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Esomeprazole is commonly prescribed proton pump inhibitor for gastritis and peptic ulcer disease. Most of the time in clinical practice, phenytoin and esomeprazole are prescribed for patients of generalized seizures with concomitant peptic ulcer. Hence there are chances of drug-drug interaction because of modulations of isoenzymes CYP2C9 and CYP2C19, are involved in metabolism of phenytoin and esomeprazole. But it is important to maintain the therapeutic level of phenytoin in plasma for effective seizures control. So, the aim of the study was to determine the effect of esomeprazole on the pharmacokinetics of phenytoin in rabbits. In a parallel design study, phenytoin, 30 mg/kg/day per oral was given daily for 14 days. On day 15, blood samples were taken at various time intervals between 0-24 hours. In esomeprazole-phenytoin group, phenytoin was administered for seven days as mentioned earlier and from day 8th onward, esomeprazole 2.8 mg/kg along with phenytoin 30 mg/kg/day was administered till 14th days and blood samples were drawn as above on 15th day. Plasma phenytoin levels were assayed by HPLC and pharmacokinetic parameters were calculated. In esomeprazole-phenytoin group, there was a significant increase of t1/2el than phenytoin alone group and significant increase in AUC0-24 was also observed in the esomeprazole and phenytoin treated group. These results suggest that esomeprazole alters the pharmacokinetics of phenytoin. Confirmation of these results in further clinical studies will warrant changes in phenytoin dose or frequency when esomeprazole is co-administered.
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While esomeprazole significantly reduced esophageal acid exposure during conscious awakenings and recumbent-awake and asleep periods, it did not decrease the number and duration of conscious awakening or duration of recumbent-awake period.
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Obesity is associated with increased risk of gastroesophageal reflux disease (GERD).
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At present, antisecretory drugs--foremost among them the proton pump inhibitors (PPIs)--represent a keystone in Helicobacter pylori eradication therapy. The present article shall first compare the role of PPIs as compared with histamine H2 receptor antagonists, both of them in the role of antibiotic-associated antisecretory therapy, and shall then address the contribution of each of the various PPIs that have been developed until the present time to the H. pylori eradication therapies. In summary, it may be concluded that PPIs are more effective overall than H2 receptor antagonists when the two groups of antisecretory drugs are given at the usual standard doses together with antibiotics with the intention of eradicating H. pylori infection. However, all PPIs (omeprazole, lansoprazole, pantoprazole, rabeprazole, and esomeprazole) are equivalent when given together with two antibiotics to cure the infection.
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Manipulation of the extracellular and/or intracellular pH of tumors may have considerable potential in cancer therapy. The extracellular space of most tumors is mildly acidic, owing to exuberant production of lactic acid. Aerobic glycolysis - attributable largely to chronic activation of hypoxia-inducible factor-1 (HIF-1) - as well as tumor hypoxia, are chiefly responsible for this phenomenon. Tumor acidity tends to correlate with cancer aggressiveness; in part, this reflects the ability of HIF-1 to promote invasiveness and angiogenesis. But there is growing evidence that extracellular acidity per se boosts the invasiveness and metastatic capacity of cancer cells; moreover, this acidity renders cancer cells relatively resistant to the high proportion of chemotherapeutic drugs that are mildly basic, and may impede immune rejection of tumors. Thus, practical strategies for raising the extracellular pH of tumors may have therapeutic utility. In rodents, oral administration of sodium bicarbonate can raise the extracellular pH of tumors, an effect associated with inhibition of metastasis and improved responsiveness to certain cytotoxic agents; clinical application of this strategy appears feasible. As an alternative approach, drugs that inhibit proton pumps in cancer cells may alleviate extracellular tumor acidity while lowering the intracellular pH of cancer cells; reduction of intracellular pH slows proliferation and promotes apoptosis in various cancer cell lines. Well-tolerated doses of the proton pump inhibitor esomeprazole have markedly impeded tumor growth and prolonged survival in nude mice implanted with a human melanoma. Finally, it may prove feasible to exploit the aerobic glycolysis of cancers in hyperacidification therapies; intense intracellular acidification of cancer cells achieved by induced hyperglycemia, concurrent administration of proton pump inhibitor drugs, and possibly dinitrophenol, may have the potential to kill cancer cells directly, or to potentiate their responsiveness to adjunctive measures. A similar strategy, but without proton pump inhibition, could be employed to maximize extracellular tumor acidity, enabling tumor-selective release of cytotoxic drugs encased in pH-sensitive nanoparticles.
