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Proton pump inhibitors (PPIs) are commonly used drugs for the treatment of gastric reflux. Recent retrospective cohorts and large database studies have raised concern that the use of PPIs is associated with increased cardiovascular (CV) risk. However, there is no prospective clinical study evaluating whether the use of PPIs directly causes CV harm. We conducted a controlled, open-label, cross-over pilot study among 21 adults aged 18 and older who are healthy (n=11) or have established clinical cardiovascular disease (n=10). Study subjects were assigned to receive a PPI (Prevacid; 30 mg) or a placebo pill once daily for 4 weeks. After a 2-week washout period, participants were crossed over to receive the alternate treatment for the ensuing 4 weeks. Subjects underwent evaluation of vascular function (by the EndoPAT technique) and had plasma levels of asymmetric dimethylarginine (ADMA, an endogenous inhibitor of endothelial function previously implicated in PPI-mediated risk) measured prior to and after each treatment interval. We observed a marginal inverse correlation between the EndoPAT score and plasma levels of ADMA (r = -0.364). Subjects experienced a greater worsening in plasma ADMA levels while on PPI than on placebo, and this trend was more pronounced amongst those subjects with a history of vascular disease. However, these trends did not reach statistical significance, and PPI use was also not associated with an impairment in flow-mediated vasodilation during the course of this study. In conclusion, in this open-label, cross-over pilot study conducted among healthy subjects and coronary disease patients, PPI use did not significantly influence vascular endothelial function. Larger, long-term and blinded trials are needed to mechanistically explain the correlation between PPI use and adverse clinical outcomes, which has recently been reported in retrospective cohort studies.
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To determine the stability of lansoprazole and omeprazole suspensions at ambient and refrigerated temperatures using HPLC.
Although gastroesophageal reflux disease (GERD) is believed to be primarily a motor disorder, current medical therapy is based on the inhibition of acid secretion, since it is the deleterious effects of the acidic refluxate that lead to the symptoms and complications of GERD. Goals of long-term management include the relief of symptoms, healing of esophagitis and prevention of its relapse, and prevention of complications with safe, cost-effective therapy. Maintenance therapy depends on disease severity. Prokinetic drugs have a limited role except in symptomatic nonerosive GERD. Likewise, H2-receptor antagonists are useful in relapsing, nonerosive GERD or in cases of mild initial esophagitis. For severe reflux esophagitis, even high doses of H2-receptor antagonists do not appear to be as effective as proton pump inhibitors. GERD patients with severe reflux esophagitis or complications such as peptic stricture or Barrett's esophagus should be maintained on proton pump inhibitors such as lansoprazole or omeprazole. For young and otherwise healthy patients, antireflux surgery is a viable option.
In an open-label, single-centre, randomized, six-way crossover study, 40 healthy subjects received esomeprazole 20, 40 and 80 mg, and lansoprazole 15, 30 and 60 mg once daily for 5 days. The mean time with intragastric pH >4 and mean 24-h median intragastric pH on day 5 were analyzed using a mixed-model ANOVA. Post-hoc analyses were completed for 0-12-h (daytime) and 12-24-h (night-time) post-dose intervals.
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A total of 169 patients with H. pylori infection were randomly assigned to either the sequential therapy group (n = 85) or the concomitant therapy group (n = 84). A follow-up endoscopy or urea breath test was examined at least 12 weeks after eradication.
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Large prescription databases (the IMS Vector One: National and Total Patient Tracker) were used to examine national drug utilization patterns for the US pediatric population (ages 0-17 years) from 2002 through 2010.
