New Study Finds COX-2 Inhibitors Are Not Safer for the Stomach

A new report in the December 3 issue of the British Medical Journal finds that COX-2 inhibitors are just as harmful to the stomach as traditional anti-inflammatory medications like aspirin. This finding would negate the central reason the embattled family of drugs was approved in the first place.

Researchers at the University of Nottingham examined cases of 9,407 patients with upper gastrointestinal events, like stomach bleeding or stomach ulcer, from 367 general practices. 45% of the patients had received traditional non-steroidal anti-inflammatory drugs (NSAIDs), and 10% had received COX-2 inhibitors. Out of 88,867 control subjects, 33% had been given an NSAID, and 6% had been given a COX-2 inhibitor.

It was found that there was an increased risk of stomach problems with both types of pain killers. The risk was significantly higher for the COX-2 inhibitors naproxen, and rofecoxib (Vioxx), and diclofenac (Voltaren). The risk was slightly lower for celecoxib (Celebrex). Celebrex is the only COX-2 inhibitor that is still on the market in the U.S. since the others were pulled as a result of cardiovascular and other potential adverse reactions.

The report authors concluded that even though COX-2 drugs were designed to provide pain relief without the serious gastrointestinal side-effects associated with conventional NSAIDs, "we found no consistent evidence of enhanced safety against gastrointestinal events with any of the new cyclo-oxygenase-2 inhibitors [cox-2 inhibitors], compared with non-selective, nonsteroidal, anti-inflammatory drugs."
Dr. A Mark Fendrick, professor of internal medicine and health management and policy at the University of Michigan, believes that this study illuminates the increased dangers of gastrointestinal (GI) bleeding when a COX-2 inhibitor and aspirin are used together.

According to Dr. Fendrick: "The fact that cox-2 inhibitor drug users had higher rates of adverse GI events than nonusers comes as no surprise to me, Even a drug that might be safer than other alternatives doesn’t mean that the drug is completely safe." It is fine to take a cox-2 inhibitor for joint pain and an aspirin for your heart, but “when you combine these two, they really present GI problems."

Another expert, Dr. Eric Matteson, a professor of medicine at the Mayo Clinic College of Medicine in Rochester, Minnesota, believes the study reveals COX-2 inhibitors increase the risk of GI bleeding and ulcers when used in clinical practice. "These drugs were touted as prevention of adverse GI events, which is completely false. There might be some reduction in risk, but it was never prevention."

"In actual practice, the utility of these drugs is very low in terms of reducing the risk for important GI side effects," Matteson  said. "This differs from what was found in clinical trials, which is always different from what is seen in actual practice." According to Matteson this study highlights the GI risks of taking any of these drugs. "All NSAIDs increase your risk for stomach problems, including ulcers and bleeding, which can be serious and even fatal. This includes the COX-2 drugs."

Of course, if this is so, all of the hype and expense associated with the COX-2s was for naught and the only ones that benefited from the drugs were (and are) Merck and Pfizer, which have made tens of billions of dollars in profits from Vioxx, Celebrex, and Bextra.

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