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| |  DDW: Esomeprazole Effective for Relief of Moderate to Severe Nighttime Heartburn and Associated Sleep Disturbance in Patients with GERD By Bruce Sylvester NEW ORLEANS, LA -- May 18, 2004 -- Treatment with the proton pump inhibitor esomeprazole (Nexium) achieved significant improvement over placebo in relief of moderate to severe nighttime heartburn and of gastroesophageal reflux disease (GERD)-related sleep disturbance, researchers reported here today at the annual Digestive Diseases Week meeting. "We found that effective therapy for reflux disease was directly and significantly associated with a effective therapy for sleep disturbance in GERD," said lead investigator David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School in Roanoke, Virginia, United States. Describing the purpose of their study, the authors noted that a Gallup poll suggested that up to 80% of patients with GERD report sleep disturbance (Am J Gastroenterol 2003;98:1487-93) and that the primary goal of their 4-week, multicenter, randomized, double-blind study was to compare esomeprazole (20 or 40 mg once daily) to placebo for the relief of GERD-related moderate/severe nighttime heartburn and sleep disturbance. The investigators enrolled 650 subjects, ages 18 to 85, who had been diagnosed with symptomatic GERD and had a history of erosive esophagitis or episodes of heartburn or acid regurgitation for 3 months or more, a history of GERD-associated sleep disturbance ( trouble falling asleep, frequent awakening, poor sleep quality) for more tha1 month and sleep disturbance and moderate to severe nighttime heartburn on 3 or more of the last 7 days of the run-in period. Patients were excluded if they had sleep-disturbing conditions other than GERD. Subjects were allowed to continue using sleep medication, if use had been for 3 months or longer, and was expected to be stable during the study. The investigators randomized 220 subjects to esomeprazole 20 mg, 209 to 40 mg, and 221 to placebo in daily morning dosings for 4 weeks. The subjects used a daily diary card was used to record and assess nighttime heartburn symptom severity (none, mild, moderate, or severe), and relief of sleep disturbance (yes/no). "The primary endpoint was patient-recorded relief of nighttime heartburn, defined as diary card response of none on >/=6 of the last 7 days in the study (allowing for one response of mild)," the authors wrote. "A secondary endpoint was percentage of patients with relief of sleep disturbance, defined as 'yes' or 'no' response to the question, 'Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?' on >/=5 of the last 7 days in the study." The results of the study showed that nighttime heartburn relief was reported by 42% of 20 mg subjects, 44% 0f 40 mg subjects and 8% of placebo subjects. Sleep disturbance relief was reported by 85% of 20 mg subjects, 81% of 40mg subjects and 55% of placebo subjects. All esomeprazole findings vs. placebo had a significance of P < .001. "Our results are an alert to clinicians that their patients with heartburn may have significant sleep disturbance, and that sleep disturbance is quite responsive to effective control of heartburn," added Dr. Johnson. The study was supported by Astra Zeneca.
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