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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Celebrex clear winner after FDA cox-2 committee meeting
From Drug Store News, 3/7/05 by Michael Johnsen

GAITHERSBURG, Md. -- Not much in life is black or white, especially when it comes to the risk versus benefit scenarios for disease treatments. But a Food and Drug Administration advisory panel committee that met last month to discuss cox-2 inhibitor safety concerns used little gray in meting out its recommendations.

As a class of drugs, all cox-2 inhibitors carry a risk of heart disease, the committee members decided unanimously. Consequently, all cox-2 inhibitors should carry a black-box warning, most members voted, albeit specific to each drug. And none of the cox-2 inhibitors should be directly advertised to the consumer, the majority of members argued.

The FDA had promised a fast decision on the future of cox-2s following the recommendations.

Only one of the 32 panelists felt that Pfizer's Celebrex should be pulled from the market, making the market-leading arthritic pain reliever the clear choice for doctors prescribing a cox-2 inhibitor, especially because neither Pfizer's Bextra nor Merck's Vioxx fared as well in the voting--the panel was split on the sale of both of those drugs.

"If there is a cox-2 risk, it is lowest with Celebrex versus Vioxx or Bextra, asserted panelist Dr. Steven Abramson, professor and chairman of the division of rheumatology at the New York University School of Medicine.

Another panelist added that while use of Celebrex may represent an increased risk compared with placebo, that risk may be mitigated by the contraindications associated with alternative therapies, such as nonsteroidal anti-inflammatory drugs. "As we consider pulling cox-2s, are we shifting the business to less-safe alternatives?" asked one panel member. Another noted, "We've seen no data over the past two days that would warrant the huge migration of patients from [cox-2s] to NSAIDs."

The introduction of either of Merck's Arcoxia or Novartis' Prexige, the two cox-2s currently in the development pipeline, potentially will be delayed in favor of tests specifically designed to detect any heart disease contraindications.

In the short term, there still will be an erosion of the cox-2 market in favor of other prescription alternatives, such as a prescription proton-pump inhibitor/NSAID combination or even over-the-counter pain relievers. Already, Louisiana's health department has placed restrictions, effective March 15, on the dispensing of cox-2 inhibitors for its Medicaid population, requiring doctors to explain why a patient needs the medicine before pharmacists can fill the prescription. And several panelists, including chairman Alastair Wood, assistant vice chancellor at the Vanderbilt University Medical Center, recommended that patients first try a naproxen product to treat their arthritis pain, such as Bayer's Aleve.

Eventually, however, the established link between cardiovascular disease risks and the prolonged use of cox-2 inhibitors will fade into the background of public conversation. And when that happens, sales of cox-2 inhibitor prescriptions will rise again as doctors weigh the risks of cox-2 inhibitors against alternative treatment options with their patients.

Doctors can expect to have those conversations on appropriate arthritis treatments often in a patient population rife with heart disease. Out of 35.9 million seniors, 21.1 million have arthritis, and 27.9 million have heart disease--according to the National Center for Chronic Disease Prevention and Health Promotion and the American Heart Association, respectively--suggesting there is overlap between the two patient populations.

The cox-2 inhibitor market as a whole may never recapture the $5.3 billion in sales the category had reached by the end of 2004, but the class certainly will be composed of blockbuster drugs.

The market for hormone replacement therapies faced a similar dilemma in 2002, when a clinical trial found a slightly elevated risk of breast cancer in women on an HRT regimen. Sales of all estrogen/progestin combination drugs fell 46 percent in the full year following the news of the increased cancer risk, according to IMS Health figures. But sales were down only 8 perent in 2004, thanks in large part to the introduction of a low-dose Prempro by Wyeth.

Before the meeting, analysts speculated that long-term annual sales of Celebrex would not fall below $1.5 billion, a 44 percent drop from current sales, and that was before advisory panel members voiced their strong support for the cox-2 inhibitor.

COPYRIGHT 2005 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2005 Gale Group

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