WILMINGTON, Del., Nov. 18 /PRNewswire-FirstCall/ -- New clinical trial data presented this week at the 78th American Heart Association Scientific Sessions in Dallas reported that the addition of the proton pump inhibitor (PPI) esomeprazole magnesium to standard cardiac therapy for patients with coronary artery disease (CAD) significantly reduced the incidence of non-cardiac chest pain and physician visits compared to patients given a placebo.(1) Further, patients taking esomeprazole reported fewer hospitalizations for chest pain than patients taking placebo.(2)
Results from the six-month randomized prospective placebo-controlled trial showed that the group of patients taking esomeprazole (n=84) reported less chest pain (29.7 percent vs. 59.7 percent p<0.001) and fewer physician visits for chest pain (17.5 percent vs. 43.4 percent p<0.001) when compared to patients taking placebo (n=78).
“This study is important in understanding the effects of PPI therapy on non-cardiac chest pain symptoms and hospitalization in CAD patients,” said John P. Liuzzo, MD, Ph.D., Division of Interventional Cardiology, Columbia University Medical Center, New York.
The Esomeprazole Prevention of Atypical Chest Pains (EPAC) study was a six-month, randomized, prospective, placebo-controlled trial to assess the preventive benefit of treatment with esomeprazole for non-cardiac chest pain in patients with CAD. A total of 162 patients with documented obstructive, yet stable, CAD, who weren’t currently taking acid-reducing therapy for known GERD or peptic ulcer disease, received either esomeprazole 40 mg daily or a placebo in addition to their cardiac medication. The results were recorded as indicated by monthly patient/caregiver logs or telephone follow-up. Investigators and patients were blinded to treatment during follow-up.
Coronary Artery Disease and Chest Pain
CAD, the most common type of heart disease, is the leading cause of death in the United States in both men and women.(3) CAD occurs when the arteries that supply blood to the heart become hardened and narrowed due to plaque buildup, resulting in a decrease in oxygenated blood to the heart muscle. When this occurs, a person may experience angina, or chest pain. However, 10 to 40 percent of angina cases have a non-cardiac cause.(4) Studies have shown that GERD, a condition in which the acidic liquid content of the stomach backs up into the esophagus, accounts for half of all non-cardiac chest pain in CAD patients.(5) GERD also is a frequent cause of chest pain in patients without CAD.(6) Each year, approximately five million Americans visit the emergency room with primary complaints of chest pain, resulting in two million hospital admissions at a cost of about eight billion dollars.(7)
About NEXIUM(R) (esomeprazole magnesium) delayed-release capsules
NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions. NEXIUM also is indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous non-steroidal anti-inflammatory drug (NSAID) therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of previous stomach ulcer.
The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. For full prescribing information for NEXIUM please visit http://www.nexium-us.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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This press release contains forward-looking statements with respect to AstraZeneca’s business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company’s Annual Report/Form 20-F for 2004.
References (1) Liuzzo JP, et al. A prospective, randomized, placebo-controlled evaluation of Nexium for CAD patients. The EPAC Study - Esomeprazole Prevention of Atypical Chest Pains. Proceedings of the 78th American Heart Association Scientific Sessions. (2) Ibid. (3) What is coronary artery disease? From National Heart, Lung, and Blood Institute Web site. Updated August 2003. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html. (4) Diop D, et al. Definition, classification, and pathophysiology of acute coronary ischemic syndromes. Emerg Med Clin North Am 2001;19:259-67. Van Miltenberg AJ, et al. Incidence and follow-up of Braunwald subgroups of unstable angina. J Am Coll Cardiol 1995;25:1286-92. Israel DH, et al. Angiographic correlation of complex lesions in acute coronary syndromes. In: Ambrose, J, ed. Complex Lesions in Acute Coronary Syndromes. New York, NY, US: Future Publishing, 1996:49-72. All three citations from Liuzzo JP et al. Proton-pump inhibitor use by coronary artery disease patients is associated with fewer chest pain episodes, emergency department visits and hospitalizations. Aliment Pharmacol Ther 2005;22:95-100. (5) Liuzzo JP et al. Chest pain from gastroesophageal reflux disease in patients with coronary artery disease. Cardiol Rev 13:167-173, 2005. (6) Liuzzo JP et al. Proton-pump inhibitor use by coronary artery disease patients is associated with fewer chest pain episodes, emergency department visits and hospitalizations. Clinical Cardiology, 28:369-374, 2005. (7) Schappert SM. National Hospital Ambulatory Medical Care Survey: 1992 emergency department summary. Vital Health Stat 13 1997;125:1-108. Hutter AM, et al. Acute coronary syndromes: chest discomfort evaluation in the hospital. J Am Coll Cardiol 2000;35:853-62. Both citations from Liuzzo JP et al. Proton-pump inhibitor use by coronary artery disease patients is associated with fewer chest pain episodes, emergency department visits and hospitalizations. Aliment Pharmacol Ther 2005;22:95-100.
AstraZeneca
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