s-1743 and Diarrhea

Bismuth + proton pump inhibitor (PPI) + amoxicillin + levofloxacin is one of the bismuth quadruple therapy regimens widely used for the eradication of H. pylori infection. The recommended dosage of levofloxacin is 500 mg once daily or 200 mg twice daily to eradicate H. pylori infection. The aim of the present open-label, randomized control trial was to compare the effectiveness, safety, and compliance of different dosages of levofloxacin used to cure Helicobacter pylori infection. Eligible patients were randomly assigned to receive esomeprazole, amoxicillin, colloidal bismuth pectin and levofloxacin 500 mg once/day (group A) or levofloxacin 200 mg twice/day (group B) for 14 days. The primary outcome was the eradication rates in the intention-to-treat (ITT) and per protocol (PP) analyses. Overall, 400 patients were enrolled. The eradication rates in group A and group B were 77.5% and 79.5% respectively, in the ITT analysis, and 82.9% and 86.4%, respectively, in the PP analysis. No significant differences were found between two groups in terms of eradication rate, adverse effects or compliance. Oral levofloxacin 200 mg twice daily was similar in efficacy for eradicating H. pylori infection to oral levofloxacin 500 mg once daily but with lower mean total costs.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Diarrhea; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole; Exanthema; Female; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Middle Aged; Prospective Studies; Treatment Outcome

To evaluate safety, tolerability, and symptom improvement with once-daily esomeprazole in children with endoscopically proven gastroesophageal reflux disease (GERD).. In this 8-week, multicenter, randomized, uncontrolled, double-blind study, children ages 1 to 11 years were stratified by weight to receive esomeprazole 5 or 10 mg (children < 20 kg) or 10 or 20 mg (children ≥ 20 kg) once daily. Safety and tolerability was assessed by evaluating adverse events (AEs; both treatment- and non-treatment-related AEs) and changes from baseline in medical history, physical examinations, and clinical laboratory tests. Investigators scored symptom severity every 2 weeks using the Physician's Global Assessment (PGA). Patients' parents rated GERD symptoms of heartburn, acid regurgitation, and epigastric pain (none to severe, 0-3) at baseline (based on past 72 hours) and daily (from past 24 hours).. Of 109 patients randomized, 108 had safety data. AEs were experienced by 68.0% and 65.2% of children <20 kg receiving esomeprazole 5 and 10 mg, respectively, and 83.9% and 82.8% of children ≥ 20 kg receiving esomeprazole 10 and 20 mg, respectively, regardless of causality. Overall, only 9.3% of patients reported 13 treatment-related AEs; the most common were diarrhea (2.8% [3/108]), headache (1.9% [2/108]), and somnolence (1.9% [2/108]). Vomiting, a serious AE in 2 patients, was not judged by the investigator to be related to treatment. At the final visit, PGA scores improved significantly from baseline (P < 0.001). Of 58 patients with moderate to severe baseline PGA symptom scores, 91.4% had lower scores by the final visit. GERD symptom scores were significantly improved from baseline to the final week of the study in all of the treatment groups (P < 0.01) CONCLUSIONS:: In children ages 1 to 11 years with endoscopically proven GERD, esomeprazole (at daily doses of 5, 10, or 20 mg) was generally well tolerated. The frequency and severity of GERD-related symptoms were significantly reduced during the active treatment period.

Topics: Child; Child, Preschool; Diarrhea; Double-Blind Method; Esomeprazole; Female; Gastroesophageal Reflux; Headache; Humans; Infant; Male; Pediatrics; Proton Pump Inhibitors; Treatment Outcome

