s-1743 and Peptic-Ulcer

Proton-pump inhibitors (PPIs) and vonoprazan are recommended as first-line therapies for erosive esophagitis (EE). However, it is uncertain how the magnitude of efficacy and safety of first-line therapy, the choice of individual PPIs or vonoprazan in the treatment of EE remains controversial. This study aimed to evaluate the efficacy and safety of vonoprazan and PPIs in healing esophageal mucosal injury in patients with EE.. Relevant databases were searched to collect randomized controlled trials of proton pump inhibitors and vonoprazan in the treatment of reflux esophagitis up to December 2021. Studies on standard-dose PPIs or vonoprazan that were published in Chinese or English and assessed healing effects in EE were included in the analysis. Stata16.0 was used to conduct a network Meta-analysis to evaluate the efficacy and safety of the treatment.. A total of 41 literatures were included with 11,592 enrolled patients. For the endoscopic cure rate, all the PPIs and vonoprazan significantly improve compared to Placebo; Based on the surface under the cumulative ranking curve, Ilaprazole ranked first, followed by esomeprazole, vonoprazan, pantoprazole, lansoprazole, omeprazole, rabeprazole and placebo therapy ranked the last. For the rate of adverse events, there was no significant difference among all the PPIs, vonoprazan, and placebo.. Ilaprazole, esomeprazole and vonoprazan have more advantages in mucosal erosion healing, there was no significant difference in the comparative safety among all interventions.

Topics: Abdominal Injuries; Esomeprazole; Esophagitis, Peptic; Humans; Network Meta-Analysis; Peptic Ulcer; Proton Pump Inhibitors; Rabeprazole

Aspirin and P2Y

Topics: Adenosine; Aspirin; Cardiovascular Diseases; Clopidogrel; Drug Administration Schedule; Drug Dosage Calculations; Drug Interactions; Esomeprazole; Gastrointestinal Hemorrhage; Gene Expression; Humans; Hydrogen-Ion Concentration; Peptic Ulcer; Prasugrel Hydrochloride; Proton Pump Inhibitors; Purinergic Antagonists; Receptors, Purinergic P2Y12; Ticagrelor; Ticlopidine

Topics: Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Dose-Response Relationship, Drug; Esomeprazole; Gastrointestinal Hemorrhage; Global Health; Humans; Incidence; Peptic Ulcer; Proton Pump Inhibitors; Risk Assessment

Peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD) are not uncommon in elderly patients. Clinical presentations of these acid-related disorders may be atypical in the geriatric population. Older individuals are at increased risk for poor outcomes in complicated PUD and for development of GERD complications. Multiple risk factors (eg, Helicobacter pylori [HP], use of nonsteroidal anti-inflammatory drugs [NSAIDs], aspirin) contribute to the development of PUD. Recent data has shown that HP-negative, NSAID-negative idiopathic peptic ulcers are on the rise and carry a higher risk of recurrent ulcer bleeding and mortality. Effective management of PUD in the geriatric population relies on identification and modification of treatable risk factors. Elderly patients with GERD often require long-term acid suppressive therapy. Proton pump inhibitors (PPI) including esomeprazole are effective in the treatment of reflux esophagitis, maintenance of GERD symptomatic control, and management of PUD as well as its complications. Potential safety concerns of long-term PPI use have been reported in the literature. Clinicians should balance the risks and benefits before committing elderly patients to long-term PPI therapy.

Topics: Aged; Anti-Ulcer Agents; China; Esomeprazole; Female; Gastroesophageal Reflux; Hong Kong; Humans; Male; Peptic Ulcer

The fixed-dose acetylsalicylic acid (ASA)/esomeprazole capsule combines the cardiovascular (CV) protective effects of low-dose ASA with the gastroprotective effects of the proton pump inhibitor esomeprazole. It is approved for use as a convenient once-daily regimen in the prevention of CV and cerebrovascular events in patients requiring continuous low-dose ASA who are at risk of developing gastric and/or duodenal (peptic) ulcers. In two large, 26-week, randomized, double-blind, multinational, phase III trials (ASTERIX and OBERON) in patients who were receiving low-dose ASA for the prevention of CV events and who had an increased risk of ulcer development, the incidence of endoscopy-proven peptic ulcers (primary endpoint) was significantly lower with the addition of esomeprazole 20 mg/day versus placebo. Moreover, patient-reported dyspeptic symptoms (epigastric pain and epigastric burning) were reported in significantly fewer patients in the low-dose ASA plus esomeprazole group than in the low-dose ASA plus placebo group. Low-dose ASA plus esomeprazole treatment was generally well tolerated, with a similar adverse event profile to that seen with low-dose ASA plus placebo.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Aspirin; Capsules; Cardiovascular Diseases; Drug Combinations; Esomeprazole; Humans; Peptic Ulcer; Platelet Aggregation Inhibitors; Prodrugs; Proton Pump Inhibitors

Low-dose aspirin (ASA, 75 - 325 mg/day) is widely used for the primary and secondary prevention of cardiovascular (CV) diseases. However, the value of primary prevention ASA is uncertain as the reduction in occlusive events needs to be weighed against the significant increase in major bleedings. Prevention with antisecretory drugs has been proposed to reduce the incidence of ASA-induced gastrointestinal (GI) bleedings, but non-adherence to gastro-protection is of concern, as it significantly increases the risk of upper GI adverse events. Beside patients and physicians education, one approach to overcome non-adherence is the development of fixed-dose combination.. This review explores the results of clinical studies on the influence of the combination esomeprazole (ESA) and ASA on pharmacokinetic (PK) parameters, and the role for such combination in prevention of CV events in patients at risk of gastric ulcers.. Patients at risk of ASA-induced gastroduodenal ulcer might benefit from a fixed ASA and proton pump inhibitor (PPI) combination. PK and PD parameters suggest there is no significant interaction between these drugs. Nevertheless, attention must be paid on the appropriate use of such combination, that is, still balancing the risk:benefit ratio in a real-life setting, and any increase in the proportion of patients receiving ASA and PPI should be considered as a warning signal.

Topics: Anti-Ulcer Agents; Aspirin; Cardiovascular Diseases; Drug Interactions; Esomeprazole; Humans; Peptic Ulcer; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic

Low-dose acetyl salicylic acid (ASA) for preventing cardiovascular and cerebrovascular events is now one of the most frequently prescribed medications in some Western countries. However, it is associated with significant morbidity and mortality as a consequence of the development of gastric and duodenal ulcers and their complications. Recent randomized controlled trials in patients who are at moderately increased risk of ulcers have shown that the proton pump inhibitor esomeprazole (the S-isomer of racemic omeprazole) reduces the gastroduodenal ulcer incidence by approximately 70-85% and the gastrointestinal bleeding risk by as much as 90%. Case-control studies also indicate that the risk of ulcer bleeding is less in low-dose ASA users who concomitantly take a proton pump inhibitor. This article reviews the pharmacology of the component agents and the evidence for efficacy of the combination of esomeprazole and low-dose ASA.

Topics: Anti-Ulcer Agents; Aspirin; Cardiovascular Diseases; Cerebrovascular Disorders; Drug Therapy, Combination; Esomeprazole; Humans; Omeprazole; Peptic Ulcer; Randomized Controlled Trials as Topic; Risk

Proton pump inhibitors (PPI) are characterized by high effectiveness, selectivity and few adverse events. Development of PPI was an important issue in aspect of acid-related diseases treatment. Nowadays following PPI are available on the market: omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole. In children these drugs are the most frequently use in gastritis and duodenitis, ulcer disease with coexistence of Helicobacter pylori infection and gastroesophageal reflux disease. Pharmacokinetics of PPI is slightly different in children than in adults and so far there is a lack of randomised studies assessing the efficacy of PPI i developmental period medicine on numerous groups of patients. In our study literature review of PPI use in children and youth was presented.

Topics: Adult; Age Factors; Anti-Ulcer Agents; Child; Drug Interactions; Duodenitis; Enzyme Inhibitors; Esomeprazole; Gastritis; Gastroesophageal Reflux; Helicobacter Infections; Humans; Omeprazole; Peptic Ulcer; Proton Pump Inhibitors

The clinical response to antisecretory treatment correlates directly with the degree of inhibition of acid secretion achieved. Acid inhibition able to maintain the intragastric pH at a value greater than 4 for at least 16 h/day seems to heal even the most refractory acid-related diseases. It has also been shown that the degree of inhibition of acid secretion in response to antisecretory treatment depends on the genetic characteristics of the patient and on the presence of Helicobacter pylori infection. A possible definition of potent (or profound) acid inhibition is, therefore, the achievement of the aforementioned level of control of acid secretion regardless of patient characteristics or of the presence of H. pylori infection. Antisecretory drugs differ in their ability to reach potent acid inhibition. As far as the comparative efficacy of different drugs for inhibiting acid secretion is concerned, proton pump inhibitors are more efficient in inhibiting gastric acid secretion than histamine (H2) receptor antagonists. Among the different proton pump inhibitors, esomeprazole 40 mg/day exhibits greater antisecretory potency than the others at standard doses. Rabeprazole 20 mg/day and lansoprazole 30 mg/day exhibit a more rapid onset of action than omeprazole 20 mg/day or pantoprazole 40 mg/day.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Ulcer Agents; Benzimidazoles; Clinical Trials as Topic; Esomeprazole; Gastric Acid; Humans; Lansoprazole; Omeprazole; Pantoprazole; Peptic Ulcer; Proton Pump Inhibitors; Rabeprazole; Sulfoxides

Acid inhibition is safe and useful in several clinical settings. Proton pump inhibitors are more effective than H2-receptor antagonists in virtually all cases. Proton pump inhibitors should be used in: the eradication of Helicobacter pylori; the treatment of non-H. pylori-related peptic ulcer healing; for the prevention and treatment of non-steroidal anti-inflammatory drug-induced upper digestive lesions; for bleeding peptic lesions; and, especially, in the short-term and long-term control of gastro-oesophageal reflux disease. The timing, the dosing and the specific drugs should be adapted to the particular patient, clinical situation and local factors. For instance, in a patient with active bleeding from a duodenal ulcer, intravenous constant infusion should be the preferred treatment. When seeking oral 'potent' acid inhibition (refractory gastro-oesophageal reflux disease, and perhaps Barrett's oesophagus), available data suggest that the pharmacological and clinical profiles of esomeprazole are slightly better.

