BARCELONA, Spain—The new COX-2 selective inhibitor lumiracoxib (Prexige®, Novartis Pharmaceuticals AG) is an effective and well tolerated treatment for hip osteoarthritis (OA), and may be preferable to ibuprofen for managing pain in hypertensive OA patients, according to poster presentations at the EULAR 2007 meeting.

Lumiracoxib equals celecoxib for relief of hip OA pain

Thomas J. Schnitzer, MD, PhD, from the Northwestern Center for Clinical Research at Northwestern University Medical Center, in Chicago, Illinois, and colleagues randomized 427 patients to lumiracoxib (100 mg every day), 419 to celecoxib (200 mg every day), and 416 to placebo for treating hip OA.1 All patients had symptomatic OA for at least 3 months prior to screening, with highest pain intensity in the target hip joint relative to other OA joints; all were treated for 13 weeks followed by a 30-day follow-up period.

"Previous studies have demonstrated that lumiracoxib 100 mg qd provides effective relief from OA pain of the knee over 13 weeks. However, it has been observed that the response to naproxen treatment varies between the knee and hip joints, and it has been suggested that studies assessing the efficacy of treatments for OA pain should evaluate these joints separately. Here, we report a study to examine the efficacy of lumiracoxib 100 mg qd in patients with OA of the hip," Dr. Schnitzer said.

The primary efficacy variables were evaluation of the WOMACâ„¢ 3.1LK subscales, which assessed pain, difficulty performing daily activities (DPDA), and the patient's global assessment of disease activity using a 100 mm VAS, as well as safety and tolerability. Thirty-one percent of patients in the placebo group discontinued treatment, versus 21.1% for lumiracoxib, and 22% for celecoxib.

"Lumiracoxib was statistically significantly superior to placebo in all efficacy variables and provided similar pain relief compared to celecoxib," Dr. Schnitzer reported.

The incidence of overall adverse events (AEs) was similar in all three groups. The incidence of serious AEs was 1.9% with lumiracoxib, 0.7% with celecoxib, and 2.1% with placebo. There were no fatal serious AEs in the lumiracoxib and placebo groups. Two patients died in the celecoxib group, but these deaths were not thought to be related to the study drug. Liver enzyme levels >3 times normal occurred in two patients in the placebo group but not in any patients in the active treatment groups.

BP control better with lumiracoxib than with ibuprofen

For OA patients who also have hypertension, lumiracoxib may be a better choice than ibuprofen for pain control. Thomas M. MacDonald, MD, FRCPE, with the hypertension research centre at Ninewells Hospital and Medical School, in Dundee, Scotland, reported better BP control with the selective coxib.2

"In hypertensive subjects with OA requiring chronic NSAID therapy, pain management with lumiracoxib may result in better blood pressure control than a commonly used nonselective NSAID," Dr. MacDonald said.

The primary objective of this study was to test the hypothesis that OA patients with controlled hypertension treated with lumiracoxib 100 mg qd would have lower mean 24-hour ambulatory systolic BP than similar patients treated with ibuprofen 600 mg tid.

The investigators randomized 787 patients to lumiracoxib 100 mg qd (n = 394) or to ibuprofen 600 mg tid (n = 393) in a 4-week, randomized, double-blind, double-dummy, parallel group study.

Compared with baseline, the change in 24-hour mean ambulatory systolic BP at week 4 was about 5 mm Hg lower with lumiracoxib (95% CI: -6.1,-3.8, P <.001). Similar results were obtained for 24-hour mean ambulatory diastolic BP. Effects on OA pain and disease activity were similar for lumiracoxib and ibuprofen, as were AEs.

"In osteoarthritis patients with hypertension, lumiracoxib 100 mg qd resulted in a clinically significant lower mean 24-hour SBP compared to ibuprofen 600 mg tid. Lumiracoxib 100 mg qd and Ibuprofen 600 mg tid provided comparable improvement in symptoms of osteoarthritis," Dr. MacDonald concluded.

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References

1. Schnitzer TJ, Dattani DI, Seriolo B, et al. Lumiracoxib 100 mg once daily is effective and well tolerated in the management of hip osteoarthritis. Presented at: EULAR 2007 Meeting; June 13-16, 2007; Barcelona, Spain. Abstract SAT0260.
2. MacDonald T, Littlejohn T, Richard D, et al. Improved blood pressure control but similar efficacy with lumiracoxib 100 mg od compared to ibuprofen 600 mg tid in hypertensive patients with osteoarthritis: a randomized controlled trial. Presented at: EULAR 2007 Meeting; June 13-16, 2007; Barcelona, Spain. Abstract SAT0239.