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Clinical trial: esomeprazole for moderate-to-severe nighttime heartburn and gastro-oesophageal reflux disease-related sleep disturbances.
Aliment Pharmacol Ther 2010; 32(2):182-90AP

Abstract

BACKGROUND

Nighttime heartburn, common among patients with gastro-oesophageal reflux disease (GERD), is associated with substantial clinical effects. GERD-related sleep disturbances are underappreciated and undertreated.

AIM

To evaluate the efficacy of esomeprazole on GERD-related nighttime heartburn and associated sleep disturbances.

METHODS

In this multicentre, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe nighttime heartburn and GERD-related sleep disturbances (endoscopies not required) received esomeprazole 20 mg or placebo each morning for 4 weeks. Heartburn symptoms and GERD-related sleep disturbances were evaluated using the validated Pittsburgh Sleep Quality Index and validated Work Productivity and Activity Impairment Questionnaire.

RESULTS

The analysis included 262 patients (esomeprazole, n = 137; placebo, n = 125). Significantly more patients receiving esomeprazole achieved nighttime heartburn relief (primary end point) than those receiving placebo (34.3% vs. 10.4%; P < 0.0001). Secondary end points such as 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) favoured esomeprazole over placebo. Sleep quality, work productivity and regular daily activities also improved significantly with esomeprazole vs. placebo.

CONCLUSIONS

Esomeprazole 20 mg is effective for patients with moderate-to-severe nighttime heartburn and GERD-related sleep disturbances, improving heartburn symptoms, sleep quality, work productivity and functionality.

Authors+Show Affiliations

Gastroenterology Division, Eastern Virginia Medical School, Norfolk, VA 23502, USA. DAJEVMS@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20456306

Citation

Johnson, D, et al. "Clinical Trial: Esomeprazole for Moderate-to-severe Nighttime Heartburn and Gastro-oesophageal Reflux Disease-related Sleep Disturbances." Alimentary Pharmacology & Therapeutics, vol. 32, no. 2, 2010, pp. 182-90.
Johnson D, Crawley JA, Hwang C, et al. Clinical trial: esomeprazole for moderate-to-severe nighttime heartburn and gastro-oesophageal reflux disease-related sleep disturbances. Aliment Pharmacol Ther. 2010;32(2):182-90.
Johnson, D., Crawley, J. A., Hwang, C., & Brown, K. (2010). Clinical trial: esomeprazole for moderate-to-severe nighttime heartburn and gastro-oesophageal reflux disease-related sleep disturbances. Alimentary Pharmacology & Therapeutics, 32(2), pp. 182-90. doi:10.1111/j.1365-2036.2010.04339.x.
Johnson D, et al. Clinical Trial: Esomeprazole for Moderate-to-severe Nighttime Heartburn and Gastro-oesophageal Reflux Disease-related Sleep Disturbances. Aliment Pharmacol Ther. 2010;32(2):182-90. PubMed PMID: 20456306.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical trial: esomeprazole for moderate-to-severe nighttime heartburn and gastro-oesophageal reflux disease-related sleep disturbances. AU - Johnson,D, AU - Crawley,J A, AU - Hwang,C, AU - Brown,K, Y1 - 2010/04/29/ PY - 2010/5/12/entrez PY - 2010/5/12/pubmed PY - 2011/6/18/medline SP - 182 EP - 90 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 32 IS - 2 N2 - BACKGROUND: Nighttime heartburn, common among patients with gastro-oesophageal reflux disease (GERD), is associated with substantial clinical effects. GERD-related sleep disturbances are underappreciated and undertreated. AIM: To evaluate the efficacy of esomeprazole on GERD-related nighttime heartburn and associated sleep disturbances. METHODS: In this multicentre, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe nighttime heartburn and GERD-related sleep disturbances (endoscopies not required) received esomeprazole 20 mg or placebo each morning for 4 weeks. Heartburn symptoms and GERD-related sleep disturbances were evaluated using the validated Pittsburgh Sleep Quality Index and validated Work Productivity and Activity Impairment Questionnaire. RESULTS: The analysis included 262 patients (esomeprazole, n = 137; placebo, n = 125). Significantly more patients receiving esomeprazole achieved nighttime heartburn relief (primary end point) than those receiving placebo (34.3% vs. 10.4%; P < 0.0001). Secondary end points such as 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) favoured esomeprazole over placebo. Sleep quality, work productivity and regular daily activities also improved significantly with esomeprazole vs. placebo. CONCLUSIONS: Esomeprazole 20 mg is effective for patients with moderate-to-severe nighttime heartburn and GERD-related sleep disturbances, improving heartburn symptoms, sleep quality, work productivity and functionality. SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/20456306/Clinical_trial:_esomeprazole_for_moderate_to_severe_nighttime_heartburn_and_gastro_oesophageal_reflux_disease_related_sleep_disturbances_ L2 - https://doi.org/10.1111/j.1365-2036.2010.04339.x DB - PRIME DP - Unbound Medicine ER -