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US double‐blind, controlled trials of omeprazole and amoxycillin for treatment of Helicobacter pylori
Author(s) -
L. Laine,
Erika Johnson,
Lisa Suchower,
P Ronca,
Clara Hwang,
Garry A. Neil
Publication year - 1998
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.1998.00303.x
Subject(s) - omeprazole , medicine , helicobacter pylori , amoxicillin , gastroenterology , adverse effect , intention to treat analysis , antibacterial agent , antibiotics , microbiology and biotechnology , biology
Background: Widely variable Helicobacter pylori eradication rates have been reported with omeprazole/amoxycillin dual therapy. We present the first US double‐blind, controlled trials of this dual therapy. Methods: Three separate studies were performed: Studies 1 and 2 included patients with an active duodenal ulcer and Study 3 included patients with a documented history of duodenal ulcer. H. pylori eradication regimens in all studies were omeprazole plus amoxycillin vs. omeprazole vs. amoxycillin for 2 weeks. Doses in Study 1 were omeprazole 40 mg b.d. and amoxycillin 500 mg t.d.s., and in Studies 2 and 3 they were omeprazole 20 mg b.d. and amoxycillin 1 g t.d.s. Endoscopic biopsy tests were used for H. pylori diagnosis, and testing for H. pylori eradication was done at least 4 weeks after the completion of therapy. Amoxycillin sensitivities were performed in Study 2. Results: Intention‐to‐treat (ITT) and per protocol (PP) analyses showed that eradication rates with omeprazole/amoxycillin [ITT: 39%, 40%, 46% ( n = 72, 62, 48); PP: 50%, 46%, 54% ( n = 54, 52, 37)] were significantly greater than monotherapy with either omeprazole (ITT: 0–4%; PP: 0–5%) or amoxycillin (ITT: 2–5%; PP: 0–11%). No patients taking the dual therapy discontinued therapy due to adverse events. Amoxycillin resistance was not seen at baseline ( n = 76) or after amoxycillin therapy ( n = 56). Conclusions: Omeprazole/amoxycillin dual therapy is well tolerated but the eradication rate which can be expected in the USA is at best about 50%.