Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials

Abstract

Objective:

To investigate the resolution of heartburn and gastroesophageal reflux disease (GERD)-related sleep disturbances during the first 14 days of treatment with esomeprazole 20 mg compared to placebo in subjects with frequent nighttime heartburn and GERD-related sleep disturbances.

Research design and methods:

This was a post hoc analysis of 2 week data from two previously published, similarly designed randomized, placebo-controlled trials of 4 weeks’ duration comparing esomeprazole 20 mg, 40 mg (one study), and placebo. Inclusion and exclusion criteria for both trials were the same.

Clinical trial registration:

ClinicalTrials.gov identifier: NCT00628342.

ClinicalTrials.gov identifier: NCT00660660.

Main outcome measures:

The main outcome measures for this analysis were the resolution and/or relief of GERD-related sleep disturbances during 2 weeks of treatment with esomeprazole 20 mg or placebo. Resolution and/or relief of heartburn symptoms were also measured.

Results:

In trial 1, 455 subjects were randomized, with 225 and 229 receiving esomeprazole 20 mg and placebo, respectively. In trial 2, 276 subjects were randomized, with 142 and 132 receiving esomeprazole and placebo, respectively. After 2 weeks, significantly more subjects who received esomeprazole 20 mg (50.5% [95% confidence interval: 43.8%–57.1%] and 39.4% [31.2%–47.6%] in trials 1 and 2, respectively) had resolution of sleep disturbances compared to placebo (19.9% [14.6%–25.2%] and 16.0% [9.6%–22.4%], respectively; p < 0.0001 for both trials). The median time to resolution of sleep disturbances with esomeprazole 20 mg was 1 day in both trials. After 2 weeks, significantly more subjects receiving esomeprazole 20 mg (32.3% [26.1%–38.5%] and 26.3% [18.9%–33.6%] in trials 1 and 2, respectively) had resolution of nighttime heartburn symptoms compared to placebo (5.4% [2.4%–8.4%] and 4.8% [1.1%–8.5%], respectively; p < 0.0001 for both trials).

Conclusions:

Esomeprazole 20 mg significantly and effectively reduced nighttime heartburn and GERD-related sleep disturbances in the first 2 weeks of treatment compared to placebo, with rapid resolution of sleep disturbances in the first days of treatment.

Keywords: :

• Esomeprazole
• GERD
• Heartburn
• Proton pump inhibitors

Transparency

Declaration of funding

The studies were funded by AstraZeneca, which entered into an agreement with Pfizer for the over-the-counter (OTC) rights for Nexium (esomeprazole magnesium). This manuscript includes data owned by AstraZeneca.

Declaration of financial/other relationships

D.A.J. has disclosed that he is a consultant and/or has served on advisory boards for Takeda Pharmaceutical Company, Pfizer Inc., Janssen Pharmaceutical Companies, Medigus Ltd, and Medscape. He is a member of the speakers bureau for Takeda and is a clinical investigator for AstraZeneca and Takeda. A.L.M. and V.H. have disclosed that they are employees of Pfizer Consumer Healthcare. P.N. has disclosed that he is an employee of AstraZeneca.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Medical writing support was provided by Diane Sloan PharmD of Peloton Advantage LLC and was funded by Pfizer.

Notes

*Gelusil is a registered trade name of WellSpring Pharmaceutical Corp., Sarasota, FL, USA