Edamura Kazuya, King Jonathan N, Seewald Wolfgang, Sakakibara Nobuhiro, Okumura Masahiro
Laboratory of Veterinary Surgery, Department of Veterinary Medicine, College of Bioresource Sciences, Nihon University, 1866 Kameino, Fujisawa, Kanagawa 252-0880, Japan.
J Vet Med Sci. 2012 Sep;74(9):1121-31. doi: 10.1292/jvms.11-0529. Epub 2012 May 17.
The efficacy and tolerability of robenacoxib for the treatment of osteoarthritis in dogs were evaluated in a prospective, multicenter, randomized, noninferiority design clinical trial. A total of 32 dogs presenting with osteoarthritis were allocated randomly to receive, orally once daily for 28 days, either 1-2 mg/kg robenacoxib (n=21) or 3.5-5 mg/kg carprofen (n=11). Dogs were assessed by clinicians and owners using numerical rating scale scores at baseline and days 14 and 28. The primary efficacy endpoint was the global functional disability score, which was the sum of clinician scores for standing posture, lameness at walk, lameness at trot, willingness to raise the contralateral limb and pain at palpation. There was a good to excellent level of efficacy in both treatment groups. Differences between days 14 and 28 compared to day 0 were significant for all 11 clinician and owner scores for robenacoxib, and for 6 of 11 scores for carprofen. The efficacy of robenacoxib was numerically superior to carprofen for all 13 endpoints, but differences were not statistically significant. For the global functional disability score, the estimated efficacy of robenacoxib was 1.244 (95% confidence interval 0.555-2.493) relative to carprofen. The tolerability of both treatments was good as assessed from adverse events, clinical signs, and hematology and serum biochemistry variables. In conclusion, once daily administration of robenacoxib tablets had noninferior efficacy and tolerability compared to carprofen for the treatment of the clinical signs of osteoarthritis in dogs.
在一项前瞻性、多中心、随机、非劣效性设计的临床试验中,评估了罗贝考昔治疗犬骨关节炎的疗效和耐受性。共有32只患有骨关节炎的犬被随机分配,每天口服一次,持续28天,分别给予1-2mg/kg罗贝考昔(n=21)或3.5-5mg/kg卡洛芬(n=11)。在基线、第14天和第28天,由临床医生和犬主使用数字评分量表对犬进行评估。主要疗效终点是整体功能残疾评分,该评分是临床医生对站立姿势、行走跛行、小跑跛行、抬起对侧肢体的意愿以及触诊疼痛的评分总和。两个治疗组的疗效均为良好至优秀水平。与第0天相比,罗贝考昔的所有11项临床医生和犬主评分以及卡洛芬的11项评分中的6项在第14天和第28天的差异均具有统计学意义。在所有13个终点上,罗贝考昔在数值上的疗效均优于卡洛芬,但差异无统计学意义。对于整体功能残疾评分,相对于卡洛芬,罗贝考昔的估计疗效为1.244(95%置信区间0.555-2.493)。从不良事件、临床体征以及血液学和血清生化变量评估,两种治疗的耐受性均良好。总之,与卡洛芬相比,每日一次服用罗贝考昔片在治疗犬骨关节炎临床症状方面具有非劣效的疗效和耐受性。