PMID- 34196973 OWN - NLM STAT- MEDLINE DCOM- 20210930 LR - 20211002 IS - 1939-1676 (Electronic) IS - 0891-6640 (Print) IS - 0891-6640 (Linking) VI - 35 IP - 5 DP - 2021 Sep TI - Clinical safety of robenacoxib in cats with chronic musculoskeletal disease. PG - 2384-2394 LID - 10.1111/jvim.16148 [doi] AB - BACKGROUND: Evaluate the clinical safety of robenacoxib in cats with chronic musculoskeletal disease (CMSD). ANIMALS: Four hundred forty-nine client-owned cats with CMSD. METHODS: Pooled analysis of safety variables from 4 prospective randomized blinded clinical trials of robenacoxib (n = 222) versus placebo (n = 227), administered orally once daily for 4 to 12 weeks. Safety was evaluated from reported adverse events (AEs) and abnormalities detected on hematology and serum and urine chemistry analyses. RESULTS: The number of cats with at least 1 AE was not significantly different (P = .15) with robenacoxib (n = 106, 47.8%) compared to placebo (n = 93, 41.0%). The relative risk of at least 1 AE (incidence robenacoxib/placebo) was 1.15 (95% confidence interval 0.93-1.43). There was no significant difference between groups in the number of clinical signs (range, 0-9) per cat (P = .23). Serum creatinine concentrations were higher during robenacoxib administration compared to placebo (+4.36 mumol/L, 95% confidence interval 0.21-8.50), but no related adverse clinical effects were detected. In the subgroup of 126 cats with evidence of chronic kidney disease, the relative risk of at least 1 AE (robenacoxib/placebo) was 1.09 (95% confidence interval 0.78-1.52, P = .61). CONCLUSIONS AND CLINICAL IMPORTANCE: Robenacoxib was not associated with increased risk of AEs compared to placebo when administered for 4 to 12 weeks to cats with CMSD. The generalizability of the results to general practice is limited by the fact that cases with severe and uncontrolled concomitant diseases were not included. CI - (c) 2021 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals LLC on behalf of American College of Veterinary Internal Medicine. FAU - King, Jonathan N AU - King JN AUID- ORCID: 0000-0002-4194-9015 AD - Elanco Animal Health, Companion Animal Development, Basel, Switzerland. FAU - Seewald, Wolfgang AU - Seewald W AD - Elanco Animal Health, Companion Animal Development, Basel, Switzerland. FAU - Forster, Sophie AU - Forster S AUID- ORCID: 0000-0001-9991-5531 AD - Elanco Animal Health, Companion Animal Development, Basingstoke, UK. FAU - Friton, Gabriele AU - Friton G AUID- ORCID: 0000-0003-2654-6717 AD - Elanco Animal Health, Companion Animal Development, Basel, Switzerland. FAU - Adrian, Derek E AU - Adrian DE AUID- ORCID: 0000-0002-0226-6182 AD - Translational Research in Pain Program, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA. AD - Comparative Pain Research and Education Center, North Carolina State University, Raleigh, North Carolina, USA. FAU - Lascelles, B Duncan X AU - Lascelles BDX AUID- ORCID: 0000-0002-2950-9009 AD - Translational Research in Pain Program, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA. AD - Comparative Pain Research and Education Center, North Carolina State University, Raleigh, North Carolina, USA. AD - Thurston Arthritis Center, UNC School of Medicine, Chapel Hill, North Carolina, USA. AD - Center for Translational Pain Research, Department of Anesthesiology, Duke University, Durham, North Carolina, USA. LA - eng PT - Journal Article DEP - 20210701 PL - United States TA - J Vet Intern Med JT - Journal of veterinary internal medicine JID - 8708660 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 0 (Phenylacetates) RN - 9N3CBB0BIQ (Diphenylamine) RN - Z588009C7C (robenacoxib) SB - IM MH - Animals MH - Anti-Inflammatory Agents, Non-Steroidal/adverse effects MH - *Cat Diseases/drug therapy MH - Cats MH - Diphenylamine/adverse effects/analogs & derivatives MH - *Musculoskeletal Diseases/drug therapy/veterinary MH - Phenylacetates MH - Prospective Studies PMC - PMC8478032 OTO - NOTNLM OT - NSAID OT - adverse event OT - coxib OT - harm COIS- The studies were supported by Novartis Animal Health, now owned by Elanco Animal Health, which manufactures and distributes robenacoxib (Onsior). Jonathan N. King, Sophie Forster and Gabriele Friton are employed by, and Wolfgang Seewald is retired from, Elanco Animal Health. Derek E. Adrian was employed by North Carolina State University during the study, but has subsequently joined Elanco Animal Health. B. Duncan X. Lascelles received payment from Elanco Animal Health in the past 5 years for consultancy and speaking engagements. EDAT- 2021/07/02 06:00 MHDA- 2021/10/01 06:00 PMCR- 2021/09/01 CRDT- 2021/07/01 12:31 PHST- 2020/05/13 00:00 [received] PHST- 2021/04/23 00:00 [accepted] PHST- 2021/07/02 06:00 [pubmed] PHST- 2021/10/01 06:00 [medline] PHST- 2021/07/01 12:31 [entrez] PHST- 2021/09/01 00:00 [pmc-release] AID - JVIM16148 [pii] AID - 10.1111/jvim.16148 [doi] PST - ppublish SO - J Vet Intern Med. 2021 Sep;35(5):2384-2394. doi: 10.1111/jvim.16148. Epub 2021 Jul 1.