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The role of hyper-gastrinaemia in the incidence of colonic cancer remains to be clarified. The aim of this study was to determine whether cholecystokinin-2 (CCK-2) receptor expression predicts the sensitivity of human colonic adenomas to the proliferative effects of serum hyper-gastrinaemia. Gene expression of the classical (74 kDa) CCK-2 receptor in human colonic adenoma specimens and cell lines, was quantified by real-time PCR. Western blotting, using a CCK-2 receptor antiserum, confirmed protein expression. A transformed human colonic adenoma was grown in SCID mice, with hyper-gastrinaemia induced by proton pump inhibitors. CCK-2 receptor blockade was achieved by using neutralising antiserum. Both human colonic adenoma cell lines and biopsies expressed CCK-2 receptor mRNA at levels comparable with CCK-2 receptor transfected fibroblasts and oxyntic mucosa. Western blotting confirmed immunoreactive CCK-2 receptor bands localised to 45, 74 and 82.5 kDa. Omeprazole and lansoprazole-induced hyper-gastrinaemia (resulting in serum gastrin levels of 34.0 and 153.0 pM, respectively) significantly increased the weight of the human adenoma grafts (43% (P=0.016) and 70% (P=0.014), respectively). The effect of hypergastrinaemia on tumour growth was reversed by use of antiserum directed against the CCK-2 receptor. Hyper-gastrinaemia may promote proliferation of human colonic adenomas that express CCK-2 receptor isoforms.
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The present data confirm the importance of cagA (but not vacA and iceA) as a predictor of successful eradication. When fibrosis and lympho-epithelial lesions are present, therapy appears to be less effective. Therefore, these histological features may be involved in an unsuccessful therapeutic outcome.
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Participants were prescribed 15 mg of lansoprazole (PPI) twice daily for 3 months.
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A rapid and sensitive high-performance thin-layer chromatography (HPTLC) method has been developed for the measurement of lansoprazole in human plasma and its use for pharmacokinetic study has been evaluated. Detection and quantitation were performed without using an internal standard. A single stage extraction procedure was followed for extracting lansoprazole from plasma and a known amount of the extract was spotted on precoated silica gel 60 F254 plates using a Camag Linomat IV autosampler. Lansoprazole was quantified using a Camag TLC Scanner 3. The recovery study of authentic analytes added to plasma at 0.05 to 0.25 microg/ml was 95.37+/-2.15% and the lowest amount of lansoprazole that could be detected was 20 ng/ml plasma. The method provides a direct estimate of the amount of lansoprazole present in plasma. The method was used for the determination of plasma levels as well as pharmacokinetic parameters of lansoprazole after oral administration of two marketed preparations to healthy volunteers.
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Maintenance of normal epithelial differentiation and proliferation is an important goal in cancer chemoprevention. Because acid has a dynamic effect on cell proliferation/differentiation of Barrett's esophagus (BE) ex vivo, we investigated the relationship between differentiation, proliferation, and dysplasia in BE biopsy specimens and explored the role of normalization of intraesophageal pH in altering the BE phenotype.
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Lansoprazole is effective and safe in children. The optimal starting dosage is 30 mg/m2 or 1.4 mg/kg.
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Nine (30%) of the patients were diagnosed with GERD at EGD and/or 24 hr esophageal pH monitoring, also, 3 (10%) were diagnosed with GERD-associated esophageal motility disorder and 3 (10%) were non GERD-associated. Concerning PPI test, GERD-related NCCP had a higher positive PPI test (n = 8, 89%) than non GERD-related NCCP (n = 5, 24%) (p = 0.002).
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Proton pump inhibitors (PPIs) may cause cyanocobalamin (vitamin B12) malabsorption, but measuring serum B12 alone may underestimate the prevalence. However, B12 deficiency elevates methylmalonic acid and homocysteine, both additional markers of B12 deficiency.
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Helicobacter pylori (H. pylori) bacteria convert urea to ammonia, which has been implicated in causation of hepatic encephalopathy in patients with liver cirrhosis. The role of H. pylori infection in causation of minimal hepatic encephalopathy (MHE) has not been well studied. We looked at the relationship of H. pylori infection with MHE and hyperammonemia in patients with liver cirrhosis and the effects of anti-H. pylori treatment in patients with MHE and H. pylori infection.
