Nexium better meets patient expectations of GERD treatment

PREDICTABLE RESOLUTION OF HEARTBURN WITH NEXIUM® BETTER MEETS PATIENT EXPECTATIONS OF GERD TREATMENT 22 May 2000 -- London -- Less than two-thirds of patients with gastroesphageal reflux disease (GERD) are totally satisfied with the symptom relief provided by their medication, including proton pump inhibitors (PPIs), according to data reported today at Digestive Disease Week (DDW), San Diego, California, USA.1 GERD is a clinical condition in which reflux (backward flow) of stomach acid into the esophagus (gullet) is severe enough to cause recurrent symptoms that significantly impact on patients' lives and, in some cases, damage the esophagus. Heartburn is the major symptom of GERD. Findings from a survey1 reported by Joseph Crawley, AstraZeneca LP, Wayne, Pennsylvania, USA, involving more than 11,000 replies to a questionnaire on the level of satisfaction that heartburn sufferers experience with prescription and over-the-counter medication, indicate that there is a need for more effective GERD therapy. Significant numbers of patients reported expecting more symptom relief from their medicine than they perceive themselves to be experiencing. There is, however, good news for patients with GERD. Data from trials presented at DDW suggest that symptom resolution with Nexium® (esomeprazole, AstraZeneca), which is approved for use in Sweden, is more predictable in healing underlying esophagitis than with omeprazole, the most prescribed PPI in the class. Another clinical trial reported today, presented additional data supporting the superiority of Nexium® in resolving heartburn and healing reflux esophagitis,2 compared with omeprazole, adding yet more scientific evidence of the potential of this 3,4 , 5,6 new drug to that from the reports already presented. "GERD patients with heartburn seek medical advice for a variety of reasons, some of which are emotional, with patients being fearful of having a serious disease, while others are mainly seeking relief from their symptoms," said Mr Crawley. "A significantly greater proportion of heartburn sufferers using PPIs reported satisfaction with the symptom relief they obtained than did those using H2 -receptor antagonists, and more omeprazole users expressed satisfaction than lansoprazole users. 7 However, the greater efficacy of Nexium® may lead to better management of GERD, with increased and sustained relief from its symptoms," he concluded. Speaking from the DDW, Nancy Norton, President and Founder of the International Foundation for Functional Gastrointestinal Disorders (IFFGD), an international patient group said: "It is vital that patients suffering from the symptoms of GERD are given the most effective treatment as first-line therapy. Any advances in the treatment of gastrointestinal disorders that may enable GERD sufferers to lead a symptom-free life are welcome." Data presented at DDW have suggested that Nexium® may provide freedom from heartburn and the symptoms of GERD in significantly more reflux esophagitis patients than omeprazole. Data presented suggest that the effect is faster and more sustained with Nexium® than omeprazole and, in addition, the new drug may be superior to omeprazole, irrespective of the severity of the condition.2,3 "Our results suggest that Nexium® 40 mg once daily healed more GERD patients with erosive esophagitis at four weeks and eight weeks than did daily omeprazole 20 mg [75.9 / 94.1 percent versus 64.7 / 86.9 percent, respectively]," said Professor Peter Kahrilas, Northwestern University Medical School, Chicago, Illinois, USA, and lead investigator of the trial. "In addition, the data show that Nexium® may resolve heartburn more quickly than omeprazole, and the time to sustained resolution of heartburn may be significantly shorter with Nexium® . Most importantly, these results have been corroborated in another separate clinical trial presented at DDW," he added. Dr Martin Nicklasson, Executive Vice President GI Franchise, AstraZeneca, commented: "Nexium® is the first PPI developed as an isomer and has proven to be highly effective in providing freedom from symptoms for all GERD patients." Referring to the published Genval Guidelines for the optimal management of GERD, 8 Dr Nicklasson said: "The most effective therapy should be used for initial management of this disease. Therefore, Nexium® provides a rational first-line therapy across the full spectrum of GERD for all patients, irrespective of their symptoms or concerns." Nexium® has a tolerability profile similar to omeprazole, and the most common side effects observed are headache, abdominal pain, and diarrhoea. 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 over $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. # # # This press release contains forward-looking statements, which reflect AstraZeneca's current expectation regarding future events. The forward- looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the successful and timely completion of clinical studies, the uncertainties related to the regulatory process and the commercialisation of the drug thereafter. Investors should consult AstraZeneca's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. AstraZeneca disclaims any obligation to update these forward- looking statements. Further enquires to: Steve Brown, tel: +44 (0)20 7304 5033/Lucy Williams, tel: +44 (0)20 73045034 References 1. Crawley JA et al. How satisfied are chronic heartburn sufferers with the results they get from prescription strength heartburn medication. Abstract / Study QoL 2 Gastroenterology 2000; 118: 1292, A210 2. Kahrilas P et al. Comparison of esomeprazole, a novel PPI, versus omeprazole in GERD patients with esophagitis. Abstract / Study No 172 Gastroenterology 2000; 118: 1224, A193 3. Richter JE et al. Esomeprazole is superior to omeprazole for the healing of erosive esophagitis in GERD patients. Abstract / Study No 222 Gastroenterology 2000; 118: 343, A20 4. Lind T et al. Esomeprazole provides improved acid control versus omeprazole in patients with symptoms of GERD. Abstract / Study No 08 Gastroenterology 2000; 118: 334, A18 5. Wilder-Smith C et al. Esomeprazole 40 mg provides more effective acid control than pantoprazole 40 mg. Abstract / Study No 058 Gastroenterology 2000; 118: 352, A22 6. Rohss K et al. Esomeprazole 40 mg provides more effective acid control than Lansoprazole 30 mg. Abstract / Study No 059 Gastroenterology 2000; 118: 344, A20 7. Crawley JA et al. Does it matter why heartburn sufferers seek health care?. Abstract / Study QoL 1 Gastroenterology 2000; 118: 1291, A209 8. Dent J, Brun J, Fendrick A, et al. An evidence-based appraisal of reflux disease management - the Genval Workshop Report. Gut 1999; 44 suppl 2: S1 - S16 9. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/05/22/20000522BIT00830/bit0001.doc http://www.bit.se/bitonline/2000/05/22/20000522BIT00830/bit0002.pdf