulation management: RE-COVERY DVT/PE™, a global observational study on the management of blood clots in the legs (deep vein thrombosis, DVT) and in the lungs (pulmonary embolism, PE).22 Another recently launched study is RE-VECTO, a global program to capture data on idarucizumab usage in clinical practice.23 Idarucizumab is the first and only specific NOAC reversal agent approved for use in emergency situations when immediate reversal of the anticoagulant effect of dabigatran is required,24,25 and is widely available and stocked in over 5,500 hospitals worldwide, including more than 2,500 hospitals in Europe.21
NOTES TO THE EDITORS
About GLORIA™-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation)
GLORIA™-AF is one of the largest worldwide registry programs to investigate the long-term use of oral antithrombotic therapies in the prevention of non-valvular AF-related strokes in a routine clinical setting.2 The Registry examines physicians’ prescribing behaviours in treating AF, as well as the factors behind their prescribing decisions. The study is collecting long-term safety and effectiveness data on a range of antithrombotics, including warfarin, ASA (aspirin), and NOACs for stroke prevention in AF, as well as patient outcomes data.2,26
The Registry Program will enrol up to 56,000 patients newly diagnosed with AF at risk of stroke from up to 2,200 sites in nearly 50 countries.2 Phase II of GLORIA™-AF began after the first NOAC, dabigatran etexilate, was approved in November 2011 in the U.S.21
For more information please visit: https://www.gloria-af.com/public/about.html (link is external)
About dabigatran etexilate
Clinical experience of dabigatran equates to over 6 million patient-years in all licensed indications worldwide.21 Dabigatran has been in the market for more than 7 years and is approved in over 100 countries.21
Currently approved indications for dabigatran are:27,28
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
Treatment of DVT and PE and the prevention of recurrent DVT and recurrent PE in adults
Dabigatran, a direct 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.27-29 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.30 In contrast to vitamin K antagonists, which variably act via different coagulation factors, dabigatran 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 mandatory dose adjustment.29,31
Dabigatran is the only non-vitamin K antagonist oral anticoagulant with an approved reversal agent, idarucizumab.24,25
About Boehringer Ingelheim
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.
In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
For more information please visit our company website www.boehringer-ingelheim.com
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
References
1. Huisman MV. et al.Two year prospective follow up of patients treated with dabigatran etexilate for stroke prevention in non-valvular atrial fibrillation: The GLORIA-AF Registry. Registry Session #4208, presented on Monday 29 August at the ESC Congress 2016, 27-31 August 2016, Rome, Italy.
2. Huisman MV. et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: A global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014;167:329–34.
3. Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
4. Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875–6.
5. Connolly SJ. et al. The long term multi-center extension of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation. 2013;128:237–43.
6. Al-Khalili F. et al. The safety and persistence of non-vitamin-K antagonist oral anticoagulants in atrial fibrillation patients treated in a well structured atrial fibrillation clinic. Curr Med Res Opin. 2016;32:779–85.
7. Amin A. et al. Early Comparison of Major Bleeding, Stroke and Associated Medical Costs Among Treatment-Naive Non-Valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban or Warfarin. Abstract #745. 57th Annual Meeting & Exposition of the American Society of Hematology, 5-8 December 2015, Orlando, USA.
8. Chan Y-H. et al. Cardiovascular, Bleeding, and Mortality Risks of Dabigatran in Asians With Nonvalvular Atrial Fibrillation. Stroke. 2016;47:441–9.
9. Deitelzweig S. et al. An early evaluation of bleeding-related hospital readmissions among hospitalized patients with nonvalvular atrial fibrillation treated with direct oral anticoagulants. Curr Med Res Opin. 2016;32:573–82.
10. Gorst-Rasmussen A. et al. Rivaroxaban versus warfarin and dabigatran in atrial fibrillation: comparative effectiveness and safety in Danish routine care. Pharmacoepidemiol Drug Saf. doi:10.1002/pds.4034.
11. Graham DJ. et al. Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated With Dabigatran or Warfarin for Nonvalvular Atrial Fibrillation. Circulation. 2015;131:157–64.