Topics: Anti-Ulcer Agents; Esomeprazole; Gastric Acid; Humans; Peptic Ulcer; Proton Pump Inhibitors

EFFECTS AND INCONVENIENCIES OF THE OLDER PRODUCTS: The proton pump inhibitors (PPIs) are now universally considered the treatment of choice for management of gastric-acid-related diseases, mainly gastro-oesophageal reflux disease (GERD). These drugs share similar properties: general structure, acid-activation step, covalent binding to the proton pump of the gastric parietal cell via the production of covalent disulphide bonds, relatively stable inhibition of H+,K+-ATPase. However, the older PPIs (omeprazole, lansoprazole et pantoprazole) have notable limitations. These drugs exhibit substantial interpatient variability and may have significant interactions with other drugs. These first-generation PPIs also do not achieve a rapid and sustained suppression of gastric acid, leading to the development of new acid-pump antagonists. The new-generation PPIs, esomeprazole and rabeprazole, offer several pharmacokinetic advantages: lower oxidative hepatic metabolism rate via the CYP 2C19 reducing the activity variations due to genetic polymorphisms and decreasing the risk of significant drug-drug interactions (advantages mainly for rabeprazole), lower metabolic clearance of esomeprazole (S-enantiomer of omeprazole) increasing plasma concentrations and acid suppression of this new PPI, higher accumulation of rabeprazole in the parietal cell due to its higher pKa. Gastric pH studies and therapeutic trials have demonstrated significant advantages of esomeprazole and rabeprazole compared with the older PPIs, which omeprazole is the prototype: a greater inhibition of acid secretion, a more rapid onset of action to provide reflux symptoms relief over 24 hours with lower GERD-related cost for rabeprazole, a sustained acid suppression, cost-effectiveness advantages for esomeprazole in the healing and maintenance of erosive esophagitis compared with lansoprazole, reduced potential for clinically significant drug-drug interactions with rabeprazole compared with omeprazole and esomeprazole. Due to their properties, esomeprazole and rabeprazole are the best candidates for "on demand" treatment of GERD.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adenosine Triphosphatases; Anti-Ulcer Agents; Benzimidazoles; Drug Interactions; Esomeprazole; Gastric Acid; Humans; Liver; Metabolic Clearance Rate; Omeprazole; Parietal Cells, Gastric; Patient Selection; Peptic Ulcer; Polymorphism, Genetic; Proton Pump Inhibitors; Proton-Translocating ATPases; Rabeprazole; Time Factors; Treatment Outcome

Pantoprazole (Protonix) is an irreversible proton pump inhibitor (PPI) that reduces gastric acid secretion. In combination with two antimicrobial agents (most commonly metronidazole, clarithromycin or amoxicillin) for 6-14 days, pantoprazole 40 mg twice daily produced Helicobacter pylori eradication rates of 71-93.8% (intent-to-treat [ITT] or modified ITT analysis) in patients without known antibacterial resistance. Pantoprazole-containing triple therapy was at least as effective as omeprazole- and similar in efficacy to lansoprazole-containing triple therapy in large trials. In the treatment of moderate to severe gastro-oesophageal reflux disease (GORD), oral pantoprazole 40 mg/day was as effective as other PPIs (omeprazole, omeprazole multiple unit pellet system, lansoprazole and esomeprazole) and significantly more effective than histamine H(2)-antagonists. Pantoprazole 20 mg/day provided effective mucosal healing in patients with GORD and mild oesophagitis. Intravenous pantoprazole 40 mg/day can be used in patients who are unable to take oral medication. Oral pantoprazole 20-40 mg/day for up to 24 months prevented relapse in most patients with healed GORD. According to preliminary data, oral pantoprazole 20 or 40 mg/day was effective at healing and preventing non-steroidal anti-inflammatory drug (NSAID)-related ulcers, and intravenous pantoprazole was at least as effective as intravenous ranitidine in preventing ulcer rebleeding after endoscopic haemostasis. Oral or intravenous pantoprazole up to 240 mg/day maintained target acid output levels in most patients with hypersecretory conditions, including Zollinger-Ellison syndrome. Oral and intravenous pantoprazole appear to be well tolerated in patients with acid-related disorders in short- and long-term trials. Tolerability with oral pantoprazole was similar to that with other PPIs or histamine H(2)-antagonists in short-term trials. Formal drug interaction studies have not revealed any clinically significant interactions between pantoprazole and other agents. In conclusion, pantoprazole is an effective agent in the management of acid-related disorders. As a component of triple therapy for H. pylori eradication and as monotherapy for the healing of oesophagitis and maintenance of GORD, pantoprazole has shown similar efficacy to other PPIs and greater efficacy than histamine H(2)-antagonists. Limited data suggest that it is also effective in Zollinger-Ellison syndrome and in preventing ulcer rebleeding.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Benzimidazoles; Clinical Trials as Topic; Dose-Response Relationship, Drug; Esomeprazole; Gastroesophageal Reflux; Helicobacter Infections; Humans; Omeprazole; Pantoprazole; Peptic Ulcer; Sulfoxides; Zollinger-Ellison Syndrome

Clinical and basic mechanisms of interaction between Helicobacter pylori and its host have been the subject of numerous publications in the past year. Two additional proton pump inhibitors (PPIs), esomeprazole and rabeprazole, have shown effectiveness in H. pylori eradication when combined with amoxicillin and clarithromycin, and esomeprazole has demonstrated its effectiveness with only one daily dose. Other important recent developments worldwide include evidence-based treatment guidelines established at a European consensus meeting, improved accuracy in the urea breath test and the stool antigen test, new recommendations for second-line therapy, and a greater understanding of antimicrobial resistance in treatment failure. In addition, new studies have confirmed that H. pylori infection and use of nonsteroidal anti-inflammatory drugs or aspirin are the major causes of peptic ulcer disease and ulcer bleeding. This paper reviews the results of these studies and their implications for future research.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Amoxicillin; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Benzimidazoles; Cardiovascular Diseases; Clarithromycin; Drug Therapy, Combination; Enzyme Inhibitors; Esomeprazole; Helicobacter Infections; Helicobacter pylori; Humans; Peptic Ulcer; Rabeprazole; Stomach Neoplasms; Treatment Outcome

Awareness of important differences in the pharmacological profile of individual optical isomers of chiral drugs led to the development of esomeprazole, the S-isomer of omeprazole, a new pharmacological entity designed to improve the clinical outcome of available proton pump inhibitors in the management of acid-related disorders. The superior acid control achieved by esomeprazole is mainly due to an advantageous metabolism compared with racemate omeprazole, leading to improved bioavailability and to enhanced delivery of the drug to the gastric proton pump.

Topics: Anti-Ulcer Agents; Drug Interactions; Esomeprazole; Humans; Omeprazole; Peptic Ulcer; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Zollinger-Ellison Syndrome

The aim of this pilot study was to evaluate the efficacy and safety of intravenous use esomeprazole, metronidazole, and/or levofloxacin in the treatment of Helicobacter pylori (H. pylori)-associated peptic ulcer complications.. Inpatients with peptic ulcer complications who were not able to take oral medicine were randomly assigned to three groups: triple therapy (esomeprazole, levofloxacin, metronidazole) and dual therapy (esomeprazole, levofloxacin/metronidazole) for 7 days. After intravenous treatment, all patients received open-label oral esomeprazole 20 mg bid for another 1 month. All subjects were followed up for gastroscopy at the seventh day of intravenous treatment to confirm the ulcer healing and. The H. pylori eradication rate of both LEV-dual therapy (33.3%, 95% CI: 9.7%-70.0%) and MTZ-dual therapy (50%, 95% CI: 21.5%-78.5%) was significantly lower than that of triple therapy (95%, 95% CI: 71.1%-97.4%) (p = .003, .016). There were no significant differences in the adverse effects among all treatment groups, and the adverse effects were rare.. The intravenous triple regimen, consisting of proton-pump inhibitor, metronidazole, and levofloxacin, could be considered in patients of H. pylori-associated peptic ulcer complications if oral medicine cannot be provided.

Topics: Amoxicillin; Anti-Bacterial Agents; Drug Therapy, Combination; Esomeprazole; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Metronidazole; Peptic Ulcer; Pilot Projects

Patients with Rockall scores ≥6 have an increased risk of long-term peptic ulcer rebleeding. This study was aimed toward investigating whether an extended course of oral esomeprazole up to 1 year decreased ulcer rebleeding in such patients.. We prospectively enrolled 120 patients with peptic ulcer bleeding and Rockall scores ≥6. After an initial 16-week oral proton pump inhibitor (PPI) treatment, patients were randomized to receive a 36-week course of oral twice-daily esomeprazole 20 mg (Group D, n = 60) or once-daily (Group S, n = 60). Thereafter, they were divided into the PPI-on-demand (n = 32) and PPI-discontinued (n = 77) subgroups. Our previous cohort with Rockall scores ≥6 served as the controls (Group C, n = 135); they received only an initial 8- to 16-week oral PPI. The primary and secondary outcomes were peptic ulcer rebleeding during the first year and the second year-and-thereafter, respectively.. For the primary outcome, groups D and S comprised a higher proportion of rebleeding-free than Group C (P = 0.008 and 0.03, log-rank test). The competing-risks regression analysis confirmed that extended PPI use and American Society of Anesthesiologists classification were independent factors contributing to the primary outcome. For the secondary outcome, PPI-on-demand had a borderline higher proportion of rebleeding-free than Group C (P = 0.07, log-rank test); however, only the Rockall score was the independent factor.. An extended 36-week course of oral esomeprazole 20 mg, twice- or once-daily for patients with Rockall scores ≥6 reduced ulcer rebleeding during the first year, but the effect needed to be further validated when PPIs were shifted to on-demand or discontinued thereafter (NCT02456012, 28/05/2015).

