Comparative evaluation of the effectiveness and tolerability of nimesulide versus rofecoxib taken once a day in the treatment of patients with knee osteoarthritis.
The treatment of osteoarthritis, a common degenerative joint disease, is focused on the relief of symptoms, mainly pain, and sometimes joint stiffness. Nonsteroidal antiinflammatory drugs are considered the treatment of choice in cases where the pain cannot be reduced with acetaminophen. This trial was conducted to compare the effectiveness of 2 nonsteroidal antiinflammatory drugs taken once daily to relieve the symptoms of osteoarthritis.


OBJECTIVE
To compare the safety and efficacy of 2 nonsteroidal antiinflammatory drugs, nimesulide versus rofecoxib, given once a day in patients with knee osteoarthritis.


METHODS
114 patients with the diagnosis of knee osteoarthritis were recruited in a randomized, double-blinded fashion, and they received a daily dose of either 300 mg of nimesulide retard or 25 mg of rofecoxib. The effectiveness was evaluated by means of: visual analog scale 0 to 10 cm measured at 0, 15, 30, and 45 minutes after the first dose and then after 2, 3, 15, and 30 days of continuous drug dosing. The quality of life was assessed by the scale of the Western Ontario and McMaster Universities on days 0, 15, and 30. The patients' opinions and that of the physicians were recorded at the end of the study.


RESULTS
The 2 groups of patients were matched for race, sex, menopause status (for females), pathologic antecedents, the duration of osteoarthritis, and the history of nonsteroidal antiinflammatory drug therapy; however, patients' affected knees could differ in the 2 treatments. The 2 drugs were equally effective in terms of overall improvement of pain and the quality of life; they were equally well tolerated. However, significant differences were found between the 2 drugs in favor of nimesulide in the relief of the pain on days 2, 3, and 30, and in the scale of Western Ontario and McMaster Universities Osteoarthritis index on day 15 and 30.


CONCLUSIONS
In this trial, both medications were effective in improving the pain and the quality of life in patients with knee osteoarthritis; however, nimesulide, compared with rofecoxib, was quicker in reducing the pain and was more effective on days 2, 3, and 30. Nimesulide was also superior in improving the quality of life after 30 days of treatment.
Herrera
José Antonio
JA
Hospital José María Vargas, Caracas, Venezuela.
González
María
M
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010147:Pain Measurement; D011446:Prospective Studies; D012107:Research Design; D018709:Statistics, Nonparametric; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013450:Sulfones; D013997:Time Factors; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013449:Sulfonamides; D013450:Sulfones; C116926:rofecoxib; C012655:nimesulide