People who take pain relievers for chronic arthritis or other joint pain are four times as likely to develop ulcers as a result of the medication churning up acid in their stomachs. Doctors are aware of the problem, and often prescribe off-label medications, such as proton-pump inhibitors, to counteract the pain. New research shows these drugs, particularly Nexium, are safe and effective at reducing the incidence of ulcers in patients taking other pain medications.
"For the first time we have a study that shows proton-pump inhibitors are effective in reducing ulcers in traditional non-steroidal anti-inflammatory drug (NSAID) users but also in COX-2 NSAID users," said Dr. James Scheiman, professor of Medicine in the Gastroenterology Division at the University of Michigan Medical School.
NSAIDs include medications such as ibuprofen and naproxon. The COX-2 inhibitors are also in the same family of drugs, but their action is more specific. These include the drugs Vioxx, Bextra, and Celebrex.
Dr. Scheiman presented the findings of the study, which was funded by Astra Zeneca, at the 68th Annual Scientific Meeting of the American College of Gastroenterology in Baltimore last week. Scheiman is a paid consultant for the company.
The study included 573 patients who were taking some type of NSAID for joint pain at least five days a week. A few were also on aspirin for cardiovascular protection. About 26 percent of the population had a history of ulcers; nearly 64 percent were over the age of 60; and 10 percent of the population fell into both categories.
After six months, patients taking either a 20 mg or 40 mg dose of Nexium and a non-specific NSAID, had an ulcer rate of 5.2 and 4.4 percent respectively. This was compared to a 12.3 percent ulcer rate for the placebo group.
The group taking a COX-2 inhibitor was much smaller, but none of these patients developed ulcers when Nexium was added to their drug regimen. However, 17 percent of the placebo group did develop an ulcer.
Overall, Nexium was well tolerated by the patients and there were no major side effects.
Nexium, and the other proton-pump inhibitors work by blocking the production and secretion of stomach acid. They are prescribed for patients with severe heartburn, but not for ulcer prevention.
"Experts in the field have recommended it [Nexium] before this study," said Dr. Scheiman, "this is just the first scientific evidence to support that recommendation."
Millions of people are taking NSAIDs to relieve pain, and previous studies have shown that 10 to 30 percent of this population might develop ulcers within a given year. Now there’s evidence to suggest these patients may not have to give up their arthritis medication, but instead can add an acid-reducing drug to prevent developing an ulcer.
Dr. Scheiman says this is good news but adds, "The only limitation is that it’s an expensive combination."
Astra Zeneca is expected to seek approval from the Food and Drug Administration to market Nexium for the prevention of ulcers in patients who are taking NSAIDs.