PMID- 20230209
OWN - NLM
STAT- MEDLINE
DCOM- 20100730
LR  - 20131121
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 26
IP  - 5
DP  - 2010 May
TI  - Intravenous esomeprazole pharmacodynamics in critically ill patients.
PG  - 1141-8
LID - 10.1185/03007991003694308 [doi]
AB  - OBJECTIVE: 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. 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 40 mg 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 > or =4 during 24-48 hours. Secondary efficacy variables 
      included the interpolated percentage of time intragastric pH was > or =4 during 
      0-24, 0-48, and 48-72 hours, the percentage of gastric aspirates collected with 
      pH > or =4 during 0-24, 24-48, 0-48, and 48-72 hours, and time to stable pH > or 
      =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 > or =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 pH > or =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 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.
FAU - Metz, David C
AU  - Metz DC
AD  - Division of Gastroenterology, University of Pennsylvania, Philadelphia, PA 19104, 
      USA. david.metz@uphs.upenn.edu
FAU - Fulda, Gerard J
AU  - Fulda GJ
FAU - Olsen, Keith M
AU  - Olsen KM
FAU - Monyak, John T
AU  - Monyak JT
FAU - Simonson, Steven G
AU  - Simonson SG
FAU - Sostek, M B
AU  - Sostek MB
LA  - eng
SI  - ClinicalTrials.gov/NCT00428701
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Ulcer Agents)
RN  - N3PA6559FT (Esomeprazole)
SB  - IM
MH  - Adult
MH  - Anti-Ulcer Agents/*administration & dosage/pharmacology
MH  - *Critical Illness
MH  - Esomeprazole/*administration & dosage/pharmacology
MH  - Humans
MH  - Treatment Outcome
EDAT- 2010/03/17 06:00
MHDA- 2010/07/31 06:00
CRDT- 2010/03/17 06:00
PHST- 2010/03/17 06:00 [entrez]
PHST- 2010/03/17 06:00 [pubmed]
PHST- 2010/07/31 06:00 [medline]
AID - 10.1185/03007991003694308 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2010 May;26(5):1141-8. doi: 10.1185/03007991003694308.