Metronidazole-based therapy (RAM) was superior to standard CLR-based therapy (RAC) for first-line H. pylori eradication. This reflects the progressive increase in CLR resistance observed in Japan.
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Clinically relevant pharmacokinetic interactions exist between gastric acid-reducing agents and certain weakly basic drugs that rely on acidic environments for optimal oral absorption. In this study, we examine whether the administration of betaine hydrochloride under fed conditions can enhance the absorption of atazanavir, an HIV-1 protease inhibitor, during pharmacologically-induced hypochlorhydria.
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Overweight/obesity in GORD patients does not appear to affect the antisecretory efficacy of a single dose of rabeprazole and pantoprazole. These data do not support adapting the dosage of rabeprazole and pantoprazole according to BMI in GORD patients when administered as an on-demand therapy schedule.
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A total of 58 participants, 29 patients and controls each, aged 22-65 years completed the study. FVHI 2:1 and FRSI 2:1 significantly correlated with no significant differences between FRSI 2:1. FRSI had good item-total correlations indicating psychometrically sound items. There were significant differences between patients and controls for FRSI scores and mean scores. FRSI 3 scores were significantly lower than FRSI 1 scores, suggesting symptoms improved after treatment. There were no significant differences between RFS 2 and 1. Significant differences between FRSI 3 and 1, but not between FVHI 3 and 1, suggest the FRSI was more sensitive to changes in reflux after 6 months' intervention than the FVHI.
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The overall cure rate of 1-week triple therapy for H. pylori eradication was not significantly different between regimens with omeprazole, lansoprazole or rabeprazole, but the impact of CYP2C19 genetic polymorphism on the cure rate appeared to differ between these PPI.
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To determine the dose of rabeprazole that decreased basal acid output to safe levels in patients with Zollinger-Ellison syndrome or idiopathic gastric acid hypersecretion.
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A new ligand exchange chiral stationary phase (new CSP) containing residual silanol group-protecting n-octyl groups on the silica surface was prepared by treating a ligand exchange CSP (original CSP) based on sodium N-[(R)-2-hydroxy-1-phenylethyl]-N-undecylaminoacetate bonded to silica gel with excess n-octyltriethoxysilane. The new and original CSPs containing an identical amount of chiral selector were applied to the resolution of α-amino acids and proton pump inhibitors (PPIs) including omeprazole, pantoprazole, lansoprazole, and rabeprazole. The separation factors (α) and resolutions (RS) were greater on the new CSP than on the original CSP except for the resolution of asparagine. The trends of the retention factors (k1) for the resolution of α-amino acids on the new and original CSPs with the variation of the organic modifier content in aqueous mobile phase were opposite to those for the resolution of PPIs. Removal of the nonenantioselective interactions between the residual silanol groups and the analytes and the improved lipophilicity of the new CSP were proposed to be responsible for the improved chiral recognition ability of the new CSP and the different retention behaviors of the enantiomers between the new and original CSPs.
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This study evaluated the efficacy and tolerability of potassium-competitive acid blocker (P-CAB), a new class of gastric acid inhibitory agents, as first-line H. pylori eradication treatment compared with 7-day proton pump inhibitor (PPI)-based triple therapy.
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Receiver operating characteristic analysis was used to determine values for the integrated oesophageal acidity and time oesophageal pH
The 14-day tetracycline- and furazolidone-containing quadruple regimen can achieve a relatively high eradication rate as rescue treatment. Some side effects including fever may occur during the treatment.
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To examine the association between the use of PPIs and the risk of incident dementia in the elderly.
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The safety and efficacy profiles of revaprazan and rabeprazole are similar for the treatment of ESD-induced ulcers.
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Patients with a chief complaint of PND without objective evidence of sinonasal inflammatory disease were enrolled in a prospective, double-blinded, randomized placebo-controlled trial using rabeprazole, 20 mg, orally twice daily or placebo for 90 days. Subjects completed two-site 24-hour pharyngeal pH probe monitoring before treatment. Outcome measures included pre- and posttreatment visual analog scales for PND symptoms, reflux symptom index, and reflux finding score (RFS).
