Comparing celecoxib with traditional nonsteroidal anti-inflammatory drugs

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Q&A

Comparing celecoxib with traditional nonsteroidal anti-inflammatory drugs

J Fam Pract. 2003 February;52(2):94-117

By

Melissa Johnson, DO

Terry Seaton, PharmD

BACKGROUND: Is celecoxib more effective or better tolerated than traditional nonsteroidal anti-inflammatory medications? NSAIDs are often used for arthritis symptom relief. Unfortunately, they may cause serious adverse effects. Researchers have developed celecoxib to provide symptom relief without the NSAID-associated gastrointestinal toxicity via cyclooxygenase 2–specific inhibition. This systematic review compared the efficacy, safety, and tolerability of celecoxib with other NSAIDs.
POPULATION STUDIED: The study analyzed data from studies of 15,187 patients with osteoarthritis or rheumatoid arthritis. Patients with osteoarthritis were older, had fewer concomitant illnesses, and took fewer other medications than did patients with rheumatoid arthritis. Most trials excluded patients with active gastrointestinal, renal, hepatic, or coagulation disorders.
STUDY DESIGN AND VALIDITY: This systematic review included all published and unpublished data, identified by extensively searching the literature and reviewing data on file with the manufacturer. These blinded, randomized trials compared celecoxib with placebo or an NSAID for at least 12 weeks and reported efficacy, tolerability, and gastrointestinal safety outcomes. The studies used various celecoxib doses, including supratherapeutic doses. Meta-analyses compared information for each outcome. Safety and tolerability analyses, but not the efficacy analysis, included data from celecoxib 800 mg per day. Comparator NSAIDs included diclofenac 75 mg twice daily, ibuprofen 800 mg 3 times daily, or naproxen 500 mg twice daily. The authors evaluated data for effectiveness for osteoarthritis separately from data for rheumatoid arthritis.
OUTCOMES MEASURED: Standardized indices measured efficacy and tolerability outcomes. Osteoarthritis trials used the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, and rheumatoid arthritis studies used the American College of Rheumatology Responder Index (ACR-20). Rates of withdrawal due to any adverse effect determined the tolerability outcome, and the combined outcome of symptomatic ulcers or episodes of bleeding, perforation, and obstruction at 12 and 24 weeks determined gastrointestinal safety. The authors also evaluated the incidence of endoscopically identified gastric ulcers. However, this outcome was not related to subsequent development of more serious ulceration or symptoms. The US Food and Drug Administration does not consider this outcome to be a valid surrogate marker for NSAIDs.
RESULTS: In all trials, celecoxib was more efficacious than placebo and equally efficacious compared with traditional NSAIDs. For osteoarthritis, celecoxib reduced WOMAC composite scores to the same extent as naproxen. The composite includes pain, stiffness, and physical function. For rheumatoid arthritis, celecoxib improved ACR-20 responder rates similarly to diclofenac and naproxen. The ACR-20 measures improvement in painful, tender, or swollen joints.

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Comparing celecoxib with traditional nonsteroidal anti-inflammatory drugs

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