Abstract
BackgroundEsomeprazole, a potent proton pump inhibitor (PPI), is widely used for the prevention of stress ulcers in intensive care unit (ICU) patients.ObjectiveThis study investigates the pharmacokinetics (PK) of esomeprazole in critically ill patients.MethodsThe study included eligible adult ICU patients who received endotracheal intubation assisted mechanical ventilation for more than 48 h and had at least an extra risk factor for stress ulcers. All enrolled patients received once-daily intravenous (IV) esomeprazole 40 mg. After the first dose of esomeprazole was administrated, serial blood samples were collected at 3, 5, 15, 30 min and 1, 2, 4, 6, 8, and 10 h. The total sample concentrations of esomeprazole were measured by UPLC-MS/MS. Esomeprazole PK parameters were analyzed using noncompartmental analysis.ResultsA total of 30 patients were evaluable. Mean age and body mass index (BMI) were 61.97 years and 23.14. PK sampling on the first dose resulted in the following median (IQR) parameters: AUC0−∞ 8.06 (6.65–9.47) mg·h/L; MRT0−∞ 4.70 (3.89–5.51) h; t1/2 3.29 (2.7–3.87) h; V 24.89 (22.09–27.69) L; CL 6.13 (5.01–7.26) L/h; and Cmax 2.56 (2.30–2.82) mg/L.ConclusionsAccording to the label of esomeprazole, our study showed different esomeprazole PK parameters in ICU patients compared with healthy volunteers. Esomeprazole has unique pharmacokinetic parameters in critically ill patients.
Highlights
Stress-induced ulcers are extremely common in intensive care unit (ICU) patients
This open-label, single-treatment exploratory trial of IV esomeprazole was conducted in an Intensive Care Unit with critically ill patients with at least one additional risk factor for stress ulcer (Clinical Trial Registry, ChiCTR1800018516)
According to the instructions of esomeprazole, the results of this study indicated that the esomeprazole PK parameters in critically ill patients were different from those in healthy volunteers
Summary
Stress-induced ulcers are extremely common in ICU patients. Because these patients usually have risk factors for stress ulcers, such as coagulopathy, mechanical ventilation for at least 48 h, a Glasgow Coma score of ≤10, or multiple organ dysfunction syndrome (MODS) [1, 2]. 5–25% of ICU patients may have obvious bleeding if they do not receive drugs to prevent stress ulcers [3]. Multiple studies have reported that stress-related ulcer bleeding may increase the mortality risk of ICU patients [4, 5]. Esomeprazole, a potent proton pump inhibitor (PPI), is widely used for the prevention of stress ulcers in intensive care unit (ICU) patients
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