Long-term therapy for the pain of osteoarthritis: a comparison of zomepirac sodium and aspirin.
In this long-term, double-blind, multicenter study, efficacy and safety of zomepirac sodium were compared with those of aspirin for treatment of the chronic pain associated with osteoarthritis in 607 patients, 405 of whom received zomepirac and 202 of whom received aspirin. Final evaluations during one year of treatment showed zomepirac significantly more effective than aspirin for reducing pain at rest (P = 0.02) and average pain (P = 0.04). Moreover, zomepirac was rated better than aspirin in physician global evaluations of overall response to therapy (P = 0.02) and patient evaluations of pain relief (P = 0.03). At the end of the one-year study, patients were permitted to extend double-blind treatment for an additional year. In final evaluations for patients who continued, zomepirac was significantly better than aspirin for relief of pain on motion (P = 0.05) and also in patient global evaluations of therapeutic response (P = 0.02). Side effect profiles during the first year of therapy were generally comparable for zomepirac and aspirin. However, complaints related to the special senses, especially tinnitus and hearing disturbances, were reported more frequently during aspirin therapy, and urogenital side effects were more common during zomepirac therapy. For both drug groups, the overall incidence of side effects was lower in the second year than in the first. This is the first published study to show a nonsteroidal antiinflammatory agent to be more effective than aspirin for the long-term treatment of pain associated with osteoarthritis.
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000503:physiopathology*; D010146:Pain / Q000188:drug therapy*; D011758:Pyrroles / Q000627:therapeutic use*; D014046:Tolmetin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*
D000700:Analgesics; D011758:Pyrroles; C020549:zomepirac; D014046:Tolmetin; D001241:Aspirin