A total of 50 patients (n = 25 in dexrabeprazole group and rabeprazole group each) completed the study. There were no significant differences in the baseline characteristics between the two groups. The VAS score (mean +/- SD) of heartburn and regurgitation in dexrabeprazole (64.8 +/- 5.1 and 64 +/- 8.1, respectively) and rabeprazole (64.4 +/- 8.7 and 57.6 +/- 9.7, respectively) groups significantly reduced (P < 0.0001) to 30 +/- 11.5, 24 +/- 10 and 32 +/- 9.5, 29.2 +/- 11.9, respectively on d 28. A significantly higher (P = 0.002) proportion of patients showed >or= 50% improvement in regurgitation with dexrabeprazole 10 mg (96%) compared to rabeprazole 20 mg (60%). Onset of symptom improvement was significantly earlier with dexrabeprazole than with rabeprazole (1.8 +/- 0.8 d vs 2.6 +/- 1.4 d; P < 0.05). The incidences of esophagitis in the dexrabeprazole group and rabeprazole group before therapy were 84% and 92%, respectively (P = 0.38). The incidence of improvement/healing of esophagitis after therapy was more (P = 0.036) in the dexrabeprazole group (95.2%) compared to the rabeprazole group (65.2%). No adverse drug reaction was seen in either group.
Based on the PubMed search, there were no published reports of acute transmural duodenitis and complicated duodenal ulcers associated with short-term exposure to tiaprofenic acid or other NSAIDs. The Naranjo adverse drug reaction (ADR) probability scale was used and a score of 6 was obtained, indicating a probable ADR from tiaprofenic acid use.
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A MEDLINE search was performed. Abstracts of the European Helicobacter pylori Study Group and the American Gastroenterological Association congresses from 1996 to 2002 were also examined. Randomized studies with at least two branches of triple therapy that differed only in terms of type of proton-pump inhibitor were included in a meta-analysis using Review Manager 4.1.
Twenty-four subjects were enrolled in the study (12 in each dose group); they were predominantly white, had a mean age of 14.2 years, and had a mean body mass index of 24.3 kg/m(2) (the 90th percentile for adolescents of this age in the United States). Mean age and weight did not differ significantly between the 2 dose groups. On day 1, C(max) was significantly greater in the rabeprazole 20-mg group compared with the rabeprazole 10-mg group (P = 0.024); on day 5/7, both AUC and C(max) were significantly greater in the rabeprazole 20-mg group compared with the rabeprazole 10-mg group (P = 0.005 and P = 0.007, respectively). Within-period comparisons for both groups indicated that the AUC and C(max) for rabeprazole and its thioether metabolite did not differ significantly from day 1 to day 5/7. In addition, the T(max) and t(1/2) were relatively unchanged from day 1 to day 5/7 in both dose groups. Treatment-emergent signs and symptoms occurred in 11 subjects, 6 in the 10-mg group and 5 in the 20-mg group. The most frequently reported AEs were headache and nausea (16.7% and 8.3%, respectively). No statistically significant differences were observed between dose groups in terms of the number of subjects with AEs.
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Compared with baseline data (7% [range, 5%-20%]), the median values of the 24-hour percent of time that intragastric pH was above 4.0 significantly increased but did not exceed 83.3% under any of the 7 regimens, which were as follows: 10 mg rabeprazole (51% [range, 28%-78%], P < .01), 20 mg rabeprazole (59% [range, 36%-83%], P < .01), 10 mg omeprazole (26% [range, 4%-33%], P < .05), 20 mg omeprazole (48% [range, 31%-73%], P < .01), 40 mg omeprazole (62% [range, 47%-87%], P < .01), 15 mg lansoprazole (34% [range, 5%-51%], P < .05), and 30 mg lansoprazole (56% [range, 20%-76%], P < .05). Significant differences were observed among 10, 20, and 40 mg omeprazole (10 mg versus 20 mg, P < .01; 10 mg versus 40 mg, P < .01; and 20 mg versus 40 mg, P < .05) and between 15 and 30 mg lansoprazole (P < .01), whereas no significant difference was observed between 10 and 20 mg rabeprazole. Nocturnal gastric acid breakthrough was observed under all regimens.
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With this model, rabeprazole is good effect for reflux esophagitis after total gastrectomy from bile reflux. Bile acid is an important factor in the mucosal lesion induced by duodenal reflux.
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Decision analysis was used to model the cost effectiveness of competing therapies based on the results of clinical trials of RAB versus RAN and estimates from the medical literature.