To evaluate safety, tolerability, and symptom improvement with once-daily esomeprazole in children with endoscopically proven gastroesophageal reflux disease (GERD).. In this 8-week, multicenter, randomized, uncontrolled, double-blind study, children ages 1 to 11 years were stratified by weight to receive esomeprazole 5 or 10 mg (children <20 kg) or 10 or 20 mg (children >or=20 kg) once daily. Safety and tolerability was assessed by evaluating adverse events (AEs; both treatment- and non-treatment-related AEs) and changes from baseline in medical history, physical examinations, and clinical laboratory tests. Investigators scored symptom severity every 2 weeks using the Physician's Global Assessment (PGA). Patients' parents rated GERD symptoms of heartburn, acid regurgitation, and epigastric pain (none to severe, 0-3) at baseline (based on past 72 hours) and daily (from past 24 hours).. Of 109 patients randomized, 108 had safety data. AEs were experienced by 68.0% and 65.2% of children <20 kg receiving esomeprazole 5 and 10 mg, respectively, and 83.9% and 82.8% of children >or=20 kg receiving esomeprazole 10 and 20 mg, respectively, regardless of causality. Overall, only 9.3% of patients reported 13 treatment-related AEs; the most common were diarrhea (2.8% [3/108]), headache (1.9% [2/108]), and somnolence (1.9% [2/108]). Vomiting, a serious AE in 2 patients, was not judged by the investigator to be related to treatment. At the final visit, PGA scores improved significantly from baseline (P < 0.001). Of 58 patients with moderate to severe baseline PGA symptom scores, 91.4% had lower scores by the final visit. GERD symptom scores were significantly improved from baseline to the final week of the study in all of the treatment groups (P < 0.01). In children ages 1 to 11 years with endoscopically proven GERD, esomeprazole (at daily doses of 5, 10, or 20 mg) was generally well tolerated. The frequency and severity of GERD-related symptoms were significantly reduced during the active treatment period.

Topics: Child; Child, Preschool; Diarrhea; Dose-Response Relationship, Drug; Double-Blind Method; Enzyme Inhibitors; Esomeprazole; Female; Gastroesophageal Reflux; Headache; Humans; Infant; Male; Severity of Illness Index; Treatment Outcome

The primary objective was to assess the safety of esomeprazole 20 or 40 mg once daily in adolescents with clinically diagnosed gastroesophageal reflux disease (GERD). A secondary aim was to assess changes in GERD symptoms after esomeprazole therapy.. In this multicenter, randomized, double-blind study, adolescents ages 12 to 17 years inclusive received esomeprazole 20 or 40 mg once daily for 8 weeks. Adverse events and changes in clinical parameters (eg, physical examination, laboratory measurements) were evaluated to assess safety. Patients or their parents or guardians scored symptom severity daily, and investigators scored overall GERD symptom severity every 2 weeks using a 4-point scale.. In the 148 adolescents with safety data, treatment-related and non-treatment-related adverse events were reported by 75% and 78% of patients in the esomeprazole 20- and 40-mg groups, respectively. Twenty-two patients (14.9%) experienced adverse events that were considered related to treatment; the most common were headache (8%, 12/148), abdominal pain (3%, 4/148), nausea (2%, 3/148), and diarrhea (2%, 3/148). No serious adverse events or clinically important findings in other safety assessments were observed. At baseline, 68% (100/147) had heartburn, 63% (93/147) had epigastric pain, 57% (84/147) had acid regurgitation, and 15% (22/147) had vomiting symptoms. Symptom scores decreased significantly in both the esomeprazole 20-mg and 40-mg groups by the final study week (P < 0.0001). Investigators rated 63.1% (94/149) of the patients as having moderate or severe symptoms at baseline; at the final visit, this percentage decreased significantly to 9.3% (13/140; P < .0001).. In adolescent patients with GERD, esomeprazole 20 or 40 mg daily for 8 weeks was well tolerated, and GERD-related symptoms were significantly reduced from baseline values in both groups.

