Celecoxib chemical structure
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Celebrex

Celecoxib is a non-steroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, acute pain, painful menstruation and menstrual symptoms, and to reduce numbers of colon and rectum growths polyps in patients with familial adenomatous polyposis. It is marketed by Pfizer under the brand name Celebrex. more...

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Pharmacology

Celecoxib is a highly selective COX-2 inhibitor and primarily inhibits this isoform of cyclooxygenase, whereas traditional NSAIDs inhibit both COX-1 and COX-2. Celecoxib is approximately 10-20 times more selective for COX-2 inhibition over COX-1. In theory, this specificity allows celecoxib and other COX-2 inhibitors to reduce inflammation (and pain) while minimizing gastrointestinal adverse drug reactions (e.g. stomach ulcers) that are common with non-selective NSAIDs. It also means that it has a reduced effect on platelet aggregation compared to traditional NSAIDs.

Adverse effects

Aside from the incidence of gastric ulceration, celecoxib exhibits a similar adverse drug reaction (ADR) profile to other NSAIDs.

Gastrointestinal ADRs

In theory the COX-2 selectivity should result in a significantly lower incidence of gastrointestinal ulceration than traditional NSAIDs. The main body of evidence touted to support this theory were the preliminary (6 month) results of the Celecoxib Long-term Arthritis Safety Study (CLASS) as published in 2000, which demonstrated a significant reduction in the incidence of gastrointestinal ulceration in those taking celecoxib versus ibuprofen or diclofenac. (Silverstein et al, 2000) The final (12 month) results from the CLASS study, however, did not indicate any advantage of celecoxib over the other NSAIDs in the study. (Malhotra, Shafiq & Pandhi, 2004)

Cardiovascular risk

The withdrawal of rofecoxib from the market in 2004 due to an increased risk of adverse cardiovascular events led to the suspicion that this was a class effect. Indeed an increased risk of heart attack and stroke was found in a National Cancer Institute study studying the use of 400-800 mg celecoxib daily for the prevention of colorectal adenoma (relative risk 2.3-3.4 vs placebo). (Solomon et al., 2005)

There is still much conjecture, however, as to whether this risk is significant for the majority of patients being treated with lower doses for osteoarthritis. The overall safety profile of celecoxib, including its cardiovascular, renal and digestive effects, will be compared to traditional anti-inflammatoris (naproxen and ibuprofen) in a randomized trial of 20,000 high risk patients that is due to begin in 2006 (PRECISION study sponsored by Pfizer)

Allergy

Celecoxib contains a sulfonamide moiety and may cause allergic reactions in those allergic to other sulfonamide-containing drugs. This is in addition to the contraindication in patients with severe allergies to other NSAIDs.

Commercial history

Celecoxib was developed by G. D. Searle & Company and marketed jointly by Searle and Pfizer under the brand name Celebrex. Searle was acquired by Pharmacia, which was then acquired by Pfizer, in part so that Pfizer could take full control of Celebrex.

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The FDA has approved revised labeling and prescribing information for Celebrex® - celecoxib capsules - Brief Article
From Drug Cost Management Report, 7/1/02

The FDA has approved revised labeling and prescribing information for Celebrex[R] (celecoxib capsules), based on results of a long-term study of gastrointestinal safety and cardiovascular safety. The study evaluated gastrointestinal safety of Celebrex at supra therapeutic doses for osteoarthritis and rheumatoid arthritis compared to common therapeutic doses of diclofenac and ibuprofen. The data showed that the estimated cumulative incidence of upper gastrointestinal (GI) complicated and symptomatic ulcers for Celebrex is 0.78%, even at doses higher those approved for osteoarthritis (OA) and rheumatoid arthritis (RA), respectively. Estimated cumulative incidence of upper GI complicated ulcers was 0.32% in the Celebrex non-aspirin users. Labeling for prescription NSAIDs show an annual rate of upper GI ulcer, gross bleeding or perforations of about 2%-4% in patients treated for one year. It is estimated that there are more than 16,000 NSAID-related deaths every year among arthritis patients in the U.S., and 107,000 hospitalizations costing $10,000-$15,000 per hospitalization. The cardiovascular safety profile of Celebrex showed no significant differences between treatment groups in the overall incidence of serious cardiovascular adverse events. Celebrex is co-marketed by Pharmacia Corporation and Pfizer Inc. For complete prescribing information contact (800) 323-4204 or www.celebrex.com.

COPYRIGHT 2002 Atlantic Information Services, Inc.
COPYRIGHT 2003 Gale Group

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