12. Larsen TB. et al. Bleeding Events Among New Starters and Switchers to Dabigatran Compared with Warfarin in Atrial Fibrillation. Am J Med. 2014;127:650–6.
13. Larsen TB. et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016;353:i3189.
14. Lin I. et al. Real-world bleeding risk among non valvular atrial fibrillation (NVAF) patients prescribed apixaban, dabigatran, rivaroxaban and warfarin: analysis of electronic health records. Abstract #P6215, presented at the ESC Congress 2015, 29 August-2 September 2015, London, UK.
15. Lip GYH. et al. Real world comparison of major bleeding risk among non-valvular atrial fibrillation patients newly initiated on apixaban, warfarin, dabigatran or rivaroxaban: A 1:1 propensity-score matched analysis. Abstract #1268-349, presented at The 65th American College of Cardiology Annual Scientific Session, 2-4 April 2016, Chicago, USA.
16. Pan X. et al. What do real world data say about safety and resource use of oral antagonists? Early analysis of newly anticoagulated non-valvular atrial fibrillation patients using either apixaban, dabigatran, rivaroxaban or warfarin. Abstract #1268-361, presented at The 65th American College of Cardiology Annual Scientific Session, 2-4 April 2016, Chicago, USA.
17. Seeger JD. et al. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost. 2015;114:1277–89.
18. Tepper P. et al. Real-world comparison of bleeding risks among non valvular atrial fibrillation patients on apixaban, dabigatran, rivaroxaban: cohorts comprising new initiators and/or switchers from warfarin. Abstract #1975, presented at the ESC Congress 2015, 29 August-2 September, London, UK.
19. Villines TC. et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114:1290–8.
20. Medi C. et al. Stroke Risk and Antithrombotic Strategies in Atrial Fibrillation. Stroke. 2010;41:2705-2713.
21. Boehringer Ingelheim Data on File.
22. ClinicalTrials.gov. RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism. https://clinicaltrials.gov/ct2/show/NCT02596230?term=re-covery&rank=1 Last accessed August 2016.
23. Boehringer Ingelheim Press release – 15 August 2016. Boehringer Ingelheim launches RE-VECTO global program to capture data on Praxbind® usage in clinical practice. https://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-launches-re-vecto-global-program Last accessed August 2016.
24. Idarucizumab European Summary of Product Characteristics, 2015.
25. Idarucizumab U.S. Prescribing Information, 2015.
26. GLORIA-AF Registry website: Registry Design. https://www.gloria-af.com/public/about-regDesign.html Last accessed August 2016.
27. GLORIA-AF Registry website: Registry Objectives. https://www.gloria-af.com/public/about-objectives.html Last accessed August 2016.
28. Dabigatran etexilate European Summary of Product Characteristics, 2016.
29. Dabigatran etexilate U.S. Prescribing Information, 2015.
30. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
31. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353(10):1028–40.
32. Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45(5):555–63.
SOURCE: Boehringer Ingelheim
Post Views: 209
ESC Congress 2016 Late Breaking Science Registry
First results from GLORIA™-AF Registry Program: Low incidences of stroke, major and life-threatening bleeding seen in non-valvular atrial fibrillation (NVAF) patients taking dabigatran etexilate1
GLORIA™-AF is one of the largest ongoing global registry programs examining the use of oral antithrombotics in real-world clinical practice2
INGELHEIM, Germany I August 29, 2016 I First outcome results from the GLORIA™-AF Registry show that treatment with dabigatran etexilate was associated with low incidences of stroke, major bleeding and life-threatening bleeding. The results from approximately 3,000 patients with non-valvular atrial fibrillation (NVAF) were presented in a late breaking science registry session at the ESC Congress 2016 in Rome, Italy.1 These data from GLORIATM-AF add to the extensive body of data supporting the safety and effectiveness profile of dabigatran for stroke risk reduction and are consistent with data seen in recently published studies assessing anticoagulant use in everyday clinical practice.3-19
The data presented are from Phase II of the GLORIA™-AF registry, and describe outcomes in 2,932 patients newly diagnosed with NVAF who were followed for two years.1 The findings show:
Low incidence of safety outcomes for dabigatran-treated patients in real-world clinical practice: only 1.12% of dabigatran-treated patients experienced a major bleed, and only 0.54% experienced a life-threatening bleed1
Dabigatran effectively reduced the risk of stroke for NVAF patients: less than 1% of dabigatran-treated patients experienced a stroke (0.63%)1,20
The safety and effectiveness of dabigatran was maintained over two years of follow up in routine clinical care1
“Real-world studies such as the GLORIA™-AF Registry complement knowledge gained from randomised controlled clinical trials and offer insights from larger, more diverse and co-morbid patient populations in varied medical settings,” said Professor Gregory Lip, Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, UK. “The findings from GLORIA™-AF show once again that the favourable risk-benefit profile of dabigatran established in the pivotal Phase III RE-LY® clinical trial is also observed in routine clinical care. This is consistent with findings from previous large real-world analyses including the US FDA Medicare analysis and the recently published results from Danish nationwide health databases, which were both independently conducted.”
