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| |  Surgery and Long-Term Esomeprazole Therapy Both Effective in Gastro-Oesophageal Reflux Disease: Presented at UEGW By Judith Moser, MD VIENNA, Austria -- October 22, 2008 -- Long-term treatment with esomeprazole and laparoscopic antireflux surgery (LARS) are both effective and well tolerated in patients with symptoms of gastro-oesophageal reflux disease (GERD), according to results from a study presented here at the 16th United European Gastroenterology Week (UEGW). Both acid-suppressive therapy with a proton pump inhibitor and LARS are therapeutic mainstays in the management of chronic GERD. The objective of the Long-Term Usage of Acid Suppression Versus Antireflux Surgery (LOTUS) trial was to compare the 2 approaches by assessing the time to treatment failure. "We [previously] had no comparative data on these 2 long-term strategies," noted lead investigator Lars Lundell, MD, Karolinska University Hospital, Huddinge, Sweden, and a member of the steering committee for the multicentre, randomised LOTUS trial. "For patients to be eligible, GERD had to be confirmed by history, endoscopy, 24-hour pH-metry, and symptom response to esomeprazole," Dr. Lundell explained upon presentation of the 3-year results here on October 21. After a run-in phase with esomeprazole 40 mg once daily, patients were randomised to receive either esomeprazole 20 mg once daily (up-titrated to either 40 mg once daily or 20 mg twice daily in case of incomplete symptom control) or LARS. Data from the 208 patients in the medication group and from the 204 patients in the surgery group were available for the 3-year analysis. At that time, 93% and 90% of patients were in remission in the medical and surgical treatment arms, respectively (P = .25). "Importantly, the dose of esomeprazole needed to be increased early on in the first year," Dr. Lundell commented. Between 1 year and 3 years, a slight tendency towards a further increase in esomeprazole was observed. In terms of severity of heartburn, there was a slight difference between the 2 therapeutic strategies, with a greater proportion of patients with mild to moderate symptoms at 3 years in the medical-treatment arm. Severity of dysphagia was minor in both studies, with only a very small difference between the 2 groups. The results were also comparable regarding flatulence. Serious adverse effects (including postoperative complications) occurred in 22% of the patients after LARS and in 14% of the patients in the medical-treatment arm. "Both LARS and continuous medical treatment were highly effective and well tolerated for the control of GERD symptoms," Dr. Lundell summarised. Follow-up is planned for up to 10 years in trial subjects. Funding for this study was provided by AstraZeneca.
[Presentation title: Comparison of Esomeprazole to Laparoscopic Anti-Reflux Surgery for the Management of Gastroesophageal Reflux Disease: A 3-Year Interim Analysis of the LOTUS Trial. Abstract 270]
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