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Efficacy and safety of celecoxib compared with placebo and etodolac for acute postoperative pain: a multicenter, double-blind, randomized, parallel-group, controlled trial.

ABSTRACT: Celecoxib is a nonsteroidal anti-inflammatory drug (selective cyclooxygenase-2 inhibitor) that is widely used. The efficacy and safety of celecoxib for treatment of acute postoperative pain were evaluated in Japanese patients. The objective was to assess whether celecoxib showed superiority over placebo treatment and non-inferiority versus etodolac (another selective cyclooxygenase-2 inhibitor) that has been widely used for the management of acute pain. A multicenter, double-blind, randomized, parallel-group, controlled study was performed, in which 616 patients with postoperative pain received celecoxib, etodolac, or placebo. Their impressions of study drug efficacy (overall assessment) and pain intensity were evaluated. Based on each patient's overall assessment of pain, the efficacy rate was 63.7% in the placebo group, 76.2% in the celecoxib group, and 68.0% in the etodolac group, with these results demonstrating superiority of celecoxib to placebo and noninferiority versus etodolac. The efficacy rate was significantly higher in the celecoxib group than in the etodolac group. There were no adverse events specific to celecoxib, and the safety of celecoxib was similar to that of placebo. Celecoxib was superior to etodolac for controlling acute postoperative pain.

SUBMITTER: Ishiguro N

PROVIDER: S-EPMC4361510 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Efficacy and safety of celecoxib compared with placebo and etodolac for acute postoperative pain: a multicenter, double-blind, randomized, parallel-group, controlled trial.

Ishiguro Naoki N Hanaoka Akio A Okada Toshiyuki T Ito Masanori M

Nagoya journal of medical science 20150201 1-2

Celecoxib is a nonsteroidal anti-inflammatory drug (selective cyclooxygenase-2 inhibitor) that is widely used. The efficacy and safety of celecoxib for treatment of acute postoperative pain were evaluated in Japanese patients. The objective was to assess whether celecoxib showed superiority over placebo treatment and non-inferiority versus etodolac (another selective cyclooxygenase-2 inhibitor) that has been widely used for the management of acute pain. A multicenter, double-blind, randomized, p ...[more]

PMID: 25797973

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Project description:ObjectiveTo determine the efficacy and safety of fremanezumab administration in Japanese and Korean patients with chronic migraine (CM).BackgroundAvailable preventive treatments for CM are limited by various efficacy and safety issues. Fremanezumab, a monoclonal antibody that targets the calcitonin gene-related peptide pathway involved in migraine pathogenesis, has been shown to be effective and well tolerated in large-scale, international Phase 3 trials.MethodsRandomized, placebo-controlled trial of patients with CM who received subcutaneous fremanezumab monthly (675 mg at baseline and 225 mg at weeks 4 and 8), fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), or matching placebo. Primary endpoint was the mean change from baseline in the monthly (28-day) average number of headache days of at least moderate severity during the 12 weeks after the first dose.ResultsAmong 571 patients randomized (safety set, n = 569; full analysis set, n = 566), the least-squares mean (±standard error [SE]) reduction in the average number of headache days of at least moderate severity per month during 12 weeks was significantly greater with fremanezumab monthly (-4.1 ± 0.4) and fremanezumab quarterly (-4.1 ± 0.4) than with placebo (-2.4 ± 0.4). The difference from the placebo group in the mean change (95% confidence interval [CI]) was -1.7 days (-2.54, -0.80) for the fremanezumab monthly group and -1.7 days (-2.55, -0.82) for the fremanezumab quarterly group (p < 0.001 vs. placebo for both fremanezumab groups). The percentage of patients with a ≥50% reduction in the average number of headache days of at least moderate severity per month (response rate) was higher with fremanezumab monthly (29.0%) and fremanezumab quarterly (29.1%) than with placebo (13.2%) in addition to other improvements in secondary endpoints, including reduction of acute medication use (mean change from baseline during 12-week period ± SE: fremanezumab monthly, -3.7 ± 0.4; fremanezumab quarterly, -3.9 ± 0.4; placebo, -2.4 ± 0.4) and improvements in disability scores (mean change from baseline in six-item Headache Impact Test score at 4 weeks after third injection ± SE: fremanezumab monthly, -8.1 ± 0.7; fremanezumab quarterly, -8.0 ± 0.7; placebo, -6.5 ± 0.7). Fremanezumab was well tolerated with a similar incidence of adverse events including injection-site reactions as placebo (patients with at least one treatment-emergent adverse event: fremanezumab total, n = 232 [61.4%]; placebo, n = 118 [61.8%]).ConclusionFremanezumab effectively prevents CM in Japanese and Korean patients and was well tolerated. No safety signal was detected.

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Dataset Information

Efficacy and safety of celecoxib compared with placebo and etodolac for acute postoperative pain: a multicenter, double-blind, randomized, parallel-group, controlled trial.

Publications

Efficacy and safety of celecoxib compared with placebo and etodolac for acute postoperative pain: a multicenter, double-blind, randomized, parallel-group, controlled trial.

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