GLORIA™-AF is one of the largest ongoing registry programs examining antithrombotic use in routine clinical care around the world. Up to 56,000 NVAF patients will be enrolled, with results expected to support physician decision-making regarding the use of antithrombotics for stroke prevention. To date, more than 34 500 patients have been included in the GLORIATM-AF Registry Program.2,21
Boehringer Ingelheim conducts a number of other studies investigating the use of its products in routine clinical care in anticoagulation management: RE-COVERY DVT/PE™, a global observational study on the management of blood clots in the legs (deep vein thrombosis, DVT) and in the lungs (pulmonary embolism, PE).22 Another recently launched study is RE-VECTO, a global program to capture data on idarucizumab usage in clinical practice.23 Idarucizumab is the first and only specific NOAC reversal agent approved for use in emergency situations when immediate reversal of the anticoagulant effect of dabigatran is required,24,25 and is widely available and stocked in over 5,500 hospitals worldwide, including more than 2,500 hospitals in Europe.21
NOTES TO THE EDITORS
About GLORIA™-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation)
GLORIA™-AF is one of the largest worldwide registry programs to investigate the long-term use of oral antithrombotic therapies in the prevention of non-valvular AF-related strokes in a routine clinical setting.2 The Registry examines physicians’ prescribing behaviours in treating AF, as well as the factors behind their prescribing decisions. The study is collecting long-term safety and effectiveness data on a range of antithrombotics, including warfarin, ASA (aspirin), and NOACs for stroke prevention in AF, as well as patient outcomes data.2,26
The Registry Program will enrol up to 56,000 patients newly diagnosed with AF at risk of stroke from up to 2,200 sites in nearly 50 countries.2 Phase II of GLORIA™-AF began after the first NOAC, dabigatran etexilate, was approved in November 2011 in the U.S.21
For more information please visit: https://www.gloria-af.com/public/about.html (link is external)
About dabigatran etexilate
Clinical experience of dabigatran equates to over 6 million patient-years in all licensed indications worldwide.21 Dabigatran has been in the market for more than 7 years and is approved in over 100 countries.21
Currently approved indications for dabigatran are:27,28
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
Treatment of DVT and PE and the prevention of recurrent DVT and recurrent PE in adults
Dabigatran, a direct 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.27-29 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.30 In contrast to vitamin K antagonists, which variably act via different coagulation factors, dabigatran 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 mandatory dose adjustment.29,31
Dabigatran is the only non-vitamin K antagonist oral anticoagulant with an approved reversal agent, idarucizumab.24,25
About Boehringer Ingelheim
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.
In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
For more information please visit our company website www.boehringer-ingelheim.com
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
References
1. Huisman MV. et al.Two year prospective follow up of patients treated with dabigatran etexilate for stroke prevention in non-valvular atrial fibrillation: The GLORIA-AF Registry. Registry Session #4208, presented on Monday 29 August at the ESC Congress 2016, 27-31 August 2016, Rome, Italy.
2. Huisman MV. et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: A global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014;167:329–34.
3. Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
4. Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875–6.
5. Connolly SJ. et al. The long term multi-center extension of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation. 2013;128:237–43.
6. Al-Khalili F. et al. The safety and persistence of non-vitamin-K antagonist oral anticoagulants in atrial fibrillation patients treated in a well structured atrial fibrillation clinic. Curr Med Res Opin. 2016;32:779–85.
