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Nexium Found to Be Well-Tolerated, Efficacious in Maintaining Healed Erosive Esophagitis WAYNE, PA -- January 3, 2002 -- Some 90 percent of clinical trial participants remained disease free from erosive esophagitis for up to 12 months after a maintenance regimen of Nexium® (esomeprazole), according to two recent studies published in Drug Safety and Alimentary Pharmacology and Therapeutics. 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 the 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 the treatment of GERD symptoms and erosive esophagitis, conditions which affect more than 10 percent of the population," said Paul N. Maton, MD, principle investigator of the study published in Drug Safety (2001; 24(8): 625-625) and director of the Digestive Diseases Research Institute in Oklahoma City, Oklahoma. In Dr. Maton's study, endpoints evaluated safety and tolerability of long-term treatment with esomeprazole in patients with healed erosive esophagitis, and to evaluate its efficacy in the maintenance of healing. Diarrhea, abdominal pain, flatulence and headache were the only treatment-related adverse events reported by 73 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. In the second 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. After six months, more patients remained healed with Nexium 40 mg (87.9 percent), 20 mg (78.7 percent) or 10 mg (54.2 percent) than with placebo (29.1 percent). In earlier studies, no additional clinical benefit was seen with Nexium 40 mg over Nexium 20 mg. 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. 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 percent) respiratory infection (6.7 percent) and diarrhea (6.4 percent). Nexium, a proton pump inhibitor (PPI) from AstraZeneca Pharmaceuticals, is indicated for the treatment of heartburn and other symptoms associated with GERD and short-term treatment (four to eight weeks) in the healing and symptomatic resolution of erosive esophagitis. Proton pump inhibitors suppress gastric acid secretion by blocking the final step in acid production. In addition, when combined with antibiotics, Nexium is indicated for the eradication of H.pylori to reduce the risk of duodenal ulcer recurrence. 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. The most frequently occurring adverse events (>1 percent) in all three groups was 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. Symptomatic response to therapy with Nexium does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Nexium is an enantiomer. Nexium should be used for the conditions, dosages and durations specified in the prescribing information. SOURCE: AstraZeneca E-mail this page to a friend or colleague! To print, use this version