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| |  ACR: Licofelone Offers Equal Efficacy With Better Tolerability Than Celecoxib for Knee Osteoarthritis By Bruce Sylvester ORLANDO, FL -- October 28, 2003 -- Licofelone is as effective as celecoxib for symptomatic osteoarthritis of the knee and shows both greater tolerability and a lower incidence of adverse events, researchers reported here on October 25th at the Annual Meeting of the American College of Rheumatology (ACR). "We found that licofelone 200 mg is as least as effective as celecoxib 200 mg, and it was better tolerated, with a notably lower rate of peripheral oedema in the licofelone group than celecoxib group," said co-investigator Peter Bias, MD, head of clinical research at Merckle GmbH Pharmaceuticals, Ulm, Germany. Licofelone is the first agent in a new class of anti-inflammatories used to inhibit all of the major enzymes of the arachidonic acid pathway: 5-lipoxygenase (5-LOX), cyclooxygenase (COX)-1 and COX-2. Isolated COX pathway inhibition causes increases in proinflammatory leukotriene production through the 5-LOX pathway. Licofelone is designed to cut production of leukotrienes and prostaglandins by inhibiting both LOX and COX enzymes, leading to reduced treatment-related gastrointestinal adverse effects. Investigators enrolled 608 subjects with symptomatic osteoarthritis of the knee in this 12-week, multicentre, randomised and double-blind study, with 302 subjects receiving licofelone 200 mg twice daily and 306 receiving celecoxib 200 mg once daily. The researchers evaluated for efficacy and safety at weeks 2, 6 and 12. Efficacy measures were changes in standard Western Ontario and MacMaster Universities scale (WOMAC) total scores from baseline to week 12. They also recorded responder rates, pain assessments, global arthritic condition and efficacy assessments by patients and doctors. Safety evaluation included changes in peripheral oedema, adverse events, blood pressure measurement and standard laboratory measures. Baseline mean WOMAC was 62.7 mm for licofelone and 62.5 mm for celecoxib. At week 12, there was a 29.0 mm mean change for licofelone and 30.2 mm mean change for celecoxib. Responder rates (defined as over 30% improvement versus baseline) for WOMAC total score were similar for both drugs: 73.0% for licofelone and 75.0% for celecoxib. Other efficacy parameters were also similar. Adverse events were lower among licofelone subjects (31.9%) than celecoxib subjects (36.4%); investigators found one symptomatic, endoscopically confirmed gastric ulcer in a celecoxib subject. They also saw worsening of peripheral oedema in 2.0% of the licofelone subjects, compared with 5.9% of the celecoxib subjects (p=0.011). Licofelone did not appear to cause any clinically relevant changes in laboratory measures of safety. The authors concluded that licofelone "appears to offer advantages over selective COX-2 inhibitors for the treatment of patients with OA [osteoarthritis] and may be suitable for long-term treatment, combining good efficacy with an improved tolerability profile." The study was funded by Merckle Pharmaceuticals, manufacturers of licofelone.
[Study title: Licofelone—a 5-LOX, COX-1 and COX-2 Inhibitor—is as Effective as Celecoxib and Shows Better Tolerability in Patients With Osteoarthritis of the Knee. Program Number 69]
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