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document
Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily : a randomised controlled trial in patients with osteoarthritis . BACKGROUND The efficacy , safety and tolerability of lumiracoxib , a novel selective cyclooxygenase-2 ( COX-2 ) inhibitor , has been demonstrated in previous studies of patients with osteoarthritis ( OA ) . As it is important to establish the long-term safety and efficacy of treatments for a chronic disease such as OA , the present study compared the effects of lumiracoxib at doses of 100 mg once daily ( o.d . ) and 100 mg twice daily ( b.i.d . ) with those of celecoxib 200 mg o.d . on retention on treatment over 1 year . METHODS In this 52-week , multicentre , randomised , double-blind , parallel-group study , male and female patients ( aged at least 40 years ) with symptomatic primary OA of the hip , knee , hand or spine were randomised ( 1:2:1 ) to lumiracoxib 100 mg o.d . ( n = 755 ) , lumiracoxib 100 mg b.i.d . ( n = 1,519 ) or celecoxib 200 mg o.d . ( n = 758 ) . The primary objective of the study was to demonstrate non-inferiority of lumiracoxib at either dose compared with celecoxib 200 mg o.d . with respect to the 1-year retention on treatment rate . Secondary outcome variables included OA pain in the target joint , patient 's and physician 's global assessments of disease activity , Short Arthritis assessment Scale ( SAS ) total score , rescue medication use , and safety and tolerability . RESULTS Retention rates at 1 year were similar for the lumiracoxib 100 mg o.d. , lumiracoxib 100 mg b.i.d . and celecoxib 200 mg o.d . groups ( 46.9 % vs 47.5 % vs 45.3 % , respectively ) . It was demonstrated that retention on treatment with lumiracoxib at either dose was non-inferior to celecoxib 200 mg o.d . Similarly , Kaplan-Meier curves for the probability of premature discontinuation from the study for any reason were similar across the treatment groups . All three treatments generally yielded comparable results for the secondary efficacy variables and all treatments were well tolerated . CONCLUSION Long-term treatment with lumiracoxib 100 mg o.d. , the recommended dose for OA , was as effective and well tolerated as celecoxib 200 mg o.d . in patients with OA . TRIAL REGISTRATION clinicaltrials.gov NCT00145301 .
34851
Intervention_Pharmacological
lumiracoxib
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Intervention_Pharmacological
celecoxib
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Intervention_Pharmacological
lumiracoxib
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Intervention_Pharmacological
lumiracoxib at doses of 100 mg once daily ( o.d . ) and 100 mg twice daily
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Intervention_Pharmacological
celecoxib 200 mg o.d .
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Intervention_Pharmacological
lumiracoxib
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Intervention_Pharmacological
lumiracoxib
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Intervention_Pharmacological
celecoxib
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Intervention_Pharmacological
lumiracoxib
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Intervention_Pharmacological
celecoxib
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Intervention_Pharmacological
lumiracoxib
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Intervention_Pharmacological
lumiracoxib
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Intervention_Pharmacological
celecoxib
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Intervention_Pharmacological
lumiracoxib
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Intervention_Pharmacological
celecoxib
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Outcome_Physical
non-inferiority
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Outcome_Pain
1-year retention on treatment rate
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Outcome_Physical
Retention rates
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Outcome_Other
retention
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Outcome_Physical
tolerated
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Outcome_Physical
tolerated
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Participant_Condition
patients with osteoarthritis .
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Participant_Age
patients with osteoarthritis ( OA ) .