Results of the ALEGRIA study in Luxembourg. An epidemiological, observational study to describe symptom impact and control in patients with GERD and an evaluation of the GERD Impact Scale.
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Abstract
Background and study aims: The aim of this observational study was to perform the first epidemiology study in a primary care patient population with GERD in the Grand Duchy of Luxembourg and to evaluate the added value of the GERD Impact Scale (GIS) patient questionnaire.
Patients and methods: 152 Patients with symptoms of GERD from 20 study centers were included. At visit 1, demographic data including lifestyle factors and the patients' symptoms were recorded. GERD symptoms and their severity, treatment changes and the GIS were all assessed at baseline (visit 1), visit 2 (4-6 weeks) and visit 3 (8-14 weeks). Analyses were performed on an intent-to-treat basis.
Results: 142 patients were included in the analysis, which comprised 50% men and 50% women with a mean BMI of 27 kg/m2. Documented lifestyle factors included consumption of caffeine-containing beverages (87% of patients), stress (62%) and alcohol consumption (53%); 44% of patients were smokers or ex-smokers. The median duration of GERD was 2.0 years. Upon inclusion, 46% were receiving, or had received, proton pump inhibitors (PPIs), antacids (44%), H2-receptor antagonists (21%) or no treatment (21%). PPIs were prescribed at the first visit in the majority of cases (94%) with 75% of patients being prescribed esomeprazole with a median daily dose of 40 mg. The GIS score correlated well with the clinician's judgment of symptom severity and was reported to help determine the appropriate treatment and evaluate the patient's response in approximately 80% of patients.
Conclusions: In this, the first epidemiological study on GERD patients in the Grand Duchy of Luxembourg, data was obtained as planned. The novel patient questionnaire was judged to be helpful by the physician and data shows that the GIS may have an added value over current assessments.