Sustained efficacy following resolution of frequent heartburn with an over-the-counter regimen of esomeprazole 20 mg or placebo for 14 days: two randomized trials

David A Peura, Anne Le Moigne, Heather Wassel, Charles Pollack, David A Peura, Anne Le Moigne, Heather Wassel, Charles Pollack

Abstract

Background: 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. 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.

Methods: Adults 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.

Results: All 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]).

Conclusions: Lower 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 registration: Registered at ClinicalTrials.gov June 11, 2011: NCT01370525 ; NCT01370538 .

Keywords: Esomeprazole; Gastric acid/secretion; Heartburn; Proton pump inhibitor.

Conflict of interest statement

Ethics approval and consent to participate

Informed consent was obtained from all individual participants included in these studies, which were conducted in accordance with the Declaration of Helsinki.

The informed consent form and study protocol for each study were approved by Alpha Independent Review Board (San Clemente, California, USA).

Competing interests

DAP has served as a consultant for AstraZeneca, Pfizer, Takeda, and Horizon.

AL is an employee of Pfizer Consumer Healthcare.

HW is an employee of Pfizer Consumer Healthcare.

CP is a former employee of Pfizer Consumer Healthcare.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Percentage of subjects with heartburn resolution at selected time points during treatment. Days with missing data were assumed to be days with heartburn. aOne or no days with heartburn. bTwo or fewer days with heartburn
Fig. 2
Fig. 2
Mean number of heartburn-free days at selected time points during treatment. Days with missing data were assumed to be days with heartburn
Fig. 3
Fig. 3
Heartburn resolution status at follow-up by status during the on-treatment period. aTwo or fewer days with heartburn. bOne or no days with heartburn
Fig. 4
Fig. 4
Number of days with heartburn during the on-treatment period by resolution status at follow-up. aOne or no days with heartburn

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