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 23 May 2018

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News

Mortality study of 18,000 patients treated with omeprazole

Increases in mortality associated with omeprazole treatment are due to pre-existing illness, including severe esophageal disease, finds a research team in the July issue of Gut.

News image

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The long term safety of potent gastric acid suppressive therapy has not been established.

In this study, researchers from England and Scotland reviewed the general practice records of 17,936 patients prescribed omeprazole between 1993 and 1995.They also retrieved details of any deaths occurring within 4 years from the National Health Service Central Registers.

The research team compared death rates with those of the general population.

All cause mortality was higher in the first year.
Gut

Overall, the records of 17,489 patients were examined.

They found that 12,703 patients received further scripts for antisecretory drugs. Of these, 8097 were for omeprazole only. A total of 3097 patients died.

The team determined that all cause mortality was higher in the first year, but fell to population expectation by the fourth year.

Furthermore, they identified significant mortality increases in the first year for deaths from neoplasms (observed/expected, 1.82), circulatory diseases (1.27), and respiratory diseases (1.37). These fell to, or below, population expectation by the fourth year.

They found that increased mortality ascribed to digestive diseases (2.56) persisted. Increased mortality rates for cancers of the stomach (4.06), colon and rectum (1.40), and trachea, bronchus, and lung (1.64) seen in the first year had disappeared by the fourth. This was not the case for cancer of the esophagus.

Of the 78 patients who died of esophageal cancer, 40 had the disease present at study registration.

Furthermore, 27 of those remaining cases had clinical evidence of Barrett’s disease, stricture, ulcer, or esophagitis at registration.

The team found that 6 deaths occurred in patients with hiatal hernia or reflux only, and 5 in patients without esophageal disease.

The research team did not identify any relationships with the number of omeprazole scripts received.

Dr Bateman's team concluded, "Increases in mortality associated with treatment are due to pre- existing illness, including pre-existing severe esophageal disease".

There was no evidence of an increased risk of esophageal adenocarcinoma in those without esophageal mucosal damage recorded at registration.

Gut 2003; 52: 942-6
16 June 2003

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