COX-2 Inhibitors Have Fewer GI Side Effects Than Other NSAIDs

Doctor's Guide October 18, 1999

PHOENIX, AZ -- October 18, 1999 -- A new class of prescription-strength pain relievers, referred to as COX-2 inhibitors and introduced within the past year, appears to reduce adverse gastrointestinal (GI) effects while retaining pain relief and anti-inflammatory qualities. Several papers being presented at the meeting of the American College of Gastroenterology (ACG) in Phoenix, October 18-20, confirm and quantify the reduction in GI side effects for some of these new pharmacologic agents.

The second most common cause of ulcers is irritation of the stomach arising from regular use of non-steroidal anti-inflammatory drugs, or NSAIDs (the predominant cause of ulcers is infection with the Helicobacter pylori organism). NSAIDs are available over-the-counter (OTC) and by prescription. These are widely used for chronic pain because they can reduce both inflammation and pain symptoms, and both physicians and patients have been forced to balance these benefits against the potential adverse effects of these medications on the stomach and digestive system.

Two new studies of COX-2 inhibitors were reported by researchers from three institutions, the University of Illinois at Chicago, Duke University, and the University of Washington School of Medicine, conducting their research under a grant from G.D. Searle & Co. One used blinded evaluations by an external independent review committee to evaluate upper gastrointestinal events in 5,155 patients taking celecoxib over a period of up to two years.

In this study, 47 percent of the patients used celecoxib for more than one year. The researchers observed an annualized incidence of upper GI side effects of 0.18 percent, which compares quite favorably to historical rates of complication in the range of 1.3 percent to 1.9 percent annualized incidence in patients using conventional NSAIDs.

The same researchers looked at the possibility that COX-2 inhibitors may impair the healing of existing upper GI lesions, comparing twice daily dosing of celecoxib with placebo and with three conventional NSAIDs-naproxen, diclofenac, and ibuprofen -administered 2-3 times daily. They found that the celecoxib patients and those taking a placebo had similar results, with the majority exhibiting improvement in symptoms according to the index of gastric mucosal change (and about 10 percent showed worsening). Fewer of those patients taking the conventional NSAIDs showed improvement, while 33 percent had worsening of symptoms recorded using the same index. This prompted the researchers to conclude that COX-2 inhibitors do not delay or impair healing of upper gastrointestinal lesions.

A third study reported at the meeting is a meta-analysis, compiling and analyzing data from 13 different randomized clinical trials that had enrolled over 21,000 patients. It compares results in patients using meloxicam, another COX-2 inhibitor, compared to conventional NSAIDs, in terms of frequency of dyspepsia symptoms, total GI adverse events, and withdrawal of medication due to adverse GI events.

This study was conducted by Dr. Philip Schoenfeld of the National Naval Medical Center, in Bethesda, MD. Based on the compilation of results from the 13 randomized clinical trials selected, these researchers found that meloxicam was associated with less dyspepsia, fewer total GI adverse events and less withdrawal of medication due to adverse GI effects. They also noted that more patients using meloxicam withdrew from the clinical trials due to lack of efficacy compared to patients using conventional NSAIDs. The study concluded that patients using meloxicam appear to have fewer GI adverse side effects than conventional NSAIDs.

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