Translational Research in Pain (TRiP) Program, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC, USA.
Elanco Animal Health, Greenfield, USA.
Sci Rep. 2021 Apr 8;11(1):7721. doi: 10.1038/s41598-021-87023-2.
The main objective of this pilot clinical trial was to evaluate outcome measures for the assessment of the nonsteroidal anti-inflammatory drug (NSAID) robenacoxib in cats with degenerative joint disease-associated pain (DJD-pain). Otherwise healthy cats (n = 109) with DJD-pain entered a parallel group, randomized, blinded clinical trial. Cats received placebo (P) or robenacoxib (R) for two consecutive 3-week periods. Treatment groups were PP, RR, and RP. Actimetry and owner-assessment data were collected. Data were analyzed using mixed-effects and generalized mixed-effects linear models. Activity data showed high within-cat and between-cat variability, and 82.4% of the values were zero. Compared to placebo, mean total activity was higher (5.7%) in robenacoxib-treated cats (p = 0.24); for the 80th percentile of activity, more robenacoxib-treated cats had a > 10% increase in activity after 3 (p = 0.046) and 6 weeks (p = 0.026). Robenacoxib treatment significantly decreased owner-assessed disability, (p = 0.01; 49% reduction in disability; effect size ~ 0.3), and improved temperament (p = 0.0039) and happiness (p = 0.021) after 6 weeks. More robenacoxib-treated cats were successes at 6 weeks (p = 0.018; NNT: 3.8). Adverse effect frequencies were similar across groups. Results identified suitable endpoints for confirmatory studies, while also indicating efficacy of robenacoxib in cats with DJD-pain.
本临床试验的主要目的是评估非甾体抗炎药(NSAID)罗非考昔治疗与退行性关节病相关疼痛(DJD-疼痛)的猫的疗效评估指标。 109 只健康状况良好的 DJD-疼痛猫进入平行组、随机、双盲临床试验。猫接受安慰剂(P)或罗非考昔(R)连续治疗 3 周。治疗组为 PP、RR 和 RP。收集活动计和主人评估数据。使用混合效应和广义混合效应线性模型进行数据分析。活动数据显示出高的个体内和个体间变异性,82.4%的数值为零。与安慰剂相比,罗非考昔治疗猫的总活动平均值更高(5.7%)(p=0.24);对于活动的第 80 个百分位数,更多罗非考昔治疗猫在 3 周(p=0.046)和 6 周(p=0.026)后活动增加超过 10%。罗非考昔治疗后,猫的主人评估残疾(p=0.01;残疾减少 49%;效应大小~0.3)、性情(p=0.0039)和幸福感(p=0.021)显著改善。6 周时,更多的罗非考昔治疗猫获得成功(p=0.018;NNH:3.8)。各组的不良反应频率相似。研究结果确定了适合验证性研究的终点,同时也表明罗非考昔治疗 DJD-疼痛猫的疗效。