Clinical trial: esomeprazole for moderate-to-severe nighttime heartburn and gastro-oesophageal reflux disease-related sleep disturbances.
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.


OBJECTIVE
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.
Johnson
D
D
Gastroenterology Division, Eastern Virginia Medical School, Norfolk, VA 23502, USA. DAJEVMS@aol.com
Crawley
J A
JA
Hwang
C
C
Brown
K
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D064098:Esomeprazole / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006356:Heartburn / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012893:Sleep Wake Disorders / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
D000897:Anti-Ulcer Agents; D064098:Esomeprazole