Abstracts Submitted for the 69th Annual Scientific Meeting of the American College of Gastroenterology: October 29–November 3, 2004, Orlando, Florida: OUTCOMES RESEARCH Liane, Schoeffel Dr.; Andreas, Naumburger Dr.; Anton, Gillessen Dr.* Private Practice, Berlin and Herz-Jesu-Hospital, Muenster, Germany. Purpose: To compare the efficacy of pantoprazole and omeprazole in the relief of gastroesophageal reflux disease (GERD)-associated sleep disturbances. Methods: A total of 915 patients with symptomatic erosive GERD (Los Angeles classification grades B-D) were randomized in this study
conducted in Germany and Lithuania. Following a 3-day pre-treatment phase, patients received either pantoprazole 40 mg qd (n = 464, ITT) or omeprazole 20 mg qd (n = 451, ITT) for 6 weeks. Patients recorded GERD-related symptoms using ReQuest™, a validated, highly sensitive GERD questionnaire. Symptoms were recorded daily during the pre-treatment phase and the first 2 weeks of treatment, and weekly during the last 4 weeks. ReQuest can be divided into two subscales: ReQuest™-GI (acid complaints,
upper abdominal/stomach complaints, lower abdominal/digestive complaints, nausea) and ReQuest™-WSO (general well-being, sleep disturbances and other complaints). Only patients who stated that they had difficulties falling asleep and experienced interrupted sleep/waking at night were included in this analysis; patients who reported nightmares were excluded. The median scores of the sleep dimension of ReQuest™-WSO and the median sum scores of ReQuest™-GI were calculated for the first two weeks of
treatment. Differences between treatment groups were compared using the one-sided Wilcoxon rank sum test (5% level). Results: At baseline, sleep disturbances were recorded by 154 and 139 patients treated with pantoprazole and omeprazole, respectively, and no significant differences in the median scores of the sleep dimension and in the median sum scores of ReQuest™-GI were observed between treatment groups.
After 1–2 weeks of treatment, pantoprazole was significantly more effective in reducing the incidence of GI symptoms and sleep disturbances than omeprazole (Table 1). In addition, the median sum scores of the GI-dimension were significantly lower following treatment with pantoprazole. Conclusions: Pantoprazole 40 mg qd is an effective
treatment regimen for patients with GERD-associated sleep disturbances and offers superior GI-symptom resolution compared to omeprazole 20 mg qd. Median scores sleep dimension/median sum scores ReQuest™-GISUPERIORITY OF PANTOPRAZOLE 40 MG VERSUS OMEPRAZOLE 20 MG IN RELIEVING GERD-ASSOCIATED SLEEP DISORDERS
731
[Article in Spanish]
Affiliations
- PMID: 14708472
Clinical Trial
[Acid-supressing capacity of omeprazole 20 mg tablets vs pantoprazole 20 and 40 mg tablets. A pilot study in volunteers]
[Article in Spanish]
R Corti et al. Acta Gastroenterol Latinoam. 2003.
Abstract
Objective: To compare the acid-supressing capacity of omeprazole (OZ) 20 mg tablets vs pantoprazole (PZ) 20 and 40 mg tablets, in healthy volunteers, with 24-h intragastric pH-metry.
Material and methods: Open, randomized, cross-over trial in 10 healthy volunteers; on days 0.8 and 22, 24-h intragastric pH-metry. Day 0, basal, thereafter 7 days with OZ or PZ 20 mg/day; day 8, pH-metry, then "wash out" for 7 days and thereafter 7 more days' therapy with PZ or OZ. On day 22 a 24-h intragastric pH control was performed again. In the last treatment stage, all of them were administered pantoprazole 40 mg/day for 8 days again with a 24-h pH recording at the end.
Results: 24-h pH-metry expressed as the time (hours) in which the pH was < or = 4 and the values as mean +/- standard deviation. BASAL 22.12 +/- 1.54, POST-OZ 9.78 +/- 6.72, POST-PZ 20 15.65 +/- 5.65, POST-PZ 40 8.57 +/- 5.93. Statistical evaluation with two way repeated measures ANOVA p < 0.0001. Newman Keuls post-hoc test: (1) vs (2) p < 0.003; (1) vs (3) p < 0.03; (2) vs (4) 0.65.
Conclusions: According to the results it might be stated that both proton pump inhibitors have acid-supressing capacity and omeprazole in equal dosis is more effective than pantoprazole as acid-supressor, with statistically significative differences. There was no difference between 20 mg omeprazole and 40 mg pantoprazole.
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