IngentaConnect Prospective Follow-Up Data from the ProGERD Study Suggest that GE...

Authors: Labenz, Joachim¹; Nocon, Marc²; Lind, Tore³; Leodolter, Andreas¹; Jaspersen, Daniel⁴; Meyer-Sabellek, Wolfgang⁵; Stolte, Manfred⁶; Vieth, Michael⁶; Willich, Stefan N.²; Malfertheiner, Peter⁷

Source: The American Journal of Gastroenterology, Volume 101, Number 11, November 2006 , pp. 2457-2462(6)

Publisher: Blackwell Publishing

Abstract:

OBJECTIVES: There is a controversy as to whether gastroesophageal reflux disease (GERD) exists as a spectrum of disease severity or as a categorial disease in three distinct groups: nonerosive (NERD) and erosive reflux disease (ERD) and Barrett's esophagus (BE). Aim of the study was to assess progression or regression of GERD over 2 yr in a large cohort of patients (N = 3,894) under routine clinical care in Germany, Austria, and Switzerland (ProGERD study).

METHOD: Patients with predominant heartburn, with or without esophagitis, were recruited and classified according to endoscopic status at baseline, i.e., NERD, erosive reflux disease-Los Angeles (ERD-LA) grade A/B and ERD-LA grade C/D, and BE. After an initial treatment with esomeprazole, they were followed, regardless of their response. Medical therapy or endoscopy was initiated at the discretion of their primary care physician, in line with routine care. At 2 yr, endoscopy with biopsy was performed according to the protocol.

RESULTS: After 2 yr, 25% of patients who had NERD at baseline progressed to LA A/B and 0.6% to LA C/D; 1.6% of patients who had LA A/B progressed to LA C/D and 61% regressed to NERD; 42% of patients who had LA C/D regressed to LA A/B and 50% regressed to NERD (all figures exclude patients with confirmed BE at baseline). At 2 yr, 22% of patients had been off medication for at least 3 months. Patients with ERD-LA grade C/D were at greatest risk of developing BE: 5.8% compared with 1.4% for ERD-LA grade A/B and 0.5% for NERD.

CONCLUSION: GERD does not seem to be a categorial disease. Progression and regression between grades was observed in this large cohort of patients under routine clinical care.

(Am J Gastroenterol 2006;101:2457-2462)

Document Type: Research article

DOI: 10.1111/j.1572-0241.2006.00829.x

Affiliations: 1: Faculty of Medicine, University of Duisburg/Essen, Ev. Jung-Stilling Hospital, Siegen, Germany 2: Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Centre, Berlin, Germany 3: AstraZeneca, R&D, Mölndal, Sweden 4: Klinikum Fulda, Fulda, Germany 5: AstraZeneca GmbH, Wedel, Germany 6: Klinikum Bayreuth, Institute of Pathology Bayreuth, Germany 7: Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Magdeburg, Germany

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Prospective Follow-Up Data from the ProGERD Study Suggest that GERD Is Not a Categorial Disease