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Formulation of proton pump inhibitors (PPIs) into oral solid dosage forms is challenging because the drug molecules are acid-labile. The aim of this study is to evaluate different formulation strategies (monolithic and multiparticulates) for three PPI drugs, that is, rabeprazole sodium, lansoprazole, and esomeprazole magnesium, using delayed release film coating applications.
Japanese GERD patients are often obese, as reported previously, but some GERD patients are underweight. Baseline symptoms and QOL in underweight GERD patients tended to be more severe than in normal-weight patients, but therapeutic response with proton pump inhibitors was about the same as in normal-weight or obese patients.
This study used claims data to identify continuously enrolled subjects diagnosed with gastroesophageal reflux disease (GERD) and newly treated with a PPI between Oct. 1, 1999 and March 31, 2000. Data were analyzed for 6 months following PPI initiation. Results were stratified by first PPI filled during the study period. Compliance (as measured by a medication-possession ratio), dosage escalation (> 25 percent of initial dose), and daily average consumption (DACON) were measured. Regression analysis was performed on GERD-related costs using treatment patterns, type of PPI drug, and compliance as independent variables of interest.
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The American Food and Drug Administration has suggested that proton pump inhibitors increase the international normalized ratio (INR) when used concomitantly with warfarin, by being metabolized by cytochrome P450 2C19. We therefore reviewed patients taking warfarin.
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These data, together with the fact that PPIs almost do not present side effects, suggest that these drugs can offer new therapeutic strategies for preterm delivery. Undoubtedly, further investigations and clinical studies are necessary before adding PPIs to the list of drugs available for the treatment of preterm delivery.
We conducted a prospective study in order to determine whether a change in PPI therapy would alter intra-oesophageal and intra-gastric acid suppression in BE patients.
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To evaluate the clinical efficacy of H. pylori detection using a molecular test and treatment outcomes of the clarithromycin-based genotypic resistance test.
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The papilla of Vater emptying into the duodenal bulb site is extremely rare and considered an aberrant condition. We report here a case with recurrent duodenal ulcer bleeding associated with this anomaly. A 42-year-old man was admitted to St. Mary Hospital because of tarry stool for three days. Despite no documented etiology to explain recurrent ulceration, the patient had about ten episodes of ulcer bleeding since 1995. On duodenoscopy, 1.0 x 0.6 cm sized active stage duodenal ulcer with oozing was observed at the posterior wall side below the pylorus. The papilla of Vater was bulging just below the pylorus. Bile juice was excreted from its opening. Pancreatic duct and common bile duct, which drained into the bulb site, were observed on ERCP. In this report, we show that recurrent duodenal ulcer can be associated with the papilla of Vater just below the pylorus.
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To evaluate the efficacy of moxifloxacin-based sequential therapy (MBST) versus hybrid therapy as a first-line treatment for Helicobacter pylori (H. pylori) infection.
Both rabeprazole and omeprazole inhibited gastric acid secretion and increased the intragastric pH to over 6.5, as well as causing a marked increase in the serum gastrin concentration. The serum gastrin level was lower with rabeprazole treatment than with omeprazole treatment at both doses. Also, the antral G-cell density was higher with omeprazole than with rabeprazole, while the increase in both the histamine content and the H+, K-ATPase mRNA level in the fundic mucosa was higher with omeprazole treatment at both doses, with the difference being significant at 100 mg/kg. Ultrastructural examination indicated that the stimulation of parietal cells by omeprazole was stronger than that by rabeprazole.
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Eradication rates did not differ significantly between the three 5-day proton pump inhibitor-based triple therapies in this study population. However, 5-day rabeprazole-based triple therapy tends to be more effective than 5-day omeprazole-based triple therapy in the eradication of H pylori, and treatment with omeprazole before eradication therapy may improve the eradication rates of 5-day omeprazole-based therapy.
We treated two patients (each aged over 90 years) with Helicobacter pylori-negative nonsteroidal anti-inflammatory drug (NSAID)-caused duodenal ulcers, and had the opportunity to determine gastric acidity by means of 24-h pH monitoring. Endoscopic and histological examination showed no remarkable atrophic change in the gastric mucosa. The gastric pH was low throughout the day and night, and the gastric pH > or = 3 holding time ratio during 24 h was 17.1% and 25.8%, respectively in the two patients, so it was considered that they had gastric acid secretion of the same level as that in normal subjects of the same age or that in the young without H. pylori infection. Because of the complication of reflux esophagitis with a hiatal hernia, rabeprazole sodium, one of the proton pump inhibitors (PPIs), was administered and both patients made excellent progress. In conclusion, gastric acid secretion in patients with H. pylori-negative NSAID-caused duodenal ulcers is fully maintained even in the elderly, so PPIs may be the first choice of treatment.