Topics: Esomeprazole; Humans; Peptic Ulcer; Peptic Ulcer Hemorrhage; Proton Pump Inhibitors; Recurrence; Ulcer

To compare triple therapy with sequential and concomitant therapies directly in a head-to-head comparison in Helicobacter pylori-infected patients.. Patients were allocated randomly as follows: a triple therapy with esomeprazole (20 mg), amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 7 days; a sequential therapy with 5 days of esomeprazole (20 mg) and amoxicillin (1000 mg) twice daily, followed by 5 days of esomeprazole (20 mg), clarithromycin (500 mg) and metronidazole (400 mg) twice daily; or a concomitant therapy consisting of esomeprazole (20 mg), amoxicillin (1000 mg), clarithromycin (500 mg) and metronidazole (400 mg) twice daily for 7 days.. A total of 356 consecutive patients were included. The eradication rates for the triple, sequential and concomitant therapies were 83.6% [95% confidence interval (CI) 76.9-90.4%], 94.2% (95% CI 90.0-98.4%) and 91.7% (95% CI 86.7-96.6%), respectively, in the intention-to-treat population. The differences were significant only between triple and sequential therapies (P=0.01). The primary resistance rates to amoxicillin, clarithromycin and metronidazole were 0.6, 10.5 and 25.9%, respectively. Concomitant therapy was significantly better than triple therapy in cases with clarithromycin resistance (P=0.01).. Ten-day sequential therapy was significantly better than 7-day triple therapy in a clinical setting with low rates of clarithromycin and dual resistance. Concomitant therapy was significantly better than standard triple therapy in the subgroup of patients with clarithromycin-resistant strains.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Peptic Ulcer; Proton Pump Inhibitors; Stomach Ulcer; Treatment Outcome; Young Adult

Currently only a few studies compare sequential and concomitant non-bismuth Helicobacter pylori therapies referring to high antibiotic resistance populations.. This multicenter prospective randomized clinical trial included 353 H. pylori positive, treatment naïve, patients. All patients had positive CLO-test and/or histology and culture. They received sequential (esomeprazole 40mg, amoxicillin 1g/bid for 5days, followed by 5days of esomeprazole 40mg, clarithromycin 500mg and metronidazole 500mg bid), or concomitant treatment (all drugs taken concomitantly bid for 10days). Eradication was confirmed by (13)C-urea breath test or histology 4-6weeks after treatment. Adverse events and adherence were evaluated.. Allocated to concomitant were 175 (72F/103M, mean 52.3years, 38.3% smokers, 25.7% ulcer disease) and 178 (87F/91M, mean 52years, 31% smokers, 19.1% ulcer disease) patients to sequential treatment. There were 303/353 (85.8%) positive cultures, with the following resistances: 34% metronidazole, 27.7% clarithromycin, and 7.9% dual. Eradication rates were, respectively, 89.1% (156/175) vs. 78.7% (140/178) by intention to treat (p=0.01, 95% CI=2.7-18) and 93.4%(156/167) vs. 82.8% (140/169) per protocol (p=0.004, 95% CI=3.6-17.6). Overall, adherence was (98.9%, 95% CI=97-100). Eradication rates according to resistance were the following: dual susceptible strains 67/69 (97.1%), 62/67 (92%) (p=0.4), metronidazole single resistant 38/39 (97.4%), 31/39 (79.5%) (p=0.03, 95% CI=3.5-33), clarithromycin single resistant 25/28 (89.3%), 26/31 (83.9%) (p=0.8), and dual resistant 9/12 (75%), 4/11 (36.4%) (p=0.1) for concomitant and sequential regimens, respectively. Side effects were comparable among regimens, except from diarrhea being more frequent among patients treated with concomitant treatment.. Concomitant treatment eradication rate overcomes 90% per protocol and has a significant advantage over sequential therapy. This is probably due to its better efficacy on metronidazole resistant strains. Both regimens were well tolerated and safe.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Biopsy; Breath Tests; Carbon Isotopes; Clarithromycin; Drug Resistance, Bacterial; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Peptic Ulcer; Proton Pump Inhibitors; Pyloric Antrum; Urea

Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.. Children aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux disease were randomized to esomeprazole 5 or 10 mg daily (<20 kg) or 10 or 20 mg daily (≥ 20 kg) for 8 weeks. Patients with erosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.. Of 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis without erosive esophagitis. Of the 45 patients who had erosive esophagitis and underwent follow-up endoscopy, 89% experienced erosion resolution. Dilation of intercellular space was reported in 24% of patients with histologic examination.. Esomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in this pediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an important histologic marker of erosive esophagitis in children.

Topics: Anti-Ulcer Agents; Child; Child, Preschool; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Infant; Male; Pediatrics; Peptic Ulcer; Proton Pump Inhibitors; Treatment Outcome; Wound Healing

The aim of the study was to evaluate erosive esophagitis healing and symptom improvement with once-daily esomeprazole in children ages 12 to 36 months with endoscopically or histologically proven gastroesophageal reflux disease (GERD).. Data from children ages 12 to 36 months were included in a post-hoc analysis of an 8-week, multicenter, randomized, and double-blind by dose strata study of patients ages 1 to 11 years with endoscopically or histologically confirmed GERD. Children were randomized to receive esomeprazole 5 or 10 mg once daily. Patients underwent endoscopy and, if required, mucosal biopsy at baseline. Patients who had erosive esophagitis (graded using the Los Angeles classification system) at baseline underwent a follow-up endoscopy at final study visit to assess healing of erosive esophagitis. Investigators scored severity of GERD symptoms at baseline and every 2 weeks using the Physician Global Assessment.. Thirty-one of 109 primary study patients ages 12 to 36 months were included in the post hoc analysis. At baseline, 15 patients (48.4%) had erosive esophagitis, underwent follow-up endoscopy, and were healed after 8 weeks of esomeprazole treatment. Of the 19 patients with moderate-to-severe baseline Physician Global Assessment symptom scores, 84.2% had lower scores by the final visit. Following esomeprazole treatment, GERD symptoms were significantly improved from baseline to final visit (P ≤ 0.0018).. Esomeprazole 5 or 10 mg may be used to successfully treat erosive esophagitis and symptoms of GERD in children as young as 1 year.Moreover, although not yet validated in pediatric patients, the Los Angeles classification system was useful in grading erosive esophagitis in children ages 12 to 36 months.

Topics: Anti-Ulcer Agents; Child, Preschool; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Infant; Male; Pediatrics; Peptic Ulcer; Proton Pump Inhibitors; Treatment Outcome; Wound Healing

To evaluate if esomeprazole prevents recurrent peptic ulcer in adult patients with a history of peptic ulcer receiving low-dose acetylsalicylic acid (ASA, aspirin) for cardiovascular protection in East Asia.. In this prospective, randomised, double-blind, placebo-controlled trial conducted in Japan, Korea and Taiwan, eligible patients receiving low-dose ASA for cardiovascular protection (81-324 mg/day) were randomised to esomeprazole 20 mg/day or placebo for ≤72 weeks. All patients received concomitant mucosal protection (gefarnate 100 mg/day). The primary endpoint was time to ulcer recurrence (Kaplan-Meier analysis). Efficacy findings are presented up to week 48, as per a planned interim analysis within the study protocol.. A total of 364 patients (79.9% men; mean age, 67.1 years) comprised the full analysis set (esomeprazole, n=182; placebo, n=182). There was a statistically significant difference in the time to ulcer recurrence between esomeprazole and placebo (HR 0.09; 96.65% CI 0.02 to 0.41; p<0.001). The estimated ulcer-free rate at week 12 was 99.3% (esomeprazole) and 89.0% (placebo). The high estimated ulcer-free rate for esomeprazole was maintained through to week 48 (98.3% vs. 81.2% of placebo-treated patients). No factors, other than female gender, reduced time to ulcer recurrence in addition to the effect of esomeprazole (p<0.001). Treatment with esomeprazole was generally well tolerated.. Daily esomeprazole 20 mg is efficacious and well tolerated in reducing the recurrence of peptic ulcer in East-Asian patients with a history of ulcers who are taking low-dose ASA for cardiovascular protection.. NCT01069939.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Asian People; Aspirin; Double-Blind Method; Drug Administration Schedule; Esomeprazole; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peptic Ulcer; Prospective Studies; Republic of Korea; Secondary Prevention; Taiwan; Treatment Outcome

Proton pump inhibitor (PPI) increases the risk of decrease in bone mineral density (BMD). However, whether calcitrol improves this situation is unknown.. The current study investigates the effects of calcitriol on BMD in patients with esomeprazole therapy.. Three hundred and eighty-six participants with gastrointestinal ulcerations were enrolled and randomly assigned into controlled and supplemented groups. Participants in the controlled group were prescribed esomeprazole (20 mg/qd), while the supplemented group was prescribed esomeprazole (20 mg/qd) and calcitriol (2.5 μg/qd). BMD, serum levels of calcium, carboxy-terminal collagen crosslinks (CTX), and alkaline-phosphatase (ALP) were assessed.. (1) No significant between-group difference of age, gender, smoking, previous glucocorticoid use and hemoglobin level was found; (2) after 10.6 ± 0.8 d of PPI therapy, BMD T score in the controlled group was slightly increased compared with initial (-1.25 ± 0.08 versus -1.28 ± 0.06, p = 0.084), while there was no change in the supplemented group (-1.25 ± 0.05 versus -1.26 ± 0.03, p = 0.308); (3) during study termination, calcium level in the supplemented group was slightly higher than the controlled group (2.05 ± 0.03 mmol/L versus 2.01 ± 0.05 mmol/L, p = 0.073), while no significant differences of CTX (366.57 ± 43.71 pg/mL versus 373.15 ± 50.23 pg/mL, p = 0.036) and ALP were found among these two groups (50.47 ± 9.32 U/L versus 52.23 ± 10.45 U/L, p = 0.075).. Patients with gastrointestinal ulcerations with esomeprazole therapy, calcitriol supplement showed no efficacy on BMD changes.

