title: Evaluation of the safety and tolerability of rivaroxaban in dogs with presumed primary immune-mediated hemolytic anemia.
abstract: OBJECTIVE
  To evaluate the safety and tolerability of rivaroxaban (RIV), an oral direct factor Xa inhibitory drug, in dogs with presumed primary immune-mediated hemolytic anemia (pIMHA).
  
  
  METHODS
  Prospective, multicenter, positive-controlled, unblinded clinical trial. Client-owned dogs were enrolled between October 2012 and March 2014.
  
  
  METHODS
  Private referral centers.
  
  
  METHODS
  Twenty-four client-owned dogs with pIMHA. Enrolled dogs were randomized in 2 treatment groups to receive by mouth RIV or clopidogrel (CL) and low-dose aspirin (LDA). All dogs were monitored for 90 days from the enrollment in the study.
  
  
  METHODS
  Enrolled dogs were given a standardized immunosuppressive protocol and RIV or CL and LDA.
  
  
  RESULTS
  There was no identifiable adverse drug reaction, evidence of hemorrhage, significant prolongation of prothrombin time or activated partial thromboplastin time, or increase in transfusion requirements associated with RIV therapy compared to CL and LDA in dogs with pIMHA. There was no significant difference between treatment groups with respect to thrombotic events, survival rates to discharge, at 1 month and 3 months from diagnosis.
  
  
  CONCLUSIONS
  This study suggests that RIV at a median dose of 0.89 mg/kg by mouth once daily was safe and well tolerated in a small group of dogs with presumed pIMHA able to tolerate oral medications and treated with a standardized immunosuppressive treatment protocol. Conclusions regarding the relative efficacy of RIV as compared to CL and LDA cannot be made due to the small size of the treatment groups and because pharmacodynamic effects were not assessed.
authors.affiliation: Internal Medicine Department, College of Veterinary Medicine, Washington State University, Pullman, WA, 99165.
authors.forename: Alice
authors.initials: A
authors.lastname: Morassi
authors.affiliation: Internal Medicine Department, Advanced Critical Care Emergency and Specialty Services, Woodland Hills, CA, 91364.
authors.forename: Domenico
authors.initials: D
authors.lastname: Bianco
authors.affiliation: Emergency and Critical Care Department, Fresno Veterinary Specialty and Emergency Center, Fresno, CA, 93719.
authors.forename: Ed
authors.initials: E
authors.lastname: Park
authors.affiliation: Cardiology Department, Southern California Veterinary Specialty Hospital, Irvine, CA, 92614.
authors.forename: Reid K
authors.initials: RK
authors.lastname: Nakamura
authors.affiliation: Emergency and Critical Care Department, Fresno Veterinary Specialty and Emergency Center, Fresno, CA, 93719.
authors.forename: George A
authors.initials: GA
authors.lastname: White
mesh_terms: D000284:Administration, Oral; D000744:Anemia, Hemolytic, Autoimmune / Q000188:drug therapy / Q000662:veterinary*; D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D001241:Aspirin / Q000008:administration & dosage / Q000627:therapeutic use*; D002140:California; D004283:Dog Diseases / Q000188:drug therapy*; D004285:Dogs; D004359:Drug Therapy, Combination; D005260:Female; D008297:Male; D011446:Prospective Studies; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014861:Washington
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000069552:Rivaroxaban; D001241:Aspirin
keywords: IMHA; anticoagulant; fXa inhibitor; pulmonary thromboembolism