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Daily omeprazole surpasses intermittent dosing in preventing relapse of oesophagitis: a US multi-centre double-blind study.
Aliment Pharmacol Ther. 1997 Apr; 11(2):373-80.AP

Abstract

INTRODUCTION

Relapse of erosive oesophagitis occurs in almost all patients if treatment is stopped after initial healing.

AIM

To assess the potential of different therapeutic regimens of omeprazole to prevent relapse of erosive reflux oesophagitis after initial healing with omeprazole.

PATIENTS AND METHODS

Patients whose active erosive reflux oesophagitis (grade > or = 2) had healed (grade 0 or 1) after 4-8 weeks of open-label omeprazole 40 mg daily (phase I) were eligible to join a multi-centre, 6-month double-blind, placebo-controlled maintenance study (phase II), which included endoscopy, symptom assessments, serum gastrin measurements, and gastric fundic biopsies. During phase I, endoscopy was performed at weeks 0, 4, and 8. At the end of phase I, 429 of 472 patients (91%) were healed, and there were significant reductions in heartburn, dysphagia and acid regurgitation. Of the 429 patients who healed, 406 joined phase II and were randomized to one of three groups: 20 mg omeprazole daily (n = 138), 20 mg omeprazole for 3 consecutive days each week (n = 137), or placebo (n = 131). During phase II, endoscopy was performed at months 1, 3, and 6 or at symptomatic relapse.

RESULTS

The percentages of patients still in endoscopic remission at 6 months were 11% for placebo, 34% for omeprazole 3-days-a-week, and 70% for omeprazole daily. Both omeprazole regimens were superior to placebo in preventing recurrence of symptoms (P < 0.001); however, omeprazole 20 mg daily was superior to omeprazole 20 mg 3-days-a-week (P < 0.001). Compared to baseline, omeprazole therapy resulted in no significant differences among treatment groups in the distribution of gastric endocrine cells.

CONCLUSIONS

These results show that after healing of erosive oesophagitis with 4-8 weeks of omeprazole, relapse of oesophagitis and recurrence of reflux symptoms can be prevented in 70% of patients with a maintenance regimen of 20 mg daily, but that intermittent dosing comprising 3 consecutive days each week significantly compromises efficacy.

Authors+Show Affiliations

Medical Service, VA Medical Center, Hines, IL 60141, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9146778

Citation

Sontag, S J., et al. "Daily Omeprazole Surpasses Intermittent Dosing in Preventing Relapse of Oesophagitis: a US Multi-centre Double-blind Study." Alimentary Pharmacology & Therapeutics, vol. 11, no. 2, 1997, pp. 373-80.
Sontag SJ, Robinson M, Roufail W, et al. Daily omeprazole surpasses intermittent dosing in preventing relapse of oesophagitis: a US multi-centre double-blind study. Aliment Pharmacol Ther. 1997;11(2):373-80.
Sontag, S. J., Robinson, M., Roufail, W., Hirschowitz, B. I., Sabesin, S. M., Wu, W. C., Behar, J., Peterson, W. L., Kranz, K. R., Tarnawski, A., Dayal, Y., Berman, R., & Simon, T. J. (1997). Daily omeprazole surpasses intermittent dosing in preventing relapse of oesophagitis: a US multi-centre double-blind study. Alimentary Pharmacology & Therapeutics, 11(2), 373-80.
Sontag SJ, et al. Daily Omeprazole Surpasses Intermittent Dosing in Preventing Relapse of Oesophagitis: a US Multi-centre Double-blind Study. Aliment Pharmacol Ther. 1997;11(2):373-80. PubMed PMID: 9146778.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Daily omeprazole surpasses intermittent dosing in preventing relapse of oesophagitis: a US multi-centre double-blind study. AU - Sontag,S J, AU - Robinson,M, AU - Roufail,W, AU - Hirschowitz,B I, AU - Sabesin,S M, AU - Wu,W C, AU - Behar,J, AU - Peterson,W L, AU - Kranz,K R, AU - Tarnawski,A, AU - Dayal,Y, AU - Berman,R, AU - Simon,T J, PY - 1997/4/1/pubmed PY - 1997/4/1/medline PY - 1997/4/1/entrez SP - 373 EP - 80 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 11 IS - 2 N2 - INTRODUCTION: Relapse of erosive oesophagitis occurs in almost all patients if treatment is stopped after initial healing. AIM: To assess the potential of different therapeutic regimens of omeprazole to prevent relapse of erosive reflux oesophagitis after initial healing with omeprazole. PATIENTS AND METHODS: Patients whose active erosive reflux oesophagitis (grade > or = 2) had healed (grade 0 or 1) after 4-8 weeks of open-label omeprazole 40 mg daily (phase I) were eligible to join a multi-centre, 6-month double-blind, placebo-controlled maintenance study (phase II), which included endoscopy, symptom assessments, serum gastrin measurements, and gastric fundic biopsies. During phase I, endoscopy was performed at weeks 0, 4, and 8. At the end of phase I, 429 of 472 patients (91%) were healed, and there were significant reductions in heartburn, dysphagia and acid regurgitation. Of the 429 patients who healed, 406 joined phase II and were randomized to one of three groups: 20 mg omeprazole daily (n = 138), 20 mg omeprazole for 3 consecutive days each week (n = 137), or placebo (n = 131). During phase II, endoscopy was performed at months 1, 3, and 6 or at symptomatic relapse. RESULTS: The percentages of patients still in endoscopic remission at 6 months were 11% for placebo, 34% for omeprazole 3-days-a-week, and 70% for omeprazole daily. Both omeprazole regimens were superior to placebo in preventing recurrence of symptoms (P < 0.001); however, omeprazole 20 mg daily was superior to omeprazole 20 mg 3-days-a-week (P < 0.001). Compared to baseline, omeprazole therapy resulted in no significant differences among treatment groups in the distribution of gastric endocrine cells. CONCLUSIONS: These results show that after healing of erosive oesophagitis with 4-8 weeks of omeprazole, relapse of oesophagitis and recurrence of reflux symptoms can be prevented in 70% of patients with a maintenance regimen of 20 mg daily, but that intermittent dosing comprising 3 consecutive days each week significantly compromises efficacy. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/9146778/Daily_omeprazole_surpasses_intermittent_dosing_in_preventing_relapse_of_oesophagitis:_a_US_multi_centre_double_blind_study_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0269-2813&amp;date=1997&amp;volume=11&amp;issue=2&amp;spage=373 DB - PRIME DP - Unbound Medicine ER -