Topics: Abdominal Pain; Adolescent; Anti-Ulcer Agents; Child; Diarrhea; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Female; Gastroesophageal Reflux; Headache; Heartburn; Humans; Male; Nausea; Severity of Illness Index; Treatment Outcome; Vomiting

Potassium-competitive acid blockers and proton pump inhibitors/sodium bicarbonate can rapidly increase intragastric pH. In this study, we aimed to compare the clinical outcomes of tegoprazan-based and esomeprazole/sodium bicarbonate-based triple therapies in the treatment of Helicobacter pylori infection.. We retrospectively reviewed the data of patients with H. pylori infection treated with a 14-day tegoprazan-based triple therapy or 14-day esomeprazole/sodium bicarbonate-based triple therapy. The primary end point was the H. pylori eradication rate with first-line treatment in an intention-to-treat analysis. Secondary end points included the eradication rate with first-line therapy in the per-protocol analysis and adverse events associated with eradication therapy.. Of the 854 included patients, 435 were treated with tegoprazan-based therapy, and 419 received esomeprazole/sodium bicarbonate-based therapy. In the intention-to-treat population, no significant difference in eradication rate was detected between the tegoprazan-treated and esomeprazole/sodium bicarbonate-treated groups (78.6% [95% confidence interval (CI), 74.6-82.3%] vs 81.4% [95% CI, 77.4-84.9%], P = 0.313). The per-protocol analysis also revealed a similar eradication rate between groups (tegoprazan vs esomeprazole/sodium bicarbonate: 85.5% [95% CI, 81.8-87.5%] vs 87.8% [95% CI, 84.1-90.7%], P = 0.339). However, abdominal discomfort and diarrhea were more common in the esomeprazole/sodium bicarbonate-treated group than in the tegoprazan-treated group (abdominal discomfort: 1.1% vs 3.8%, P = 0.012; diarrhea: 9.9% vs 21.2%, P < 0.001).. The efficacy of the esomeprazole/sodium bicarbonate-based triple therapy for H. pylori eradication was comparable with that of the tegoprazan-based triple therapy. However, esomeprazole/sodium bicarbonate-based therapy exhibited a higher risk of abdominal discomfort and diarrhea than tegoprazan-based therapy.

Topics: Anti-Bacterial Agents; Bicarbonates; Diarrhea; Esomeprazole; Helicobacter Infections; Helicobacter pylori; Humans; Retrospective Studies; Sodium Bicarbonate

Topics: Aged; Cholecalciferol; Clonazepam; Diarrhea; Esomeprazole; Female; Fluconazole; Humans; Nausea; Ondansetron; Piperacillin, Tazobactam Drug Combination; Syncope; Torsades de Pointes; Vancomycin

Topics: Aged, 80 and over; Anti-Bacterial Agents; Blood Transfusion; Colitis; Colon; Cytomegalovirus; Cytomegalovirus Infections; Diarrhea; Esomeprazole; Gastrointestinal Hemorrhage; Gastrointestinal Tract; Humans; Immunocompetence; Male; Penicillanic Acid; Piperacillin; Pneumonia; Pulmonary Disease, Chronic Obstructive; Steroids; Tazobactam; Treatment Outcome; Viremia

A 90-year-old woman who had bloody diarrhoea, nausea, weakness and reduced urine output was found to have acute kidney injury. Her inflammatory markers were raised and her chest X-ray suggested an inflammatory process. She was initially suspected to have acute kidney injury secondary to dehydration and sepsis but when her autoimmune screen returned positive for antiglomerular basement membrane antibodies our diagnosis and management strategy was reconsidered. This is a case report of Goodpasture disease presenting in an elderly patient.

