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| |  Comparable Long-Term Safety Profiles With Antireflux Surgery and Esomeprazole in Patients With GERD: Presented at DDW By Lexa W. Lee NEW ORLEANS -- May 7, 2010 -- Laparoscopic antireflux surgery (LARS) and esomeprazole both demonstrate comparable long-term safety profiles in patients with gastro-oesophageal reflux disease (GERD), as shown in a 5-year study presented here at Digestive Diseases Week (DDW) 2010. Patients with GERD can be treated effectively with either LARS or by taking proton pump inhibitors (PPIs) to suppress acid secretion. However, few controlled studies compare the long-term safety of these treatments, according to Christian Ell, MD, Department of Gastroenterology, Dr. Horst Schmidt Hospital, Wiesbaden, Germany. The aim of the study, which was presented May 5, was to compare the 5-year safety profile of standard LARS and esomeprazole, as part of LOTUS, a multi-centre, open-label, randomised trial of patients with GERD in 11 European countries. Patients were randomised to either standard LARS (n = 248) or esomeprazole 20-40 mg daily (n = 266). All patients were followed every 6 months over a 5-year period. Safety was evaluated in several ways: By comparing changes in both groups for liver function and levels of haemoglobin, vitamins B12 and D, alkaline phosphatase, and calcium (bone metabolism); monitoring levels of gastrin and chromogranin A levels for the effects of acid suppression; and monitoring serious adverse events (SAEs) including myocardial infarction, gallstones, non-cardiac chest pain, angina, and gastroenteritis. During the 5-year follow-up, mean gastrin and chromogranin A levels were elevated, which was expected with long-term acid suppression. Levels reached a plateau after 3 years. Rates of discontinuation due to AEs (unrelated to treatment) were 0.8% in the LARS patients and 5.6% in the esomeprazole group. The rate of SAEs was 28.6% in the LARS group and 24.1% in the esomeprazole group, with no clinically relevant differences between the groups. There was 1 death from lung carcinoma in the LARS group. In the esomeprazole group, 4 deaths were reported: 1 due to pneumonia, 2 from pancreatic cancer, and 1 from a fall. None of the deaths were judged to be related to treatment. Additionally, there were no clinically relevant changes in laboratory results for either group and no apparent group differences during the 5-year period. The researchers concluded there have been no safety concerns in the 5 years following LARS or daily esomeprazole for patients with GERD. Digestive Disease Week 2010 is cosponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT). [Presentation title: Safety Profile in GERD Patients 5 Yrs After Laparoscopic Antireflux Surgery or Long-Term Treatment With Esomeprazole 20-40 mg Daily in the Lotus Study. Abstract W1111]
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