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| |  DDW: Nexium (Esomeprazole) Promotes Greater Healing Than Omeprazole For Erosive Esophagitis SAN DIEGO, CA -- May 23, 2000 -- Data presented May 21 at Digestive Disease Week (DDW) indicate that the investigational drug Nexium ™ (esomeprazole magnesium) is the first proton pump inhibitor (PPI) to show a statistically significant improvement over Prilosec® (omeprazole) in healing erosive esophagitis (EE), a potentially more serious form of gastroesophageal reflux disease (GERD), and in resolution of heartburn among the same patients. A study comparing esomeprazole 40mg and omeprazole 20mg for the healing of EE was presented by Joel Richter, M.D,, Chief of the Department of Gastroenterology at the Cleveland Clinic Foundation in Cleveland, OH. This study demonstrates that treatment with esomeprazole results in greater healing of EE at four and eight weeks than omeprazole. The study shows, additionally, that esomeprazole resolved heartburn symptoms in a higher proportion of patients than omeprazole. Although not an endpoint of the study, Dr. Richter observed that the healing rate of esomeprazole at week four for EE was similar to what omeprazole achieved at week eight. He added that esomeprazole is the first PPI to demonstrate greater healing over omeprazole regardless of the severity of EE prior to treatment. Dr. Richter reported that patients received esomeprazole 40mg or omeprazole 20mg for up to eight works. The primary efficacy variable was the proportion of patients with healed EE at eight weeks. Secondary efficacy variables included the proportion of patients healed at week four, the resolution of heartburn, the time to first resolution and sustained heartburn resolution and the proportion of days/nights without heartburn. This U.S. multi-center, double-blind, randomized trial involved 2,425 patients with documented EE. Tolerability was also evaluated and the proportion of patients with treatment-related adverse events was similar for esomeprazole and omeprazole. The most commonly reported adverse events for esomeprazole in this study were headache, abdominal pain and diarrhea. In a separate study evaluating the level of acidity in the stomach and drug levels in the blood, results presented by Tore Lind, M.D., of Kransjukhuset, Skovde, Sweden, demonstrate that esomeprazole provided greater acid control than omeprazole, with less variability between patients. The greater acid control achieved with esomeprazole in these patients appeared to be related to higher drug levels in the blood. In this study, patients with symptoms of GERD all received esomeprazole 40mg, esomeprazole 20mg or omeprazole 20mg separately for five days with a washout period of 14 or more days between treatments. Additional studies presented today address the efficacy of esomeprazole in the maintenance of healing of EE due to GERD. In a six-month study presented by David A. Johnson, M.D., of Eastern Virginia School of Medicine, Norfolk, VA, results indicate that esomeprazole maintained healing rates of EE above 90 percent. Additionally, the resolution of heartburn was maintained. Nexium, like Prilosec, is in a class of medications known as PPIs, which block the final step of acid production by inhibiting the acid-producing cells, known as parietal cells, in the stomach. Nexium is a new chemical entity exhibiting a different metabolic profile that was developed as an isomer from Prilosec, the first PPI. AstraZencca submitted a New Drug Application (NDA) for Nexium to the U.S. Food and Drug Administration (FDA) on December 3, 1999. Nexium is not yet approved for use in the U.S. The compound was approved for use in Sweden on March 13, 2000. Prilosec was launched in 1989. The prescription medication is the most prescribed acid inhibitor in the U.S. Prilosec is generally well tolerated but is not for every patient. The most common side effects are headache, diarrhea and abdominal pain. About 21 million Americans may have GERD, based on self-reported episodes of heartburn on two-or-more days a week. Symptoms of GERD can include heartburn, a rising burning sensation behind the breastbone caused by harsh stomach acid backing up into the esophagus, or a sour taste in the mouth. Acid can irritate and sometimes damage the delicate lining of the esophagus, which may lead to a potentially more serious condition, erosive esophagitis (EE). Complications from EE may include narrowing or ulceration of the esophagus. DDW is the largest international meeting within the gastrointestinal and hepatic healthcare community and is sponsored annually by four professional associations: American Association for the Study of Liver Diseases (AASLD); American Gastromenterological Association (AGA); American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT). With approximately 5,000 abstracts anticipated for presentation, DDW encompasses all aspects of digestive disease research and clinical practice. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. In the U.S., AstraZeneca is a $7.4 billion healthcare business with approximately 9,500 employees. Related Links: Prilosec (omeprazole) and AstraZeneca.
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