A study has shown that the proton pump inhibitor Esomeprazole ( Nexium ) maintains normal gastric acid levels in patients with Zollinger-Ellison syndrome or idiopathic gastric acid hypersecretion.

Twenty-one patients received one of several doses of Esomeprazole, depending on the degree of their acid output and symptoms at various times throughout the trial.
The results showed that at 12 months, Esomeprazole 40 mg twice daily controlled basal acid output in 14 study participant ( 67 percent ), Esomeprazole 80 mg twice daily was required to control acid output in 4 study participants ( 19 percent ), and Esomeprazole 80 mg given three times daily maintained acid output in 1 study participant.
Adequate acid output control was defined as <5 mmol/h for patients who had prior gastric-acid-reducing surgery, and as <10 mmol/h for patients who hadn't had the surgery.
Further, 18 of 20 patients whose acid was controlled by day 10 maintained control for the duration of the study.
No patients showed evidence of erosive esophagitis or gastric or duodenal ulcers at 12 months.

" Zollinger-Ellison syndrome places individuals under constant attack from higher than normal amounts of acid that their stomachs produce. Therefore, people with the condition require treatment that can continuously interfere with this faulty mechanism," said lead investigator David Metz, at University of Pennsylvania Health System. " The study shows that Esomeprazole provided early and sustained acid suppression to help control symptoms of the disease. These results corroborate previous research on the effectiveness of proton pump inhibitors in treating gastric acid hypersecretion."

Based on this study, the FDA ( Food and Drug Administration ) has approved a new indication for Nexium for the treatment of Zollinger-Ellison Syndrome.
Nexium already is indicated for the treatment of gastroesophageal reflux disease ( GERD ) in adults and children ages 12 to 17, and to reduce the risk of NSAID-associated gastric ulcers in at-risk patients.

Zollinger-Ellison syndrome, a serious chronic condition, is characterized by the development of a tumor or tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach.
Zollinger-Ellison syndrome is rare, affecting fewer than three out of every million Americans, but it is chronic, difficult to treat, and may be life-threatening.
Most people with Zollinger-Ellison syndrome are prone to recurrent gastric and duodenal ulcers; other symptoms include abdominal pain, diarrhea and increased fat in the stools.
Zollinger-Ellison Syndrome develops randomly for unknown reasons in most instances. About 25 percent of cases are linked to a genetic syndrome known as multiple endocrine neoplasia type 1 ( MEN-1 ). Nearly half to two-thirds of people with Zollinger-Ellison syndrome develop cancerous gastrinomas. These tumors generally arise within the pancreas and/or the duodenum, and may spread to the lymph nodes or liver.

Source:

1) DDW, 2006

2) FDA, 2006


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