s-1743 and Vomiting

To characterize the pharmacodynamics and systemic exposure of esomeprazole in 26 preterm infants and term neonates with symptoms of gastroesophageal reflux and pathologic acid exposure.. Enrolled patients received oral esomeprazole 0.5 mg/kg once daily for 7 days. Twenty-four-hour esophagogastric pH-impedance monitoring was performed at baseline and on day 7. Pharmacokinetic analysis was performed on day 7. Symptoms occurring during the baseline and day 7 studies were recorded on a symptom chart.. There were no significant differences from baseline to day 7 of therapy in the frequency of bolus reflux, consistency of bolus reflux (liquid, mixed, or gas), extent of bolus reflux, or bolus clearance time. Acid bolus reflux episodes were reduced on therapy (median 30 vs 8, P < .001), as was the reflux index (mean % time esophageal pH < 4, 15.7% vs 7.1%, P < .001). The estimated geometric mean of area under the plasma concentration time curve during the dosing interval and observed maximum plasma concentration was 2.5 micromol x h/L and 0.74 micromol/L, respectively. The number of gastroesophageal reflux symptoms recorded over 24 hours was lower on therapy (median 22 vs 12, P < .05).. In preterm infants and term neonates esomeprazole produces no change in bolus reflux characteristics despite significant acid suppression.

Topics: Administration, Oral; Anti-Ulcer Agents; Crying; Electric Impedance; Esomeprazole; Esophageal pH Monitoring; Female; Food; Gagging; Gastroesophageal Reflux; Humans; Infant, Newborn; Infant, Premature; Irritable Mood; Male; Vomiting

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

Topics: Abdominal Pain; Adult; Amoxicillin-Potassium Clavulanate Combination; Biopsy, Needle; Esomeprazole; Female; Fever; Gastritis; Gastroscopy; Humans; Immunohistochemistry; Infusions, Intravenous; Prognosis; Rare Diseases; Severity of Illness Index; Streptococcal Infections; Tomography, X-Ray Computed; Treatment Outcome; Vomiting

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

Hypomagnesemia is a rare cause of hypoparathyroidism that can have a very serious clinical presentation. We report the case of a 62-year-old woman hospitalized for exploration of acute tetraparesis with vomiting and swallowing disorders associated with a severe hypocalcemia. Biological explorations revealed hypoparathyroidism (PTH=16ng/L) related to low plasma and erythrocyte magnesium (0.32 and 1.32mmol/L, respectively) as well as hypocalciuria and hypomagnesuria linked to gastrointestinal malabsorption. Etiologic investigations led to the discovery of Giardiasis lamblia on duodenal biopsies and a long-term treatment with proton pump inhibitors (PPI) (omeprazole followed by esomeprazole), both being recently described as causal factors of hypomagnesemic hypoparathyroidism. After treatment of the parasite (by metronidazole) and discontinuation of the PPI, both calcium and magnesium levels returned to normal. Selective malabsorption has been previously reported in patients with giardiasis. The specific mechanism of PPI participation in the genesis of hypomagnesemia remains a subject of debate.

Topics: Deglutition Disorders; Duodenum; Esomeprazole; Female; Giardiasis; Humans; Hypocalcemia; Hypoparathyroidism; Magnesium Deficiency; Middle Aged; Omeprazole; Proton Pump Inhibitors; Quadriplegia; Vomiting

Topics: Acute Disease; Anti-Inflammatory Agents; Anti-Ulcer Agents; Dyspepsia; Esomeprazole; Female; Hematuria; Humans; Male; Methylprednisolone; Middle Aged; Nausea; Nephritis, Interstitial; Prednisone; Proton Pump Inhibitors; Vomiting