Abstract
Purpose: To characterize the relationship between percent time with intragastric pH > 4 and patients achieving complete healing of erosive esophagitis (EE), and to determine if there is a threshold percent time pH > 4 for maximal healing. Methods: This is an exploratory analysis of data from a proof-of-concept study (ClinicalTrials.gov identifier: NCT00206180; AstraZeneca study code: D9612L00062) in adults with endoscopically verified Los Angeles (grade C or D) EE (Aliment Pharmacol Ther 2007;25:617–28). Patients were treated with 2 different doses of esomeprazole (10 or 40 mg once daily for 4 wks, chosen in random order) in an attempt to achieve a range of intragastric pH levels. All patients with evaluable EE healing and 24-h intragastric pH monitoring on day 5 were included in the final analysis. A curve was fitted to data using piecewise quadratic logistic regression. Point summaries using 10% increments of percent time pH > 4 were computed for purposes of graphic illustration. Results: Data were available from 134 patients. While overall the percent time pH > 4 correlated with greater EE healing, the curve displayed a non-linear function (Figure). Maximum healing rates, defined as the mean percentage of patients completely healed in each pH group, were achieved at approximately 60% time pH > 4. Acid suppression above this apparent threshold did not yield further increases in EE healing rates.Figure: Fitted curve (including 95% confidence region) of EE healing and observed mean EE healing rates in 10% intervals of time with intragastric pH > 4. Error bars indicate standard error of the mean.Conclusion: Healing of EE (LA grade C and D) at 4 wks appears to reach a threshold after which increased healing cannot be achieved despite an increase in number of hours of pH control. The apparent pH-healing threshold of pH > 4 for 60% of the day may or may not be due to randomness and small sample sizes, and warrants further clinical study with a larger patient group.
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