The risk of acute pancreatitis associated with acid-suppressing drugs

Authors

  • I. A. Eland,

    1. Pharmaco-epidemiology Unit, Departments of Internal Medicine and Epidemiology & Biostatistics, Erasmus University Medical School, Rotterdam, The Netherlands,
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  • C. Huerta Alvarez,

    1. CEIFE, Spanish Centre for Pharmacoepidemiologic Research, Madrid, Spain and
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  • B. H. CH. Stricker,

    1. Pharmaco-epidemiology Unit, Departments of Internal Medicine and Epidemiology & Biostatistics, Erasmus University Medical School, Rotterdam, The Netherlands,
    2. Drug Safety Unit, Inspectorate for Health Care, The Hague, The Netherlands
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  • L. A. Garcı´a Rodrı´guez

    1. CEIFE, Spanish Centre for Pharmacoepidemiologic Research, Madrid, Spain and
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Dr I.A. Eland, Pharmaco-epidemiology Unit, Erasmus University Medical School, Laboratory of Internal Medicine II, L448, PO Box 2040, 3000 CA Rotterdam, The Netherlands. Tel.: 0031 10 4635944; Fax: 0031 10 4633964; E-mail: eland@inw2.azr nL

Abstract

Aims To assess the risk of acute pancreatitis associated with use of acid-suppressing drugs.

Methods We conducted a retrospective cohort study with a nested case-control design within the General Practice Research Database (GPRD) in the United Kingdom. The cohort included 180 178 persons aged 20–74 years, who had received at least one prescription of cimetidine, famotidine, nizatidine, ranitidine, lansoprazole, or omeprazole from January 1992 to September 1997 and who did not have major risk factors for pancreatic diseases. Patients with a computerized medical history compatible with idiopathic acute pancreatitis were validated through review of medical records. For the nested case-control analysis 1000 controls were randomly selected from the study population.

Results We identified 88 potential cases of idiopathic acute pancreatitis. Medical records were available for 86. After review of these records 36 cases of acute pancreatitis were confirmed. Seven cases occurred during nonuse, corresponding to a background incidence rate (IR) of 4.4/100 000 person-years (PY). Six cases occurred during current use of ranitidine (IR 10.5/100 000 PY), five patients were current users of cimetidine (IR 13.9/100 000 PY), and three were current users of omeprazole (IR 7.8/100 000 PY). There were no cases among current users of famotidine, lansoprazole, or nizatidine. Relative risk (RR) compared with nonuse and corrected for age, gender, calendar year and use of medication known to be associated with acute pancreatitis was 1.3 (95% CI: 0.4,4.1) for ranitidine, 2.1 (95% CI: 0.6,7.2) for cimetidine, and 1.1 (95% CI: 0.3,4.6) for omeprazole.

Conclusions The results of this study do not support an association between acute pancreatitis and the use of acid-suppressing drugs, although a substantial increase in risk cannot be excluded with confidence.

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