Long-term effect on symptoms and quality of life of maintenance therapy with esomeprazole 20 mg daily: a post hoc analysis of the LOTUS trial. (January 2015)

• Record Type: Journal Article
• Authors: Lundell, Lars; Hatlebakk, Jan; Galmiche, Jean-Paul; Attwood, Stephen E.; Ell, Christian; Fiocca, Roberto; Persson, Tore; Nagy, Péter; Eklund, Stefan; Lind, Tore
• Is Part Of: Current medical research and opinion. Volume 31:Number 1(2015:Jan.)
• Page Start: 65
• Page End: 73
• Publication Date: 2015-01
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2014.980500
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>To assess the long-term effect on symptoms and quality of life of esomeprazole 20 mg once daily, a recommended dose for maintenance therapy of gastroesophageal reflux disease (GERD).</p> </sec> <sec id="ss2"> <title>Research design and methods:</title> <p>This is a <italic>post hoc</italic> analysis of 5 year data from patients in the LOTUS trial (ClinicalTrials.gov identifier: NCT00251927) who were randomized to esomeprazole 20 mg once daily. All participants had chronic, symptomatic GERD responsive to treatment. Gastrointestinal symptoms were assessed by physicians and by using patient-reported outcome instruments. Investigations included gastrointestinal endoscopy (with biopsy sampling), 24 hour esophageal pH monitoring and laboratory measurements.</p> </sec> <sec id="ss3"> <title>Results:</title> <p>In total, 157 of 256 patients randomized to esomeprazole 20 mg once daily remained on this dose until the end of follow-up or study discontinuation, whereas 99 patients had their dose increased because of inadequate symptom control (of these, 29 subsequently returned to the allocated dose). On logistic regression, a long objectively defined GERD history, smoking, female sex, absence of <italic>Helicobacter pylori</italic> infection and high supine baseline acid reflux into the esophagus were associated with an increased likelihood of requiring dose escalation to esomeprazole 40 mg daily (all <italic>p</italic> < 0.05). Symptoms were fairly stable and quality of life was normal throughout follow-up in patients remaining on esomeprazole 20 mg once daily, with no more than mild symptom severity, and mean (standard deviation) percentage time with intraesophageal pH <4 was reduced from 10.7 (10.7) pre-randomization to 6.3 (10.2) at 6 months and 4.9 (7.3) at 5 years. The number of serious adverse events was low (0.079 per patient per year).</p> </sec> <sec id="ss4"> <title>Limitations:</title> <p> <italic>Post hoc</italic> analysis with no control group.</p> </sec> <sec id="ss5"> <title>Conclusions:</title> <p>Esomeprazole at a maintenance dose of 20 mg once daily offers effective long-term treatment for chronic GERD in patients initially responsive to the medication, with durable symptom control and sustained reductions in intraesophageal acid exposure.</p> </sec> </abstract>