7. Amin A. et al. Early Comparison of Major Bleeding, Stroke and Associated Medical Costs Among Treatment-Naive Non-Valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban or Warfarin. Abstract #745. 57th Annual Meeting & Exposition of the American Society of Hematology, 5-8 December 2015, Orlando, USA.
8. Chan Y-H. et al. Cardiovascular, Bleeding, and Mortality Risks of Dabigatran in Asians With Nonvalvular Atrial Fibrillation. Stroke. 2016;47:441–9.
9. Deitelzweig S. et al. An early evaluation of bleeding-related hospital readmissions among hospitalized patients with nonvalvular atrial fibrillation treated with direct oral anticoagulants. Curr Med Res Opin. 2016;32:573–82.
10. Gorst-Rasmussen A. et al. Rivaroxaban versus warfarin and dabigatran in atrial fibrillation: comparative effectiveness and safety in Danish routine care. Pharmacoepidemiol Drug Saf. doi:10.1002/pds.4034.
11. Graham DJ. et al. Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated With Dabigatran or Warfarin for Nonvalvular Atrial Fibrillation. Circulation. 2015;131:157–64.
12. Larsen TB. et al. Bleeding Events Among New Starters and Switchers to Dabigatran Compared with Warfarin in Atrial Fibrillation. Am J Med. 2014;127:650–6.
13. Larsen TB. et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016;353:i3189.
14. Lin I. et al. Real-world bleeding risk among non valvular atrial fibrillation (NVAF) patients prescribed apixaban, dabigatran, rivaroxaban and warfarin: analysis of electronic health records. Abstract #P6215, presented at the ESC Congress 2015, 29 August-2 September 2015, London, UK.
15. Lip GYH. et al. Real world comparison of major bleeding risk among non-valvular atrial fibrillation patients newly initiated on apixaban, warfarin, dabigatran or rivaroxaban: A 1:1 propensity-score matched analysis. Abstract #1268-349, presented at The 65th American College of Cardiology Annual Scientific Session, 2-4 April 2016, Chicago, USA.
16. Pan X. et al. What do real world data say about safety and resource use of oral antagonists? Early analysis of newly anticoagulated non-valvular atrial fibrillation patients using either apixaban, dabigatran, rivaroxaban or warfarin. Abstract #1268-361, presented at The 65th American College of Cardiology Annual Scientific Session, 2-4 April 2016, Chicago, USA.
17. Seeger JD. et al. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost. 2015;114:1277–89.
18. Tepper P. et al. Real-world comparison of bleeding risks among non valvular atrial fibrillation patients on apixaban, dabigatran, rivaroxaban: cohorts comprising new initiators and/or switchers from warfarin. Abstract #1975, presented at the ESC Congress 2015, 29 August-2 September, London, UK.
19. Villines TC. et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114:1290–8.
20. Medi C. et al. Stroke Risk and Antithrombotic Strategies in Atrial Fibrillation. Stroke. 2010;41:2705-2713.
21. Boehringer Ingelheim Data on File.
22. ClinicalTrials.gov. RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism. https://clinicaltrials.gov/ct2/show/NCT02596230?term=re-covery&rank=1 Last accessed August 2016.
23. Boehringer Ingelheim Press release – 15 August 2016. Boehringer Ingelheim launches RE-VECTO global program to capture data on Praxbind® usage in clinical practice. https://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-launches-re-vecto-global-program Last accessed August 2016.
24. Idarucizumab European Summary of Product Characteristics, 2015.
25. Idarucizumab U.S. Prescribing Information, 2015.
26. GLORIA-AF Registry website: Registry Design. https://www.gloria-af.com/public/about-regDesign.html Last accessed August 2016.
27. GLORIA-AF Registry website: Registry Objectives. https://www.gloria-af.com/public/about-objectives.html Last accessed August 2016.
28. Dabigatran etexilate European Summary of Product Characteristics, 2016.
29. Dabigatran etexilate U.S. Prescribing Information, 2015.
30. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
31. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353(10):1028–40.
32. Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45(5):555–63.
SOURCE: Boehringer Ingelheim
Post Views: 209