Topics: Adult; Bone Density; Bone Density Conservation Agents; Calcitriol; Drug Therapy, Combination; Esomeprazole; Female; Humans; Male; Middle Aged; Peptic Ulcer; Proton Pump Inhibitors; Treatment Outcome

Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective and common treatment for chronic pain disorders, but long-term use is associated with risk of potentially life-threatening gastrointestinal adverse events (AEs). The proton pump inhibitor esomeprazole has been found to be effective for gastroprotection in NSAID users, but few long-term studies have been conducted in Japan.. This was an open-label, multicentre, single-arm, prospective 1-year study of treatment with esomeprazole (20 mg once daily) in Japanese patients (aged ≥20 years) with endoscopic evidence of previous peptic ulcer and receiving daily oral NSAID therapy (at a stable dose) for a chronic condition. Eligibility was not dictated by type of oral NSAID. The primary objective was to determine long-term safety and tolerability of esomeprazole. Efficacy for prevention of peptic ulcers was also determined (Kaplan-Meier method). All statistical analyses were descriptive.. A total of 130 patients (73.1% women, mean age 62.1 years, 43.8% Helicobacter pylori-positive) received treatment with esomeprazole in addition to long-term NSAID therapy (most commonly for rheumatoid arthritis [n=42] and osteoarthritis [n=34]). Loxoprofen, meloxicam and diclofenac were the most commonly used NSAIDs; cyclo-oxygenase (COX)-2 selective agents were used by 16.2% of patients (n=21). Long-term compliance with esomeprazole (capsule counts) was >75% for the majority of patients. Although 16.9% of patients (n=22) experienced AEs judged to be possibly related to treatment with esomeprazole, they were mostly mild and transient. The most commonly reported possibly treatment-related AEs were abnormal hepatic function, headache, increased γ-glutamyltransferase levels and muscle spasms (2 patients each). Overall, 95.9% (95% confidence interval: 92.3, 99.4) of patients remained ulcer free at 1 year.. Long-term treatment with esomeprazole (20 mg once daily) is well tolerated and efficacious for preventing ulcer recurrence in Japanese NSAID users with a history of peptic ulcer.. ClinicalTrials.gov identifier NCT00595517.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Diclofenac; Esomeprazole; Female; gamma-Glutamyltransferase; Headache; Humans; Japan; Liver Function Tests; Male; Meloxicam; Middle Aged; Osteoarthritis; Peptic Ulcer; Phenylpropionates; Proton Pump Inhibitors; Secondary Prevention; Spasm; Thiazines; Thiazoles; Time Factors

The increasing trend of antibiotic resistance requires effective second-line Helicobacter pylori (H. pylori) treatment in high prevalence area of H. pylori. The aim of our study was to evaluate the reinfection rate of H. pylori after second-line treatment that would determine the long-term follow up effect of the rescue therapy.. A total of 648 patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test or invasive tests. In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.. The recrudescence rate of the EBMT was 1.7% and of the MEA group 3.3% (p = 0.67). The annual reinfection rate of H. pylori of EBMT was found to be 4.45% and the MEA group 6.46%. Univariate analysis (Log-rank test) showed no association with any clinical risk factor for reinfection.. The long-term reinfection rate of H. pylori stayed low in both of bismuth-containing quadruple therapy and moxifloxacin-based triple therapy; thus reinfection cannot affect the choice of second-line treatment.. Clinical Trial Registration Number NCT01792700.

Topics: Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Aza Compounds; Breath Tests; Disease-Free Survival; Drug Therapy, Combination; Esomeprazole; Female; Fluoroquinolones; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Kaplan-Meier Estimate; Longitudinal Studies; Male; Metronidazole; Middle Aged; Moxifloxacin; Organometallic Compounds; Peptic Ulcer; Quinolines; Recurrence; Stomach Neoplasms; Tetracycline; Treatment Outcome

This randomized, 4-way crossover study assessed the single-dose pharmacokinetics and relative bioavailability of naproxen and esomeprazole after administration of a fixed-dose combination tablet of enteric-coated (EC) naproxen 500 mg and non-EC esomeprazole magnesium 20 mg (NAP/ESO tablet). Equivalent doses of an EC naproxen tablet plus an EC esomeprazole magnesium capsule taken concomitantly, an EC naproxen tablet alone, or an EC esomeprazole magnesium capsule alone were used as comparators. Forty healthy adults were randomized to receive 4 study treatments with a washout interval ≥12 days. Naproxen plasma profiles were similar between the NAP/ESO tablet and EC naproxen, although median t(max) was longest for the NAP/ESO tablet (5.3 vs 3.5-4.0 hours). Naproxen C(max), AUC(0-∞), and AUC(0-t) showed bioequivalence between naproxen formulations. The NAP/ESO tablet produced much shorter esomeprazole t(max) than the EC esomeprazole formulation (0.45 vs 2.5 hours). Esomeprazole C(max) and AUCs were comparable between the EC esomeprazole formulation administered with or without EC naproxen but were lower with the NAP/ESO tablet. In conclusion, there are no pharmacokinetic drug interactions between naproxen and esomeprazole. The NAP/ESO tablet is bioequivalent to EC naproxen, and as expected, the bioavailability of non-EC esomeprazole from the NAP/ESO tablet is lower than the EC esomeprazole formulation.

Topics: Administration, Oral; Adolescent; Adult; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Area Under Curve; Biological Availability; Capsules; Cross-Over Studies; Drug Combinations; Drug Interactions; Drug Therapy, Combination; Esomeprazole; Female; Humans; Least-Squares Analysis; Male; Middle Aged; Models, Biological; Naproxen; Peptic Ulcer; Prospective Studies; Proton Pump Inhibitors; Tablets, Enteric-Coated; Young Adult

  The eradication rates of Helicobacter pylori (H. pylori) with standard treatments are decreasing worldwide as in Greece. Studies with new antibiotic combinations are needed to find better methods of eradication. Therefore, the aim of this study was to evaluate efficacy and tolerability of a 10-day, four-drug, three-antibiotic, nonbismuth-containing concomitant regimen.. This is a prospective, open-label, multicenter study that included 131 patients infected with H. pylori. All patients were diagnosed with peptic ulcer disease or nonulcer dyspepsia by endoscopy. H. pylori infection was established by at least two positive tests among rapid urease test, gastric histology, and (13) C-urea breath test. For 10 days, all patients received esomeprazole 40mg, amoxycillin 1000mg, clarithromycin 500mg, and metronidazole 500mg, all b.d. eradication was assessed with (13) C urea breath test 8weeks after the start of treatment. Intention-to-treat and per-protocol eradication rates were determined.. One hundred and twenty-seven of the 131 patients completed the study. At intention-to-treat analysis, the eradication rate was 91.6% (95% confidence interval (CI), 85.5-95.7%). For the per-protocol analysis, the eradication rate was 94.5% (95% CI, 89-97.8%). Adverse events were noted in 42 of 131 (32.1%); drug compliance was excellent with 96.9% of the patients taking more than 90% of the prescribed medication.. A 10-day concomitant regimen appears to be an effective, safe, and well-tolerated treatment option for first-line H. pylori eradication in Greece.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Disease Eradication; Drug Therapy, Combination; Esomeprazole; Female; Greece; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Peptic Ulcer; Prospective Studies

Aspirin-related peptic ulcers are a common disorder. However, whether or not aspirin should be continued during treatment for aspirin-related ulcers remains unclear.. To compare esomeprazole alone with esomeprazole plus aspirin in the treatment of aspirin-related peptic ulcers and to investigate the independent factors associated with the failure of ulcer healing.. From January 2008 to July 2011, patients with aspirin-related peptic ulcers were randomized to receive esomeprazole (40 mg per day) alone or esomeprazole (40 mg per day) plus aspirin (100 mg per day) for 8 weeks. The subjects with Helicobacter pylori infection were treated with standard triple therapy. Follow-up endoscopy was carried out at the end of the 8th week. The primary end point was the healing of peptic ulcers.. In all, 178 patients (89 receiving esomeprazole alone and 89 receiving esomeprazole plus aspirin) were enrolled and underwent follow-up endoscopy. The healing rate of ulcers by modified intention-to-treat analysis was 82.5% (95% confidence interval (CI), 74.2-90.8%) among patients treated with esomeprazole alone and 81.5% (95% CI, 73.0-90.0%) among patients treated with esomeprazole plus aspirin (difference, 1.0%; 95% CI, -11.2 to 12.6%). The per-protocol analysis yielded similar results (healing rate: 83.1% vs. 83.8%, respectively; difference, 0.7%; 95% CI, -11.2 to 12.6%). Multivariate analysis disclosed that use of steroids during treatment (odds ratio: 5.6; 95% CI, 1.1-27.7%) was the only independent factor associated with the failure of ulcer healing.. The observed ulcer healing rates were comparable in the esomeprazole and esomeprazole-plus-aspirin groups, but the wide CIs do not rule out clinically meaningful differences of more than 10%.

