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

response of "none" on at least 6 of the 7 days, allowing for one "mild" response. Relief of GERD-related sleep disturbance was defined as a "yes" response on no more than 2 of 7 consecutive days. Complete resolution of sleep disturbance was defined as 7 consecutive days of no trouble sleeping the previous night(1).

The primary objective was to demonstrate a difference in the relief of nighttime heartburn between NEXIUM 20 mg and placebo after four weeks of treatment. Secondary objectives included assessing the impact of treatment with NEXIUM versus placebo on GERD-related sleep disturbances(1).

About NEXIUM(R) (esomeprazole magnesium)

NEXIUM 40 mg and 20 mg daily are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE). NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for treatment of heartburn and other symptoms associated with GERD.

IMPORTANT SAFETY INFORMATION

NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which NEXIUM is an enantiomer.

As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Like other proton pump inhibitors, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts, an
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SOURCE AstraZeneca
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