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Two boys, aged 8 and 7 years, had the classic symptoms of GERD. They were treated with antacid without improvement of the esophagic lesions. Subsequent esophageal biopsy results showed marked eosinophilic infiltration. From this moment on, eosinophilic esophagitis started to be considered the main diagnosis.
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Spectrophotometric procedures for determination of two irreversible proton pump inhibitors, lansoprazole (I) and pantoprazole sodium sesquihydrate (II) are presented. Two methods were based on charge transfer complexation reaction of these drugs, where they act as n-donors, with either pi acceptor 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) and with sigma acceptor as iodine. A third method was also investigated depending on ternary complex formation with eosin and copper (II). The colored products were quantified spectrophotometrically using absorption bands at 457 nm for DDQ (method A) at 293 and 359 nm for iodine (method B) and at 549 nm using ternary complex formation (method C), for both drugs. The molar combining ratio and the optimum assay conditions were studied. These methods determined the lansoprazole in concentration ranges from 10 to 90, 1.48 to 6.65 and 3.69 to 16.61 microg ml(-1) with mean percentage recovery 99.63% for DDQ, 99.71%, 99.18% for iodine and 99.76% for ternary complex and with relative standard deviation 0.11, 0.24, 0.13 and 0.36%, respectively. For pantoprazole, the concentration ranges were 10-60, 17.7-141.6 and 4.3-25.9 microg ml(-1) with mean percentage recovery 99.51, 98.97, 99.84 and 99.46% and relative standard deviation 0.53, 1.21, 0.65, 0.81% for the three mentioned methods, respectively. Investigation of the formed complexes was made with respect to its composition, molar ratio of the reaction, association constant K(C)AD, molar absorptivity epsilon(lambda)AD and free energy change deltaG for methods (A) and (B). The proposed methods have been applied successfully to the analysis of the cited drugs either in pure form or in pharmaceutical formulations, with good accuracy and precision, compared statistically with those given by the reported methods. They are recommended for quality control and routine analysis.
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Lansoprazole orally disintegrating tablet, which rapidly disintegrates on the tongue or in water, provides a dosing alternative for patients with difficulty in swallowing. Gastric and nasogastric tubes are increasingly placed in patients with more severe swallowing disorders.
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A total of 124 patients with Helicobacter pylori infection, diagnosed on the basis of gastric histology, rapid urease test and (13)C-urea breath test, were studied. These patients received omeprazole, 20 mg/day, lansoprazole, 30 mg/day, or pantoprazole, 40 mg/day, for 2 weeks according to a randomized protocol. (13)C-Urea breath test was repeated on days 4, 7 and 14 while on therapy and 7 days after proton pump inhibitor withdrawal.
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A ligand exchange chiral stationary phase (CSP) developed previously in this laboratory by bonding (R)-phenylglycinol derivative, sodium N-[(R)-2-hydroxy-1-phenylethyl]-N-undecylaminoacetate, to silica gel was successfully applied to the resolution of proton pump inhibitors (PPIs) including omeprazole, pantoprazole, lansoprazole and rabeprazole. For example, the separation factors (α) for the resolution of omeprazole, pantoprazole, lansoprazole and rabeprazole were 4.27, 5.28, 2.77 and 4.06, respectively, and the resolutions (R(S)) were 2.53, 2.55, 1.93, and 2.01, respectively, when 65% acetonitrile aqueous solution containing 0.5mM CuSO(4) and 0.05mM triethylamine was used as a mobile phase. Based on the chromatographic behaviors for the resolution of PPI analogues on CSP 1, a chiral recognition mechanism utilizing the sulfoxide oxygen and the benzimidazole ring nitrogen of PPIs as bidentate coordination donors to form an enantioselective ternary complex with the central Cu(II) ion and the chiral stationary bidentate ligand was proposed.
