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

WILMINGTON, Del., June 2 /PRNewswire-FirstCall/ -- Two studies from AstraZeneca (NYSE: AZN) show that symptomatic gastroesophageal reflux disease (GERD) patients treated with NEXIUM(R) (esomeprazole magnesium) 20 mg daily experienced greater relief from nighttime heartburn and GERD-related sleep disturbances compared with patients taking placebo over four weeks(1). NEXIUM 20 mg is indicated for the treatment of heartburn and other symptoms associated with GERD. NEXIUM, in a class of drugs called proton pump inhibitors (PPIs), demonstrated efficacy in relieving moderate-to-severe nighttime heartburn and GERD-related sleep disturbances in two randomized, placebo-controlled trials(2). These findings were presented in three separate abstracts at Digestive Disease Week 2009 in Chicago.

GERD is a condition that occurs when acidic stomach contents back up into the esophagus, often causing painful and uncomfortable symptoms such as heartburn. A study of U.S. patients with symptomatic GERD shows that approximately seven in 10 experience symptoms when they go to bed at night, and more than half are awakened by their symptoms after falling asleep(3). Studies suggest that nighttime GERD symptoms can be more severe than GERD that is symptomatic only during the day(3)(4)(5).

"Nighttime symptoms are particularly bothersome for people with GERD because they can disrupt a full night's sleep," said David A. Johnson, M.D., Professor of Medicine and Chief of Gastroenterology at the Eastern Virginia School of Medicine in Norfolk, Virginia. "This study shows that NEXIUM can be an effective treatment option for people with GERD whose sleep is disrupted by heartburn."

Before treatment with NEXIUM, patients had moderate-to-severe nighttime heartburn and GERD-related sleep disturbances on 3 out of 7 days. GERD-related sleep 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 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, and digoxin).

Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced.

NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered.

NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information.

For additional information, questions, or to request a copy of the NEXIUM prescribing information, please contact the Information Center at AstraZeneca at 1-800-236-9933, Monday through Friday, from 8 a.m. to 6 p.m. ET, excluding holidays.

About Digestive Disease Week

Digestive Disease Week(R) 2009 (DDW(R)) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 30 - June 4, 2009 in Chicago, Illinois. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

About AstraZeneca

AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business. For more information about AstraZeneca in the US or our AZ&Me Prescription Savings programs, please visit: www.astrazeneca-us.com.

References:

(1) Johnson DA, Hwang C, Brown KA. Esomeprazole for the relief of nighttime heartburn in patients with gastroesophageal reflux disease (GERD)-related sleep disturbances. Abstract submitted to DDW 2009.

(2) Data on File. AstraZeneca Pharmaceuticals LP. 271410.

(3) Farup C, Kleinman L, Sloan S, et al. The impact of nocturnal symptoms associated with gastroesophageal reflux disease on health-related quality of life. Arch Intern Med. 2001;161:45-52.

(4) Shaker R, Castell DO, Schoenfeld PS, et al. Nighttime heartburn is an under-appreciated clinical problem that impacts sleep and daytime function: The results of a Gallup survey conducted on behalf of the American Gastroenterological Association. Am J Gastroenterol. 2003;98:1487-1493.

(5) Brunton S, McGuigan J. Differentiating nighttime GERD: Issues for clinicians. JFP. 2005:1073-1078.


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