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Identifying Clinical Predictors of Heartburn Resolution With Over-the-Counter Esomeprazole


Johnson, David A., MD, MACG1; LeMoigne, Anne2; Li, Jing2; Lind, Tore3; Pollack, Charles2

American Journal of Gastroenterology: October 2015 - Volume 110 - Issue - p S937

1. Eastern Virginia Medical School, Norfolk, VA;

2. Pfizer Consumer Healthcare, Madison, NJ;

3. Consultant, Gothenburg, Sweden.

Introduction: Identifying factors associated with complete resolution of heartburn (HB) during treatment may help set appropriate expectations for the use of over-the-counter (OTC) proton-pump inhibitor therapy for frequent HB. These analyses were conducted to determine patient-level factors related to HB resolution during treatment with esomeprazole (ESO) at the approved OTC dose/duration.

Methods: Data were pooled from the first 14 days in subjects with frequent HB randomly assigned to double-blind treatment with ESO 20 mg (n=921; administered as 22.3 mg esomeprazole magnesium trihydrate) or placebo (n=909) in 6 similarly designed studies conducted at US study centers. Subjects recorded HB episodes in daily diaries throughout the 14-day treatment period. Multivariate analyses were conducted to identify predictors of complete HB resolution, defined as no 24-hour HB for 7 consecutive days. The following clinical predictors were assessed using a stepwise logistic regression adjusted for study: treatment, study site, age (as a continuous variable), gender, race, pre-treatment HB frequency, and the occurrence of HB during treatment. Additional analyses explored alternate endpoints, including complete resolution of daytime and nighttime HB episodes for 7 consecutive days, and other predictive variables only available in subsets of the overall data set. Pre-treatment HB frequency was primarily ≥2 days/week; mean age was 45.5 years (range: 18-90 years).

Results: Treatment with ESO (p < .0001), age (p=.0006), nighttime HB during treatment (p < .0001), and lower pre-treatment HB frequency (p < .0001) were significant predictors of complete resolution of 24-hour HB. Significant predictors of complete resolution of daytime HB (4 studies) were treatment with ESO, age, nighttime HB during treatment, and lower pre-treatment daytime HB frequency (p < .0001 for all). Treatment with ESO, age, frequency of pre-treatment nighttime HB, and daytime HB during treatment were predictors of complete resolution of nighttime HB (p < .0001 for all).

Conclusion: Patient factors associated with complete resolution of HB with ESO 20 mg included increasing age, absence of nighttime HB during treatment, and less-frequent pre-treatment HB.

© The American College of Gastroenterology 2015. All Rights Reserved.