In all groups there was a decrease in the AUC(0-24) when carbamazepine was coadministered with esomeprazole. The decrease in AUC(0-24) (22.78 ± 4.71 to 10.46 ± 2.29), C(max) (2.76 ± 0.77 to 1.412±1.08), T(max) (2.83 ± 0.17 to 3 ± 0.40) was statistically significant (P < 0.05) when esomeprazole was given along with carbamazepine. Additionally, absorption and elimination constant were also altered significantly.
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Eradication of Helicobacter pylori using empiric therapy has become difficult as a result of increasing resistance to antibiotics. We evaluated the efficacy of specific treatments, selected based on response of bacterial samples to culture with clarithromycin, levofloxacin, and metronidazole, for patients infected with resistant strains of H pylori.
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Gastro-oesophageal reflux disease is a common medical problem that places a significant financial burden on outpatient pharmaceutical expenditure. A substantial proportion of this expenditure can be attributed to the use of proton pump inhibitors (PPIs). The aim of this analysis was to evaluate the cost-effectiveness of PPIs currently licensed in Italy in the acute treatment of reflux oesophagitis.
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Off-label or unlicensed medicine use is very common in paediatric practice, ranging from 11 to 80 %, and is one of the predisposing factors for adverse events (23-60 %). Medicine indications are the third leading reason for doctors to perform off-label prescriptions.
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To determine whether prolonged low-dose intravenous omeprazole could reduce rebleeding for patients with comorbidities.
Patients experiencing heartburn (for > or = 6 months) were studied in this randomized, double-blind, multicenter study. Following a 3-day placebo run-in, 440 patients were randomized to 14 days' treatment with esomeprazole 40 mg once daily (o.d.), esomeprazole 20 mg twice daily (b.i.d.) or placebo. Heartburn symptoms were recorded daily. Endoscopy and 24-h esophageal pH-monitoring were performed to determine the presence of gastroesophageal reflux disease (GERD). The esomeprazole treatment test was considered positive if patients' symptoms improved during the treatment period compared with symptoms recorded on Day 0.
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A probabilistic model was developed to compare the costs and effectiveness of five proton pump inhibitors (PPIs) in endoscopy-negative, symptomatic NERD patients who had complete resolution of heartburn symptoms following 4 weeks of open-label acute PPI treatment. The total annual expected costs (euro, 2003 values) and utilities gained per patient were measured over a 1-year horizon from the perspective of the UK NHS. Model uncertainty was addressed by sensitivity analyses.
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This was a prospective, randomised, open-label trial. A total of 189 consecutive patients diagnosed with peptic ulcer and H. pylori infection were enrolled. Patients were randomly divided into two groups: LEC group--levofloxacin 500 mg, esomeprazole 40 mg and clarithromycin 500 mg once daily for 7 days; AEC group--amoxicillin 1 g, esomeprazole 40 mg and clarithromycin 500 mg twice daily for 7 days.
The burden of gastroesophageal reflux disease (GERD) results from its widespread prevalence and the unfavorable impact of its symptoms on well-being and quality of life. Whereas abnormalities of the antireflux barrier (lower esophageal sphincter) are important in the pathophysiology of GERD, pharmacologic therapy for GERD is based on suppression of acid, which is responsible for the majority of the symptoms and for epithelial damage. Proton pump inhibitors (PPIs) are the agents of choice for achieving the goals of medical therapy in GERD, which include symptom relief, improvement in quality of life, and healing and prevention of mucosal injury. As a class, these drugs are extremely safe. The newest PPI, esomeprazole, brings a statistically significant increase in healing of mucosal injury and symptom relief in patients with erosive esophagitis, compared with omeprazole and lansoprazole. This article reviews the role of medical therapy in the short- and long-term management of symptomatic patients with or without erosive esophagitis, including extraesophageal presentations, GERD during pregnancy, and Barrett's esophagus. Management of refractory patients is addressed.
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Total PPI usage increased from 34.2 to 50.8 DDD/1000 population/day over the study period. Expenditure on samples per dispensed prescription was higher when a PPI was new on the market and diminished over 5-6 years to a relatively constant level. The rapid decline in this ratio was demonstrated by a case study following esomeprazole from launch in Australia for almost 5 years clearly demonstrating the initial investment to drive sales.
