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| |  DG DISPATCH - ACG: Esomeprazole (Nexium) Resolves Heartburn In Symptomatic GERD By Jill Stein Special to DG News
NEW YORK, NY -- October 18, 2000 -- The new proton pump inhibitor, Nexium (esomeprazole), is effective for the treatment of symptomatic gastroesophageal reflux disease. Dr. Philip O. Katz, with the Graduate Hospital in Philadelphia, Pennsylvania, presented the results of his study at the 65th Annual Scientific Meeting of the American College of Gastroenterology, in New York City. Dr. Katz and colleagues assessed the efficacy of esomeprazole in patients with symptomatic gastroesophageal reflux disease (GERD) who were drawn from two multi-center, phase III trials. Patients with a six-month history of heartburn who were negative for erosive esophagitis by esophagogastroduodenoscopy and had episodes of heartburn for at least four days during the previous seven days prior to enrolment were randomized to one of three treatment groups for four weeks. Patients were randomized to receive esomeprazole 40 mg once daily, esomeprazole 20 mg once daily or placebo. Patients maintained daily symptom diaries throughout the studies. "While proton pump inhibitors are the most effective acid-suppressing agents, even currently available proton pump inhibitors may fail to completely resolve GERD in many patients," Dr. Katz said. "More effective acid suppression may provide better relief to patients with acid-related disease." Esomeprazole is the s-isomer of Prilosec (omeprazole). It has a higher bioavailability than omeprazole and has also been shown to be more effective than omeprazole in controlling gastric pH in symptomatic GERD as well as healing and symptom resolution in patients with erosive esophagitis, he continued. For this reason, the investigators believed it may also be more effective for relieving heartburn in endoscopy-negative GERD patients with acid disease. Results of both studies showed that the percentage of patients with complete resolution of heartburn was roughly threefold higher in the esomeprazole 40 mg and 20 mg groups than in the placebo group. The mean percentage of heartburn-free days was higher in the esomeprazole groups than in the placebo group in each study. First resolution of heartburn occurred earlier in both esomeprazole groups than with placebo. Sustained resolution of heartburn also occurred significantly faster with esomeprazole treatment than with placebo in each study. The most common adverse events for all treatment groups were headache, nausea and diarrhea. Dr. Katz said the findings demonstrate that esomeprazole, at daily doses of 40 mg or 20 mg, was effective for the complete resolution of heartburn in patients with symptomatic GERD who were endoscopy-negative and had heartburn as their key symptom. Also, both doses of esomeprazole provided substantially more heartburn-free days and shorter times to first and sustained resolution of heartburn than placebo in these patients.
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