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The objectives of present work was to design and characterize the rabeprazole sodium loaded microcapsules prepared by solvent evaporation technique using ethyl cellulose (EC) based various mucoadhesive polymer, followed by a triple coating with Eudragit L100. The Box-behnken design (BBD) was applied for optimization of formulations containing EC, HPMCK100M and Eudragit L100 as factors for selected responses like entrapment efficiency, mucoadhesive property and drug release in 24 h. The prepared microcapsules were characterized for particle size, drug content, swelling index, mucoadhesive strength, and in vivo antiulcer activity. FT-IR studies revealed that there was no drug-polymer interaction. SEM studies revealed that microcapsules were non-aggregated, spherical shape and smooth appearance. In vitro drug release data from microcapsules was fitted to different kinetic models to explain release profiles. The correlation coefficient value (r(2)) indicated that the drug release followed Higuchi model. Analysis of variance (ANOVA) showed significant difference in the release of drug from all formulations at p < 0.05 level. Accelerated stability study of optimized formulation (F4) upto 6 months showed there was no change in drug content and release characteristics during storage. In vivo antiulcer activity showed that the optimized microcapsules were able to protect rat stomach against ulcer formation vis-à-vis aqueous solution of the drug showed only negligible and minimum effect.
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To compare the efficacy and side effect profiles of three furazolidone and amoxicillin-based quadruple rescue therapies for the eradication of Helicobacter pylori (H pylori).
E3810 is a new H+,K(+)-ATPase inhibitor with a substituted benzimidazole, which is under clinical investigation for peptic ulcer treatment in Japan and the USA. Three separate studies were conducted to evaluate the safety and to establish the pharmacokinetic profile of E3810 after oral administration to healthy male subjects. E3810 was administered as: single oral doses (1, 3, 10, 20, 40 and 80 mg) in fasting conditions, a single oral dose (20 mg) after a meal and repeated oral doses (20 and 40 mg) once daily for 7 days. The concentrations of E3810 and its metabolites in plasma and urine were determined by HPLC methods with UV detection. E3810 was generally well tolerated by all subjects. In the single-dose study, Cmax and AUC increased with increasing doses in the dose range examined. The mean plasma half-life was about 1.0 hour and was dose-independent. The apparent oral clearance of E3810 ranged from 4.37 to 8.40 ml/min/kg. No significant deviation from linear pharmacokinetics was observed. Approximately, 30% of a dose was excreted into the urine as thioether carboxylic acid-E3810 and its glucuronide. The mean serum protein binding was 96.3%. No effect of food intake on the Cmax and AUC was observed while tmax after a meal was 1.7 hours longer than that in the fasting conditions. No appreciable change in drug pharmacokinetics was observed during repeated oral dosing of E3810.
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Proton pump inhibitors have been reported to modify the level of Helicobacter pylori gastritis.
The objective of the current study was to develop and validate a reversed-phase high-performance liquid chromatographic method for the quantitative determination of process-related impurities and degradation products of rabeprazole sodium in pharmaceutical formulation. Chromatographic separation was achieved on the Waters Symmetry Shield RP18 (250 mm × 4.6 mm) 5 μm column with a mobile phase containing a gradient mixture of solvent A (mixture of 0.025 M KH2PO4 buffer and 0.1% triethylamine in water, pH 6.4 and acetonitrile in the ratio of 90:10 v/v, respectively) and solvent B (mixture of acetonitrile and water in the ratio of 90:10 v/v, respectively). The mobile phase was delivered at a flow rate of 1.0 mL/min and with UV detection at 280 nm. Rabeprazole sodium was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Rabeprazole sodium was found to degrade significantly under acid hydrolysis, base hydrolysis, oxidative, and thermal degradation conditions. The degradation products were well-resolved from the main peak and its impurities, thus proving the stability-indicating power of the method. The mass balance was found to be in the range of 97.3-101.3% in all of the stressed conditions, thus proving the stability-indicating power of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness.
Gastroesophageal reflux (GER) is commonly observed in children, particularly during the first year of life. Pharmacological therapy is mostly reserved for symptomatic infants diagnosed with GER disease (GERD), usually as defined in a recent consensus statement. The purpose of the present article was to review the reported adverse effects of pharmacological agents used in the treatment of paediatric GERD. We conducted this review using the electronic journal database Pubmed and Cochrane database systematic reviews using the latest 10-year period (1 January 2003 to 31 December 2012). Our search strategy included the following keywords: omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, rantidine, cimetidine, famotidine, nizatidine, domperidone, metoclopramide, betanechol, erythromycin, baclofen, alginate. We used Pubmed's own filter of: 'child: birth-18 years'. All full articles were reviewed and we only included randomized controlled trials retrieved from our search. We addressed a summary of our search on a drug-by-drug basis with regard to its mechanism of action and clinical applications, and reviewed all of the adverse effects reported and the safety profile of each drug. Adverse effects have been reported in at least 23% of patients treated with histamine H2 receptor antagonists (H2 RAs) and 34% of those treated with proton pump inhibitors (PPIs), and mostly include headaches, diarrhoea, nausea (H2 RAs and PPIs) and constipation (PPIs). Acid suppression may place immune-deficient infants and children, or those with indwelling catheters, at risk for the development of lower respiratory tract infections and nosocomial sepsis. Prokinetic agents have many adverse effects, without major benefits to support their routine use.
