Los Angeles-A novel study has revealed that the proton pump inhibitor (PPI) NEXIUM® (esomeprazole magnesium) is capable of maintaining normal gastric acid levels in those patients suffering Zollinger-Ellison syndrome or idiopathic gastric acid hypersecretion (IGH).
Zollinger-Ellison syndrome (ZES), a rare but 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. ZES is rare, affecting fewer than three out of every million Americans (less than 1,000 people)1, but it is chronic, difficult to treat, and may be life-threatening. Most people with ZES are prone to recurrent gastric and duodenal ulcers; other symptoms include abdominal pain, diarrhea and increased fat in the stools.
Twenty-one patients received one of several doses of NEXIUM, depending on the degree of their acid output and symptoms at various times throughout the trial. The results showed that at 12 months, NEXIUM 40 mg twice daily controlled basal acid output (AO) in 14 study participant (67 percent), NEXIUM 80 mg twice daily was required to control AO in 4 study participants (19 percent), and NEXIUM 80 mg given three times daily maintained AO 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 (located in the upper region of the small intestine) 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, MD, Professor of Medicine, and the Director of the Acid-Peptic Program, Division of Gastroenterology, University of Pennsylvania Health System. "The study shows that NEXIUM provided early and sustained acid suppression to help control symptoms of the disease. These results corroborate previous research on the effectiveness of PPIs in treating gastric acid hypersecretion."
The 12-month, open-label trial evaluated the effects of NEXIUM on basal acid output (AO) control in patients with ZES or idiopathic (of unknown cause) gastric acid hypersecretion (IGH). Patients (n=21) being treated with a PPI for ZES (n=19) or IGH (n=2) were switched to NEXIUM 40 mg twice daily (n=19) or NEXIUM 80 mg twice daily (n=2). At baseline and day 10, patients received a gastric analysis (i.e., basal AO test) to measure the amount of acid secreted by the stomach. Patients with controlled AO at day 10 remained on their current dose and were re-tested at three, six and 12 months. In those with uncontrolled acid, doses were titrated up to as high as 240 mg/day until AO was controlled. (Investigators could increase the dose of NEXIUM at their discretion throughout the trial.) Patients underwent an endoscopy at baseline, at six months and at 12 months to check for the presence of gastric or duodenal ulcers and/or erosive esophagitis. NEXIUM was generally well tolerated at all doses.