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Fifty-seven studies fulfilled the inclusion criteria. Based on the mean 24-h gastric pH, the relative potencies of the five PPIs compared to omeprazole were 0.23, 0.90, 1.00, 1.60, and 1.82 for pantoprazole, lansoprazole, omeprazole, esomeprazole, and rabeprazole, respectively. Compared with healthy volunteers, patients with GERD needed a 1.9-fold higher dose and Helicobacter pylori-positive individuals needed only about 20% of the dose to achieve a given increase in mean 24-h intragastric pH.
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The aim of this study was to test the efficacy of 10-day moxifloxacin-based triple therapy versus 2-week quadruple therapy for the second-line treatment of Helicobacter pylori infection.
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In patients with Los Angeles (LA) grade C or D oesophagitis, a positive relationship has been established between the duration of intragastric acid suppression and healing.
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Ulcer healing rates (95% CI) for intention-to-treat and per-protocol populations were: EAC + placebo 91% (87-95%) and 94% (90-97%); OAC + omeprazole 92% (88-95%) and 96% (92-98%). Corresponding H. pylori eradication rates were: EAC + placebo 86% (81-90%) and 89% (84-93%); OAC + omeprazole 88% (83-92%) and 90% (85-93%). Both eradication regimens were well tolerated, and patient compliance was high.
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In this placebo-controlled, double-blind, crossover study, 16 healthy male volunteers received 20 mg esomeprazole daily for one week. On day 7, in an acute experiment, the subjects then consumed 500 ml beer within 5 min. Subsequently, gastroesophageal reflux was monitored by pH-metry over a period of 3 h. In addition, gastric emptying was measured by ultrasonography and blood concentrations of ethanol, cholecystokinin and gastrin were determined.
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This open-label, randomized, 2-way crossover study was conducted in healthy Bangladeshi male subjects in compliance with the Declaration of Helsinki and International Conference on Harmonisation guidelines. Subjects were randomly assigned to receive the test formulation followed by the reference formulation or vice versa, as a single dose of esomeprazole 40 mg after a 12-hour overnight fast. A washout period of 1 week was maintained between treatments. Following oral administration, blood samples were collected at 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 7, 9, and 12 hour(s) after dosing and analyzed for esomeprazole concentrations using a validated HPLC method. Pharmacokinetic parameters, including C(max), AUC(0-12), and AUC(0-infinity), were determined with a non-compartmental method. The formulations were to be considered bioequivalent if the natural log (ln)-transformed ratios of the pharmacokinetic parameters were within the predetermined bioequivalence range of 80% to 125%, according to the US Food and Drug Administration (FDA) requirement. The within- and between-group differences were examined using ANOVA. Tolerability was assessed by monitoring vital signs and conducting subject interviews regarding adverse events. Interviewers were not blinded to study design.
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NMR diffusion measurements are based on signal attenuation. In the case of complex mixtures for which some molecules are diffusing quickly while others are significantly slower, it is challenging to obtain a diffusion ordered spectroscopy (DOSY)-type 2D map giving reliable information on all molecules. In this paper, we propose a new gradient sampling approach based on a sigmoid shape allowing the acquisition of a significant number of points for both the fast and slow diffusing molecules. We applied this new gradient sampling strategy to deformulate two medicines whose composition was known (Esomeprazole) or unknown (Mebendazole). PFG NMR associated with a sigmoid gradient ramp is an exciting strategy to study drugs as a whole, i.e., the active ingredient(s) and excipients.
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The pharmacist-recorded PPI intervention rate per 100 high-dose PPI prescriptions was 1.67 for the PPI prompt group and 0.17 for the control group (P < 0.001). During the first 28 days of the trial, 196 interventions resulted in 34 instances of PPI step-down, with 28 of these occurring in PPI prompt pharmacies. Cost savings attributable to the prompt were AUD 7.98 (£4.95) per month per PPI prompt pharmacy compared with AUD 1.05 (£0.65) per control pharmacy.
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One hundred and seventy-nine patients, mean age 45.8 +/- 16.8, completed the study. Treatment with omeprazole or pantoprazole prior to urea breath test (UBT) was associated with low false negative results, while lansoprazole and esomeprazole caused clinically unacceptable high false negative rates (pantoprazole 2.2% vs. lansoprazole 16.6%, P = 0.02, vs. esomeprazole 13.6%, P = 0.05; omeprazole 4.1% vs. lansoprazole 16.6%, P = 0.05).