Background Significant elevations of liver enzymes have been reported in patients taking NSAIDs. Among all NSAIDs, diclofenac and aspirin have been associated with the highest rates of liver toxicity. In previous trials with patients in the US and Canada treated for osteoarthritis (OA), the incidence of hepatic adverse events in patients receiving celecoxib 200 or 400 mg per day was similar to placebo and significantly lower than the incidence for patients receiving diclofenac 100 or 150 mg per day.
Objectives We compared the hepatic tolerability of celecoxib and the most commonly used regimen of diclofenac in the treatment of OA of the knee, hip, or hand in 13,274 patients enrolled in SUCCESS-1, a multinational, double-blind, randomised trial.
Methods In the SUCCESS-1 in OA trial, patients with OA from Europe and South Africa, Asia, Latin America, and the US and Canada were evaluated for 12 weeks using fixed dosages of celecoxib 200 mg per day, celecoxib 400 mg per day, or diclofenac 100 mg per day. Patients with pretreatment ALT or AST >/= 3x ULN were excluded. Laboratory tests were obtained at pretreatment and at the final visits.
Results Overall, patients were mostly female (78%), and had a mean age of 62 (± 10.4) years. Previous daily diclofenac use was comparable (p = 0.57). Clinically meaningful elevations (>/= 3x ULN) in ALT and AST were significantly more frequent in the diclofenac- vs celecoxib-treated patients (p < 0.001) at 12 weeks. In parallel, physician-reported hepatic adverse events, including hepatic dysfunction and increases from pretreatment ALT and AST, were significantly more frequent in patients treated with diclofenac (p < 0.01).
Conclusion Celecoxib, with its greater hepatic tolerability than the most commonly prescribed regimen of diclofenac, offers a clinical advantage over diclofenac in the management of OA patients.
Sponsored by Pharmacia Corporation and Pfizer Inc.
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