Topics: Acute Kidney Injury; Aged, 80 and over; Albuterol; Anti-Bacterial Agents; Anti-Glomerular Basement Membrane Disease; Bronchodilator Agents; Ceftriaxone; Diarrhea; Esomeprazole; Fatal Outcome; Female; Humans; Nausea; Palliative Care; Patient Comfort; Plasma Exchange; Proton Pump Inhibitors

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

Ulipristal acetate is a novel selective progesterone receptor modulator for the treatment of benign gynecological conditions such as uterine myoma. As a Biopharmaceutical Classification System (BCS) II compound, it is highly soluble at low pH but has low solubility at neutral conditions. Esomeprazole, a proton pump inhibitor used widely for treatment of gastric and duodenal ulcers, efficiently increases gastric pH. Thus, the aim of this study was to determine the effects of esomeprazole on the pharmacokinetics of ulipristal acetate.. This was a nonrandomized, single sequence, 2 period, open, study in 18 healthy female subjects. Subjects received oral ulipristal acetate tablets (10 mg) once on Days 1 and 13 and daily esomeprazole administrations (20 mg) from Days 9 through 14.. Co-administration of esomeprazole decreased geometric mean Cmax of ulipristal acetate by 65% (geometric mean ratio point estimate (90% CI): 0.35 (0.28 - 0.42)), and delayed median tmax from 0.75 to 1.00 h (Hodges-Lehmann estimate of difference (90% CI): tmax 0.63 (0.25 - 1.25)) but had minor effects on AUCs of +15% and +11% (geometric mean ratio point estimates (90% CI): AUC0-t 1.15 (1.02 - 1.31) and AUC0-∞ (1.11 (0.98 - 1.27)), respectively. A total of 6 adverse events were reported by 4 subjects, none of them being serious.. Concomitant use of ulipristal acetate with esomeprazole at therapeutic concentrations led to a modified absorption rate while exposure in terms of AUC remained close to bioequivalence limits. In the context of chronic administration of ulipristal acetate, no clinically significant effects are expected from co-administration with drugs increasing gastric pH.

Topics: Adolescent; Adult; Analysis of Variance; Area Under Curve; Contraceptive Agents; Diarrhea; Drug Interactions; Esomeprazole; Female; Gastric Juice; Humans; Hydrogen-Ion Concentration; Middle Aged; Norpregnadienes; Proton Pump Inhibitors; Reference Values; Therapeutic Equivalency; Young Adult

Esomeprazole, the S-isomer of omeprazole, was launched in the UK in September 2000. The first proton pump inhibitor, omeprazole, has been marketed in the UK for over 10 years. However, the adverse event database of newly marketed drugs is limited, and it is only after widespread clinical use that the adverse effect profile of a drug is ascertained more comprehensively. This study aims to monitor the safety of esomeprazole prescribed in the primary care setting in England using prescription-event monitoring (PEM).. A postmarketing surveillance study using the observational cohort technique of PEM. Patients were identified from dispensed prescriptions for esomeprazole issued by general practitioners between September 2000 and April 2001. Questionnaires ('green forms') requesting clinical event data on these patients were sent to prescribers approximately 6 months after the date of the first dispensed prescription for each individual patient. Incidence densities (IDs), expressed as the number of first reports of an event/1000 patient-months of exposure (PME), were calculated. Significant differences between IDs for events reported in the first month (ID1) and the following 5 months (ID2-6) of exposure were regarded as potential signals. Other methods for signal detection such as medical evaluation of selected events and evaluation of reasons for stopping were also applied.. Green forms containing clinically useful information for 11 595 patients (median age 56 years; 53.2% female) were received. Diarrhoea was the event with the highest ID1 in month 1 (8.0 per 1000 patient months of exposure). Adverse events that occurred significantly more often in the first month of treatment with esomeprazole compared with months 2-6 included diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, headache/migraine, intolerance, malaise/lassitude, pruritus, unspecified adverse effects and abnormal sensation.. The safety profile of esomeprazole was consistent with the prescribing information and experience reported in the literature.

