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AstraZeneca Studies Show Relief of Nighttime Heartburn and Reduction in GERD-Related Sleep Disturbances
Date:6/2/2009

p disturbances were defined as trouble sleeping due to heartburn and other symptoms of GERD.

In one study, relief of nighttime heartburn was significantly greater for patients treated with NEXIUM 20 mg once daily (n=137) compared with placebo (n=125) after four weeks (34.3% vs. 10.4%, P < .0001)(1). In addition, relief of GERD-related sleep disturbances was significantly greater for patients treated with NEXIUM 20 mg once daily compared with placebo (71.5% vs. 55.2%, P=.006)(1).

In a second four-week study, 84% of patients experienced relief of GERD-related sleep disturbances with NEXIUM 20 mg once daily (n=220) compared to 54% with placebo (n=221; P < .0001). In addition, relief of nighttime heartburn was significantly greater for patients treated with NEXIUM 20 mg once daily compared with placebo (50% vs 13% , P < .0001).

NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles. The most frequently reported adverse reactions with NEXIUM include headache, diarrhea, and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Please visit www.nexium-us.com or call 1-800-236-9933 for the NEXIUM full Prescribing Information.

About the Studies

The multicenter, randomized, double-blind, placebo-controlled study was conducted in 262 patients, male and female, ages 18 to 85 years old. All patients had at least a three-month history of heartburn and at least a one-month history of sleep disturbances associated with GERD. Patients received either NEXIUM 20 mg once daily or placebo for four weeks(1).

Nighttime heartburn symptom frequency and severity were assessed using a daily diary card. The primary end point, relief of nighttime heartburn, was defined as a daily diary card
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SOURCE AstraZeneca
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