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Esomeprazole Helps Prevent Ulcers Among Chronic Users of Nonsteroidal Anti-Inflammatory Drugs: Presented at ACG

By Charlene Laino

BALTIMORE, MD -- October 22, 2003 -- Proton pump inhibitor therapy can significantly reduce the risk of gastroduodenal ulcers and associated upper gastrointestinal symptoms in chronic users of nonsteroidal anti-inflammatory drugs (NSAIDs).

James Scheiman, MD, professor of internal medicine at the University of Michigan Health System, Ann Arbor, United States, presented the findings here on October 14^th at the 68^th Annual Scientific Meeting of the American College of Gastroenterology.

For the study, 573 patients who had taken non-selective or cyclooxygenase-2 (COX-2) selective NSAIDs at least five days a week for four weeks were randomly assigned to receive 20 mg of esomeprazole, 40 mg of esomeprazole or placebo daily for six months.

Although all the patients had tested negative for Helicobacter pylori infection, they were at high risk for ulcer, Dr. Scheiman said. About two-thirds were age 60 years or older, 26% had had an ulcer in the past and 10% fell into both categories. More than 80% of the patients suffered from rheumatoid arthritis or osteoarthritis, and some were taking multiple NSAIDs, including aspirin. About 15% were taking COX-2 inhibitors.

The patients underwent endoscopy and an upper gastrointestinal (GI) symptom evaluation by the investigators at baseline and after one, three and six months. By six months, 12% of patients taking placebo had developed an ulcer, compared with 5% and 4%, respectively of those on low-dose and high-dose esomeprazole. This corresponds to a reduction in risk of 64.2% and 57.7%, respectively, for 40 mg and 20 mg of esomeprazole, relative to placebo, Dr. Scheiman said.

Also, only 24% and 19% of patients who took 40 mg and 20 mg of esomeprazole, respectively, had heartburn at the end of six months, compared with 37% of those on placebo (P=0.0022; P=0.0002). Twenty-one percent and 15% of patients on high-dose and low-dose esomeprazole reported acid regurgitation versus 34% on placebo (P=0.0096; P<0.0001), the study showed.

In the subset of patients taking COX-2-inhibitors, 19% in the placebo arm developed ulcers, while none of the patients in either esomeprazole arm did. But the numbers were too small to show statistical significance, Dr. Scheiman said.

The drug was well tolerated, Dr. Scheiman added: Only 6% of patients taking esomeprazole discontinued treatment because of adverse effects, compared with 13% of patients on placebo. Serious adverse events occurred in 11% of patients in the placebo arm and 8% in either of the esomeprazole arms.

AstraZeneca, which markets esomeprazole under the brand Nexium®, helped fund the study.


[Study title: Esomeprazole Reduces Gastric and Duodenal Ulcer Development Among High Risk NSAID Users. Abstract 28]

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