Abstract
BackgroundA two-week course of therapy with an over-the-counter proton-pump inhibitor (PPI) is recommended for frequent heartburn. Limited research has been conducted on the sustained efficacy of short-term PPI therapy after treatment cessation. Esomeprazole 20 mg was evaluated in the seven-day follow-up period after the two-week treatment period using pooled data from two identical randomized, double-blind, placebo-controlled studies.MethodsAdults without confirmed diagnoses of gastroesophageal reflux disease experiencing heartburn at least two days/week in the past four weeks were eligible. Subjects received treatment with esomeprazole 20 mg or placebo once daily for 14 days. Heartburn episodes were documented using daily diaries. Missing data during the two-week treatment period were assumed to be days with heartburn. The proportion of subjects with heartburn resolution while on treatment and during the seven days of follow-up was assessed. Predictors of resolution during this post-treatment period were evaluated using a stepwise logistic regression model.ResultsAll subjects in the pooled analysis set who reported diary data for at least three follow-up days were analyzed (N = 584). This cut-off was used to ensure that sufficient data were collected for these analyses. Greater run-in heartburn frequency was a significant negative predictor of heartburn resolution during follow-up (P < 0.001). Among the on-treatment efficacy variables, the best predictor of resolution during follow-up was resolution during the last seven days of treatment (odds ratio: 3.81 [95% confidence interval: 2.40, 6.05; P < 0.0001]).ConclusionsLower baseline heartburn frequency and heartburn resolution during the last seven days of treatment were associated with a greater likelihood of heartburn resolution during the seven-day follow-up.Trial registrationRegistered at ClinicalTrials.gov June 11, 2011: NCT01370525; NCT01370538.
Highlights
A two-week course of therapy with an over-the-counter proton-pump inhibitor (PPI) is recommended for frequent heartburn
NEXT-1 and NEXT-2 were two identical phase 3, randomized, double-blind, placebo-controlled studies designed to determine the efficacy of a 14-day regimen of esomeprazole 20 mg for treating frequent heartburn in subjects who are likely to self-treat with OTC medications without consulting a healthcare provider
Statistical analyses The analyses presented in this report are based on pooled data from the full analysis set from NEXT-1 and NEXT-2
Summary
A two-week course of therapy with an over-the-counter proton-pump inhibitor (PPI) is recommended for frequent heartburn. Limited research has been conducted on the sustained efficacy of short-term PPI therapy after treatment cessation. The World Gastroenterology Organization’s guidelines for treating frequent heartburn (two or more days/week) recommend a two-week course of treatment with an OTC PPI along with lifestyle and dietary modifications [3]. In. Peura et al BMC Gastroenterology (2018) 18:69 the US, OTC esomeprazole 20 mg is approved for 14 days of treatment for frequent heartburn, a treatment course that can be repeated once every four months; if symptoms persist or recur within this time frame the individual should consult a physician [3, 5]. Analyses assessing the degree to which the symptomatic response is sustained after discontinuation of a short-term course of OTC PPIs are limited. Determining whether the level of heartburn resolution while on treatment has an impact on the duration of response following treatment cessation is important to clinical practice
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