Randomised double blind trial of etoricoxib and indometacin in treatment of acute gouty arthritis

Abstract

Objective To assess the safety and efficacy of etoricoxib, a selective cyclo-oxygenase-2 inhibitor, in comparison with indometacin in the treatment of acute gouty arthritis. Design Randomised, double blind, active comparator controlled trial. Setting 43 outpatient study centres in 11 countries. Participants 142 men and eight women (75 patients per treatment group) aged 18 years or over presenting with clinically diagnosed acute gout within 48 hours of onset. Interventions Etoricoxib 120 mg administered orally once daily versus indometacin 50 mg administered orally three times daily, both for 8 days Main outcome measures Patients' assessment of pain in the study joint over days 2 to 5 (primary end point); investigators' and patients' global assessments of response to treatment and tenderness of the study joint (key secondary end points). Results Etoricoxib showed efficacy comparable to indometacin. Patients' assessment of pain in the study joint (0-4 point Likert scale, "no pain" to "extreme pain") over days 2 to 5 showed a least squares mean change from baseline of − 1.72 (95% confidence interval − 1.90 to − 1.55) for etoricoxib and − 1.83 ( − 2.01 to − 1.65) for indometacin. The difference between treatment groups met prespecified comparability criteria. All other efficacy end points, including those reflecting reduction in inflammation and analgesia, provided corroborative evidence of comparable efficacy. Significant pain relief was evident at the first measurement, 4 hours after the first dose of treatment. Prespecified safety analyses revealed that drug related adverse experiences occurred significantly less frequently with etoricoxib (22.7%) than with indometacin (46.7%) (P=0.003), although overall adverse experience rates were similar between the two treatment groups. Conclusion Etoricoxib 120 mg once daily provides rapid and effective treatment for acute gouty arthritis comparable to indometacin 50 mg three times daily. Etoricoxib was generally safe and well tolerated in this study.

Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout: A randomized controlled trial

“…Etoricoxib, a selective inhibitor of COX-2, was designed to provide analgesic and antiinflammatory effects with decreased GI side effects (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). A previous study of etoricoxib in acute gout demonstrated efficacy comparable to that of indomethacin (28). The present study, the largest study of gout reported to date, confirms and extends these results, showing that etoricoxib at a daily dose of 120 mg achieved comparable reductions in pain and inflammation and was associated with a lower incidence of adverse experiences than indomethacin at a daily dose of 150 mg.…”

“…Etoricoxib, a highly selective COX-2 inhibitor, has shown antiinflammatory, analgesic, and antipyretic activity in models of acute and chronic pain and inflammation (25)(26)(27). In a recently reported 8-day active-comparator-controlled study of etoricoxib versus indomethacin in the treatment of acute gout, etoricoxib was shown to be comparable to indomethacin in terms of the patient's assessment of pain, as well as the patient's and investigator's global assessments of response to therapy (28). The present study was designed to replicate and confirm the efficacy of a single daily dose of 120 mg of etoricoxib in the treatment of acute gout, as compared with 50 mg of indomethacin taken 3 times a day, and to provide additional safety data in patients with acute gout.…”

Þvagsýrugigt - læknanleg liðbólga

“…Þau slá á verki og liðbólgu ásamt því að baeta starfsgetu liðar-ins. 43 Lyfin hafa svipaða virkni en COX-2 hemlar hafa líklega minni aukaverkanir í meltingarvegi. Nota þarf hámarksskammta og halda áfram meðferð í nokkra daga eftir að einkenni bráðrar liðbólgu hafa gengið yfir.…”

Use of etoricoxib in patients with gout in real clinical practice

“…Было проведено 2 двойных слепых рандомизирован-ных 7-дневных контролируемых исследования, в которых сравнивали эторикоксиб и индометацин у пациентов с ата-кой острого подагрического артрита [10,11]. В первое ис-следование вошло 150 пациентов (11 стран), во второе -189 пациентов (8 стран).…”