Effects of rabeprazole on early symptom relief in gastro-oesophageal reflux disease: the Hellenic Rabeprazole Study Group surveillance study

Authors: Archimandritis, Athanasios J.1; Nikolopoulou, Vassiliki; Kouklakis, Georgios; Paraskevas, Emanouil; Avgerinos, Alexandros; Tsianos, Epaminontas; Triantafillidis, John K.

Source: Current Medical Research and Opinion, Volume 21, Number 4, April 2005 , pp. 603-610(8)

Publisher: LibraPharm

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Abstract:

Background: In controlled clinical trials, rabeprazole effectively improves symptoms and heals oesophageal erosions in patients with gastro-oesophageal reflux disease (GORD).

Aim: To examine symptom relief during week 1 of rabeprazole therapy, in addition to GORD healing, in a clinical practice setting.

Methods: In this 8-week, prospective, multicentre, postauthorisation surveillance study conducted in Greece, patients with GORD (intent-to-treat: efficacy, 272; safety, 273) were treated with rabeprazole 20mg once daily. The primary efficacy end point was the change from baseline in GORD symptom severity on day 1, 2, 3 and 7 using a 5-point Likert scale (1 = no symptoms; 5 = severe symptoms). Oesophageal healing was also evaluated by comparing the results of endoscopic findings at baseline and after 4 and 8 weeks of treatment.

Results: On day 1 of treatment, rabeprazole relieved GORD symptoms across all grades of oesophagitis, with statistically significant (p = 0.0001) improvement in heartburn, regurgitation, epigastric pain and dysphagia. Oesophageal healing was achieved in 77% of patients at week 4 and in 90% at week 8 and treatment was well tolerated.

Conclusions: In a clinical practice setting, rabeprazole provided rapid relief of GORD symptoms, confirming results seen in controlled clinical trials.

Keywords: EFFICACY; GASTRO-OESOPHAGEAL REFLUX DISEASE; POSTMARKETING SURVEILLANCE STUDY; PROTON PUMP INHIBITOR; RABEPRAZOLE; SAFETY

Document Type: Research article

DOI: 10.1185/030079905X41444

Affiliations: 1: Department of Pathophysiology, Laiko Gen Hospital, University of Athens Medical School, Greece

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