Choice of PPI determines treatment success in reflux esophagitis

Main Category: Acid Reflux / GERD
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 19 Oct 2005 - 10:00 PDT

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Choosing Nexium (esomeprazole) over pantoprazole significantly improves the likelihood of treatment success in reflux esophagitis (RE), according to data released today at the United European Gastroenterology Week (UEGW), in Copenhagen, Denmark. The new analysis of results from the EXPO study shows that RE patients treated with Nexium are more likely to be healed and maintained in remission than those taking pantoprazole.[1],[2]

The data revealed that choice of proton pump inhibitor (PPI), baseline RE severity according to the LA classification, and the presence of H. pylori infection, all affect healing rates in RE. Patients taking Nexium 40mg once-daily (od) had 35 per cent greater probability of healing after eight weeks of treatment compared to those on pantoprazole 40mg od.

In addition, maintenance of healed RE at six months was also dependent on the choice of PPI for maintenance therapy, as well as other factors including RE severity. The difference between PPI efficacy in maintenance therapy was even more pronounced than in the healing phase, with Nexium 20mg od offering almost 80 per cent greater chance of successful treatment after six months than pantoprazole 20mg od.

Trial lead investigator, Dr Joachim Labenz of Jung-Stilling Krankenhaus, Siegen, Germany said that the new results provide clinically important information for primary care physicians when making choices over therapy to manage RE.

"As most RE patients are treated in primary care without an endoscopy to discover the severity of their disease, it makes sense for physicians to choose the most effective and predictable PPI. This analysis of the EXPO data confirms that the choice of PPI makes a real difference to the outcome of treatment. Physicians should take this into consideration when they make a decision on the best treatment option for reflux patients."

RE occurs when the lining of the esophagus has been eroded away or damaged by continued exposure to gastric acid, due to acid reflux. Around 30 per cent of gastroesophageal reflux disease (GERD) patients suffer from RE - in certain populations its prevalence may be as high as 50-65 per cent.[3] Between 20-40 per cent of people in Europe experience recurrent heartburn, the primary symptom of GERD.[4] Estimates suggest that as many as 95 per cent of GERD patients are treated without a prior endoscopy to determine disease severity.[5],[6],[7]

Reflux symptoms cannot be used as diagnostic guidance for predicting the presence or severity of RE because there is a poor correlation between symptom severity and RE severity. However, previous data has shown that regardless of disease severity, more patients are healed and maintained in remission when treated with Nexium, compared to either pantoprazole or lansoprazole.[8],[9],[10],[11]

Information about Nexium

Nexium 40mg and 20mg tablets are indicated for GERD, treatment of erosive RE, long-term management of patients with healed esophagitis to prevent relapse, and symptomatic treatment of GERD. In combination with an appropriate antibacterial therapeutic regimen they are indicated for the eradication of H. pylori, healing of H. pylori associated duodenal ulcer and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers. In patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy Nexium tablets are indicated for healing of gastric ulcers associated with NSAID therapy, and prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk.

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 Metropole studies, confirm that Nexium provides superior acid control which translates into clinical benefits.8,9,10,11,[12],[13] Nexium is only available on prescription. The most common side-effects with Nexium are headache, diarrhoea, and abdominal pain, which occur in around one per cent of patients.

About this analysis of the EXPO data

Univariate logistic regression analyses were performed upon the EXPO healing and maintenance data to identify significant factors (p<0.05) to include in multivariate analyses.

Univariate analysis of the healing data identified PPI choice, H. pylori status, baseline RE severity and a history of GERD symptoms as significant prognostic factors. Multivariate analysis confirmed that choice of PPI, H. pylori status and RE severity affected healing rates.

Univariate analysis of the maintenance data identified choice of PPI, Barrett's Esophagus (BE), hiatus hernia, H.pylori status, RE severity, age and BMI as significant prognostic factors. Multivariate analysis identified choice of PPI, BE, H. pylori status, RE severity, age and body mass index (BMI) as independent factors affecting maintenance therapy. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

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References

[1]. Labenz J et al. Prognostic factors affecting the outcome of maintenance therapy for healed reflux esophagitis: results from the EXPO study. Abstract presented at UEGW 2005, Copenhagen
[2]. Labenz et al. Predictors of healing of reflux esophagitis: results from the EXPO study. Abstract presented at UEGW 2005, Copenhagen
[3]. Johnson DA. Evidence-based assessment of the efficacy of esomeprazole for the healing of erosive esophagitis. Expert Rev. Pharmacoeconomics Outcomes Res. 2004; 4(4): 371-82
[4]. Spechler SJ. Epidemiology and natural history of gastro-oesophageal reflux disease. Digestion 1992; 51: S24-9
[5]. Jones RH, Hungin APS, Phillips J, Mills JG. Gastro-esophageal reflux disease in primary care in Europe: clinical presentation and endoscopic findings. Eur J Gen Pract 1995;1:149-154
[6]. Carlsson R, et al. International GORD Study Group et al. Gastro-oesophageal reflux disease (GORD) in primary care - an international study of different treatment strategies with omeprazole. Eur J Gastroenterol Hep 1998;10:119-124
[7]. Johanson J, et al. Prevalence of Erosive Esophagitis (EE) in Patients with Gastroesophageal Reflux Disease (GERD). Gastroenterology 2001;120:A233 (abstr. 1219)
[8]. 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
[9]. 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
[10]. 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
[11]. 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
[12]. 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
[13]. 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