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Executive Summary

Glaxo/Roche's Zantac (ranitidine) approved labeling for gastroesophageal reflux disease (GERD) notes that the drug is effective in alleviating both day and nighttime symptoms. In a discussion of clinical trial results, the package insert states that "patient response rtes demonstrated that the effect on heartburn extends through both the day and nighttime periods." In a press release announcing FDA approval of the indication, Roche and Glaxo stated that patients with reflux disease "commonly awake from sleep due to the discomfort of heartburn, regurgitation, sour taste, coughing and choking. These nocturnal eventsare associated with increased risk of esophageal mucosal tissue damage. In some patients, aspiration of stomach contents into the lungs causes choking, significant respiratory tissue damage and pneumonia. The long duration of action of Zantac 150 mg permits twice daily therapy, thus controlling symptoms of reflux through the day, as well as overnight when the consequences of reflux are the most severe." By comparison, Robins' Reglan approved labeling states that "the principal effect of metroclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms." The recommended Reglan dose for GERD is 10-15 mg up to q.i.d. 30 minutes before meals and bedtime. FDA approved Zantac for the GERD indication, and for use as maintenance therapy to prevent relapse of duodenal ulcers, the week of June 2. Zantac now is the only H[2] antagonist product to carry the reflux indication. SmithKline's Tagamet (cimetidine) NDA for GERD is still pending at FDA. The newly approved maintenance therapy indication for Zantac states that "ranitidine has been found to be effective as maintenance therapy for patients following healing of acute duodenal ulcer. In two independent double-blind multi-center controlled trials, the number of duodenal ulcers observed was significantly less in patients treated with Zantac (150 mg hs) than in patients treated with placebo over a 12-month period." In the press release announcing the maintenance indication approval, the two companies pointed to the results of a multi-center 12 month trial comparing ranitidine to cimetidine. The study, conducted by Stephen Silvis, MD, et al and reported in the December 1985 issue of the Journal of Clinical Gastroenterology, concluded that "150 mg ranitidine hs was shown to be significantly superior to 400 mg of cimetidine hs as maintenance therapy in duodenal ulcer disease. The estimated 12 month ulcer relapse rates for ranitidine and cimetidine treated subjects were 16% and 43%, respectively."

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