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Executive Summary

TAGAMET 800 MG ONE-A-DAY DOSE IS COMPARABLE IN EFFICACY to a 1,600 mg dose of Tagamet for daytime/nighttime pain relief and ulcer healing, SmithKline said in an April 30 press release announcing the approval of the new once-daily dosage. Noting that a 1,600 mg dose of Tagamet (cimetidine) is similar to Zantac (ranitidine) 300 mg in terms of antisecretory activity, the release states that a U.S. dose-ranging trial "demonstrated that an 800 mg Tagamet bedtime tablet provided healing and daytime/nighttime relief comparable to a higher 1,600 mg nighttime dose." The release goes on to explain that "while the 1,600 mg dose extended antisecretory activity into daytime hours (slightly less than ranitidine 300 mg), the higher dose provided no additional healing or pain relief." Approval of SmithKline's once-a-day dose of Tagamet follows closely behind the December approval of Glaxo's Zantac once-a-day dose. Glaxo launched its products in March. SmithKline said it plans to introduce the new Tagamet before the end of May. SmithKline's press release may be indicative of how the firm will position the new once-a-day Tagamet against Zantac once-a-day. In the release, SmithKline asserts not only that the 800 mg dose has comparable efficacy to 1,600 mg Tagamet and consequently, to 300 mg Zantac, but also that the 800 mg dose may have safety advantages because of its lower level of antisecretory activity. Tagamet one-a-day "offers what are believed to be unique advantages over other antiulcer compounds," the release states. "These advantages include: moderate suppression of gastric acid." The firm said that "researcher and clinical leaders worldwide believe moderate acid suppression is optimum short and long-term therapy because of potential risk from intense, prolonged gastric acid inhibition." Tagamet 800 mg has "no significant effect on daytime gastric physiology, thereby permitting normal digestive response to meals," the release adds. SmithKline also stated that "the 800 mg h.s. dose showed reduced potential for drug interactions." For example, the release states, "the new regimen decreases the potential for drug interaction with theophylline." Discussing the results of Tagamet 800 mg clinicals, SmithKline said: "In international studies and in [a] double-blind, placebo-controlled U.S. trial, it was demonstrated that the 800 mg Tagamet dose attained endoscopically proven healing rates averaging 80% -- and ranging as high as 85% -- at four weeks. At eight weeks, healing rates averaged 94%." The release adds that "daytime/nighttime pain relief occurred in most patients after only one or two bedtime doses of the new 800 mg Tagamet tablet."

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