Esomeprazole Achieves Relief of Nighttime Heartburn and Improves Sleep Quality in GERD

16 Jul, 20

Introduction

A significant proportion of patients with gastro-esophageal reflux disease (GERD) experience heartburn at night. The findings of a survey conducted in 1000 US patients with heartburn demonstrated that nighttime heartburn negatively affects their sleep and work productivity the next day. Reflux events that occur during the night last longer than those occurring during daytime. One placebo-controlled study showed that esomeprazole 40 mg and 20 mg was associated with a significant relief of nighttime heartburn symptoms as compared to placebo. This study was conducted to confirm these findings for esomeprazole 20 mg taken once daily in patients with GERD.

Aim

To evaluate the efficacy of esomeprazole 20 mg taken daily before breakfast on GERD-related nighttime heartburn and sleep disturbances.

Method

Study Design

Multicenter, randomized, double-blind, placebo-controlled, prospective study

Inclusion Criteria

Patients aged 18-85 years with episodes of heartburn or acid regurgitation for ≥3 months OR history of erosive esophagitis and nighttime GERD symptoms averaging atleast 2 episodes in the 7-day period before enrollment
History of sleep disturbances for >1 month before enrollment
Experiencing GERD-related sleep disturbances and moderate to severe nighttime heartburn on atleast 3 of the last 7 nights of the run-in period

Exclusion Criteria

Patients with conditions other than GERD known to affect sleep
Shift workers with working hours between midnight to 6 am
Patients who had gastrointestinal bleeding

Treatment Strategy

After a 1- to 2-week run-in period, patients were randomized to receive 20 mg esomeprazole once daily before breakfast or placebo for 4 weeks
Daily diary card was used to evaluate the symptom severity every morning

Endpoints

Relief of nighttime heartburn was defined as a daily diary response of ‘none’ on >6 days of the last 7 days of the study
Complete resolution of nighttime heartburn was defined as daily diary response of ‘none’ for consecutive 7 days
Complete resolution of GERD-related sleep disturbances defined as a daily response of ‘no’ for consecutive 7 days
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Work productivity evaluated using Work Productivity and Activity Impairment Questionnaire: Sleep Disturbance-GERD (WPAI-SLEEP-GERD)
Adverse events

Results

A total of 262 patients were recruited with 137 and 125 in the esomeprazole and placebo groups respectively
Significantly more patients from the esomeprazole group achieved complete resolution and relief of heartburn as shown in figure 1.

Figure 1. Percentage of patients with complete resolution and relief of heartburn

Relief of GERD-related sleep disturbances (P = 0.006), days without GERD-related sleep disturbances (P = 0.0003) and complete resolution of sleep disturbances (P < 0.0001) favored esomeprazole over placebo
The study group was associated with better sleep quality, work productivity and regular daily activities as compared to placebo

The incidence of adverse events was 21% vs 18.2% in the study group and placebo respectively
There were no serious adverse events related to esomeprazole use

Conclusion

Treatment with esomeprazole 20 mg once daily significantly achieved relief of nighttime heartburn symptoms and improved sleep quality, work productivity and functionality in patients with moderate-to-severe nighttime heartburn and gastro-esophageal reflux disease-related sleep disturbances.

Aliment Pharmacol Ther. 2010 Jul;32(2):182-90. Doi: 10.1111/j.1365-2036.2010.04339.x.