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Review examines clinical, practice implications of direct-acting oral anticoagulants
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The direct-acting oral anticoagulants available in the United States, the European Union and several other regions are “a major advance” in anticoagulation therapy, according to a recent review published in the European Journal of Haematology.
“Although effective, vitamin K antagonists and heparins have limitations,” the researchers wrote. “In recent years, several direct-acting oral anticoagulants have been developed to overcome some of these limitations.”
Antonio Gomez-Outes
Antonio Gomez-Outes, MD, PhD, division of pharmacology and clinical evaluation, Medicines for Human Use, Spanish Agency for Medicines and Medical Devices, and colleagues reviewed data on four direct-acting oral anticoagulants: the direct thrombin inhibitor dabigatran etexilate (Pradaxa, Boehringer Ingelheim) and three direct-activated factor X inhibitors: rivaroxaban (Xarelto, Bayer HealthCare), apixaban (Eliquis, Bristol-Myers Squibb) and edoxaban (Lixiana/Savaysa, Daiichi-Sankyo).
Data were collected from studies that supported the current indications and from postmarketing experience. The investigators examined data on the pharmacology, efficacy, safety, and practical recommendations of these therapies, as well as ongoing studies and future perspectives.
Efficacy and safety analyses of direct-acting oral anticoagulants were based on data in the prophylaxis of venous thromboembolism (VTE) with hip or knee replacement; initial and long-term VTE treatment; extended VTE therapy, stroke and systemic embolism prevention in patients with nonvalvular atrial fibrillation; and secondary prevention of major adverse CV events after an ACS.
Practical recommendations focus on both physician adherence to guidelines, patient adherence to therapy, anticoagulant choice, measuring renal function and red blood count, managing food and drug interactions, monitoring anticoagulation activity, addressing overdose and bleeding complications, therapy timing and drug use in patients undergoing surgery, other invasive procedures or anesthesia.
Compared with vitamin K antagonists, the direct-acting oral anticoagulants have a predictable dose response and fewer interactions among drugs, the researchers found. Further, they do not require routine laboratory monitoring or parenteral administration.
However, these agents still have disadvantages, the researchers highlighted. Drawbacks include decreased efficacy in patients who are not fully compliant; lack of widely accessible, uniform monitoring tests and specific antidotes; the possibility of drug–drug interactions, specifically with p-glycoprotein and/or cytochrome P 450 3A4 inhibitors/inducers, renal dependency in elimination; and risk for bleeding.
“[Direct-acting oral anticoagulant] use according to product labeling and scientific recommendations is essential to obtain the optimal benefit from the new compounds,” the researchers wrote. “Ongoing trials will help to further refine the use of the direct-acting oral anticoagulants in particular subsets of patients within the approved indications and in new clinical settings.” – by Julia Ernst, MS
Disclosure: Gomez-Outes reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
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