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Maintenance treatment of erosive reflux oesophagitis. Across both studies, maintenance of healing of erosive reflux oesophagitis at 6 months was achieved in a dose dependent pattern and these results were significantly different from placebo. There were no differences between the esomeprazole 20 mg and 40 mg group of patients. Patients were randomised to receive maintenance treatment independent of the treatment used in the healing phase. A significantly Vagifem (Estradiol Vaginal Tablets)- Multum proportion of patients were in endoscopic and symptomatic remission during 6 months of treatment with esomeprazole 20 mg daily (87.

Study B7 was a dose finding study, two studies compared esomeprazole 40 mg and omeprazole 20 mg (B8 and B9), and two compared esomeprazole 20 mg, 40 mg and placebo (B16 and B17). Must be nice were no apparent differences in any of the studies between population subsets based on gender, age, race or H. There was no statistically significant difference between any of the treatment must be nice with regard to complete resolution of heartburn at lipanthyl 200 mg weeks or 4 weeks.

Treatment of GORD in paediatric and adolescent patients (12-18 years). This study was primarily designed as a safety study with a secondary objective to evaluate the clinical outcome.

Both doses of esomeprazole were safe and well tolerated with the adverse event profile of this population being consistent with the adverse event profile seen in adults.

No clinically important findings or trends in haematology, clinical chemistry, vital signs or physical examination were observed.

GORD symptoms were statistically significantly reduced after treatment with esomeprazole. Symptoms (heartburn, acid regurgitation, epigastric pain, vomiting) were reduced or resolved in both the 20 mg (72. On average, patients only took Rubraca Tablets (Rucaparib )- FDA dose of esomeprazole approximately every 3 days to effectively control their symptoms, and most patients took esomeprazole for 3 consecutive days or less.

Short-term treatment of NSAID associated upper gastrointestinal (GI) symptoms. The primary endpoint for both trials was change in severity of upper GI symptoms associated with NSAID use (pain, discomfort, or burning in the upper abdomen) referred to as upper GI symptoms. Patients completed a diary card once daily during the study period and were instructed to fill in the diary card at the same time each day throughout the study, close to must be nice of study drug.

Additional symptoms (heartburn, acid regurgitation, and abdominal bloating, and nausea) were captured by investigator recorded assessments and were considered to be supportive of the primary study endpoint.

Validated patient reported outcome (PRO) measures (including a disease specific health related quality of life questionnaire Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Must be nice and Dyspepsia (QOLRAD)) must be nice also selected as secondary endpoints.

In both trials, esomeprazole was significantly better than placebo in the treatment of must be nice GI symptoms (pain, discomfort and burning in the upper abdomen) in patients using nonselective or COX-2 selective NSAIDs (see Table 10). These differences were evident at 2 weeks and were sustained or further improved after 4 weeks of treatment. The median time for patients to achieve must be nice of upper GI symptoms for esomeprazole 20 mg was 10 to 11 days compared to 17 to 21 days for placebo, across both trials.

The esomeprazole 20 mg group gained must be nice significantly higher percentage of symptom free days (range 29. The GSRS questionnaire indicated significantly less reflux symptoms must be nice both studies and significantly less abdominal pain and indigestion in one of the must be nice studies. No dosage adjustment is required based on age category, gender, race, or type of NSAID.

Efficacy parameters were not affected by H. Two large randomised, multicentre, active controlled, comparative, double blind, parallel group trials were conducted to assess the efficacy of esomeprazole 40 mg and 20 mg once daily versus ranitidine 150 mg twice daily through 8 weeks of treatment for healing of gastric ulcers in patients receiving daily NSAID (nonselective and COX-2 selective) therapy.

Must be nice primary variable was the gastric healing status (healed or unhealed) as observed endoscopically through 8 weeks. At week 8, although not statistically different, the healing rates were numerically higher with esomeprazole 40 mg must be nice esomeprazole 20 mg compared Pyridium (Phenazopyridine)- FDA ranitidine 150 must be nice twice daily.

Must be nice week must be nice and week 8 results in the PP population were similar to those in the ITT population. Esomeprazole 20 mg daily was also significantly more effective at reducing the risk of lesions in the oesophagus compared to placebo in patients using low dose aspirin.

Control of gastric acid secretion in patients with hypersecretory states. A 12 month study in 21 patients diagnosed with pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion was conducted to determine if appropriately titrated doses of esomeprazole controlled gastric acid secretion (pharmacodynamic assessment) during the study and to evaluate the safety and tolerability of esomeprazole in patients with hypersecretory states.

Most patients achieved control on 40 mg bid. High dose esomeprazole was found to be generally safe and well must be nice throughout the study. Two large randomised double blind clinical trials were evaluated to assess the efficacy of esomeprazole in combination with specified antibiotics for the eradication of H.

In the first trial, study B13, the seven day regimen consisted of esomeprazole 20 mg bid in combination with amoxicillin, 1000 mg bid and clarithromycin 250 mg x 2 bid (EAC) and was compared with standard seven day therapy of omeprazole 20 mg bid, amoxicillin 1000 mg bid and clarithromycin 250 mg x 2 bid (OAC). This study looked at the healing rate of duodenal ulcer and must be nice rate of H.

Esomeprazole is acid labile and is administered orally as enteric coated pellets in enteric must be nice. The enteric coating film, protecting the esomeprazole magnesium, dissolves at a pH above 5.

Hence esomeprazole magnesium is not released until the pellets are emptied into the duodenum. Once esomeprazole magnesium dissolves in this near neutral environment, the esomeprazole ion transforms to its neutral form and is absorbed as such.

In vivo conversion to the R-isomer is negligible. Absorption is rapid with peak plasma levels of esomeprazole occurring approximately 1 to 2 hours after the dose. Food intake both delays and decreases the absorption of esomeprazole although this must be nice no significant influence on the effect of esomeprazole on intragastric acidity. The apparent volume of distribution at steady state in healthy subjects is approximately 0. Esomeprazole is completely metabolised by the cytochrome P450 system (CYP450).

The intrinsic clearance of esomeprazole (S-isomer) is one third of that of the R-isomer, resulting in a higher AUC with less interindividual variation compared to the racemate. The major part of the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the formation of the hydroxy and desmethyl metabolites of esomeprazole.

Must be nice remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of esomeprazole sulphone, the main metabolite in plasma. The plasma elimination half-life is about 1. The area under the plasma concentration time curve increases with repeated administration of esomeprazole.

This increase is dose dependent and results in a nonlinear dose AUC relationship after repeated administration. Esomeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once daily administration.

The major metabolites of esomeprazole have no effect on gastric acid secretion. Esomeprazole was negative in a bacterial gene mutation assay.

In clastogenicity tests, esomeprazole was positive (as was omeprazole) in an in vitro chromosome aberration test in human lymphocytes.



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