Topics: Adverse Drug Reaction Reporting Systems; Cohort Studies; Diarrhea; Drug Monitoring; Dyspepsia; England; Esomeprazole; Esophageal Diseases; Female; Humans; Male; Middle Aged; Omeprazole; Primary Health Care; Product Surveillance, Postmarketing; Proton Pump Inhibitors

Clostridium difficile is a gram-positive, anaerobic, spore-forming, rod-shaped bacterium responsible for most of the hospital-acquired diarrhea in developed countries. The organism received its name because it was difficult to isolate and grow in culture. Infections in the elderly have been associated with significant morbidity and mortality as well as prolonged hospitalization.. A 72-year-old white male presented with a 5-day history of abdominal pain, nausea, and severe diarrhea but no fever or chills. He had had recent chemotherapy for Merkel cell carcinoma of the right ear. Medical history included hypothyroidism for 10 years and non-Hodgkin's lymphoma in remission for 4 years after a stem cell transplant. The patient was receiving oral vancomycin, levofloxacin, thyroxine, and esomeprazole. He had severe infection secondary to chemotherapy for Merkel cell carcinoma; in addition, he had failed to respond to metronida-zolc and vancomycin treatment, with the resulting development of colon dilatation and hypoalbuminemia. Colonoscopy showed severe ulceration with inflammation suggestive of severe persistent colitis. At that point, the patient was given 1 dose of IV immunoglobulin (IVIG) 400 mg/kg; vancomycin treatment was continued. Two days after IVIG therapy, the patient's diarrhea improved, with complete resolution after 6 days; bowel dilatation resolved completely after 7 days; and oral intake improved after 2 days. The patient continued on a tapering dose of vancomycin for 6 weeks. He was discharged home and had no recurrence despite antibiotic use for pseudomonas and staphylococcus bacteremia.. Severe C difficile colitis has been reported more frequently in the literature recently, especially in elderly patients. Tissue culture assay is the best diagnostic test to detect the cytotoxin; enzyme immunoassay is the test used in most hospitals, but it has a sensitivity of only -75%. Treatment options remain limited to eradicate this serious infection. Antibiotic therapy, infection control measures, and early diagnosis are essential components of successful outcome for this disease. This patient's infection resolved with the addition of IVIG with no recurrence, suggesting the possible benefit of this treatment in certain patients with severe colitis who do not respond to standard therapy.

Topics: Aged; Anti-Bacterial Agents; Carcinoma, Merkel Cell; Clostridioides difficile; Cytotoxins; Diarrhea; Ear Neoplasms; Enterocolitis, Pseudomembranous; Esomeprazole; Humans; Immunoglobulins, Intravenous; Immunologic Factors; Levofloxacin; Male; Metronidazole; Ofloxacin; Skin Neoplasms; Thyroxine; Vancomycin

To evaluate the drug interaction between fosamprenavir (FPV) and esomeprazole (ESO) after repeated doses in healthy adults.. Subjects received ESO 20 mg once daily (qd) for 7 days followed by either ESO 20 mg qd + FPV 1400 mg twice daily (bid) or ESO 20 mg qd + FPV 700 mg bid + ritonavir (RTV) 100 mg bid for 14 days in arms 1 and 2, respectively. After a 21- to 28-day washout, subjects received either FPV 1400 mg bid for 14 days (arm 1) or FPV 700 mg bid + RTV 100 mg bid for 14 days (arm 2). Pharmacokinetic sampling was conducted on the last day of each treatment.. Simultaneous coadministration of ESO 20 mg qd with either FPV 1400 mg bid or FPV 700 mg bid + RTV 100 mg bid had no effect on steady-state amprenavir pharmacokinetics. The only effect on plasma ESO exposure was a 55% increase in area under the plasma concentration-time curve during a dosing interval, tau[AUC0-tau], after coadministration of ESO 20 mg qd with FPV 1400 mg bid.. FPV 1400 mg bid or FPV 700 mg bid + RTV 100 mg bid may be coadministered simultaneously with ESO without dose adjustment. However, the impact of staggered administration of proton pump inhibitors (PPI) on plasma amprenavir exposure is unknown at present.

Topics: Administration, Oral; Adolescent; Adult; Carbamates; Diarrhea; Drug Administration Schedule; Drug Combinations; Esomeprazole; Female; Furans; Headache; Humans; Male; Middle Aged; Nausea; Organophosphates; Ritonavir; Sulfonamides