A double-blind study of pantoprazole and ranitidine in treatment of acute duodenal ulcer
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Pantoprazole is a new substituted benzimidazole, which is a potent inhibitor of gastric acid secretion by its inhibition of H+,K+-ATPase. Pantoprazole, 40 mg, was compared with the H2-receptor antagonist ranitidine, 300 mg, in the healing of acute duodenal ulcer. Two hundred seventy-six patients with endoscopically diagnosed duodenal ulcer were studied in this multicenter double-blind study. Patients were reendoscopied after two weeks of treatment, and those patients whose ulcers remained unhealed were also endoscoped after an additional two weeks of treatment. The primary end point was the complete healing of the ulcer. Demographic characteristics were comparable in both treatment groups. After two weeks of treatment, 90/124 (73%) patients in the pantoprazole group had healed ulcers compared with 57/126 (45%) patients in the ranitidine group (P<0.001, per-protocol analysis). After four weeks, the cumulative healing rates were 92% and 84% in the pantoprazole and ranitidine groups, respectively (P=0.073). Symptoms were also improved at week 2, with 84% and 72% of patients in the pantoprazole and ranitidine groups, respectively, reporting no ulcer pain (P<0.05, per-protocol analysis). Both treatments were well tolerated. This study has confirmed the superiority of pantoprazole compared with ranitidine in the healing of duodenal ulcers and pain relief after two weeks of treatment and has shown pantoprazole to be well tolerated in this indication.
Key wordspantoprazole ranitidine duodenal ulcer multinational dosage
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- 3.Simon B, Müller P, Hartmann M, Bliesath H, Lühmann R, Huber R, Bohnenkamp W, Wurst W: Pentagastrin-stimulated gastric acid secretion and pharmacokinetics following single and repeated intravenous administration of the gastric H+,K+-ATPase-inhibitor pantoprazole (BY1023/SK&F96022) in healthy volunteers. Z Gastroenterol 28:443–447, 1990PubMedGoogle Scholar
- 4.Simon B, Müller P, Marinis E, Lühmann R, Huber R, Hartmann M, Wurst W: Effect of repeated oral administration of BY1023/SK&F96022—a new substituted benzimidazole derivative—on pentagastrin-stimulated gastric acid secretion and pharmacokinetics in man. Aliment Pharmacol Ther 4:373–379, 1990PubMedGoogle Scholar
- 5.Reill L, Erhardt F, Fishcer R, Londong W: Intragastric pH and serum gastrin after one week of treatment with pantoprazole, ranitidine or placebo. Gastroenterology 104:A177, 1993 (abstract)Google Scholar
- 6.Hartmann M, Theiss U, Bliesath H, Wieckhorst G, Lühmann R, Wurst W, Postius S, Lücker PW: Comparison of the 24 h intragastric pH profiles following single and repeated oral intake of pantoprazole 40 mg and omeprazole 20 mg in healthy male volunteers. Gastroenterology 104:A95, 1993 (abstract)Google Scholar
- 9.Mulder CJJ, Schipper DL: Omeprazole and ranitidine in duodenal ulcer healing. Analysis of comparative clinical trials. Scand J Gastroenterol 25(suppl 178):62–66, 1990Google Scholar
- 13.Gugler R, Hartmann M, Rudi J, Bliesath H, Brod I, Klotz U, Huber R, Steinijans VW, Wurst W: Lack of interaction of pantoprazole and diazepam in man. Z Gastroenterol 102(suppl):A77, 1992Google Scholar
- 16.Lanzon-Miller S, Pounder RE, Hamilton MR, Ball S, Chronos NAF, Raymond F, Olausson M, Cederberg C: Twenty-four-hour intragastric acidity and plasma gastrin concentration before and during treatment with either ranitidine or omeprazole. Aliment Pharmacol Ther 1:329–251, 1987Google Scholar