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Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis.
Aliment Pharmacol Ther. 2002 Mar; 16(3):445-54.AP

Abstract

BACKGROUND

In numerous clinical trials, proton pump inhibitors have demonstrated potent acid suppression and healing of erosive oesophagitis, as well as successful symptom relief for the entire spectrum of gastro-oesophageal reflux disease.

AIM

The 'Future of Acid Suppression Therapy' (FAST) trial evaluated, in actual clinical practice, the timing of symptom relief, changes in symptom severity, health-related quality of life and safety in endoscopically confirmed erosive gastro-oesophageal reflux disease treated with rabeprazole.

METHODS

This open-label, multicentre study enrolled 2579 patients to receive rabeprazole treatment using 20 mg once daily for 8 weeks. Between two clinical visits (at enrollment and week 8), patients used an interactive voice response system to rate gastro-oesophageal reflux disease symptoms. Subgroup analyses of efficacy were conducted for gender, age, Hetzel-Dent grade, presence of Barrett's oesophagus and for patients reporting previously ineffective symptom relief with omeprazole or lansoprazole.

RESULTS

On day 1, rabeprazole significantly decreased daytime and night-time heartburn severity, regurgitation and belching. Complete relief of daytime and night-time heartburn was achieved in 64.0% and 69.2% of symptomatic patients, respectively, on day 1, and in 81.1% and 85.7% of patients, respectively, on day 7. Patients with moderate or severe heartburn symptoms at baseline achieved an even greater degree of satisfactory symptom relief (none or mild) from day 1 onwards. The median time to satisfactory heartburn relief was 2 days. Subgroup analyses showed no consistent differences in efficacy compared to the overall population treated. Health-related quality of life in patients was significantly lower than that of the US general population and improved significantly after 8 weeks of rabeprazole therapy. Rabeprazole was well tolerated, with headache as the most common adverse event, reported by less than 2% of the study population.

CONCLUSIONS

In this large, open-label trial, rabeprazole rapidly and effectively relieved gastro-oesophageal reflux disease symptoms in most patients with erosive oesophagitis. Substantial symptom relief was noted on day 1; improvement continued over the first week and at week 4. By week 8, the health-related quality of life had also improved vs. baseline.

Authors+Show Affiliations

Oklahoma Foundation for Digestive Research, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104-5022, USA. malcolm-robinson@ouhsc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

11876697

Citation

Robinson, M, et al. "Onset of Symptom Relief With Rabeprazole: a Community-based, Open-label Assessment of Patients With Erosive Oesophagitis." Alimentary Pharmacology & Therapeutics, vol. 16, no. 3, 2002, pp. 445-54.
Robinson M, Fitzgerald S, Hegedus R, et al. Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis. Aliment Pharmacol Ther. 2002;16(3):445-54.
Robinson, M., Fitzgerald, S., Hegedus, R., Murthy, A., & Jokubaitis, L. (2002). Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis. Alimentary Pharmacology & Therapeutics, 16(3), 445-54.
Robinson M, et al. Onset of Symptom Relief With Rabeprazole: a Community-based, Open-label Assessment of Patients With Erosive Oesophagitis. Aliment Pharmacol Ther. 2002;16(3):445-54. PubMed PMID: 11876697.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis. AU - Robinson,M, AU - Fitzgerald,S, AU - Hegedus,R, AU - Murthy,A, AU - Jokubaitis,L, AU - ,, PY - 2002/3/6/pubmed PY - 2002/6/5/medline PY - 2002/3/6/entrez SP - 445 EP - 54 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 16 IS - 3 N2 - BACKGROUND: In numerous clinical trials, proton pump inhibitors have demonstrated potent acid suppression and healing of erosive oesophagitis, as well as successful symptom relief for the entire spectrum of gastro-oesophageal reflux disease. AIM: The 'Future of Acid Suppression Therapy' (FAST) trial evaluated, in actual clinical practice, the timing of symptom relief, changes in symptom severity, health-related quality of life and safety in endoscopically confirmed erosive gastro-oesophageal reflux disease treated with rabeprazole. METHODS: This open-label, multicentre study enrolled 2579 patients to receive rabeprazole treatment using 20 mg once daily for 8 weeks. Between two clinical visits (at enrollment and week 8), patients used an interactive voice response system to rate gastro-oesophageal reflux disease symptoms. Subgroup analyses of efficacy were conducted for gender, age, Hetzel-Dent grade, presence of Barrett's oesophagus and for patients reporting previously ineffective symptom relief with omeprazole or lansoprazole. RESULTS: On day 1, rabeprazole significantly decreased daytime and night-time heartburn severity, regurgitation and belching. Complete relief of daytime and night-time heartburn was achieved in 64.0% and 69.2% of symptomatic patients, respectively, on day 1, and in 81.1% and 85.7% of patients, respectively, on day 7. Patients with moderate or severe heartburn symptoms at baseline achieved an even greater degree of satisfactory symptom relief (none or mild) from day 1 onwards. The median time to satisfactory heartburn relief was 2 days. Subgroup analyses showed no consistent differences in efficacy compared to the overall population treated. Health-related quality of life in patients was significantly lower than that of the US general population and improved significantly after 8 weeks of rabeprazole therapy. Rabeprazole was well tolerated, with headache as the most common adverse event, reported by less than 2% of the study population. CONCLUSIONS: In this large, open-label trial, rabeprazole rapidly and effectively relieved gastro-oesophageal reflux disease symptoms in most patients with erosive oesophagitis. Substantial symptom relief was noted on day 1; improvement continued over the first week and at week 4. By week 8, the health-related quality of life had also improved vs. baseline. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/11876697/Onset_of_symptom_relief_with_rabeprazole:_a_community_based_open_label_assessment_of_patients_with_erosive_oesophagitis_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=2002&volume=16&issue=3&spage=445 DB - PRIME DP - Unbound Medicine ER -