title: Prothrombin complex concentrates as reversal agents for new oral anticoagulants: lessons from preclinical studies with Beriplex.
abstract: Although new oral anticoagulants (NOACs) represent an advance in anticoagulant therapy over vitamin K antagonists (VKAs), they nevertheless have a low, but significant risk for bleeding complications. Reversal agents for VKAs, such as prothrombin complex concentrates (PCCs), are currently being evaluated in preclinical studies for NOAC reversal. This article reviews the preclinical data for the most extensively studied PCC for NOAC reversal, Beriplex, a 4-factor PCC. The results from the Beriplex studies are also compared with those obtained with other reversal agents, including different nonactivated PCCs, activated PCCs, and recombinant activated factor VII.
authors.affiliation: CSL Behring, Preclinical R&D, PO Box 1230, Marburg 35002, Germany. Electronic address: Gerhard.Dickneite@cslbehring.com.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Dickneite
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry / Q000494:pharmacology; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000494:pharmacology; D001777:Blood Coagulation / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004353:Drug Evaluation, Preclinical; D005164:Factor IX / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D005167:Factor VII / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D005170:Factor X / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000494:pharmacology; D006470:Hemorrhage / Q000139:chemically induced / Q000188:drug therapy*; D006487:Hemostasis / Q000187:drug effects; D006490:Hemostatics / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008954:Models, Biological; D011516:Prothrombin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D004338:Drug Combinations; D065427:Factor Xa Inhibitors; D006490:Hemostatics; C525441:factor IX, factor VII, factor X, prothrombin drug combination; D005167:Factor VII; D011516:Prothrombin; D005164:Factor IX; D005170:Factor X
keywords: Anticoagulant reversal; Beriplex; New oral anticoagulants; Prothrombin complex concentrate