TY - JOUR
T1 - Intravenous esomeprazole pharmacodynamics in critically ill patients
AU - Metz, David C.
AU - Fulda, Gerard J.
AU - Olsen, Keith M.
AU - Monyak, John T.
AU - Simonson, Steven G.
AU - Sostek, M. B.
N1 - Funding Information:
D.C.M. has disclosed that he is a stockholder in Johnson & Johnson; has worked as an advisor to AstraZeneca, TAP, Wyeth, Santarus, and Nycomed; that he has received grants from AstraZeneca, and TAP; and that he sits on an advisory board for Santarus. G.J.F. has disclosed that he has received grant support from AstraZeneca. K.M.O. has disclosed that he has received grant support from AstraZeneca, Astellas, Carmel Pharma, and Takeda; and that he is on a speakers’ bureau for AstraZeneca. J.T.M. and M.B.S. have disclosed that they are employees of AstraZeneca. S.G.S. has disclosed that he is an employee and stockholder of AstraZeneca.
Funding Information:
The authors thank the study investigators and Anny S. Wu, PharmD, Lisa M. Klumpp, PhD, and Judy Fallon, PharmD, from Scientific Connexions (Newtown, PA) for medical writing support (funded by AstraZeneca LP, Wilmington, DE).
PY - 2010/5
Y1 - 2010/5
N2 - Objective: A widely held belief contends that food-induced proton pump activation is important for optimal proton pump inhibitorinduced inhibition of gastric acid secretion. This study was undertaken to assess intragastric acid control with intravenous (IV) esomeprazole in critically ill patients. Research design and methods: 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 40mg for 48 hours and could continue for another 24 hours if no prepyloric enteral feedings were planned. Clinical trial registration: D9612L00107; ClinicalTrials.gov Identifier NCT00428701. Main outcome measures: The primary efficacy variable was the linear-interpolated percentage of time intragastric pH was 4 during 2448 hours. Secondary efficacy variables included the interpolated percentage of time intragastric pH was 4 during 024, 048, and 4872 hours, the percentage of gastric aspirates collected with pH 4 during 024, 2448, 048, and 4872 hours, and time to stable pH 4. Safety was assessed based on adverse events (AEs), physical examinations, vital signs, laboratory tests, and electrocardiograms. Results: Forty-five patients were enrolled (one was excluded because of previous partial gastrectomy). Interpolated mean percentage time pH 4 was 88.8, 80.7, and 83.5 for 2448, 024, and 048 hours, respectively. For 072 hours, 78 of gastric aspirates had pH 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. Conclusions: In this noncontrolled exploratory study, twice-daily IV esomeprazole 40mg rapidly decreased intragastric acidity and effectively maintained pH 4 during 072 hours in fasting, critically ill, mechanically ventilated patients at high risk for stress ulcers.
AB - Objective: A widely held belief contends that food-induced proton pump activation is important for optimal proton pump inhibitorinduced inhibition of gastric acid secretion. This study was undertaken to assess intragastric acid control with intravenous (IV) esomeprazole in critically ill patients. Research design and methods: 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 40mg for 48 hours and could continue for another 24 hours if no prepyloric enteral feedings were planned. Clinical trial registration: D9612L00107; ClinicalTrials.gov Identifier NCT00428701. Main outcome measures: The primary efficacy variable was the linear-interpolated percentage of time intragastric pH was 4 during 2448 hours. Secondary efficacy variables included the interpolated percentage of time intragastric pH was 4 during 024, 048, and 4872 hours, the percentage of gastric aspirates collected with pH 4 during 024, 2448, 048, and 4872 hours, and time to stable pH 4. Safety was assessed based on adverse events (AEs), physical examinations, vital signs, laboratory tests, and electrocardiograms. Results: Forty-five patients were enrolled (one was excluded because of previous partial gastrectomy). Interpolated mean percentage time pH 4 was 88.8, 80.7, and 83.5 for 2448, 024, and 048 hours, respectively. For 072 hours, 78 of gastric aspirates had pH 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. Conclusions: In this noncontrolled exploratory study, twice-daily IV esomeprazole 40mg rapidly decreased intragastric acidity and effectively maintained pH 4 during 072 hours in fasting, critically ill, mechanically ventilated patients at high risk for stress ulcers.
KW - Drug administration routes
KW - Esomeprazole
KW - Intensive care units
KW - PH
KW - Ulcer
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U2 - 10.1185/03007991003694308
DO - 10.1185/03007991003694308
M3 - Article
C2 - 20230209
AN - SCOPUS:77951060437
SN - 0300-7995
VL - 26
SP - 1141
EP - 1148
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 5
ER -