Topics: Aged; Anti-Ulcer Agents; Aspirin; Cardiovascular Diseases; Chi-Square Distribution; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Peptic Ulcer; Platelet Aggregation Inhibitors; Risk Factors; Surveys and Questionnaires; Taiwan; Treatment Outcome

The use of proton pump inhibitors for prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastrointestinal adverse events is well documented. However, data regarding the efficacy and safety of this approach in Japan are scarce.. To evaluate the efficacy and tolerability of esomeprazole in preventing NSAID-induced peptic ulcers in Japanese at-risk patients.. Male and female Japanese adult patients (aged ≥ 20 years) with endoscopically confirmed history of peptic ulcers who required long-term oral NSAID therapy for a chronic inflammatory condition were randomised to 24 weeks' treatment with esomeprazole 20 mg once daily or matching placebo. The primary end point was the Kaplan-Meier estimated proportion of ulcer-free patients.. Overall, 343 patients were randomised to treatment (esomeprazole, n = 175; placebo, n = 168). The Kaplan-Meier estimated ulcer-free rate over the 24-week treatment period was significantly higher (log-rank P < 0.001) in esomeprazole-treated patients (96.0%; 95% CI 92.8, 99.1) than in placebo recipients (64.4%; 95% CI 56.8, 71.9). Esomeprazole was effective at preventing peptic ulcers in both Helicobacter pylori-positive and -negative patients (96.3% vs. 95.5% of patients ulcer-free, respectively); however, in the placebo group, the proportion of ulcer-free patients at 24 weeks was markedly lower among H. pylori-positive than -negative patients (59.7% vs. 69.9%). The NSAID type did not seem to affect the estimated ulcer-free rate with esomeprazole. Treatment with esomeprazole was well tolerated.. Esomeprazole 20 mg once daily is effective and safe in preventing ulcer recurrence in Japanese patients with a definite history of peptic ulcers who were taking an NSAID (ClinicalTrials.gov identifier: NCT00542789).

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Asian People; Double-Blind Method; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peptic Ulcer; Time Factors

High dose intravenous proton pump inhibitor after endoscopic therapy for peptic ulcer bleeding has been recommended as adjuvant therapy. Whether oral proton pump inhibitor can replace intravenous proton pump inhibitor in this setting is unknown. This study aims to compare the clinical efficacy of oral and intravenous proton pump inhibitor after endoscopic therapy.. Patients with high-risk bleeding peptic ulcers after successful endoscopic therapy were randomly assigned as oral lansoprazole or intravenous esomeprazole group. Primary outcome of the study was re-bleeding rate within 14 days. Secondary outcome included hospital stay, volume of blood transfusion, surgical intervention and mortality within 1 month.. From April 2010 to Feb 2011, 100 patients were enrolled in this study. The re-bleeding rates were 4% (2/50) in the intravenous group and 4% (2/50) in the oral group. There was no difference between the two groups with regards to the hospital stay, volume of blood transfusion, surgery or mortality rate. The mean duration of hospital stay was 1.8 days in the oral lansoprazole group and 3.9 days in the intravenous esomeprazole group (p > 0.01).. Patients receiving oral proton pump inhibitor have a shorter hospital stay. There is no evidence of a difference in clinical outcomes between oral and intravenous PPI treatment. However, the study was not powered to prove equivalence or non-inferiority. Future studies are still needed.. NCT01123031.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Administration, Intravenous; Administration, Oral; Aged; Anti-Ulcer Agents; Blood Transfusion; Endoscopy; Esomeprazole; Female; Humans; Lansoprazole; Length of Stay; Male; Middle Aged; Peptic Ulcer; Peptic Ulcer Hemorrhage; Proton Pump Inhibitors; Secondary Prevention; Treatment Outcome

We performed a prospective, randomized, controlled study to compare the combination of esomeprazole and clopidogrel vs clopidogrel alone in preventing recurrent peptic ulcers in patients with atherosclerosis and a history of peptic ulcers. We also investigated the effects of esomeprazole on the antiplatelet action of clopidogrel.. From January 2008 to January 2010, long-term clopidogrel users with histories of peptic ulcers who did not have peptic ulcers at an initial endoscopy examination were assigned randomly to receive the combination of esomeprazole (20 mg/day, before breakfast) and clopidogrel (75 mg/day, at bedtime), or clopidogrel alone for 6 months. A follow-up endoscopy examination was performed at the end of the sixth month and whenever severe symptoms occurred. Platelet aggregation tests were performed on days 1 and 28 for 42 consecutive patients who participated in the pharmacodynamic study.. The cumulative incidence of recurrent peptic ulcer during the 6-month period was 1.2% among patients given the combination of esomeprazole and clopidogrel (n = 83) and 11.0% among patients given clopidogrel alone (n = 82) (difference, 9.8%; 95% confidence interval, 2.6%-17.0%; P = .009). In the group given the combination therapy, there were no differences in the percentages of aggregated platelets on days 1 and 28 (31.0% ± 20.5% vs 30.1% ± 16.5%).. Among patients with atherosclerosis and a history of peptic ulcers, the combination of esomeprazole and clopidogrel reduced recurrence of peptic ulcers, compared with clopidogrel alone. Esomeprazole does not influence the action of clopidogrel on platelet aggregation.

Topics: Aged; Aged, 80 and over; Aryl Hydrocarbon Hydroxylases; Atherosclerosis; Clopidogrel; Cytochrome P-450 CYP2C19; Drug Interactions; Endoscopy, Gastrointestinal; Esomeprazole; Female; Genotype; Humans; Male; Middle Aged; Peptic Ulcer; Phenotype; Platelet Aggregation; Platelet Aggregation Inhibitors; Platelet Function Tests; Prospective Studies; Proton Pump Inhibitors; Risk Assessment; Secondary Prevention; Taiwan; Ticlopidine; Time Factors; Treatment Outcome

Efficacy of a continuous high-dose intravenous infusion of esomeprazole, followed by an oral regimen after successful endoscopic therapy for peptic ulcer bleeding (PUB) was established in the PUB study (ClinicalTrials. gov identifier: NCT00251979). Mortality rates and detailed safety and tolerability results from this study are reported here.. This was a double-blind, randomized study in patients ≥18 years with overt signs of upper gastrointestinal bleeding, following endoscopic diagnosis of a single gastric or duodenal ulcer (≥5 mm) with stigmata indicating current/ recent bleeding (Forrest class Ia, Ib, IIa, or IIb). Postendoscopic hemostasis, patients received intravenous esomeprazole (80 mg/30 minutes, then 8 mg/hour for 71.5 hours) or placebo. Postinfusion, all patients received open-label oral esomeprazole 40 mg once daily for 27 days. Mortality rates were analyzed using Fisher's exact test; other safety variables were analyzed descriptively.. A total of 767 patients were randomized; 764 comprised the safety analysis set (375 patients received esomeprazole, 389 placebo). Baseline characteristics were similar across the two treatment groups. Three deaths from the esomeprazole treatment group and eight from the placebo group occurred during the trial (0.8% versus 2.1%; P=0.22). From these 11 all-cause deaths, one (esomeprazole group; rebleeding from duodenal ulcer) occurred during the 72-hour intravenous treatment phase. Adverse event (AE) frequency was similar for the two groups over the intravenous treatment phase (esomeprazole, 39.2%; placebo, 41.9%), with gastrointestinal disorders being most commonly reported (12.3% and 19.8%, respectively). Serious AEs were mostly related to bleeding events. Infusion-site reactions (mild, transient) were reported in 4.3% of esomeprazole-treated patients versus 0.5% of placebo patients. These did not lead to treatment discontinuation.. Esomeprazole, given as a continuous high-dose intravenous infusion followed by an oral regimen after successful endoscopic therapy for PUB, was well tolerated, with no apparent safety concerns from either the high-dose intravenous treatment or oral phases.

Topics: Administration, Oral; Adult; Aftercare; Aged; Aged, 80 and over; Dosage Forms; Double-Blind Method; Esomeprazole; Female; Hemostasis, Endoscopic; Humans; Infusions, Intravenous; Male; Middle Aged; Monitoring, Physiologic; Peptic Ulcer; Peptic Ulcer Hemorrhage; Proton Pump Inhibitors; Secondary Prevention; Treatment Outcome

The purpose of this study was to evaluate the influence of adding Lactobacillus acidophilus to a triple regimen for Helicobacter pylori eradication in untreated patients with peptic ulcers or ulcer-scars. This was a pre-randomized, single-blind, interventional, treatment-efficacy study with active controls and parallel-assignment, set in Coimbra, Portugal, on 62 consecutive H. pylori-positive untreated adults with peptic ulcers or ulcer-scars, diagnosed by gastroduodenoscopy, with pre-treatment direct Gram-staining and culture of gastric biopsies. The first 31 patients received esomeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg (EAC), all b.i.d., for 8 days. The remaining 31 added L. acidophilus, 5 × 10(9) organisms per capsule, 3 + 2 i.d. for 8 days (EACL). The main outcome measure was (13)C urea breath test (UBT), ≥6 weeks after completion of therapy. Successful eradication (UBT-negativity after treatment), was similar in both groups (EAC = 80.6%; EACL = 83.9%, p = 0.740) by both intention-to-treat and per-protocol analysis. The non-eradicated strains were susceptible in vitro to both antibiotics. Adding L. acidophilus to EAC triple therapy did not increase H. pylori eradication rates. Considering the cost and the burden of ingesting five extra capsules daily, supplementing the EAC therapy with L. acidophilus, at this dose, shows no benefit. Further studies with different dosages and duration of treatment, and other probiotics or probiotic combinations are required to improve eradication.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Clarithromycin; Combined Modality Therapy; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lactobacillus acidophilus; Male; Microbial Sensitivity Tests; Middle Aged; Peptic Ulcer; Probiotics; Single-Blind Method; Treatment Outcome; Urea; Young Adult

To determine whether once-daily esomeprazole 40 mg or 20 mg compared with placebo reduces the incidence of peptic ulcers over 26 weeks of treatment in patients taking low-dose acetylsalicylic acid (ASA) and who are at risk for ulcer development.. Multinational, randomised, blinded, parallel-group, placebo-controlled trial.. Cardiology, primary care and gastroenterology centres (n=240).. Helicobacter pylori-negative patients taking daily low-dose ASA (75-325 mg), who fulfilled one or more of the following criteria: age ≥18 years with history of uncomplicated peptic ulcer; age ≥60 years with either stable coronary artery disease, upper gastrointestinal symptoms and five or more gastric/duodenal erosions, or low-dose ASA treatment initiated within 1 month of randomisation; or age ≥65 years. All patients were ulcer-free at study entry.. Once-daily, blinded treatment with esomeprazole 40 mg, 20 mg or placebo for 26 weeks.. The primary end point was the occurrence of endoscopy-confirmed peptic ulcer over 26 weeks.. A total of 2426 patients (52% men; mean age 68 years) were randomised. After 26 weeks, esomeprazole 40 mg and 20 mg significantly reduced the cumulative proportion of patients developing peptic ulcers; 1.5% of esomeprazole 40 mg and 1.1% of esomeprazole 20 mg recipients, compared with 7.4% of placebo recipients, developed peptic ulcers (both p<0.0001 vs placebo). Esomeprazole was generally well tolerated. Conclusions Acid-suppressive treatment with once-daily esomeprazole 40 mg or 20 mg reduces the occurrence of peptic ulcers in patients at risk for ulcer development who are taking low-dose ASA. Clinical trial registration number ClinicalTrials.gov identifier: NCT00441727.