Children with healed erosive esophagitis have up to 83% clinical relapse and of the 83%, 45% had endoscopic relapse. Correlation of endoscopic relapse with clinical symptom is poor. Higher grades of esophagitis and higher BMI are risk factors for endoscopic relapse.
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The association of lansoprazole and amoxicillin at the administered doses has a low efficiency on H. pylori eradication in duodenal ulcer patients. Further studies are warranted to definitely assess the eradicating efficiency of such combination and also to determine the optimal dose of its components, the minimal duration of therapy and the ideal moment for its administration.
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Patients with active Helicobacter pylori infection underwent a baseline 14C-UBT (UBT-1) followed by treatment with lansoprazole 30 mg/day for 14 to 16 days. On day 13, patients returned for a repeat standard UBT (UBT-2). Between days 14 to 16, patients underwent a modified UBT (UBT-3), which included consuming 200 ml of 0.1 N citrate solution 30 min before and at the time of 14C-urea administration. Breath samples were collected 10 and 15 min after 14C-urea ingestion. Mean 14CO2 excretion and the number of FN and equivocal UBT results were compared for the three UBTs.
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Interleukin (IL)-8 has been reported to participate in neutrophil infiltration in Helicobacter pylori (H. pylori)-induced gastritis in humans. In this study, we investigated the anti-inflammatory actions beyond the suppression of acid secretion by proton pump inhibitors (PPI), such as omeprazole and lansoprazole, on IL-8 production by gastric epithelial cells (MKN45) and human umbilical vein endothelial cells (HUVEC) and on the transendothelial migration of polymorphonuclear neutrophils (PMN).
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To evaluate the efficacy and safety of a one-week triple therapy without bismuth and metronidazole in duodenal ulcer healing and symptom relief.
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The pH of the gastric contents was significantly higher in the +PPI experiments than in the -PPI experiments (p < 0.05), since mean values of 4.3 +/- 2.5 and 2.2 +/- 1.6, respectively, were recorded at the end of the gastric emptying of the meal. The HGL concentrations recorded during the meal were found to be higher in the experiments with lansoprazole (p < 0.05) than in those without lansopra- zole, but the HGL secretion levels (-PPI: 15.4 +/- 8.0 mg; +PPI: 19.0 +/- 7.4 mg) and the intragastric lipolysis (-PPI: 24.0 +/- 8.0%; +PPI: 23.6 +/- 6.8%) were not significantly affected by lansoprazole (p > 0.05 in both cases).
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This study demonstrated the following order of antisecretory potency: 30 mg lansoprazole = 40 mg omeprazole > 15 mg lansoprazole approximately 20 mg omeprazole.
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The degree of conservation among phyla of early mechanisms that pattern the left-right (LR) axis is poorly understood. Larvae of sea urchins exhibit consistently oriented LR asymmetry. The main part of the adult rudiment is formed from the left coelomic sac of larvae, the left hydrocoel. Although this left preference is conserved among all echinoderm larvae, its mechanism is largely not understood. Using two marker genes, HpNot and HpFoxFQ-like, which are asymmetrically expressed during larval development of the sea urchin Hemicentrotus pulcherrimus, we examined in this study the possibility that the recently discovered ion flux mechanism controls asymmetry in sea urchins as it does in several vertebrate species. Several ion-transporter inhibitors were screened for the ability to alter the expression of the asymmetric marker genes. Blockers of the H(+)/K(+)-ATPase (omeprazole, lansoprazole and SCH28080), as well as a calcium ionophore (A23187), significantly altered the normal sidedness of asymmetric gene expression. Exposure to omeprazole disrupted the consistent asymmetry of adult rudiment formation in larvae. Immuno-detection revealed that H(+)/K(+)-ATPase-like antigens in sea urchin embryos were present through blastula stage and exhibited a striking asymmetry being present in a single blastomere in 32-cell embryos. These results suggest that, as in vertebrates, endogenous spatially-regulated early transport of H(+) and/or K(+), and also of Ca(2+), functions in the establishment of LR asymmetry in sea urchin development.