FDA Approves Nexium for Prevention of NSAID-Induced Gastric Ulcers
Nexium approved for reduced risk of stomach ulcer development among NSAID users
WILMINGTON, DE., November 29, 2004 -- AstraZeneca announced that a new indication for its prescription acid inhibitor Nexium (esomeprazole magnesium) has been approved by the FDA. Nexium is now indicated for reducing the risk of gastric (stomach) ulcers developing among patients on continuous therapy with non-steroidal anti-inflammatory drugs (NSAIDs).
The FDA also issued an approvable letter for the indication of the healing of gastric ulcers associated with NSAIDs therapy.
"NSAIDs play a crucial role in providing relief to many pain sufferers. However potentially serious side effects are often a deterrent to continue long-term treatment," says James Schieman, MD, gastroenterologist at University of Michigan Health System. "Health care professionals now can offer their patients on NSAID therapy, who may be at risk for developing gastric ulcers, a therapeutic option that may lessen the possibility of such stomach injury occurring."
A total of 1,429 patients, ranging in age from 19 to 89, were evaluated in two separate multi-center, double-blind, placebo-controlled clinical studies. Patients were given either a non-selective or COX-2 selective NSAID along with either Nexium 20 mg or 40 mg once a day. Nexium 20 mg and 40 mg demonstrated comparable benefits in providing excellent risk reduction with the proportion of NSAID patients remaining free of gastric ulcers ranging from 95.4% to 96.7% in one study, and 94.7% to 95.3% in the second study.
An estimated 100-plus million prescriptions are written for NSAIDs each year in the United States. Every day approximately 30 million people worldwide take NSAIDs. NSAIDs, which include such popular pain medications as aspirin, ibuprofen and naproxen, are a common cause of stomach ulcers and have been associated with side effects ranging from stomach upset to potentially life threatening stomach bleeding. In fact, NSAID use leads to more than 103,000 hospitalizations and 16,500 deaths each year in the United States.
Beyond its newest indication for risk reduction for the development of gastric ulcers among patients on continuous NSAID therapy, Nexium is recommended for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease. The drug is also approved for healing erosive esophagitis. Studies show that up to 94 percent of patients were healed with Nexium. Most erosions heal in 4 to 8 weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. The most common side effects of Nexium are headache, diarrhea and abdominal pain. Symptom relief does not rule out the existence of other serious stomach conditions. For full prescribing information for Nexium, visit www.purplepill.com
Source: AstraZeneca www.astrazeneca-us.com
Posted: November 2004
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