Elderly Medicare Study
Real-World Study including PRADAXA and rivaroxaban
Learn the results of an observational, retrospective study, which included PRADAXA and rivaroxaban, assessing primary outcomes of thromboembolic stroke, intracranial hemorrhage, major extracranial bleeding (including major gastrointestinal bleeds), and mortality.
There are no randomized head-to-head comparisons of PRADAXA and rivaroxaban for safety and efficacy.
INDICATIONS AND USAGE
Pradaxa® (dabigatran etexilate mesylate) capsules is indicated:
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
PRADAXA is contraindicated in patients with:- active pathological bleeding;
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 and restart PRADAXA as soon as medically appropriate.
Risk of Bleeding
- For emergency surgery/urgent procedures
- In life-threatening or uncontrolled bleeding
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
Treatment and Reduction in the Risk of Recurrence of DVT/PE & Prophylaxis of DVT/PE Following Hip Replacement Surgery
The most serious adverse reactions reported with PRADAXA were related to bleeding.
DVT/PE After Hip Replacement Surgery
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).
USE IN SPECIFIC POPULATIONS
Pregnancy: The limited available data on PRADAXA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.
Lactation: Breastfeeding is not recommended.
Geriatric: Risk of bleeding increases with age.
CL-PX-100007 March 2018
COPYRIGHT (C) 2018 BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ALL RIGHTS RESERVED
The opinions, ideas, and recommendations expressed in this educational activity are those of the faculty only and are not necessarily endorsed by, nor do they necessarily reflect, those of their affiliated institutions, pmiCME, pmiCME Advisory Boards and Consultants, DBC Pri-Med, LLC.
Clinical judgment must guide each clinician in weighing the possible risks, benefits, or contraindications of any diagnostics, interventions or treatments discussed. Clinicians should review manufacturers’ product information and consider these with the recommendations of other authorities when applying the assessment and/or clinical management strategies discussed in this activity to the care of their patients.
pmiCME educational activities are developed and conducted in accordance with the ACCME's Essential Areas and Policies. It is the mission of pmiCME to develop and present educational activities that are timely, fair-balanced, scientifically rigorous, and that serve to improve patient outcomes. To that end, we welcome your comments about how to better serve your needs.
pmiCME Accredited Provider
Pri-Med programs are owned and operated by DBC Pri-Med, LLC, a division of Diversified Communications, Inc. pmiCME, the accredited division of Pri-Med, is accredited with commendation by the ACCME and approved as a provider of continuing education by the AANP. pmiCME is the accredited provider for this activity.
Disclosures and Conflict of Interest
pmiCME requires all individuals in a position to influence educational content for pmiCME-certified CME activities to disclose relevant personal financial relationships with commercial interests prior to contributing to its educational activities. pmiCME assesses disclosed relationships and follows a defined process to resolve real or implied conflicts to ensure, to the best of its ability, that all educational content is free of commercial bias. Financial disclosures are listed in the activity syllabus and will also be printed on the slides and announced at the start of each presentation.
Discussion of Off-Label Uses and Investigational Products
During the course of their presentations, the faculty may mention uses of products that have not been approved in the United States for the indication(s) being discussed. All presenters are instructed to notify participants when they are discussing unapproved uses or investigational agents. In addition, specific slides will include notation of the off-label use or investigational agent being discussed. Views presented related to unapproved uses of products are solely those of the presenter(s) and are not endorsed by pmiCME or DBC Pri-Med, LLC.
Questions? If you have questions about this activity, please email email@example.com or call (877) 477-4633.