May 17, 2011 In an evaluation of contemporary antireflux therapies for chronic gastroesophageal reflux disease (GERD), most patients who received treatment with either the proton pump inhibitor esomeprazole or laparoscopic antireflux surgery achieved and remained in disease remission for 5 years, according to a study in the May 18 issue of JAMA.
"GERD is a highly prevalent disorder caused by the reflux of gastric contents into the esophagus. It is a chronic, relapsing disease that negatively affects patients' health-related quality of life and reduces work productivity," according to background information in the article. Two treatment options are long-term medication (such as with a proton pump inhibitor [PPI]) or surgery (laparoscopic antireflux surgery [LARS]). Some patients are reluctant to take long-term medication and may prefer to have antireflux surgery. Few studies have compared pharmaceutical treatment for GERD with LARS, particularly over a longer term.
Jean-Paul Galmiche, M.D., F.R.C.P., of Nantes University, Nantes, France, and colleagues compared maintenance therapy for chronic GERD provided by the PPI esomeprazole (dose-adjusted when required) with standardized LARS in patients who responded well to acid-suppressive therapy. The 5-year randomized trial was conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients. A total of 372 patients (192 assigned to receive esomeprazole [20 to 40 mg/d, allowing for dose adjustments]; 180 assigned to undergo LARS) completed 5-year follow-up. The primary outcome for the study was time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates.
The researchers found that at 5 years, an estimated 85 percent of patients in the LARS group and an estimated 92 percent in the esomeprazole group remained in remission. The esomeprazole group showed similar levels of symptoms of heartburn and acid regurgitation from the beginning of the study up to 5 years, whereas these symptoms decreased in the LARS group after randomization.
"At 5 years, acid regurgitation was significantly worse in the esomeprazole group than in the LARS group (13 percent vs. 2 percent, respectively), although there was no significant difference between the groups in the severity of heartburn (16 percent vs. 8 percent), epigastric [an area of the abdomen] pain (18 percent vs. 18 percent), or diarrhea (15 percent vs. 16 percent). At 5 years, dysphagia [difficulty swallowing] remained significantly more common in the LARS group than in the esomeprazole group (11 percent vs. 5 percent, respectively), as did bloating (40 percent vs. 28 percent, respectively) and flatulence (57 percent vs. 40 percent, respectively)," the authors write.
Serious adverse events were reported by 28.6 percent of patients who underwent LARS and by 24.1 percent of patients in the esomeprazole group over 5 years.
"This large, multicenter randomized trial demonstrated that with modern forms of antireflux therapy, either by drug-induced acid suppression or after LARS, most patients remain in remission for at least 5 years," the authors conclude.
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- J.-P. Galmiche, J. Hatlebakk, S. Attwood, C. Ell, R. Fiocca, S. Eklund, G. Langstrom, T. Lind, L. Lundell. Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD: The LOTUS Randomized Clinical Trial. JAMA: The Journal of the American Medical Association, 2011; 305 (19): 1969 DOI: 10.1001/jama.2011.626
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