Efficacy and tolerability of lumiracoxib 100 mg once daily in knee osteoarthritis: a 13-week, randomized, double-blind study vs. placebo and celecoxib

Abstract

Lumiracoxib 100 mg od provided effective relief from the pain of knee OA, with efficacy similar to celecoxib 200 mg od, and was well tolerated.

Response to Nonsteroidal Anti-inflammatory Drugs in African Americans with Osteoarthritis of the Knee

“…There has been some evidence of an increased placebo response among African American patients in clinical trials for depression and schizophrenia, compared with white patients. 37,38 Response to NSAIDs in African Americans with OA Elevated rates of placebo response have been reported in other OA trials, 39,40 and a study to evaluate baseline factors as a prediction of placebo response in a large OA study concluded that placebo responders were more likely to report moderate levels of pain at baseline. 41 In the latter study, patients from the placebo arm of a trial evaluating the effects of risedronate on pain and joint space narrowing in knee OA were stratified according to 20% and 50% declines in WOMAC pain scores between baseline and 6 months.…”

Lumiracoxib: the evidence of its clinical impact on the treatment of osteoarthritis

“…AUSCAN, Australian/Canadian OA Hand Index; bid, twice daily; CX, celecoxib; db, double-blind; dd, double-dummy; DPDA, difficulty in performing daily activities; LSM, least squares mean; LX, lumiracoxib; mc, multicenter; NR, not reported; OA, osteoarthritis; od, once daily; PL, placebo; RCT, randomized controlled trial; RX, rofecoxib; wk, week; WOMAC, Western Ontario and McMaster Universities OA Index. (Schnitzer et al 2004b;Lehmann et al 2005;Sheldon et al 2005), one RCT published in abstract form (Pavelka et al 2005), and an additional analysis from TARGET published in abstract form , has shown that the pain relief [as assessed by pain intensity on a visual analog scale (VAS)] with lumiracoxib is superior to that gained with placebo and similar to that with celecoxib, rofecoxib, ibuprofen, naproxen, and diclofenac in patients with OA of the hand, hip, or knee (Tables 3 and 4). The efficacy of lumiracoxib does not appear to be dose dependent, with the 100 mg dose providing similar efficacy to the 400 mg dose.…”

“…Level 1 ) and level 2 evidence (Lehmann et al 2005;Sheldon et al 2005) demonstrated that lumiracoxib improves joint stiffness and overall function [assessed using the difficulty in performing daily activities (DPDA) and stiffness subscales of the WOMAC questionnaire or the AUSCAN] compared with placebo (Table 5). These improvements were similar to that achieved with diclofenac and celecoxib, and are expected to have a positive impact on the quality of life of the patient.…”

“…Responders to treatment were defined as patients who either had: a) reduction of ≥50% from baseline and an absolute reduction of ≥20 either in OA pain intensity (100 mm VAS) or WOMAC DPDA subscale score (rescaled to 0-100); or b) reduction of ≥20% and an absolute reduction of ≥10 in at least two of the following variables: OA pain intensity (100 mm VAS), WOMAC DPDA subscale score (rescaled to 0-100) or patient's global assessment of disease activity (100 mm VAS). These criteria demonstrated that a significantly greater proportion of patients receiving active treatment were considered responders compared with placebo (data not stated, reported graphically; all P<0.05 vs placebo) Fleischmann et al 2005;Lehmann et al 2005;Sheldon et al 2005).…”

“…Lumiracoxib A pooled analysis of the trials by Lehmann et al (2005) and Sheldon et al (2005) investigated the response to treatment using PASS (Dougados et al 2007). PASS defines the symptom score beyond which patients consider themselves to be well (0-100 mm VAS): ≤32.3 mm for pain intensity, ≤32 mm for disease activity, and ≤21.08 for WOMAC function score.…”