Official websites use. Share sensitive information only on official, secure websites. Lumiracoxib is a selective cyclooxygenase-2 inhibitor effective in the treatment of osteoarthritis OA with a superior gastrointestinal GI safety profile as compared to traditional non-steroidal anti-inflammatory drugs NSAIDs, ibuprofen and naproxen.
This safety study compared the GI tolerability, the blood pressure BP profile and the incidence of oedema with lumiracoxib and rofecoxib in the treatment of OA. Rofecoxib was withdrawn worldwide due to an associated increased risk of CV events and lumiracoxib has been withdrawn from Australia, Canada, Europe and a few other countries following reports of suspected adverse liver reactions.
This randomised, double-blind study enrolled patients aged greater than or equal to 50 years with primary OA across 51 centres in Europe. The study was conducted for 6 weeks and assessments were performed at Weeks 3 and 6. The primary safety measures were the incidence of predefined GI adverse events AEs and peripheral oedema. The secondary safety measures included effect of treatment on the mean sitting systolic and diastolic blood pressure msSBP and msDBP.
Tolerability of lumiracoxib mg was assessed by the incidence of AEs. Lumiracoxib and rofecoxib displayed similar GI safety profiles with no statistically significant difference in predefined GI AEs between the two groups The incidence and severity of individual predefined GI AEs was comparable between the two groups.
Only one patient in the lumiracoxib group and three patients in the rofecoxib group had a moderate or severe event. A similar percentage of patients in both groups showed an improvement in target joint pain and disease activity.
