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Safety and efficacy of long-term maintenance therapy with oral dose of rabeprazole 10 mg once daily in Japanese patients with reflux esophagitis.
Intern Med 2011; 50(3):179-88IM

Abstract

OBJECTIVE

The aim of this prospective clinical study was to evaluate the efficacy and safety of long-term proton pump inhibitor (PPI) treatment for two years in Japanese patients with reflux esophagitis (RE).

METHODS

The efficacy and safety of two-year (104-week) treatment with rabeprazole (RPZ) 10 mg were studied in patients confirmed to have been cured of RE by PPI and who required long-term maintenance therapy with PPI. We performed serial endoscopy, checked gastroesophageal reflux disease (GERD) symptoms, adverse events, laboratory values and serum gastrin. We also monitored gastric mucosal histology, atrophy and polyps.

RESULTS

The endoscopic non-relapse rate for RE was 87.3% for the 104-week period. GERD symptoms improved based on the fact that the mean change from baseline in GERD symptom score after treatment was a negative value. Treatment was safe; and atrophy was found to have developed in virtually no cases. A few new benign fundic gland or hyperplastic polyps developed throughout the study, but no ECL carcinoids were found to have developed. Serum gastrin levels tended to increase up to 24 weeks, but there were no subsequent changes thereafter up to 104 weeks.

CONCLUSION

The results confirmed oral RPZ 10 mg to be effective for maintenance therapy in Japanese patients with RE. Although effects on the gastric mucosa were not ruled out, long-term use of RPZ was confirmed to be safe overall.

Authors+Show Affiliations

Department of Internal Medicine, Saga Medical School, Japan. fujimoto@med.saga-u.ac.jpNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

21297318

Citation

Fujimoto, Kazuma, et al. "Safety and Efficacy of Long-term Maintenance Therapy With Oral Dose of Rabeprazole 10 Mg once Daily in Japanese Patients With Reflux Esophagitis." Internal Medicine (Tokyo, Japan), vol. 50, no. 3, 2011, pp. 179-88.
Fujimoto K, Hongo M, Maintenance Study Group. Safety and efficacy of long-term maintenance therapy with oral dose of rabeprazole 10 mg once daily in Japanese patients with reflux esophagitis. Intern Med. 2011;50(3):179-88.
Fujimoto, K., & Hongo, M. (2011). Safety and efficacy of long-term maintenance therapy with oral dose of rabeprazole 10 mg once daily in Japanese patients with reflux esophagitis. Internal Medicine (Tokyo, Japan), 50(3), pp. 179-88.
Fujimoto K, Hongo M, Maintenance Study Group. Safety and Efficacy of Long-term Maintenance Therapy With Oral Dose of Rabeprazole 10 Mg once Daily in Japanese Patients With Reflux Esophagitis. Intern Med. 2011;50(3):179-88. PubMed PMID: 21297318.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of long-term maintenance therapy with oral dose of rabeprazole 10 mg once daily in Japanese patients with reflux esophagitis. AU - Fujimoto,Kazuma, AU - Hongo,Michio, AU - ,, Y1 - 2011/02/01/ PY - 2011/2/8/entrez PY - 2011/2/8/pubmed PY - 2011/5/20/medline SP - 179 EP - 88 JF - Internal medicine (Tokyo, Japan) JO - Intern. Med. VL - 50 IS - 3 N2 - OBJECTIVE: The aim of this prospective clinical study was to evaluate the efficacy and safety of long-term proton pump inhibitor (PPI) treatment for two years in Japanese patients with reflux esophagitis (RE). METHODS: The efficacy and safety of two-year (104-week) treatment with rabeprazole (RPZ) 10 mg were studied in patients confirmed to have been cured of RE by PPI and who required long-term maintenance therapy with PPI. We performed serial endoscopy, checked gastroesophageal reflux disease (GERD) symptoms, adverse events, laboratory values and serum gastrin. We also monitored gastric mucosal histology, atrophy and polyps. RESULTS: The endoscopic non-relapse rate for RE was 87.3% for the 104-week period. GERD symptoms improved based on the fact that the mean change from baseline in GERD symptom score after treatment was a negative value. Treatment was safe; and atrophy was found to have developed in virtually no cases. A few new benign fundic gland or hyperplastic polyps developed throughout the study, but no ECL carcinoids were found to have developed. Serum gastrin levels tended to increase up to 24 weeks, but there were no subsequent changes thereafter up to 104 weeks. CONCLUSION: The results confirmed oral RPZ 10 mg to be effective for maintenance therapy in Japanese patients with RE. Although effects on the gastric mucosa were not ruled out, long-term use of RPZ was confirmed to be safe overall. SN - 1349-7235 UR - https://www.unboundmedicine.com/medline/citation/21297318/Safety_and_efficacy_of_long_term_maintenance_therapy_with_oral_dose_of_rabeprazole_10_mg_once_daily_in_Japanese_patients_with_reflux_esophagitis_ L2 - https://joi.jlc.jst.go.jp/JST.JSTAGE/internalmedicine/50.4238?from=PubMed DB - PRIME DP - Unbound Medicine ER -