Evaluation of the efficacy and safety of etoricoxib compared with naproxen in two, 138-week randomised studies of patients with osteoarthritis

Abstract

Objectives: To assess the efficacy and safety of etoricoxib 60 mg once daily and naproxen 500 mg twice daily over a 138-week treatment period in patients with osteoarthritis (OA). Methods: Two 1-year randomised, double blind, parallel group two-part base studies (part I 12 weeks; part II 40 weeks), followed by an 86-week extension, in patients with OA (hip or knee) were conducted at 80 clinical centres (19 countries). The studies had identical designs. Patients taking placebo in part I received etoricoxib or naproxen (1:1 ratio) in part II and the extension; patients taking etoricoxib or naproxen in part I continued to receive the same treatment throughout the entire length of the studies. Co-primary efficacy end points were patient global assessment of disease status, and WOMAC questionnaire pain subscale and physical function subscale (100 mm VAS). Efficacy over 138 weeks was assessed by graphical analysis. Safety was assessed by observation of adverse experiences and laboratory and physical evaluations. Results: 997 patients entered (615 completed) the base studies. Of these patients, 463 patients entered the extensions. A total of 161 and 152 patients in the etoricoxib and naproxen groups, respectively, completed 138 treatment weeks. Etoricoxib and naproxen showed similar efficacy throughout the 138 weeks of treatment. For etoricoxib and naproxen, respectively, WOMAC pain assessments were 67 and 67 mm (baseline); 28 and 29 mm (1 year), and 34 and 33 mm (138 weeks). Results for the other efficacy end points were similar to those seen with the WOMAC pain assessments. Both etoricoxib and naproxen were generally well tolerated. Conclusion: Both etoricoxib and naproxen demonstrated long-term clinical efficacy for the treatment of OA. Etoricoxib and naproxen were generally well tolerated.

Cardiovascular and Gastrointestinal Effects of Etoricoxib in the Treatment of Osteoarthritis: A Systematic Review and Network Meta-analysis

“…A final 10 studies were included in our study after further reviewing full texts [21][22][23][24][25][26][27][28][29][30]: eight were excluded because they were not RCTs, three were without peer review, seven involved non-OA patients, one did not involve etoricoxib, 16 reported no outcome of interest, two did not utilize adequate comparators, and one was excluded for other reasons (Figure 1). …”

“…The results were consistent when we included studies of patients with OA of the hip or knee joints over a duration of 12 weeks (OR=0.65, 95% CrI=0.08∼4.91, P=0.33 with placebo, OR=0.99, 95% CrI=0.01∼95.15, P=0.50 with celecoxib, OR=0.84, 95% CrI=0.07∼10.07, P=0.44 with ibuprofen, OR=2.11, 95% CrI=0.14∼31.37, P=0.72 with naproxen) ( Figure 3B) [26][27][28][29][30]. In analysis according to dose of etoricoxib, 30 mg of and 60 mg or higher dose of etoricoxib did not increase the risk of CV events compared with comparators during 12 weeks ( Figure 3C).…”

Naproxen: A universal analgesic with a minimal risk of cardiovascular events

“…[32], в котором 997 больных ОА в течение 138 нед (2,5 года!) при-нимали эторикоксиб 60 мг или напроксен 1000 мг/сут.…”

Back Pain and Its Treatment

“…В ходе клинических исследований показана эф-фективность препарата в лечении острых (первичная дисме-норея, подагрический артрит, боль, связанная со стоматоло-гическими операциями) и хронических (остеоартроз, ревма-тоидный артрит, анкилозирующий спондилоартрит, хрониче-ская боль в спине) болевых синдромов [42,[44][45][46][47][48][49][50]. В частно-сти, при ревматоидном артрите эторикоксиб в дозе 90 мг 1 раз в сутки оказался эффективнее плацебо и напроксена в дозе 500 мг 2 раза в сутки.…”

“…При лечении остео-артроза эторикоксиб в дозе 60 мг/сут показал хорошую эф-фективность, сравнимую с напроксеном в дозе 1000 мг/сут и диклофенаком в дозе 150 мг/сут. Результаты сравнительного исследования эффективности эторикоксиба и напроксена в лечении пациентов с остеоартрозом позволили предполо-жить наличие более благоприятного профиля безопасности в отношении ЖКТ у эторикоксиба [42,50].…”