Giraudel Jerome M, Gruet Philippe, Alexander Debbie G, Seewald Wolfgang, King Jonathan N
Novartis Centre de Recherche Santé Animale SA, CH-1566 StAubin FR, Switzerland.
Am J Vet Res. 2010 Jul;71(7):710-9. doi: 10.2460/ajvr.71.7.710.
To evaluate the efficacy and tolerability of oral administration of robenacoxib for treatment of acute pain and inflammation associated with musculoskeletal disorders in cats.
155 cats requiring relief of signs of pain and inflammation associated with acute musculoskeletal disorders.
The study was a multicenter, prospective, randomized, masked, noninferiority field trial. Cats were allocated randomly to 1 of 3 treatment groups: group 1 (1.0 to 2.4 mg of robenacoxib/kg, q 24 h), group 2 (1.0 to 2.4 mg of robenacoxib/kg, q 12 h [daily dosage, 2.0 to 4.8 mg/kg]), and group 3 (ketoprofen [mean dosage, 1 mg/kg, q 24 h]). All cats were administered tablets PO for 5 or 6 days. The primary efficacy endpoint was the investigator global assessment score, which was the sum of scores of signs of pain, inflammation, and mobility assessed in a masked manner by veterinary investigators at baseline, day 2, and day 4 or 5. Cat owners monitored in a nonmasked manner secondary responses by observation of cats' activity, behavior, appetite, and interactions. Safety was assessed by monitoring adverse events, clinical signs, and hematologic and plasma biochemical variables (before and after treatment).
No significant differences were detected among the 3 treatment groups for any primary or secondary efficacy endpoints or for tolerability variables. Robenacoxib tablets administered once daily were significantly more palatable than ketoprofen tablets.
Robenacoxib tablets administered once daily had noninferior efficacy and tolerability, and superior palatability, compared with the active control drug, ketoprofen, for the treatment of signs of acute pain and inflammation associated with musculoskeletal disorders in cats.
评估口服罗贝考昔治疗猫肌肉骨骼疾病相关急性疼痛和炎症的疗效及耐受性。
155只需要缓解与急性肌肉骨骼疾病相关疼痛和炎症体征的猫。
本研究为多中心、前瞻性、随机、双盲、非劣效性现场试验。猫被随机分配至3个治疗组之一:第1组(罗贝考昔1.0至2.4毫克/千克,每24小时一次),第2组(罗贝考昔1.0至2.4毫克/千克,每12小时一次[日剂量,2.0至4.8毫克/千克]),第3组(酮洛芬[平均剂量,1毫克/千克,每24小时一次])。所有猫口服给药5或6天。主要疗效终点为研究者整体评估评分,该评分是兽医研究者在基线、第2天以及第4或5天以双盲方式评估的疼痛、炎症和活动度体征评分之和。猫主人以非双盲方式通过观察猫的活动、行为、食欲和互动来监测次要反应。通过监测不良事件、临床体征以及血液学和血浆生化指标(治疗前后)评估安全性。
在任何主要或次要疗效终点以及耐受性变量方面,3个治疗组之间均未检测到显著差异。每日给药一次的罗贝考昔片比酮洛芬片口感更佳。
与活性对照药物酮洛芬相比,每日给药一次的罗贝考昔片在治疗猫肌肉骨骼疾病相关急性疼痛和炎症体征方面具有非劣效的疗效和耐受性,且口感更佳。