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Acid Reflux: Studies support Nexium efficacy in erosive esophagitis healing maintenance

FORT WAYNE, PA -- Recently published studies indicate that Nexium (esomeprazole magnesium) is highly effective and well-tolerated in the maintenance of healing of erosive esophagitis.

Erosive esophagitis is a more severe, potentially serious form of gastroesophageal reflux disease (GERD) which occurs when stomach acid backs up into the esophagus and, over an extended period of time, erodes the esophageal lining. It is estimated that some six million Americans are affected by this condition.

"These studies add even more support to the body of clinical and scientific knowledge that supports the use of Nexium as a generally well-tolerated and efficacious therapy for erosive esophagitis," said Paul N. Maton, MD, principal investigator of a study published in Drug Safety and director of the Digestive Diseases Research Institute in Oklahoma City, Oklahoma.

Dr. Maton's study, reported in Drug Safety (2001; 24(8):625-635), evaluated safety and tolerability of open-label, long-term treatment with esomeprazole in patients with healed erosive esophagitis, and the efficacy in the maintenance of healing over 12 months.

Minor side effects

Diarrhea, abdominal pain, flatulence and headache were the only treatment-related adverse events reported by greater than 3 percent of patients. Plasma gastrin levels increased as expected and reached a plateau after three months.

In addition, evaluation of gastric biopsies revealed an overall decline in chronic inflammation and atrophy, and intestinal metaplasia findings remained essentially unchanged.

Symptomatic response to therapy with Nexium does not preclude the presence of gastric malignancy, says a release from manufacturer AstraZeneca. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Nexium is an enantiomer.

Findings endorsed

In a multi-center, randomized, double-blind, placebo-controlled study, reported in Alimentary Pharmacology and Therapeutics (2001; 15(7): 927-935), 375 patients with healed erosive esophagitis received 40, 20 or 10 mg. of Nexium daily, or placebo. The study endpoint was to assess the efficacy of Nexium in maintaining healing of erosive esophagitis at six months, and to assess long-term safety and tolerability.

After six months, more patients remained healed with Nexium 40 mg (87.9%), 20 mg (78.7%) or 10 mg (54.2%) than with placebo (29.1%). In general, adverse effects were mild to infrequent and not significantly different between groups. The most frequently reported adverse events over the six-month period were headache (7.8%) respiratory infection (6.7%) and diarrhea (6.4%).

In another 6-month controlled clinical study reported in the American Journal of Gastroenterology (2001:96:27-34), more patients remained healed with Nexium 40 mg (93.6%), 20 mg (93.2%), and 10 mg (57.1%) than placebo (29.1%).

20 mg once a day

Recommended dosage for maintenance of healing of erosive esophagitis is 20 mg once daily. No additional clinical benefit was seen with Nexium 40 mg over Nexium 20 mg. Controlled studies do not extend beyond 6 months.

The safety of Nexium was also assessed in four randomized comparative clinical trials, which included 1,240 patients on Nexium 20 mg; 2,434 patients on Nexium 40 mg and 3,008 patients on omeprazole 20 mg daily. Most frequently occurring adverse events in all three groups were headache (5.5%, 5.0% and 3.8% respectively) and diarrhea (no difference among the three groups).

Nausea, flatulence, abdominal pain, constipation and dry mouth also occurred at similar rates among patients taking Nexium or omeprazole. AstraZeneca says Nexium should be used for the conditions, dosages and durations specified in the prescribing information.

For more information or a copy of the full prescribing information for Nexium, contact Ed Weirauch at 1-800-942-0424, ext. 1977, or via e-mail at edward.weirauch@astrazeneca.com or reference the World Wide Web at www.purplepill.com

SEARCH Nexium in the Drugs.com database, HERE 

Posted: April 2002


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