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Randomized Controlled Trial
. 2008 Mar 7:9:32.
doi: 10.1186/1471-2474-9-32.

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

Roy Fleischmann  1 , Hyman Tannenbaum, Neha P Patel, Marianne Notter, Peter Sallstig, Jean-Yves Reginster
Affiliations
Randomized Controlled Trial

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

Roy Fleischmann et al. BMC Musculoskelet Disord. .

Abstract

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.

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Figures

Figure 1
Figure 1
Patient disposition. †Following an announcement of a possible increase in CV risk with celecoxib, some patients withdrew consent (4%) and some (12.9%) were discontinued after a protocol amendment excluded patients with an elevated CV risk or a history of CV or cerebrovascular disease; o.d. = once daily; b.i.d. = twice daily; ITT = intention-to-treat.
Figure 2
Figure 2
Kaplan-Meier estimates of the probability (%) of premature discontinuation for any reason (ITT population). o.d. = once daily; b.i.d. = twice daily; ITT = intention-to-treat.
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