Dabigatran Etexilate with Cilostazol Interaction Details
Brand Names Associated with Dabigatran Etexilate
- Dabigatran
- Pradaxa®
Brand Names Associated with Cilostazol
- Cilostazol
- Pletal®
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Jan 08, 2024
Interaction Effect
Increased risk of bleeding
Interaction Summary
Dabigatran etexilate treatment can cause significant and, sometimes, fatal bleeding. Risk is further increased with concomitant use of drugs that also increase the risk of bleeding, including antiplatelet agents. Coadministration of direct oral anticoagulant (DOAC; including dabigatran) and prescription antiplatelet therapy (predominantly clopidogrel) resulted in increased risk of major hemorrhage in a study of elderly patients who received a coronary artery stent compared with antiplatelet therapy alone , but coadministration of a DOAC (including dabigatran) and antiplatelet therapy (predominantly low-dose aspirin) did not significantly alter the incidence of major bleeding or clinically relevant non-major bleeding compared to DOAC therapy alone in another study of patients with VTE or atrial fibrillation . Promptly evaluate any signs or symptoms of blood loss (eg, a drop in Hb and/or HCT or hypotension) and discontinue use of dabigatran etexilate in patients with active pathological bleeding .
Severity
Major
Onset
Unspecified
Evidence
Theoretical
How To Manage Interaction
Dabigatran etexilate increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Risk is further increased with concomitant use of drugs that also increase the risk of bleeding, including antiplatelet agents. Promptly evaluate any signs or symptoms of blood loss (eg, a drop in hemoglobin and/or hematocrit or hypotension) and discontinue use of dabigatran etexilate in patients with active pathological bleeding.
Mechanism Of Interaction
Additive effects on hemostasis
Literature Reports
A) Concomitant use of direct oral anticoagulant (DOAC) and antiplatelet therapy (APT; n=78) compared to DOAC therapy alone (n=329) did not significantly alter the incidence of major bleeding (1.3% vs 1.2%) or clinically relevant non-major bleeding (10.2% vs 6.4%) over 6 months of treatment in a retrospective study. Patients were primarily Caucasian men with a mean age of 63.7 years. Patients receiving concurrent APT had significantly higher mean body mass index (30.7 vs 28.4), mean CHA2DS2-VASc score (4.28 vs 3.85), and were more likely to have diabetes (26.9% vs 17.3%) compared with those prescribed DOAC monotherapy. DOACs were prescribed for VTE treatment or atrial fibrillation, and included apixaban (58.5%), rivaroxaban (38.1%), and dabigatran (3.4%). Single antiplatelet therapy was utilized in 94.9% (74 patients), with aspirin 81 mg once daily as the most common regimen (69 patients). Other APT regimens included aspirin 81 mg twice daily (3 patients), aspirin 325 mg daily (1 patient), clopidogrel 75 mg daily (1 patient), and dual APT with aspirin 81 mg and clopidogrel 75 mg daily (4 patients) .
B) In a retrospective study of patients 65 years or older who received a coronary artery stent (N=70,900), coadministration of direct oral anticoagulant (DOAC; dabigatran or rivaroxaban) and prescription antiplatelet therapy (predominantly clopidogrel) significantly increased the risk of major hemorrhagic events compared with antiplatelet therapy alone (HR, 2.36; 95% CI, 1.91 to 2.93) over 12 months following stent placement; this risk was similar to coadministration of warfarin and antiplatelets (HR, 2; 95% CI, 1.83 to 2.18). When patients were stratified by index atrial fibrillation (AF) status, the risk of major hemorrhagic events was also significantly increased with coadministration of DOAC and antiplatelet therapy for both AF (HR, 1.94; 95% CI, 1.48 to 2.54; n=10,238) and non-AF groups (HR, 3.09; 95% CI, 2.15 to 4.46; n=60,662). Hemorrhages in the first 30 days after stenting were considered periprocedural morbidity and excluded. The average observation period was 11.5 months, with 24.470,270 person-days of exposure; antiplatelet only therapy accounted for 73.8% of person-days of exposure, antiplatelets plus DOACs for 0.6%, and antiplatelets plus warfarin for 4.7% .
Dabigatran Etexilate Overview
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Dabigatran is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in adults and children 3 months of age and older who have been treated with an injectable anticoagulant ('blood thinner'). It is also used to reduce the risk of a DVT and PE from happening again after initial treatment is completed in adults and children 3 months of age and older. Dabigatran is used to help prevent DVT and PE in adults who have had hip replacement surgery. Dabigatran is also used to help prevent strokes or serious blood clots in adults who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.
Cilostazol Overview
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Cilostazol is used to reduce the symptoms of intermittent claudication (pain in the legs that worsens when walking and improves when resting that is caused by narrowing of the blood vessels that supply blood to the legs). Cilostazol is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs.
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Definitions
Severity Categories
Contraindicated
These drugs, generally, should not be used together simultaneously due to the high risk of severe adverse effects. Combining these medications can lead to dangerous health outcomes and should be strictly avoided unless otherwise instructed by your provider.
Major
This interaction could result in very serious and potentially life-threatening consequences. If you are taking this drug combination, it is very important to be under close medical supervision to minimize severe side effects and ensure your safety. It may be necessary to change a medication or dosage to prevent harm.
Moderate
This interaction has the potential to worsen your medical condition or alter the effectiveness of your treatment. It's important that you are monitored closely and you potentially may need to make adjustments in your treatment plan or drug dosage to maintain optimal health.
Minor
While this interaction is unlikely to cause significant problems, it could intensify side effects or reduce the effectiveness of one or both medications. Monitoring for changes in symptoms and your condition is recommended, and adjustments may be made if needed to manage any increased or more pronounced side effects.
Onset
Rapid: Onset of drug interaction typically occurs within 24 hours of co-administration.
Delayed: Onset of drug interaction typically occurs more than 24 hours after co-administration.
Evidence
Level of documentation of the interaction.
Established: The interaction is documented and substantiated in peer-reviewed medical literature.
Theoretical: This interaction is not fully supported by current medical evidence or well-documented sources, but it is based on known drug mechanisms, drug effects, and other relevant information.
How To Manage The Interaction
Provides a detailed discussion on how patients and clinicians can approach the identified drug interaction as well as offers guidance on what to expect and strategies to potentially mitigate the effects of the interaction. This may include recommendations on adjusting medication dosages, altering the timing of drug administration, or closely monitoring for specific symptoms.
It's important to note that all medical situations are unique, and management approaches should be tailored to individual circumstances. Patients should always consult their healthcare provider for personalized advice and guidance on managing drug interactions effectively.
Mechanism Of Interaction
The theorized or clinically determined reason (i.e., mechanism) why the drug-drug interaction occurs.
Disclaimer: The information provided on this page is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare professional regarding your specific circumstances and medical conditions.
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Information for our drug interactions is compiled from several drug compendia, including:
The prescribing information for each drug, as published on DailyMED, is also used.
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