Influence of Helicobacter pylori Eradication Therapy on the Occurrence of Gastrointestinal Events in Patients Treated with Conventional Nonsteroidal Antiinflammatory Drugs Combined with Omeprazole

BERNARD BANNWARTH, ETIENNE DORVAL, AGNES CAEKAERT, and PHILIPPE BARTHELEMY

ABSTRACT.

Objective. To evaluate the effect of eradication treatment of Helicobacter pylori and the influence of H. pylori status on the incidence of gastrointestinal (GI) events in rheumatic patients receiving longterm conventional nonsteroidal antiinflammatory drug (NSAID) therapy combined with omeprazole.

Methods. Patients (n = 919) requiring longterm NSAID therapy entered this multicenter, open label, parallel group study. H. pylori positive patients were randomized to receive either eradication therapy (omeprazole 20 mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid for 7 days) or no therapy. Both these groups and the H. pylori negative patients were given omeprazole, 20 mg once daily, along with NSAID for the study duration (5-8 weeks). Treatment failure (primary outcome variable) was defined as the occurrence of severe GI event (symptomatic ulcer, bleeding, perforation) or dyspepsia leading to discontinuation of NSAID therapy, unscheduled consultation, or upper GI tract endoscopy.

Results. Treatment failure was recorded in 9/294 (3.06%) infected patients receiving eradication therapy, 8/219 (3.65%) infected patients receiving omeprazole alone, and 5/391 (1.28%) H. pylori negative patients (p > 0.05). H. pylori eradication did not appear to influence the incidence and severity of dyspeptic symptoms in infected patients.

Conclusion. Our results do not support the use of H. pylori eradication therapy in rheumatic patients receiving conventional NSAID along with omeprazole. (J Rheumatol 2002;29:1975-80)

Key Indexing Terms:

NONSTEROIDAL ANTIINFLAMMATORY DRUGS
HELICOBACTER PYLORI
GASTRODUODENAL SIDE EFFECTS
OMEPRAZOLE

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From the Department of Rheumatology, Groupe Hospitalier Pellegrin, and Division of Therapeutics, EA 525, Université Victor Segalen, Bordeaux; Department of Gastroenterology, CHU Trousseau, Tours; and Laboratoires AstraZeneca, Rueil-Malmaison, France.

Supported by Laboratoires AstraZeneca France.

B. Bannwarth, MD, Professor, Department of Rheumatology, Groupe Hospitalier Pellegrin and Division of Therapeutics, Université Victor Segalen; E. Dorval, MD, Professor, Department of Gastroenterology, CHU Trousseau; A. Caekaert, MD; P. Barthelemy, MD, Laboratoires AstraZeneca.

Address reprint requests to Pr. B. Bannwarth, Service de Rhumatologie, Groupe Hospitalier Pellegrin, 33076 Bordeaux Cedex, France. E-mail: bernard.bannwarth@u-bordeaux2.fr

Submitted July 20, 2001; revision accepted March 27, 2002.

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