Intravenous esomeprazole pharmacodynamics in critically ill patients
| Autor: | Steven G. Simonson, David C. Metz, Gerard J. Fulda, Keith M. Olsen, Mark Sostek, John T. Monyak |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Adult
Mechanical ventilation business.industry Critical Illness medicine.medical_treatment Esomeprazole General Medicine Anti-Ulcer Agents Intensive care unit law.invention Clinical trial Treatment Outcome law Pharmacodynamics Intensive care Anesthesia Humans Medicine Gastric acid Risk factor business medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 26:1141-1148 |
| ISSN: | 1473-4877 0300-7995 0042-8701 |
| DOI: | 10.1185/03007991003694308 |
| Popis: | A widely held belief contends that food-induced proton pump activation is important for optimal proton pump inhibitor-induced inhibition of gastric acid secretion. This study was undertaken to assess intragastric acid control with intravenous (IV) esomeprazole in critically ill patients.This open-label, single-arm, exploratory trial was conducted at five university or regional hospital intensive care units in the US. Adult patients admitted to an intensive care unit who required mechanical ventilation and had at least one additional risk factor for stress-induced ulcer received twice-daily IV esomeprazole 40 mg for 48 hours and could continue for another 24 hours if no prepyloric enteral feedings were planned.D9612L00107; ClinicalTrials.gov Identifier NCT00428701.The primary efficacy variable was the linear-interpolated percentage of time intragastric pH wasor =4 during 24-48 hours. Secondary efficacy variables included the interpolated percentage of time intragastric pH wasor =4 during 0-24, 0-48, and 48-72 hours, the percentage of gastric aspirates collected with pHor =4 during 0-24, 24-48, 0-48, and 48-72 hours, and time to stable pHor =4. Safety was assessed based on adverse events (AEs), physical examinations, vital signs, laboratory tests, and electrocardiograms.Forty-five patients were enrolled (one was excluded because of previous partial gastrectomy). Interpolated mean percentage time pHor =4 was 88.8%, 80.7%, and 83.5% for 24-48, 0-24, and 0-48 hours, respectively. For 0-72 hours,or =78% of gastric aspirates had pHor =4. Median time to stable pH was 1 hour (95% confidence interval: 0.67, 2.00). Treatment was well tolerated, with no evidence of gastrointestinal bleeding. A total of 75 AEs occurred in 34 patients, none considered treatment related.In this noncontrolled exploratory study, twice-daily IV esomeprazole 40 mg rapidly decreased intragastric acidity and effectively maintained pH/=4 during 0-72 hours in fasting, critically ill, mechanically ventilated patients at high risk for stress ulcers. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|