First Trial to Confirm Esomeprazole Provides Relief for Non-GERD Dyspepsia

MONTRÉAL, Canada -- Results from a new study show that treatment with Nexium® (esomeprazole) is effective for relieving upper-abdominal symptoms in patients with non-gastroesophageal reflux disease (non-GERD) dyspepsia.

These findings, presented at the World Congress of Gastroenterology (WCOG), are from the first trial of its kind, conducted to investigate the effect of proton pump inhibitor (PPI) therapy on patients with non-GERD dyspepsia, a notoriously difficult to treat group of patients.^²

The trial, involving uninvestigated (no endoscopy performed) patients, found that at both four and eight weeks, Nexium provided a significantly higher overall response rate than placebo (P <.001). 47.3 percent of patients responded at eight weeks of treatment with Nexium 40mg qd, compared to 33.7 percent on placebo (following the initial week of 40mg Nexium qd).

Professor Sander Van Zanten, Dalhousie University, Canada, said that the results of the study provide convincing evidence that a substantial proportion of non-GERD dyspepsia patients will respond to acid suppression therapy with Nexium.

"Many primary care patients who present with upper-abdominal symptoms such as epigastric pain or burning are not referred for further investigation and there has been much uncertainty whether they will respond to treatment with a proton pump inhibitor. These results support the use of Nexium for managing patients with dyspepsia and provide physicians with the evidence for treating this difficult to treat patient population."

Dyspepsia is a very common complaint, occupying about four percent of all primary care consultations.^2,3 It also represents a considerable economic burden, with one study estimating that dyspepsia may be costing society £1 billion each year in the UK.⁴

The data also show that 62.7 percent of uninvestigated non-GERD dyspepsia patients who had a positive response to a one-week AST of Nexium 40 mg qd (defined as no more than mild symptoms at the end of the seven-day treatment) experienced complete symptom resolution after a further seven weeks of Nexium 40 mg, compared to 47.2 percent on placebo (P <.05). This suggests that a one-week acid suppression trial will help to predict whether patients will respond after eight weeks. However a certain proportion of non-responders at one week will respond by eight weeks, indicating that it is worthwhile to give these patients a treatment trial for up to eight weeks.

Information about Nexium
Nexium works by deactivating the proton (acid) pumps that produce stomach acid, thus reducing the amount of acid that is in the stomach, helping to treat heartburn and other symptoms of GERD. Several comparative clinical trials with more than 15,000 patients with Nexium, including the EXPO, the EAZEE and Metropol studies, confirm that Nexium provides superior acid control which translates into clinical benefits.^5,6,7,8,9,10 Nexium is only available on prescription. The most common side-effects with Nexium are headache, diarrhea, and abdominal pain, which occur in around one percent of patients.

References:
1. Velhuyzen Van Zanten S et al. An acid suppression trial with esomeprazole identifies patients with non-GERD dyspepsia who will respond to prolonged acid suppression: a randomised controlled trial of 1250 uninvestigated primary care patients. Abstract presented at the World Congress of Gastroenterology, Montreal, 2005.
2. Jones R, Lydeard S. Prevalence of symptoms of dyspepsia in the community. BMJ 1989; 298: 30-32
3. Marsland DW et al. Content of family practice. Part I. Rank order of diagnoses by frequency. Part II. Diagnosis by disease category and age/sex distribution. J Fam Pract 1976; 3: 37-68
4. Moayyedi P, Mason J. Clinical and economic consequences of dyspepsia in the community. Gut 2002 May; 50 Suppl 4: iv10-2
5. Labenz J et al. A randomised comparative study of esomeprazole 40 mg
versus pantoprazole 40 mg for healing erosive oesophagitis:
the EXPO study. Aliment Pharmacol Ther 2005; 21: 739-746
6. Castell D et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol 2002;97:575-83
7. Lauritsen K et al. Esomeprazole 20 mg and lansoprazole 15 mg in maintaining healed reflux esophagitis: Metropole study results. Aliment Pharmacol Ther 2003;17:333-41
8. Fennerty MB et al. Efficacy of esomeprazole 40 mg vs. lansoprazole 30 mg for healing moderate to severe erosive oesophagitis. Aliment Pharmacol Ther 2005;21(4):455-63
9. Richter J et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomised controlled trial. Am J Gastroenterol 2001;96:656-65
10. Kahrilas P et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux esophagitis patients: a randomised controlled trial. Aliment Pharmacol Ther 2000;14:1249-58

Source: AstraZeneca