Clinical safety of robenacoxib in cats with chronic musculoskeletal disease.

Abstract

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 μmol/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.