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Robenacoxib versus meloxicam for the control of peri-operative pain and inflammation associated with orthopaedic surgery in cats: a randomised clinical trial.

Speranza C, Schmid V, Giraudel JM, Seewald W, King JN - BMC Vet. Res. (2015)

Bottom Line: No significant differences were detected during the follow-up treatment with robenacoxib tablets for approximately 9 days compared with placebo via clinician assessments at 28 hours and the VF, or in owner assessments on Days 1-VF.There were no significant differences in frequencies of reported adverse events, clinical observations and haematology or clinical chemistry variables between the groups.Follow-up treatment with oral robenacoxib tablets for approximately 9 days was well tolerated, but there were no differences in the efficacy scores after Day 1 compared with the group receiving meloxicam s.c. followed by placebo control.

View Article: PubMed Central - PubMed

Affiliation: Novartis Santé Animale S.A.S, Clinical Development, F-92506, Rueil Malmaison Cedex, France. cindy.speranza@novartis.com.

ABSTRACT

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used in veterinary medicine. Robenacoxib is a NSAID with high selectivity for the cyclo-oxygenase-2 enzyme. In this study, the efficacy and safety of robenacoxib were evaluated in a prospective, randomised, active- and placebo-controlled masked clinical trial in 147 cats undergoing orthopaedic surgery. Cats were randomised into two treatment groups: Group 1, robenacoxib (2 mg/kg) administered via subcutaneous (s.c.) injection before surgery, followed by robenacoxib tablets (1-2.4 mg/kg) administered post-operatively for approximately 9 days (n = 101) and Group 2, meloxicam (0.3 mg/kg) administered s.c. before surgery, followed by placebo tablets administered post-operatively for approximately 9 days (n = 46). Cats were assessed using numerical rating scales (NRSs) by clinicians before surgery and at 3, 8, 22 and 28 hours after surgery and at the final visit (VF on approximately Day 10), and daily by their owners from Day 1 to the VF.

Results: The primary end point was the global investigator score which was the sum of clinician NRSs for posture, behaviour and pain on palpation/manipulation. The efficacy of the single robenacoxib injection, assessed during 3 to 22 hours, was statistically non-inferior to meloxicam, with a relative efficacy of 1.029 (95% confidence interval, 0.847-1.231). No significant differences were detected during the follow-up treatment with robenacoxib tablets for approximately 9 days compared with placebo via clinician assessments at 28 hours and the VF, or in owner assessments on Days 1-VF. There were no significant differences in frequencies of reported adverse events, clinical observations and haematology or clinical chemistry variables between the groups.

Conclusions: Single s.c. injection of robenacoxib before surgery had non-inferior efficacy compared with meloxicam in controlling post-operative pain and inflammation in cats undergoing orthopaedic surgery. Follow-up treatment with oral robenacoxib tablets for approximately 9 days was well tolerated, but there were no differences in the efficacy scores after Day 1 compared with the group receiving meloxicam s.c. followed by placebo control.

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Related in: MedlinePlus

Mean (±SD) global investigator scores at assessment times V1 to V5. For an explanation of the global investigator scores (0 = best possible, 9 = worst possible) see Table 3.
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Fig1: Mean (±SD) global investigator scores at assessment times V1 to V5. For an explanation of the global investigator scores (0 = best possible, 9 = worst possible) see Table 3.

Mentions: The efficacy of the injectable products was assessed by comparing clinician assessments in the first 24 hours (V2 to V4). Scores were numerically but not statistically significantly lower (better) with robenacoxib for the primary end point and three of the five secondary end points (Table 6). The global investigator scores were low at all time points in both the groups and decreased with time after T1 + 3 hours (Figure 1).Table 6


Robenacoxib versus meloxicam for the control of peri-operative pain and inflammation associated with orthopaedic surgery in cats: a randomised clinical trial.

Speranza C, Schmid V, Giraudel JM, Seewald W, King JN - BMC Vet. Res. (2015)

Mean (±SD) global investigator scores at assessment times V1 to V5. For an explanation of the global investigator scores (0 = best possible, 9 = worst possible) see Table 3.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4379761&req=5

Fig1: Mean (±SD) global investigator scores at assessment times V1 to V5. For an explanation of the global investigator scores (0 = best possible, 9 = worst possible) see Table 3.
Mentions: The efficacy of the injectable products was assessed by comparing clinician assessments in the first 24 hours (V2 to V4). Scores were numerically but not statistically significantly lower (better) with robenacoxib for the primary end point and three of the five secondary end points (Table 6). The global investigator scores were low at all time points in both the groups and decreased with time after T1 + 3 hours (Figure 1).Table 6

Bottom Line: No significant differences were detected during the follow-up treatment with robenacoxib tablets for approximately 9 days compared with placebo via clinician assessments at 28 hours and the VF, or in owner assessments on Days 1-VF.There were no significant differences in frequencies of reported adverse events, clinical observations and haematology or clinical chemistry variables between the groups.Follow-up treatment with oral robenacoxib tablets for approximately 9 days was well tolerated, but there were no differences in the efficacy scores after Day 1 compared with the group receiving meloxicam s.c. followed by placebo control.

View Article: PubMed Central - PubMed

Affiliation: Novartis Santé Animale S.A.S, Clinical Development, F-92506, Rueil Malmaison Cedex, France. cindy.speranza@novartis.com.

ABSTRACT

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used in veterinary medicine. Robenacoxib is a NSAID with high selectivity for the cyclo-oxygenase-2 enzyme. In this study, the efficacy and safety of robenacoxib were evaluated in a prospective, randomised, active- and placebo-controlled masked clinical trial in 147 cats undergoing orthopaedic surgery. Cats were randomised into two treatment groups: Group 1, robenacoxib (2 mg/kg) administered via subcutaneous (s.c.) injection before surgery, followed by robenacoxib tablets (1-2.4 mg/kg) administered post-operatively for approximately 9 days (n = 101) and Group 2, meloxicam (0.3 mg/kg) administered s.c. before surgery, followed by placebo tablets administered post-operatively for approximately 9 days (n = 46). Cats were assessed using numerical rating scales (NRSs) by clinicians before surgery and at 3, 8, 22 and 28 hours after surgery and at the final visit (VF on approximately Day 10), and daily by their owners from Day 1 to the VF.

Results: The primary end point was the global investigator score which was the sum of clinician NRSs for posture, behaviour and pain on palpation/manipulation. The efficacy of the single robenacoxib injection, assessed during 3 to 22 hours, was statistically non-inferior to meloxicam, with a relative efficacy of 1.029 (95% confidence interval, 0.847-1.231). No significant differences were detected during the follow-up treatment with robenacoxib tablets for approximately 9 days compared with placebo via clinician assessments at 28 hours and the VF, or in owner assessments on Days 1-VF. There were no significant differences in frequencies of reported adverse events, clinical observations and haematology or clinical chemistry variables between the groups.

Conclusions: Single s.c. injection of robenacoxib before surgery had non-inferior efficacy compared with meloxicam in controlling post-operative pain and inflammation in cats undergoing orthopaedic surgery. Follow-up treatment with oral robenacoxib tablets for approximately 9 days was well tolerated, but there were no differences in the efficacy scores after Day 1 compared with the group receiving meloxicam s.c. followed by placebo control.

Show MeSH
Related in: MedlinePlus