Topics: Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Aspirin; Esomeprazole; Female; Humans; Male; Middle Aged; Peptic Ulcer; Young Adult

To observe the effect of birid triple viable on peptic ulcer patients with Helicobacter pylori(H.pylori) infection.. A total of 120 peptic ulcer patients with H.pylori infection was randomly divided into 2 groups. The control group was treated with the triple therapy including Esomeprazole, Amoxicillin, and Furazolidone. The treatment group was treated with the same triple therapy plus birid triple viable. The pH values of the gastric juice, bacterial culture of the gastric juice, the therapy-related side effects and the healing rate of ulcer and erosive were observed before the treatment and after a 14-day-treatment respectively. The (14)C-urea breath test((14)C-UBT) was used to evaluate the H.pylori eradication rates 4 weeks after the treatment.. After the treatment, pH values of the gastric juice in both groups were significantly higher than those before the treatment (P<0.05). When pH values of the gastric juice ≥4, the positive rate of bacterial culture in the treatment group was lower than that of the control group (80.0% and 97.4% respectively, P<0.05). The rate of adverse effects in the treatment group was lower than that in the control group (11.7% and 30% respectively, P<0.05).After a 2-week treatment, the healing rate of ulcer and erosion was 80% and 68.7% in the treatment group, and 73.3% and 40.7% in the control group. The healing rate of ulcer had no significant difference in the 2 groups (P>0.05),while the healing rate of erosion in the treatment group was higher than that of the control group (P<0.05).The H.pylori eradication rates evaluated by per-protocol (PP) analysis in the treatment group was significantly higher than that of the control group (80.4% and 62.4% respectively, P<0.05).. The combined use of birid triple viable and the triple therapy of H.pylori in peptic ulcer patients with H.pylori infection can reduce the bacteria of the gastric juice and therapy-related side effects. It can increase the H.pylori eradication rate and promote the healing of erosion.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Lactobacillus acidophilus; Male; Peptic Ulcer

Low-dose aspirin is standard treatment for prevention of cardiovascular events in at-risk patients. However, long-term administration of low-dose aspirin is associated with a greater risk of adverse events, including gastroduodenal ulcers. This study determined the efficacy of esomeprazole for reducing the risk of gastric and/or duodenal ulcers and dyspeptic symptoms in patients receiving continuous, low-dose aspirin therapy.. Patients aged > or =60 yr, without baseline gastroduodenal ulcer at endoscopy, who were receiving aspirin 75-325 mg once daily, were randomized to esomeprazole 20 mg once daily or placebo for 26 wk. The presence of endoscopic gastric and/or duodenal ulcers and esophageal lesions was assessed at weeks 8 and 26. Upper gastrointestinal symptoms were assessed at weeks 8, 16, and 26.. The intention-to-treat population comprised 991 patients (esomeprazole, N = 493; placebo, N = 498). Twenty-seven patients (5.4%) in the placebo group developed a gastric or duodenal ulcer during 26 weeks' treatment compared with eight patients (1.6%) in the esomeprazole group (life-table estimates: 6.2%vs 1.8%; P= 0.0007). At 26 wk, the cumulative proportion of patients with erosive esophagitis was significantly lower for esomeprazole versus placebo (4.4% and 18.3%, respectively; P < 0.0001). At 26 wk, esomeprazole-treated patients were more likely to experience resolution of heartburn, acid regurgitation, and epigastric pain (P < 0.05).. Esomeprazole 20 mg once daily reduces the risk of developing gastric and/or duodenal ulcers and symptoms associated with the continuous use of low-dose aspirin in patients aged > or =60 yr without preexisting gastroduodenal ulcers.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Dose-Response Relationship, Drug; Double-Blind Method; Endoscopy, Gastrointestinal; Enzyme Inhibitors; Esomeprazole; Female; Follow-Up Studies; Global Health; Humans; Incidence; Male; Peptic Ulcer; Retrospective Studies; Risk Factors; Treatment Outcome

This prospective, randomized, controlled study was conducted to compare the efficacies of high-dose and low-dose esomeprazole-based triple therapies for Helicobacter pylori eradication in Taiwan.. From January 2004 to June 2006, 240 H. pylori-infected patients were randomly assigned to undergo high-dose (40 mg b.d.) or low-dose (40 mg o.d.) esomeprazole combined with clarithromycin (500 mg b.d.) and amoxicillin (1 g b.d.) for one week. Follow-up endoscopy was performed at eight weeks after the end of treatment to evaluate the response to therapy.. Intention-to-treat analysis demonstrated no differences between eradication rates of high-dose and low-dose groups (92% vs. 90%, respectively, P > 0.05). Per-protocol analysis yielded comparable results (95% vs. 93%). Both groups exhibited similar frequencies of adverse events (13% vs. 11%) and drug compliance (96% vs. 93%). Multivariate analysis indicated that only good compliance (odds ratio: 10.3, 95% CI, 3.0-35.7) was an independent predictor of treatment success.. This work demonstrates that low-dose esomeprazole-based triple therapy yields a similar eradication rate as high-dose esomeprazole-based therapy in Taiwan. Since the cost of the low-dose regime is lower than that of the high-dose regime, low-dose esomeprazole-based triple therapy can reasonably be recommended for the first-line eradication of H. pylori for Taiwanese and probably most Asians.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Dose-Response Relationship, Drug; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Peptic Ulcer; Pilot Projects; Prospective Studies; Treatment Outcome

The aim of the research was to determine the effectivity and the safety of the intravenous application of Esomeprazole (Nexium - Astra Zeneca) like prevention of the development of stress-ulcers of the gastric mucous with high risk patients at ICU with mechanic ventilation.. 47 patients subjected to mechanic ventilation over 48 hours with availability of just one more risk factor for development of stress-ulcers of gastric musous were included in the study. Samples of gastric juice for determination of the acidity and presence of fresh erythrocytes and microbiological cultures from gastric contents, wash away of the mouth cavity and tracheal aspiration were tested on the 1st, the 3rd and the 5th day from the start of the treatment. At the end of the therapy there has been determinated the outcome - survivor or died and total quantity of the haemotransfusions.. The acidity of the gastric juice changed in the range over pH 5 during the 24 hours by the application of esomeprazole. Fibrogastroscopic examinations were performed of patients who were found to have fresh erythrocytes in the gastric contents. No one was registered with bleeding of the gastric mucous. The isolated microorganisms of the gastric juice and wash away of mouth cavity were identical with those of tracheobronchial aspiration in about 13 %.. In our study the application of esomeprazole i.v. was effective and safe approach for profilaxy of the stress-ulcers and the bleeding of the gastric mucous. Comparative studies with H2-blockers and sucralfat are necessary for clarifying and objectifying the significance of the microbiologic isolates of the gastric contents and wash away from mouth cavity and their relation to the development of nosocomial pneumonia.

Topics: Anti-Ulcer Agents; APACHE; Esomeprazole; Female; Gastric Acid; Gastric Acidity Determination; Gastric Mucosa; Humans; Injections, Intravenous; Intensive Care Units; Male; Middle Aged; Peptic Ulcer; Respiration, Artificial; Stress, Psychological; Treatment Outcome

This prospective, randomized, controlled, head-to-head study was conducted to compare the efficacies of esomeprazole- and pantoprazole-based triple therapies for Helicobacter pylori eradication.. From January 2002 to October 2003, 200 H. pylori-infected patients were randomly assigned to undergo twice daily treatment with esomeprazole 40 mg (n = 100) or pantoprazole 40 mg (n = 100) combined with clarithromycin 500 mg and amoxicillin 1 g for 1 wk (ECA and PCA groups, respectively). Follow-up endoscopy was performed at 8 wks after the end of treatment to assess the treatment response.. Intention-to-treat analysis demonstrated a significantly higher eradication rate for the ECA group than for the PCA group (94%vs 82%, respectively, p= 0.009). Per-protocol analysis also showed similar results (97%vs 84%, p= 0.003). Both groups had similar frequencies of adverse events (15%vs 24%) and drug compliance (97%vs 96%). Multivariate analysis disclosed that the use of esomeprazole (OR: 1.56, 95% CI, 1.11-2.19) and good compliance 7.39 (95% CI, 1.27-42.95) were independent predictors of treatment success. Alcohol drinking was an independent predictor of eradication failure (OR: 0.18; 95% CI, 0.06-0.54).. Esomeprazole-based triple therapy demonstrated a higher eradication rate than pantoprazole-based regimen. The differences in eradiation efficacies between the two study groups may be related to the more powerful acid inhibition effect and stronger anti-H. pylori activity of esomeprazole compared to pantoprazole.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Alcohol Drinking; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Benzimidazoles; Clarithromycin; Drug Therapy, Combination; Enzyme Inhibitors; Esomeprazole; Female; Follow-Up Studies; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Pantoprazole; Patient Compliance; Peptic Ulcer; Pilot Projects; Prospective Studies; Proton Pump Inhibitors; Sulfoxides; Treatment Outcome

