Elderly Medicare Study
Real-World Study including PRADAXA and rivaroxaban
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 common adverse reactions reported with PRADAXA were related to gastritis-like symptoms and 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.
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Discussion of Off-Label Uses and Investigational Products
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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.