New clinical trials data on the efficacy and tolerability of lumiracoxib (Prexige^ÂR) provide evidence that the selective cyclooxygenase-2 (COX-2) inhibitor taken 100 mg daily offers reduced pain intensity in the target knee compared to placebo while improving the functional status of patients' osteoarthritis (OA) of the knee, according to posters presented at the 9th World Congress of the Osteoarthritis Research Society International in Chicago, Illinois.

R. Lehman and colleagues demonstrated that lumiracoxib 100 mg once daily for 13 weeks revealed significant improvements in pain intensity from the first measurement at week 2, with a significant reduction of 42% in pain intensity at completion of the study (P < .01 versus placebo).¹

The second trial showed a similar a similar decrease in pain intensity,² with significant improvements throughout the study, and a 38% decrease in pain intensity at the completion of the trial period (P < .001 versus placebo).

These findings emerged from 2 similarly designed 13-week, randomized, placebo- and active-controlled trials compared lumiracoxib 100 mg once daily, 100 mg once daily with a loading dose of 200 mg once daily for the first two weeks, and celecoxib (Celebrex^ÂR) 200 mg once daily versus to placebo.

The trials were designed using three co-primary efficacy variables including functional status assessment criteria: OA pain intensity in the target knee; patients' global assessment of disease activity; and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMACâ„¢) questionnaire. Improvement in patients' functional status was further assessed using the OMERACT-OARSI functional status criteria.³

In both 13-week studies, lumiracoxib 100 mg once daily was comparable to celecoxib 200 mg once daily, with significant improvements in functional status compared with placebo, with no statistically significant difference observed between active treatment groups. ^1-3

In addition, the number of patients discontinuing treatment due to adverse events, including serious adverse events, was similar between placebo and the active treatment groups. ^1-3 Furthermore, no significant difference was observed between all treatment groups for the incidence of liver enzyme elevations, as defined by the parameters of the studies.

Results from the Therapeutic Arthritis Research & Gastrointestinal Event Trial (TARGET), published in August 2004 in The Lancet, demonstrated that lumiracoxib has a cardiovascular profile similar to that of the conventional nonsteroidal antiinflammatory drugs ibuprofen and naproxen.

Novartis Pharma AG, the manufacturer of lumiracoxib, has filed applications for regulatory approval worldwide based on data from more than 40 preclinical and clinical studies in OA, rheumatoid arthritis, acute pain and primary dysmenorrhea involving more than 31,000 adult patients.

To date, lumiracoxib (Prexige^ÂR) has been approved in 21 countries, including the United Kingdom, Australia, New Zealand, and several countries in Latin America, including Argentina, Brazil and Mexico.

On November 30, 2004, Novartis announced that it has at least temporarily withdrawn its European Union Mutual Recognition Procedure application to the European Medicines Evaluation Agency for Prexige^ÂR subject the outcome of the agency's cardiovascular safety review of all selective COX-2 inhibitors. The US Food and Drug Administration plans to meet in mid-February for its own safety review of COX-2 inhibitors.

References

1. Lehmann R, Brzosko M, Kopsa P, et al . Lumiracoxib 100 mg once daily is effective and well tolerated in the management of knee osteoarthritis. Presented at: The 9th World Congress of the Osteoarthritis Research Society International; December 2-5 2004; Chicago, Illinois. Poster Presentation 335.

2. Beaulieu A, Sheldon E, Paster Z, et al . Lumiracoxib 100 mg once daily is an efficacious and well tolerated therapy for knee osteoarthritis. Presented at: The 9th World Congress of the Osteoarthritis Research Society International; December 2-5 2004; Chicago, Illinois. Poster Presentation 140.

3. Sheldon E, Beaulieu A, Paster Z et al . Lumiracoxib 100 mg once daily is effective in treating osteoarthritis as assessed by OMERACT-OARSI criteria. Presented at: The 9th World Congress of the Osteoarthritis Research Society International; December 2-5 2004; Chicago, Illinois. Poster Presentation.