A pilot study of continuous pantoprazole intravenous infusion as a safe and effective therapy for severe erosive oesophagitis

Digestive Diseases and Sciences recently published a pilot study investigating the efficacy and safety of pantoprazole as a continuous intravenous infusion for treatment of severe erosive oesophagitis.

Erosive reflux oesophagitis is a common complication occurring in gastro-oesophageal reflux disease (GORD) and is estimated to affect 2% of people who report symptoms of heartburn. Although this condition is not normally life threatening, it has the potential to progress to more serious disease if left untreated. Conditions such as Barett’s oesophagus or adenocarcinoma are well known sequaelae of reflux oesophagitis, and are associated with significant morbidity and mortality. While non-pharmacological therapy forms the basis of management of GORD, medication also has a role to play in treating exacerbations. Drugs with proven efficacy in treatment of reflux oesophagitis are the H₂ receptor antagonists and the proton pump inhibitors (PPIs). In terms of efficacy, PPIs including pantoprazole have been shown to be more effective than H₂ receptor antagonists in resolution of erosive oesophagitis in a number of randomised controlled trials.

While the oral use of pantoprazole in GORD is well established the use of an intermittent intravenous infusion has been shown by several investigators to allow faster healing than oral therapy. This study in hospitalised patients with Hetzel-Dent grade 4 erosive oesophagitis was designed to examine the efficacy of continuous infusion versus once daily infusion of pantoprazole in severe erosive oesophagitis. The study group received a continuous IV infusion consisting of an 80 mg loading dose, followed by 8 mg/hr for three days while the control group were administered 40mg IV once daily for three days. Both groups then received 40 mg orally once daily for a further 4 days. In the patients who received the continuous infusion, healing was either complete within the seven days (50%) or greatly improved. Of the control group no total healing was observed in any patient with partial healing apparent in 83% of patients.

At present it is difficult to make a direct comparison between intravenous and oral regimens as data for the oral route is not available at one week. However analysis of several oral regimens suggests a relatively lower rate of healing than that observed from continuous infusion. In terms of symptomatic relief and adverse effect profile there was no significant difference between the study and control groups. In both groups GORD related symptoms were alleviated in four to five days and the main side effects were diarrhoea and headache. These effects occurred at higher rates than seen with oral therapy but had resolved by the second day of treatment.

The results from this study are encouraging and suggest that continuous pantoprazole intravenous infusion is superior to once daily infusion for patients with severe erosive oesophagitis. Continuous pantoprazole intravenous infusion appears to be both a safe and effective treatment for erosive oesophagitis and may be a viable alternative to oral pantoprazole. Due to the preliminary nature of this study however, further investigation against an oral control is needed to reach definitive conclusions. A pharmacoeconomic analysis may also be warranted to determine the cost effectiveness of the intravenous route.

Reference:

1. Cai Q, Barrie M, Olejeme H, Rosenburg M. A pilot study of efficacy and safety of continuous intravenous infusion of pantoprazole in the treatment of severe erosive esophagitis. Dig Dis Sci 2007.