title: Clinical safety of robenacoxib in feline osteoarthritis: results of a randomized, blinded, placebo-controlled clinical trial.
abstract: The objective of this study was to evaluate the clinical safety of the non-steroidal anti-inflammatory drug (NSAID) robenacoxib in cats with osteoarthritis. Degenerative joint disease, including osteoarthritis, is highly prevalent in cats and many cases have associated pain and impaired mobility. Although NSAIDs are used routinely to control pain and inflammation in cats with osteoarthritis, there are safety concerns because of the high concurrent prevalence of chronic kidney disease (CKD) and the paucity of data on the safety of these drugs in target clinical populations.
  
  
  
  A total of 194 cats with osteoarthritis were recruited and randomly allocated to receive either robenacoxib at a dosage of 1.0-2.4 mg/kg (n = 95) or placebo (n = 99) tablets PO q24h for 28 days. Safety was assessed in 193 cats, including a subgroup of 40 animals with concurrent CKD, defined as serum creatinine concentration ⩾1.6 mg/dl and urine specific gravity <1.030. Safety endpoints included reports of adverse events, results of clinical examinations, including body weight, and clinical chemistry and hematology variables.
  
  
  
  In all 193 cats and the subgroup of 40 animals with concurrent CKD, there were no differences between groups in frequencies of reported adverse events, body weight change or results of serum or urine chemistry or hematology variables.
  
  
  
  Robenacoxib was well tolerated when administered daily for 1 month in cats with osteoarthritis, including cats with evidence of concurrent CKD. There was no clinical indication of damage to the gastrointestinal tract, kidney or liver.
authors.affiliation: Elanco Animal Health, Clinical Development, Basel, Switzerland jonathan.king@novartis.com.
authors.forename: Jonathan N
authors.initials: JN
authors.lastname: King
authors.affiliation: Elanco Animal Health, New Product Development, Greensboro, NC, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: King
authors.affiliation: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Budsberg
authors.affiliation: Comparative Pain Research Laboratory, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC, USA Center for Comparative Medicine and Translational Research, North Carolina State University, Raleigh, NC, USA Center for Pain Research and Innovation, School of Dentistry, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: B Duncan X
authors.initials: BD
authors.lastname: Lascelles
authors.affiliation: Elanco Animal Health, New Product Development, Greensboro, NC, USA Current address: AlcheraBio LLC, Clinical Services, Edison, NJ, USA.
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Bienhoff
authors.affiliation: Elanco Animal Health, New Product Development, Greensboro, NC, USA.
authors.forename: Linda M
authors.initials: LM
authors.lastname: Roycroft
authors.affiliation: Elanco Animal Health, New Product Development, Greensboro, NC, USA.
authors.forename: Elizabeth S
authors.initials: ES
authors.lastname: Roberts
mesh_terms: D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D002371:Cat Diseases / Q000188:drug therapy*; D002415:Cats; D004159:Diphenylamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010003:Osteoarthritis / Q000188:drug therapy / Q000662:veterinary*; D010648:Phenylacetates / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010648:Phenylacetates; D004159:Diphenylamine; C551524:robenacoxib