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Nexium Shown to Reduce Gastric Ulcers in At-Risk Patients Using Long-Term NSAIDs

Clinical Trial Data, as Highlighted in Next Month's American Journal of Gastroenterology, Demonstrate Reduced Gastric Ulcer Risk in Patients Taking Non-selective and Selective COX-2 NSAIDs

WILMINGTON, D.E. -- March 22, 2006 -- Results from two clinical trials, to be published in the April 2006 edition of the American Journal of Gastroenterology, indicate that Nexium(R) (esomeprazole magnesium) can reduce the incidence of gastric (stomach) ulcers in patients at risk of developing gastric ulcers and who regularly take either non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2-selective NSAIDs.(1)

NSAIDs are a class of pain relief medications that include traditional, non-selective drugs, such as ibuprofen, naproxen and aspirin, and newer COX-2- selective agents. Non-selective NSAIDs are known for increasing the risk of gastric ulcers, particularly among older patients who take them regularly or who have a history of gastric ulcers.

Pooled data from the double-blind, randomized, six-month trials showed that significantly fewer patients taking either Nexium 20 mg or Nexium 40 mg, in addition to their regular non-selective NSAID/COX-2-selective therapy, developed an ulcer at six months, compared to those taking a placebo (5.2% and 4.6%, respectively, vs. 17%, p<0.001).(1) These differences were seen as early as the first month of treatment and maintained throughout the study duration.(1)

"Paradoxically, NSAID use is common among patients at high risk for gastric ulcers or other complications associated with these medications. Although COX-2-selective drugs generally cause fewer gastric ulcers than non-selective NSAIDs, these events aren't completely eliminated, and the residual side-effect rate still may be high," said James M. Scheiman, MD, Division of Gastroenterology, Department of Internal Medicine, University of Michigan. "Data from the two trials showed that Nexium was effective in reducing stomach ulcers in at-risk patients who require chronic NSAID treatment."

In the first trial, known as Verification of Esomeprazole for NSAID Ulcers and Symptoms (VENUS), a significantly smaller percentage of patients taking Nexium 20 mg or 40 mg developed a gastric or duodenal (occurring in the beginning of the small intestine) ulcer, compared to patients on placebo (5.3% and 4.7%, respectively, versus 20.4%, p<0.001 and p<0.0001).(1) In the second trial, Prevention of Latent Ulceration Treatment Options (PLUTO), the ulcer rates were 5.2 and 4.4% for patients on Nexium 20 mg and 40 mg, respectively, versus 12.3% for those on placebo (p=0.018 and p=0.007).(1)

About the Trials

The two studies were similar, double-blind, randomized, placebo-controlled trials involving a total of 844 (U.S.) and 585 (multinational) patients who were randomly assigned in a 1:1:1 ratio to treatment with either Nexium 20 mg, Nexium 40 mg or a placebo. Patients were continuous NSAID users (i.e., receiving daily non-selective NSAID or COX-2 therapy for at least four weeks before and throughout the duration of the six-month trial) at risk of developing a gastric or duodenal ulcer as a result of older age (greater than or equal to 60 years) and/or a history of previous gastric ulcers. At the time of the study, patients were free of ulcers and Helicobacter pylori infection and showed no evidence of GI bleeding or perforation within the prior six months.

AstraZeneca R&D, Sweden, funded the study through a research grant.

About NSAID-ulcer Risk

Chronic NSAID use is a common cause of gastric ulcers and has been associated with side effects ranging from indigestion to potentially life- threatening stomach bleeding.(2) Of the more than 14 million Americans who use NSAIDs regularly to treat chronic pain,(3) up to 25% may be affected by NSAID-related ulcers.(4) Each year, there are an estimated 103,000 hospitalizations and 16,500 deaths in the United States attributed to complications from NSAID-associated gastric ulcers.(5) Among the elderly, NSAID use accounts for nearly one third of gastric-ulcer-related hospitalizations,(6) with an associated four-fold increased risk of death.(7)

About Nexium(R) (esomeprazole magnesium) Delayed-release Capsules

Nexium is indicated for reducing the risk of gastric ulcers developing among at-risk patients on continuous NSAID therapy. Patients are considered to be at risk if they are age 60 plus or if they have a history of previous gastric ulcer. Nexium also is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease, as well as for the healing and maintenance of erosive esophagitis, a condition in which stomach acid begins to wear away the inner lining of the esophagus. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions.

The most frequently reported adverse events with Nexium include headache, diarrhea and abdominal pain.


REFERENCES:
1. Scheiman JM, et al. (2006) Prevention of Ulcers by Esomeprazole in At- Risk Patients Using Non-Selective NSAIDs and COX-2 Inhibitors. Am J Gastroenterology 0 (0), -.doi: 10.1111/j.1572-0241.2006.00499.x.
2. Scheiman JM and Fendrick AM. Practical approaches to minimizing gastrointestinal and cardiovascular safety concerns with COX-2 inhibitors and NSAIDs. Arthritis Research & Therapy 2005, 7(Suppl 4):S23-S29.
3. The Dangers of Aspirin and NSAIDs. American College of Gastroenterology. Available at: http://acg.gi.org/patients/women/asprin.asp.
4. Blower AL. Scand J Rheumatol 1996;25(suppl 105):13-26. Singh G. Am J Med 1998;105:31S-38S.
5. Wolfe M, Lichtenstein R, Singh G. Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs. N Engl J Med 1999;340:1888-1899.
6. Griffin MR et al. Nonsteroidal anti-inflammatory drug use and increased risk for peptic ulcer disease in elderly persons. Ann Intern Med 1991;114:257-263.
a. Griffin MR et al. Nonsteroidal anti-inflammatory drug use and death from peptic ulcer disease in elderly persons. Ann Intern Med 1988;109:359-363.
b. Laine L et al. Gastrointestinal health care resource utilization with chronic use of COX-2-specific inhibitors versus traditional NSAIDs. Gastroenterology 2003;125:389-395.
c. (All citations above from Abraham NS et al. National adherence to evidence-based guidelines for the prescription of nonsteroidal anti- inflammatory drugs. Gastroenterology 2005;129:1171-1178.)
7. Griffin MR et al. Nonsteroidal anti-inflammatory drug use and death from peptic ulcer disease in elderly persons. Ann Intern Med 1988;109:359-363. From Abraham NS et al. National adherence to evidence- based guidelines for the prescription of nonsteroidal anti-inflammatory drugs. Gastroenterology 2005;129:1171-1178.


SOURCE: AstraZeneca

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