Mortality study of 18 000 patients treated with omeprazole



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Bateman, Colin-Jones, Hartz, et al

population studied was large, and the follow up prolonged and
complete. Thirdly, the number of incident oesophageal
tumours diagnosed after enrolment (38) was large.

It has been suggested that, based on symptoms alone,
patients with oesophageal reflux are at nearly eight fold
increased risk of adenocarcinoma.21 Our data indicate that in
our population, any increase in oesophageal cancer risk may
be confined to those with evidence of mucosal structural
damage, and that simple symptomatic reflux may not pose
significant risks. This conclusion is consonant with that of
Cohen and Parkman22 that structural damage, and Barrett’s
oesophagus in particular, are the critical factors. Our data
showing a fall in gastric cancer death rates by the fourth year
of the study to slightly below population expectation suggest
that gastric cancer risk is neither intrinsically raised in the
population studied nor influenced in the period under review
by omeprazole or other antisecretory drug prescribing. Our
results are reassuring given concern that treatment might
cause early gastric atrophy,23 24 although any increased
incidence of gastric atrophy associated with antisecretory
treatment might take longer than the period under review to
influence mortality from gastric cancer. We conclude that
treatment with omeprazole per se did not increase the risks of
dying from general or neoplastic disease. Our data also suggest
that raised risks of oesophageal malignancy are associated
with underlying severe oesophageal disease.

APPENDIX

Group members: S Thomas, D N Bateman, Judy Bland, Fiona Ander-
son, Elizabeth Wray, Wolfson Unit of Clinical Pharmacology,
University of Newcastle upon Tyne, UK; D Colin Jones, Shirley Wood,
Vivienne Barrett, Department of Gastroenterology, Queen Alexandra
Hospital, Portsmouth, UK; M Langman, J Mant, P Brettle, Theresa
Grimley, Madeleine Rowsby, Ros Salter, Departments of Medicine and
General Practice, University of Birmingham, Birmingham, UK; R F
Logan, Gwyn Campion, Margaret Edmond, Department of Epidemiol-
ogy and Public Health, Queens Medical Centre, Nottingham, UK; M
Murphy, M Vessey, Pauline Marshall, Division of Public Health and
Primary Health Care, Institute of Health Sciences, Oxford University,
Oxford, UK; K R Paterson, Gill Paice, Department of Clinical Pharma-
cology, Royal Infirmary, Glasgow, UK; S Hartz, Sue West, Innovative
Clinical Solutions Ltd, UK; and R Rowsell, AstraZeneca UK Ltd, Luton,
Beds, UK.

Authors’ affiliations

D N Bateman, S Thomas, Wolfson Unit of Clinical Pharmacology,
University of Newcastle upon Tyne, UK

D Colin-Jones, Department of Gastroenterology, Queen Alexandra
Hospital, Portsmouth, UK

S Hartz, Innovative Clinical Solutions Ltd, UK

M Langman, J Mant, Departments of Medicine and General Practice,
University of Birmingham, Birmingham, UK

R F Logan, Department of Epidemiology and Public Health, Queens
Medical Centre, Nottingham, UK

M Murphy, M Vessey, Division of Public Health and Primary Health
Care, Institute of Health Sciences, Oxford University, Oxford, UK
K R Paterson, Department of Clinical Pharmacology, Royal Infirmary,
Glasgow, UK

R Rowsell, AstraZeneca UK Ltd, Luton, Beds, UK

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