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RA as well as RAM therapy are safe and effective rescue regimens for H. pylori infection after eradication failure by the standard triple therapy.
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Due to a grade A (> 95%) success rate for H. pylori eradication by PP analysis, similar compliance and adverse events, hybrid therapy seems to be an appropriate eradication regimen in Taiwan.
On day 0, mean intragastric pH AUC was significantly higher before the esomeprazole than before the rabeprazole treatment in four of the five time intervals analysed. On days 1 and 5, mean intragastric pH AUC was higher after rabeprazole than esomeprazole during 5-11, 14-24 and 0-24 h after dosing. Mean pH AUC in the first 5 h after dosing on day 5 was higher after esomeprazole than rabeprazole (P=0.012). On day 1, mean per cent times pH > 3 and > 4 were significantly greater after rabeprazole than esomeprazole during 0-14, 14-24 and 0-24 h. On day 5, mean serum gastrin AUC0-4 was higher (P = 0.017) after rabeprazole than esomeprazole (335 vs. 316 pg/mL.h).
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The eradication rates in the rabeprazole-amoxicillin-clarithromycin (RAC) and lansoprazole-amoxicillin-clarithromycin (LAC) groups were 75% and 69%, respectively, on an intention-to-treat basis, and 80% and 75%, respectively, on a per protocol basis. The eradication rate for clarithromycin-resistant strains was significantly lower than that for clarithromycin-sensitive strains (24% vs. 86%, P < 0.05). For clarithromycin-sensitive strains in the LAC group, there was a tendency for a lower eradication rate in extensive than poor metabolizers. The eradication rate in extensive metabolizers in the RAC group tended to be higher than that in extensive metabolizers in the LAC group (89% vs. 78%, P = 0.079726).
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To evaluate the efficacy of two new regimes as second-line options in a randomized and prospective study.
A simple, sensitive and rapid spectrofluorimetric method for determination of itopride hydrochloride in raw material and tablets has been developed. The proposed method is based on the measurement of the native fluorescence of the drug in water at 363 nm after excitation at 255 nm. The relative fluorescence intensity-concentration plot was rectilinear over the range of 0.1-2 μg/mL (2.5 × 10(-7)-5.06 × 10(-6) mole/L), with good correlation (r = 0.9999), limit of detection of 0.015 μg/mL and a lower limit of quantification of 0.045 μg/mL. The described method was successfully applied for the determination of itopride hydrochloride in its commercial tablets with average percentage recovery of 100.11 ± 0.32 without interference from common excipients. Additionally, the proposed method can be applied for determination of itopride in combined tablets with rabeprazole or pantoprazole without prior separation. The method was extended to stability study of itopride. The drug was exposed to acidic, alkaline, oxidative and photolytic degradation according to ICH guidelines. Moreover, the method was utilized to investigate the kinetics of the alkaline, acidic and oxidative degradation of the drug. A proposal for the degradation pathways was postulated.
The poor specificity of the proton-pump inhibitor (PPI) test does not support such an approach to establish a diagnosis of GERD in a primary care setting.
Gastric wash-based PCR and a pyrosequencing assay were used to rapidly detect and estimate the number of 23S rRNA SNPs in clinical isolates of H. pylori. Not only is this a less invasive technique, but it can also diagnose drug resistance.
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Intraluminal electrical impedance is a novel technique, which is able for the first time to provide a qualitative assessment of refluxed material moving from the stomach to the oesophagus. In other words, the presence of air can be differentiated from that of liquid, because the former is characterised by high and the latter by low impedance compared with baseline. Moreover, the combined measurement of electrical impedance and pH-metry permits to distinguish acid from non-acid liquid reflux. One of the most important clinical applications of this method is to assess the reasons for poor response of GORD patients to high-dose proton pump inhibitors. This case report describes the results of impedance in the evaluation of a young woman, who did not respond to twice-daily doses of rabeprazole. She continued to complain of heartburn as major symptom and impedance allowed us to clarify that it was not related to acid or non-acid reflux, but to air swallowing. Therefore, this technique identified aerophagia to be responsible for persistent heartburn despite high-dose proton pump inhibitor and prevented the adoption of more aggressive, but probably unuseful therapies, such as the surgical one.
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Rabeprazole has been shown to be more potent and faster than other proton pump inhibitors in in vitro studies and highly effective in decreasing oesophageal acid exposure in patients with gastro-oesophageal reflux disease (GERD).