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New study creates controversy regarding the safety of cox-2 inhibitors

Monday January 27, 2003 10:25 PM GMT

Celebrex (TM) and its peptic ulcer protection under research

Hong Kong research shows Celebrex may not protect against peptic ulcer or kidney complications of other NSAIDs.


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Celebrex along with other cox-2 inhibitors form a new group of anti-inflammatory drugs believed to be associated with a decreased incidence of stomach ulcers when compared to other NSAIDs, according earlier studies. These drugs have been frequently used in the management of arthritis.

As opposed to older anti-inflammatory drugs which block both cox-1 and cox-2, The newer group does not block cox-1 enzyme which is responsible for the protection of the stomach lining. cox-2 is the enzyme responsible for the production of prostaglandins responsible for the mediation of pain and inflammation. By selectively blocking cox-2 (pain) and not cox-1 (ulcer protection) they were thought to be safer than older drugs. Indeed previous studies confirmed this.

These drugs, also include Vioxx and Bextra.

But their safety has been called into question recently. The new study, which focused on arthritis patients at high risk of recurrent ulcers, escalates the controversy involving Celebrex, showing nearly 10 percent each year would develop another bleeding ulcer.

The study found the found the same rates with older anti-inflammatory drugs. Neither treatment protected as many patients from dangerous kidney complications as past studies showed.

About 25 percent of those in the Celebrex group and 31 percent in the diclofenac/Prilosec group suffered kidney complications, including high blood pressure and swollen ankles; about 6 percent in each group suffered life-threatening kidney failure.

The Hong Kong researchers said that physicians need to be aware that these drugs may not provide the safety it was once thought to have. This could mean that physicians need to be more cautious when prescribing these drugs to patients at increased risk of GIT bleeding (such as those with a history of peptic ulcer) or renal disease, and maybe add anti-ulcer drugs to their prescriptions.

The study, published in the New England Journal of Medicine, included 287 patients who had a previous bleeding ulcer and so were at very high risk of developing another, potentially life-threatening ulcer.

Article reviewed by:

Dr. Tamer Fouad, M.D.


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