One study involved 909 rheumatoid arthritis patients who were randomly given medication - some were treated with either rofecoxib using the recommended starting dose for rheumatoid arthritis once daily, rofecoxib at half the recommended starting dose for rheumatoid arthritis once daily, naproxen at the usual prescription strength for rheumatoid arthritis. twice daily, or a placebo for 12 weeks. Naproxen is a non-steroidal anti-inflammatory drug (NSAID) that is also commonly used for the treatment of rheumatoid arthritis.
The study found that rofecoxib at the recommended starting dose for rheumatoid arthritis given once daily provided pain relief to the same degree as the above naproxen dose which was given twice daily, and also gave superior pain relief compared to the placebo on all primary and key secondary measures. Specifically, both this dose of rofecoxib and naproxen were found to significantly reduce the number of tender joints (p<0.05) and the number of swollen joints (p<0.05), compared to placebo. In addition, significant improvements on the patient and investigator respective global assessments of disease activity were observed with rofecoxib and naproxen, compared to placebo (p<0.05). Rofecoxib at half the recommended starting dose for rheumatoid arthritis once daily showed significant improvements compared to placebo for only the patient and investigator global assessments. All active treatments had favorable tolerability, with similar adverse event rates observed across all groups.
Rheumatoid arthritis is a chronic disease in which the body's immune system attacks the joints, ultimately destroying them and rendering them immobile. The disease affects approximately one percent of the world's population, and occurs more often in men than in women.
Rofecoxib has been approved by regulatory agencies in more than 60 countries for treating the signs and symptoms of osteoarthritis, pain and inflammation, based on efficacy and safety studies involving nearly 4,000 patients during the clinical development of this important new therapy. To date, more than 33 million prescriptions have been written for rofecoxib in the United States alone.
Common side effects reported in osteoarthritis clinical trials with rofecoxib included upper-respiratory infection, diarrhea, and nausea. People who have had an allergic reaction to rofecoxib, aspirin or NSAIDs should not take rofecoxib. Safety and effectiveness in children below the age of 18 have not been studied.
In the Philippines, rofecoxib has been approved by the Bureau of Food and Drug for the treatment of the acute and chronic signs and symptoms of osteoarthritis and rheumatoid arthritis, the relief of pain, and the treatment of menstrual pain. Rofecoxib is a prescription medicine. Patients are encouraged to always consult their doctor.