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Overall, 483,074 patients met the selection criteria; of these, 157,248 used a clopidogrel-PPI combination. On average, 30.5% of patients in the pre- and 19.9% in the post-communication period used a clopidogrel-PPI combination therapy. Among clopidogrel users, the probability of using clopidogrel-PPI combinations fell by over 40% in the post-communication period (OR = 0.57; p<0.001); the proportion of patients using esomeprazole fell from 12.9% to 5.3%, and the proportion using omeprazole fell from 10.1% to 6.3%. Among combination therapy users, the probability of patients using a combination with a CYP2C19 inhibitor decreased by 53% (OR = 0.47; p<0.001); however, 31.5% of patients were still prescribed a clopidogrel-PPI combination therapy. Trends were similar for all and newly treated patients, regardless of clopidogrel indication and physician specialty.
Rabeprazole achieves similar H. pylori eradication rates to omeprazole and lansoprazole when co-prescribed with antibiotics. Low doses of rabeprazole (10 mg b.d.), when administered with two antibiotics, may be sufficient to eradicate H. pylori infection.
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To evaluate whether the supplementation with an inactivated preparation of L. acidophilus could improve the efficacy of a standard anti-H. pylori therapy.
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Treatment of Helicobacter pylori (H. pylori) infection is paramount for the management of prevalent gastrointestinal disorders and in the prevention of gastric cancer. Due to increasing antimicrobial resistance, performance of standard triple therapies has now declined to unacceptably low levels.
Recent reports have hypothesized a role for exogenously administered gastrin in regulating beta cell function or activity. We surmised that a class of agents, proton pump inhibitors (omeprazole, esomeprazole, pantoprazole, rabeprazole, lansoprazole), known to increase serum gastrin levels could have such an effect, and that data might be available in our database which could address such an effect. We examined our electronic database to obtain glycohemoglobin (HgbA1c) levels measured in the past two years from all type II diabetics and extracted from those diabetics who were concurrently taking a proton pump inhibitor. A comparison of these groups showed an average HgbA1c of 7.6% for type II diabetics not taking a proton pump inhibitor (n=282) and an average HgbA1c of 7.0% for type II diabetics concurrently taking a proton pump inhibitor (n=65), T=-3.61, p=0.002. These data support the hypothesis that proton pump inhibitors can be used to treat type II diabetes.
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In H. pylori-negative men who are CYP2C19 homozygous or heterozygous extensive metabolizers, the intragastric pH after a single dose of 20 mg rabeprazole is higher during first 5-6 h than that after a single dose of 20 mg omeprazole.
The third-line treatment regimen for Helicobacter pylori after failure of clarithromycin- and metronidazole-based therapies is not yet established. Sitafloxacin (STX) is a quinolone that possesses potent in vitro activity against H. pylori. In this study, the susceptibility of H. pylori isolates to STX was examined and the efficacy of STX-based triple therapy as a third-line regimen was evaluated. STX showed minimum inhibitory concentrations (MICs) of ≤1 μg/mL against all 100 H. pylori isolates, and the MIC(90) (MIC for 90% of the organisms) of STX was 5 log(2) dilutions lower than that of levofloxacin (LVX). The MIC(50) (MIC for 50% of the organisms) of STX against gyrA mutants was 0.12 μg/mL and was significantly lower than that of LVX (8 μg/mL). The activity of STX at pH 5.5 was significantly less than that at pH 7.0. In the clinical trial, 28 patients with two eradication failures were treated with STX-based triple therapy [rabeprazole 10 mg twice daily (b.i.d.), amoxicillin 750 mg b.i.d. and STX 100mg b.i.d. for 7 days]. The eradication rate was 75% using intention-to-treat analysis and 80% using per-protocol analysis. Two gyrA mutant strains were eradicated. Amongst participants, a low pepsinogen I/II ratio was associated with successful eradication. These results suggest that STX could be active against most clinical H. pylori isolates and that STX-based triple therapy is a promising and safe third-line therapy.
The efficacy of seven-day rabeprazole-based triple therapy is similar to 7-day omeprazole-based triple therapy for the eradication of H. pylori infection.
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Standard-dose rabeprazole was as effective as high-dose omeprazole in relieving symptoms by day 4 of treatment and in healing oesophageal lesions, but had a faster onset of action in patients with severe heartburn. This suggests that the improved pharmacological properties of rabeprazole translate into a clinically relevant advantage.