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July 25, 2001
A recent managed care, clinical trial reported that Mobicox (meloxicam), a COX-II selective NSAID used for symptomatic treatment of rheumatoid arthritis and painful osteoarthritis, showed significantly greater "patient success" than other commonly-used prescription NSAIDs.
The randomized study, which compared Mobicox to "usual care," or whatever prescription-NSAID patients' individual physicians selected as their osteoarthritis treatment, was presented for the first time last month at the Annual European Congress of Rheumatology in Prague, Czech Republic.
The usual care treatment group included other prescription osteoarthritis medicines, such as: piroxicam, diclofenac, naproxen, Celebrex (celecoxib) and Vioxx (rofecoxib).
"The difference in patient success between Mobicox and the usual care NSAID group is clinically meaningful and important information for both patients and physicians," said Gurkirpal Singh, MD, Professor of Medicine Immunology and Rheumatology, Stanford University Medical School and an investigator in the trial.
"Patients taking Mobicox were considerably more satisfied with their treatment, which suggests to us that Mobicox is an important treatment alternative for osteoarthritis - one that seems to work well and that patients can tolerate."
The trial, called "IMPROVE" (Impact of Meloxicam on Prescription Regimens
in Osteoarthritis vs. Everyday Care), found that more than two-thirds (67 per cent) of patients taking Mobicox were classified as successes, compared to less than half (45 per cent) of patients in the usual care group, with a range from 22 per cent to 62 per cent. Treatment success was defined as patients completing the trial without changing treatments, or those who no longer needed an NSAID for their osteoarthritis care.
"Products such as MOBICOX represent a promising new generation of NSAID-
class drugs," said John Wallace, Ph.D., Professor of Pharmacology & Therapeutics, University of Calgary. "Unlike older NSAIDs which have significant side effects, new products target particular enzymes to reduce pain and inflammation, while limiting the impact on enzymes that protect the lining of the stomach. Studies have shown that these targeted products result in fewer complications for patients."
The IMPROVE trial followed more than 1,300 osteoarthritis patients for six months and measured patient satisfaction and treatment success, as defined above. Half of the enrolled patients were prescribed Mobicox, and the other half was given whatever prescription-NSAID (other than Mobicox) their individual doctors selected, referred to as "everyday care."
"The IMPROVE trial is unique because we went directly to the patients and asked them how satisfied they were with their medical care for their osteoarthritis," said Dr. Singh. "In the practice of medicine, the most important thing is what works for the patient, and this is the first time we explicitly measured that in an arthritis study."
As with many osteoarthritis patients in the "real world," the primary reasons for study patients changing or discontinuing their NSAID treatment were lack of efficacy or the presence of adverse events, such as intolerable gastrointestinal (stomach) side effects. After six months of therapy, fewer osteoarthritis patients taking Mobicox discontinued or switched their treatment because of lack of efficacy or side effects, including gastrointestinal (GI) side effects, compared to patients treated with other commonly used NSAIDs. In addition, when patients rated their satisfaction with their osteoarthritis care after one and six months of therapy, patients taking Mobicox were significantly more satisfied than those taking the usual care NSAIDs.
"We know that some NSAIDs have been associated with unsatisfactory side effects and that some can cause unbearable stomach problems," said Ken Croitoru, MD, Professor of Medicine, Division of Gastroenterology, McMaster University.
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