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Effect of Esomeprazole on Nighttime Heartburn and Sleep Quality in Patients with GERD

A Randomized, Placebo-Controlled Trial

Johnson, David A., M.D.1; Orr, William C., Ph.D2; Crawley, Joseph A.3; Traxler, Barry3; McCullough, Joseph, Ph.D3; Brown, Kurt A., M.D.3; Roth, Thomas, Ph.D4

American Journal of Gastroenterology: September 2005 - Volume 100 - Issue 9 - p 1914–1922
ORIGINAL CONTRIBUTIONS: ESOPHAGEAL
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OBJECTIVES Sleep disturbances are common in patients with gastroesophageal reflux disease (GERD). This study examined the effects of esomeprazole on nighttime heartburn, GERD-related sleep disturbances, sleep quality, work productivity, and regular activities.

METHODS This multicenter, randomized, double-blind, placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn (recorded by patient diary during screening). Patients received oral esomeprazole 40 mg (n = 220) or 20 mg (n = 226) or placebo (n = 229) once daily for 4 wk. The primary outcome was relief of nighttime heartburn. Secondary outcomes included resolution of sleep disturbances, sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire, and work productivity measured by the Work Productivity and Activity Impairment Questionnaire.

RESULTS Nighttime heartburn was relieved in 53.1% (111/209), 50.5% (111/220), and 12.7% (28/221) of patients who received esomeprazole 40 mg, esomeprazole 20 mg, and placebo, respectively. Differences (95% CI) versus placebo were 40.5% (32.4%, 48.5%) and 37.8% (29.9%, 45.7%) and were highly significant (p < 0.0001). GERD-related sleep disturbances resolved in significantly more (p < 0.0001) patients who received esomeprazole 40 (73.7%) or 20 mg (73.2%) than in those who received placebo (41.2%). Both esomeprazole groups had greater PSQI global score changes from baseline (p < 0.0001 vs placebo) and more (p < 0.0001 vs placebo) work hours saved per week per patient compared with baseline (esomeprazole 40 mg, 11.6 h; esomeprazole 20 mg, 12.3 h; placebo, 6.2 h).

CONCLUSIONS Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity.

1Eastern VA School of Medicine, Norfolk, Virginia

2Lynn Health Science Institute, Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma

3Astra Zeneca LP, Wilmington, Delaware

4Henry Ford Hospital, Detroit, Michigan

Reprint requests and correspondence: David A. Johnson, M.D., 885 Kempsville Rd, Suite 114, Norfolk, VA 23502.

Received June 23, 2005; accepted July 20, 2005.

© The American College of Gastroenterology 2005. All Rights Reserved.
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