Pradaxa® (dabigatran etexilate mesylate) Data to be Presented at European Society of Cardiology Congress 2014 Hot Line session presentations to feature renal function data from pivotal RE-LY® trial and global GLORIA™-AF registry updates
RIDGEFIELD, Conn., Aug. 25, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that data from nine company-sponsored Pradaxa® (dabigatran etexilate mesylate) studies will be presented at the European Society of Cardiology (ESC) Congress 2014, August 30 to September 3 in Barcelona, Spain. The abstracts will feature data about the use of dabigatran in patients with non-valvular atrial fibrillation (NVAF) and for patients who have experienced deep venous thrombosis (DVT) and pulmonary embolism (PE). Other presentations also highlight findings from pharmacokinetic and pharmacodynamics studies on dabigatran.
More information about the data presentations is as follows:
Special Sessions: Hot Line
- Session: Registry Hot Line: Atrial fibrillation and myocardial infarction
Sunday, August 31, Helsinki (The Hub) - Central Village, 8:30 a.m. CEST/2:30 a.m. EDT
- Global registry on long-term oral antithrombotic treatment in patients with atrial fibrillation: baseline characteristics of the first 10,000 patients in GLORIA™-AF Phase II (M. Huisman); Abstract No. 896
- Session: Clinical Trial Update Hot Line: Stable CAD and atrial fibrillation
Tuesday, September 2, Brussels - Central Village, 2:18 p.m. CEST/8:18 a.m. EDT
- Favorable effects of dabigatran versus warfarin on renal function change over time in patients with atrial fibrillation: results from the RE-LY® Trial (M. Bohm); Abstract No. 5686
- RE-LY: Discussant review and Panel Discussion (C. B. Granger); Abstract No. 5687
- Session: Oral anticoagulation in practice
Tuesday, September 2, Tbilisi - Village 7, 8:45 a.m. CEST/2:45 a.m. EDT
- Dabigatran-induced anticoagulant and bleeding effects can be reversed with both prothrombin complex concentrates and a specific antidote (idarucizumab) in a lethal porcine polytrauma model (O. Grottke); Abstract No. 4844
- Session: Poster session 3: Atrial fibrillation: miscellaneous
Sunday, August 31, Poster area - Central Village, 2:00-6:00 p.m. EST/8:00 a.m.-12:00 p.m. EDT
- Pharmacokinetics and pharmacodynamics of dabigatran etexilate 75 mg BID in patients with severe chronic kidney disease: prospective validation of a post hoc determined dose (J. Kooiman); Abstract No. P2427
- Session: Poster session 4: Coronary artery disease and comorbidities
Monday, September 1, Poster area - Central Village, 8:30 a.m.-12:30 p.m. CEST/2:30-6:30 a.m. EDT
- Activated prothrombin complex concentrate reverses dabigatran-induced bleeding in a lethal porcine polytrauma model (O. Grottke); Abstract No. P3625
- Session: Poster session 5: Atrial fibrillation – clinical
Monday, September 1, Poster area - Central Village, 2:00-6:00 p.m. CEST/8:00 a.m.-12:00 p.m. EDT
- Antithrombotic treatment pattern and baseline characteristics of dabigatran and vitamin K antagonist cohorts in North America - The GLORIA-AF registry program (M. Huisman); Abstract No. P4394
- Session: Poster session 6: Thrombosis and anticoagulation – I
Tuesday, September 2, Poster area - Central Village, 8:30 a.m.-12:30 p.m. CEST/2:30-6:30 a.m. EDT
- Treatment of acute pulmonary embolism with dabigatran or warfarin: A pooled analysis of efficacy data from RE-COVER® and RE-COVER II™ (M. Feuring); Abstract No. P5509
- Session: Poster session 7: Platelets and antiplatelet therapy: Miscellaneous
Tuesday, September 2, Poster area - Central Village, 2:00-6:00 p.m. CEST/8:00 a.m.-12:00 p.m. EDT
- Pharmacokinetic and pharmacodynamic effects of ticagrelor and dabigatran etexilate coadministration in healthy male volunteers (M. Lobmeyer); Abstract No. P6490
- Dabigatran versus warfarin in patients with pacemaker or defibrillator wires in the RE-LY trial: the role of contact activation (M. Brueckmann); Abstract No. P6274
About Pradaxa® (dabigatran etexilate mesylate) Capsules
Indications and Usage
Pradaxa®(dabigatran etexilate mesylate) capsules is indicated:
- to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation;
- for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days;
- to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant
(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
• use of indwelling epidural catheters
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients who are or will be anticoagulated.
PRADAXA is contraindicated in patients with:
- active pathological bleeding;
- known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA;
- mechanical prosthetic heart valve
WARNINGS & PRECAUTIONS
Increased Risk of Thrombotic Events after Premature Discontinuation
Premature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
Risk of Bleeding
- PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue PRADAXA in patients with active pathological bleeding.
- Risk factors for bleeding include concomitant use of medications that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). PRADAXA's anticoagulant activity and half-life are increased in patients with renal impairment.
- Reversal of Anticoagulant Effect: A specific reversal agent for dabigatran is not available. Hemodialysis can remove dabigatran; however clinical experience for hemodialysis as a treatment for bleeding is limited. Activated prothrombin complex concentrates, recombinant Factor VIIa, or concentrates of factors II, IX or X may be considered but their use has not been evaluated. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.
Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
The use of PRADAXA is contraindicated in patients with mechanical prosthetic valves due to a higher risk for thromboembolic events, especially in the post-operative period, and an excess of major bleeding for PRADAXA vs. warfarin. Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.
Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure
Concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.
Reduction of Risk of Stroke/Systemic Embolism in NVAF
- For patients with moderate renal impairment (CrCl 30-50 mL/min), consider reducing the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
- For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA and P-gp inhibitors.
Treatment and Reduction in the Risk of Recurrence of DVT/PE
- For patients with CrCl <50 mL/min, avoid use of PRADAXA and concomitant P-gp inhibitors
The most serious adverse reactions reported with PRADAXA were related to bleeding.
- Most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding & gastrointestinal (GI) events
- PRADAXA 150 mg resulted in higher rates of major and any GI bleeds compared to warfarin.
- In patients >75 years of age, the risk of major bleeding may be greater with PRADAXA vs warfarin.
- Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer).
- Rates of any GI bleeds were higher in patients receiving PRADAXA 150 mg vs warfarin and placebo
- In the active-controlled studies, there was a higher rate of clinical myocardial infarction (MI) in PRADAXA patients [20 (0.66/100) patient-years)] vs warfarin [5 (0.17/100 patient-years)]. In the placebo-controlled study, there was similar rate of non-fatal and fatal clinical MI in PRADAXA patients [1 (0.32/100 patient-years)] vs placebo [1 (0.34/100 patient-years)].
- GI adverse reactions were similar in patients receiving PRADAXA 150 mg vs warfarin. They were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage).
Drug hypersensitivity reactions were reported in < 0.1% of patients receiving PRADAXA.
Other Measures Evaluated
In NVAF patients, a higher rate of clinical MI was reported in patients who received PRADAXA (0.7/100 patient-years for 150 mg dose) than in those who received warfarin (0.6).
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PRADAXA® is a registered trademark of Boehringer Ingelheim Pharma GmBH and Co. KG and used under license.
RE-LY® and RE-COVER® are registered trademarks of Boehringer Ingelheim International GmbH and used under license.
GLORIA™-AF and RE-COVER II™ are trademarks of Boehringer Ingelheim International GmbH and used under license.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.