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October 9, 1996

Practice Guidelines for Treatment of Peptic Ulcer Disease

JAMA. 1996;276(14):1136. doi:10.1001/jama.1996.03540140024011

To the Editor.  —Dr Soll1 states that ranitidine plus bismuth subcitrate has received preliminary approval from the FDA. To clarify his comments, the product Soll refers to is ranitidine bismuth citrate (Tritec), which is a novel salt of ranitidine with a complex of bismuth and citrate developed by Glaxo Wellcome. Ranitidine bismuth citrate, when used in conjunction with clarithromycin, has been recommended for approval by the joint Anti-infective and Gastrointestinal Drugs Advisory committees of the FDA.Several studies reviewed by the FDA committees to support this recommendation showed ranitidine bismuth citrate plus clarithromycin was well tolerated and eradicated H pylori infection in 82% to 94% of patients.2-4 These trials employed rigorous testing methods to ascertain the presence of infection and to confirm the eradication of infection. To be confirmed as being infected with H pylori, patients had to have at least 2 different positive diagnostic tests performed by central laboratory personnel