Esomeprazole is efficient for acid-dependent diseases of the gastrointestinal tract in patients with chronic hepatitis and hepatic cirrhosis as it can reduce the disease symptoms and cause the epithelization of erosive and ulcerative defects of the mucous coat. The terms of the cicatrisation of erosive and ulcerative defects of the mucous coat of the esophagus, stomach and duodenum are comparable in patients with liver diseases and in the population (without chronic hepatic diseases). The simultaneous application of Nexium and modern hepatotropic drugs does not cause the development of hepatotoxic reactions.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Chronic Disease; Esomeprazole; Female; Gastric Acid; Hepatitis, Chronic; Humans; Liver Cirrhosis; Male; Middle Aged; Peptic Ulcer

Side effects of proton pump inhibitors (PPI) can be linked to the changes in the intestinal microbiome that occur during therapy, especially in long-term users. Therefore, the microbiome might also be a key player in the reduction of PPI side effects. We tested the effects of a three-month intervention with a multispecies synbiotic on intestinal inflammation, gut barrier function, microbiome composition, routine laboratory parameters and quality of life in patients with long-term PPI therapy. Thirty-six patients received a daily dose of a multispecies synbiotic for three months and were clinically observed without intervention for another three months. After intervention 17% of patients reached normal calprotectin levels; the overall reduction did not reach statistical significance (-18.8 ng/mg; 95%CI: -50.5; 12.9, p = 0.2). Elevated zonulin levels could be significantly reduced (-46.3 ng/mg; 95%CI: -71.4; -21.2; p < 0.001). The abundance of Stomatobaculum in the microbiome was reduced and Bacillus increased during the intervention. Furthermore, albumin, alkaline phosphatase and thrombocyte count were significantly increased and aspartate transaminase was significantly decreased during intervention. Gastrointestinal quality of life showed significant improvements. In conclusion, microbiome-related side effects of long-term PPI use can be substantially reduced by synbiotic intervention. Further studies are warranted to optimize dosage and duration of the intervention.

Topics: Aged; Alkaline Phosphatase; Anti-Ulcer Agents; Aspartate Aminotransferases; Bacillus; Clostridiales; Dysbiosis; Esomeprazole; Female; Gastroesophageal Reflux; Gastrointestinal Microbiome; Gene Expression Regulation; Haptoglobins; Humans; Lactobacillus; Lactococcus; Leukocyte L1 Antigen Complex; Male; Middle Aged; Pantoprazole; Peptic Ulcer; Pilot Projects; Prebiotics; Probiotics; Protein Precursors; Proton Pump Inhibitors; Quality of Life

Critically ill patients admitted to intensive care units (ICUs) are at high risk of developing upper gastrointestinal bleeding due to GI stress ulceration (SU). The major independent risk factors for the development of GI bleeding in the ICUs include mechanical ventilation (MV) and coagulopathy. There is no enough evidence regarding the most appropriate dosing of esomeprazole as stress ulcer prophylaxis (SUP) in critically ill patients. This is a retrospective cohort study conducted at King Abdulaziz Medical City-Riyadh between January and December 2018 to determine the efficacy and safety of two different regimens of esomeprazole (20 vs 40 mg) as SUP in critically ill patients with major risk factors of GI stress ulceration. A total of 1864 patients were reviewed, 387 patients meeting inclusion criteria were enrolled. The propensity score was used to adjust for clinically and statistically relevant variables. We considered a P value of <.05 as statistically significant. 49 patients (12.6%) had received Esomeprazole 20 mg during the study period. Compared with Esomeprazole 20 mg, Esomeprazole 40 mg was not superior in GI bleeding prevention (aOR 2.611, 95% CI 0.343-20.247, P = .356). In addition, neither ICU C. difficle, ICU mortality within 30 days, ICU LOS, hospital LOS, ICU re-admission within 6 months, RBCs transfusion, nor platelets transfusion requirements were significant. On the other hand, Esomeprazole 40 mg was statistically associated with Enterobacteriaceae, Pneumonia, and longer MV duration.

Topics: Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Cohort Studies; Critical Illness; Dose-Response Relationship, Drug; Esomeprazole; Female; Gastrointestinal Hemorrhage; Humans; Intensive Care Units; Length of Stay; Male; Middle Aged; Peptic Ulcer; Proton Pump Inhibitors; Retrospective Studies; Risk Factors

The eradication rate of Helicobacter pylori (H. pylori) has been decreasing every year, mainly due to the increase in antibiotic resistance. In fact, many other factors may affect H. pylori eradication. To analyze the clinical factors affecting the initial eradication therapy in Chinese patients with H. pylori infection. We conducted a retrospective study on 264 outpatients who were diagnosed with H. pylori-associated chronic gastritis and peptic ulcer disease between January and December 2015 at a large tertiary hospital in China. The patients were divided into three groups: ECA, RCA, and RCM (R: 20 mg rabeprazole, E: 40 mg esomeprazole, C: 0.5 g clarithromycin, A: 1.0 g amoxicillin and M: 0.4 g metronidazole). The patients were treated for 14 days and followed up for 1 year. The 14C-urea breath test (14C-UBT) was performed 4 weeks after the completion of the eradication therapy. The eradication rate was higher in ≥ 40-year-old patients than in < 40-year-old-patients (85.7% vs. 54.7%, p = 0.002). Multivariate analyses revealed only age ≥ 40 years to be significantly associated with a high H. pylori eradication rate [odds ratio (OR) 4.58, p = 0.003]. The H. pylori eradication rate in patients with duodenal ulcers was significantly higher than that in patients with gastric ulcers (79% vs. 60%, p = 0.012). Age could be a predictor of successful H. pylori eradication. Patients with duodenal ulcers had a higher H. pylori eradication rate than those with other lesions.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Peptic Ulcer; Proton Pump Inhibitors; Rabeprazole; Retrospective Studies

Topics: Aged, 80 and over; Endoscopy, Digestive System; Esomeprazole; Female; Gastric Juice; Humans; Omeprazole; Peptic Ulcer; Proton Pump Inhibitors

Our aims were to assess risks of early rebleeding after successful endoscopic hemostasis for Forrest oozing (FIB) peptic ulcer bleeding (PUBs) compared with other stigmata of recent hemorrhage (SRH).. These were post hoc multivariable analyses of a large, international, double-blind study (NCT00251979) of patients randomized to high-dose intravenous (IV) esomeprazole (PPI) or placebo for 72 h. Rebleeding rates of patients with PUB SRH treated with either PPI or placebo after successful endoscopic hemostasis were also compared.. For patients treated with placebo for 72 h after successful endoscopic hemostasis, rebleed rates by SRH were spurting arterial bleeding (FIA) 22.5%, adherent clot (FIIB) 17.6%, non-bleeding visible vessel (FIIA) 11.3%, and oozing bleeding (FIB) 4.9%. Compared with FIB patients, FIA, FIIB, and FIIA had significantly greater risks of rebleeding with odds ratios (95% CI's) from 2.61 (1.05, 6.52) for FIIA to 6.66 (2.19, 20.26) for FIA. After hemostasis, PUB rebleeding rates for FIB patients at 72 h were similar with esomeprazole (5.4%) and placebo (4.9%), whereas rebleed rates for all other major SRH (FIA, FIIA, FIIB) were lower for PPI than placebo, but the treatment by SRH interaction test was not statistically significant.. After successful endoscopic hemostasis, FIB patients had very low PUB rebleeding rates irrespective of PPI or placebo treatment. This implies that after successful endoscopic hemostasis the prognostic classification of FIB ulcers as a high-risk SRH and the recommendation to treat these with high-dose IV PPI's should be re-evaluated.

Topics: Administration, Intravenous; Aged; Double-Blind Method; Electrocoagulation; Endoscopy, Digestive System; Epinephrine; Esomeprazole; Female; Hemostasis, Surgical; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Peptic Ulcer; Peptic Ulcer Hemorrhage; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Surgical Instruments; Treatment Outcome; Vasoconstrictor Agents

Whether minocycline can replace tetracycline in Helicobacter pylori (H. pylori) eradication remains unclear. The aim of this study was to determine the efficacy, safety, patient compliance and risk factors of a combination regimen of esomeprazole, minocycline, metronidazole and bismuth (EMMB) for H. pylori eradication.. In this prospective single-center study, 152 patients in the first-line therapy group and 64 in the second-line therapy group received EMMB therapy (esomeprazole 20 mg twice daily, minocycline 100 mg twice daily, metronidazole 400 mg four times daily and bismuth potassium citrate 110 mg four times daily) for 14 days. The eradication outcome was assessed by (13) C-urea breath test 6-12 weeks after treatment.. EMMB therapy achieved eradication rates of 85.5% [95% confidence interval (CI) 79.6-91.4%] using intention-to-treat (ITT) analysis, 90.3% (95% CI 84.7-95.1%) using modified intention-to-treat (mITT) analysis and 92.6% (95% CI 88.1-96.3%) using per-protocol (PP) analysis as the first-line therapy; and 82.8% (95% CI 71.9-90.6%), 86.9% (95% CI 77.1-95.1%) and 89.5% (95% CI 80.7-96.5%) as the second-line therapy, respectively. In the first-line group, 35.6% of the patients experienced adverse effects, 4.7% discontinued medications because of adverse effects and good compliance was achieved in 91.3%, while the results were 36.5%, 3.2% and 90.5% in the second-line therapy group. Poor compliance was identified as an independent predictor of treatment failure.. The efficacy of EMMB therapy for H. pylori eradication as first-line and second-line regimens in a region with high rates of antibiotic resistance is satisfactory with relatively good patient compliance and high safety.

