Multivariate Analysis of Clinical Predictors of Sleep Disturbance Related to Frequent Nighttime Heartburn and Acid Regurgitation Symptoms in Individuals Taking Esomeprazole 20 mg or Placebo

Abstract

Introduction: Determine predictors of gastroesophageal reflux disease (GERD)-related sleep disturbance resolution with 14-day esomeprazole (ESO) 20 mg (administered as 22.3 mg ESO magnesium trihydrate) or placebo treatment. Methods: Data were pooled from the first 14 days in subjects with frequent nighttime heartburn (HB) and GERD-related sleep disturbances assigned to ESO 20 mg or placebo in 2 similarly designed randomized, double-blind studies.(1,2) Multivariate analyses were performed to identify predictors of complete resolution of GERD-related sleep disturbance (no sleep disturbance for 7 consecutive days as documented on subject diary cards). Clinical variables (treatment; study; site; age; gender; BMI [available in 1 study]; run−in sleep disturbance frequency; 24−hour, daytime, and nighttime HB) were assessed by stepwise logistic regression. Results: In the pooled data set, treatment (P<.0001), absence of daytime (P=.0018) or nighttime HB (P<.0001), and lower run−in sleep disturbance frequency (P<.0001) were significant predictors of complete resolution of GERD-related sleep disturbance at 14 days (Table 1, 2).Table 1: Complete Resolution of Sleep Disturbance by 14 DaysTable 2: Predictors of Complete Resolution of Sleep Disturbance at 14 DaysConclusion: Individuals with less frequent baseline sleep disturbance and those without daytime or nighttime HB during the first 14 days’ treatment were more likely to have complete resolution of GERDrelated sleep disturbance. Studies were funded by AstraZeneca, which entered into an agreement with Pfizer for the over-thecounter rights for NEXIUM® (esomeprazole magnesium). Medical writing support provided by Diane Sloan, PharmD, of Peloton Advantage, LLC; funded by Pfizer.