Topics: Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Confidence Intervals; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Middle Aged; Minocycline; Patient Compliance; Peptic Ulcer; Prospective Studies; Tetracycline

Topics: Diagnosis, Differential; Diarrhea; Digestive System Surgical Procedures; Duodenal Neoplasms; Duodenal Ulcer; Duodenum; Endoscopy, Digestive System; Esomeprazole; Fluid Therapy; Gastrinoma; Humans; Male; Middle Aged; Neoplasm Staging; Osmolar Concentration; Peptic Ulcer; Proton Pump Inhibitors; Rehydration Solutions; Tomography, Emission-Computed, Single-Photon; Tomography, X-Ray Computed; Treatment Outcome; Water-Electrolyte Balance

Complications of peptic ulcer disease (PUD) like gastric outlet obstruction (GOO) and biliary fistula have become extremely rare with the advent of proton-pump inhibitors.This is a case of PUD presenting with GOO, a cholecystoduodenal fistula discovered incidentally on upper gastrointestinal endoscopy, and the presence of pneumobilia on a contrast-enhanced CT of the abdomen. A gastrojejunostomy with internal pyloric exclusion was performed. Since the patient did not have any signs of biliary tract disease,we decided not to operate on the fistula to prevent injury to the bile duct. The patient had an uneventful recovery.

Topics: Amoxicillin; Anti-Bacterial Agents; Biliary Tract Diseases; Clarithromycin; Esomeprazole; Gastric Bypass; Gastric Outlet Obstruction; Humans; Intestinal Fistula; Male; Middle Aged; Peptic Ulcer; Postprandial Period; Proton Pump Inhibitors; Treatment Outcome; Vomiting; Weight Loss

There is little evidence regarding the benefit of stress ulcer prophylaxis (SUP) outside a critical care setting. Overprescription of SUP is not devoid of risks. This prospective study aimed to evaluate the use of proton pump inhibitors (PPIs) for SUP in a general surgery department.. Data collection was performed prospectively during an 8-week period on patients hospitalized in a general surgery department (58 beds) by pharmacists. Patients with a PPI prescription for the treatment of ulcers, gastro-oesophageal reflux disease, oesophagitis or epigastric pain were excluded. Patients admitted twice during the study period were not reincluded. The American Society of Health-System Pharmacists guidelines on SUP were used to assess the appropriateness of de novo PPI prescriptions.. Among 255 patients in the study, 138 (54%) received a prophylaxis with PPI, of which 86 (62%) were de novo PPI prescriptions. A total of 129 patients (94%) received esomeprazole (according to the hospital drug policy). The most frequent dosage was at 40 mg once daily. Use of PPI for SUP was evaluated in 67 patients. A total of 53 patients (79%) had no risk factors for SUP. Twelve and two patients had one or two risk factors, respectively. At discharge, PPI prophylaxis was continued in 33% of patients with a de novo PPI prescription.. This study highlights the overuse of PPIs in non-intensive care unit patients and the inappropriate continuation of PPI prescriptions at discharge. Treatment recommendations for SUP are needed to restrict PPI use for justified indications.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Esomeprazole; Female; Humans; Inappropriate Prescribing; Male; Medical Audit; Middle Aged; Peptic Ulcer; Prospective Studies; Proton Pump Inhibitors; Stress, Physiological; Surgery Department, Hospital; Switzerland; Young Adult

The most effective schedule of proton pump inhibitor (PPI) administration following endoscopic hemostasis of bleeding ulcers remains uncertain.. To compare the treatment effects of continuous infusion and low-dose esomeprazole therapies in patients with non-variceal upper gastrointestinal (GI) bleeding.. This prospective clinical study compared continuous infusion of esomeprazole (80 mg bolus followed by 8 mg∕h continuous infusion for 72 h) and low-dose esomeprazole (40 mg twice daily IV) treatments in GI bleeding patients with peptic ulcer presenting a high risk of re-bleeding, who were administered a successful endoscopic homeostasis. The primary end point was the occurrence of re-bleeding during hospitalization and within one month of discharge. Secondary outcomes were defined as duration of hospitalization, need of transfusion, surgical treatment, and mortality rate. After 72 h, both groups were switched to oral esomeprazole therapy for one-month.. A hundred thirty-two subjects were enrolled. Re-bleeding occurred in 11 (16.7%) patients in the infusion therapy group and in 12 (18.2%) patients in the low-dose group (P=0.819) within the first 72 h. No patient experienced re-bleeding in the first month following discharge. There was no statistical significant difference between the two groups in terms of transfusion need, durations of hospitalization, need for surgery and mortality rate.. PPI infusion therapy following endoscopic hemostasis treatment was not found superior to low-dose PPI therapy in the terms of re-bleeding, need of surgery and mortality.

Topics: Aged; Blood Transfusion; Dose-Response Relationship, Drug; Esomeprazole; Female; Gastrointestinal Hemorrhage; Hemostasis, Endoscopic; Hospitalization; Humans; Infusions, Intravenous; Length of Stay; Male; Middle Aged; Peptic Ulcer; Prospective Studies; Proton Pump Inhibitors; Recurrence; Upper Gastrointestinal Tract; Vascular Surgical Procedures

Conflicting results have been reported whether patients with non-ulcer dyspepsia (NUD) respond differently to Helicobacter pylori (H. pylori) eradication treatment compared with patients with peptic ulcer diseases (PUD). The aim of this study was to evaluate any difference in H. pylori eradication rates between patients with NUD and PUD according to each proton pump inhibitor (PPI).. From September, 2004 to April, 2007, we retrospectively reviewed 2,297 patients with NUD (1,050 patients) or PUD (1,247 patients) infected with H. pylori. All patients received a standard 1 week triple therapy comprising of one of the five PPIs (pantoprazole, esomeprazole, omeprazole, lansoprazole, rabeprazole), clarithromycin and amoxicillin. The follow-up H. pylori test was performed 4 weeks after the completion of therapy.. There was no significant difference in the eradication rates between the two groups. In comparison of eradication rates according to PPI, omeprazole- based triple therapy group showed higher eradication rate than other groups in patients with NUD, but not in patients with PUD.. This study failed to show any difference in H. pylori eradication rate between patients with NUD and PUD. There is no convincing evidence that the eradication rate may be affected by different PPI.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Data Interpretation, Statistical; Drug Therapy, Combination; Dyspepsia; Enzyme Inhibitors; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Middle Aged; Omeprazole; Pantoprazole; Peptic Ulcer; Proton Pump Inhibitors; Rabeprazole

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Dose-Response Relationship, Drug; Double-Blind Method; Endoscopy, Gastrointestinal; Enzyme Inhibitors; Esomeprazole; Female; Follow-Up Studies; Humans; Incidence; Male; Peptic Ulcer; Retrospective Studies; Risk Factors; Treatment Outcome

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Alcohol Drinking; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Benzimidazoles; Clarithromycin; Drug Therapy, Combination; Enzyme Inhibitors; Esomeprazole; Female; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Pantoprazole; Patient Compliance; Peptic Ulcer; Proton Pump Inhibitors; Sulfoxides; Treatment Outcome

In vitro activity of rifampicin has been shown against H. pylori. It has also been reported that the prevalence of H. pylori is low in patients with tuberculosis treated with rifampicin. Clinical trials are required to establish the efficacy of rifampicin as a salvage therapy for eradication of H. pylori. We aimed to evaluate the efficacy of rifampicin-based salvage therapy for eradication of H. pylori in patients with peptic ulcer disease. Twenty-eight patients with peptic ulcer disease who either had failed eradication of H. pylori or had a recurrence of H. pylori following successful eradication were included in the prospective study. The inclusion criteria included one or more failed attempts at eradication and presence of H. pylori infection as evidenced by positivity of at least two of three tests: rapid urease test (RUT), 14C urea breath test (UBT), and histology. The subjects were treated with a 10-day regimen consisting of rifampicin, 450 mg od, tetracycline, 1 g bd, and esomeprazole, 40 mg bd. Four weeks after completion of therapy, H. pylori status was assessed by RUT, 14C, UBT, and histology. Liver function tests were done before and at the end of therapy. The study subjects included 25 males and 3 females with a mean age of 33.7+/-8.92 years (range: 22-65 years). The median duration of symptoms was 42 months, with a range of 1-180 months. The median number of eradication attempts was two, with one prior attempt in 6 (21.4%), two attempts in 19 (67.9%), and three attempts in 3 (10.7%) patients. Successful H. pylori eradication as defined by concomitant negativity of RUT, UBT, and histology with special stains was achieved in 32.1% (9/28) of patients by intention-to-treat and 33.3% (9/27) of patients by per-protocol analysis. This pilot study suggests that rifampicin-based regimes have no role as salvage eradication therapy in refractory cases of H. pylori infection with peptic ulcer disease.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Peptic Ulcer; Pilot Projects; Prospective Studies; Retreatment; Rifampin; Salvage Therapy; Tetracycline; Treatment Failure

Since their introduction in the late 1980s, proton pump inhibitors have demonstrated gastric acid suppression superior to that of histamine H2-receptor blockers. Proton pump inhibitors have enabled improved treatment of various acid-peptic disorders, including gastroesophageal reflux disease, peptic ulcer disease, and nonsteroidal antiinflammatory drug-induced gastropathy. Proton pump inhibitors have minimal side effects and few significant drug interactions, and they are generally considered safe for long-term treatment. The proton pump inhibitors omeprazole, lansoprazole, rabeprazole, and the recently approved esomeprazole appear to have similar efficacy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Benzimidazoles; Drug Interactions; Esomeprazole; Gastroesophageal Reflux; Humans; Lansoprazole; Omeprazole; Pantoprazole; Peptic Ulcer; Proton Pump Inhibitors; Rabeprazole; Sulfoxides