A randomized, pharmacokinetic and pharmacodynamic, cross-over study of duodenal or jejunal administration compared to nasogastric administration of omeprazole suspension in patients at risk for stress ulcers

Jeffrey O. Phillips, Keith Melvin Olsen, Jill A. Rebuck, Nick J. Rangnekar, Brent W. Miedema, Michael H. Metzler

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

OBJECTIVES: The aim of this study was to characterize absorption and pH control of simplified omeprazole suspension (SOS), 2 mg/ml in 8.4% sodium bicarbonate, administered via the nasogastric versus jejunal or duodenal route. METHODS: Nine critically ill surgical patients, NPO and mechanically ventilated, were enrolled in this randomized cross-over study. Patients received a single 40 mg dose of SOS by the nasogastric and either the jejunal or duodenal route. Twenty-four-hour continuous intragastric pH monitoring was performed during the study period. Sequential blood samples were collected over 24 h to characterize SOS absorption and pharmacokinetic parameters. RESULTS: Nasogastric administration of SOS resulted in lower maximum mean ± SD serum concentrations compared to jejunal/duodenal dosing (0.970 ± 0.436 vs 1.833 ± 0.416/ag/ml, p = 0.006). SOS absorption was significantly slower when administered via nasogastric tube (108.3 ± 42.0 vs 12.1 ± 7.9 min, p < 0.001). However, all routes of administration resulted in similar SOS area under the serum concentration-time curves (AUC0.∞) (415.1 ± 291.8 vs 396.7 ± 388.1 μg · h/ml, p = 0.91). Mean intragastric pH values remained >4 at 1 h after SOS administration and remained >4 for the entire 24-h study (6.32 ± 1.04, 5.57 ± 1.15, nasogastric vs jejunal/duodenal, p = 0.015), regardless of administration route. CONCLUSIONS: In critically ill surgical patients, pharmaco-kinetic parameters and subsequent pH control after the administration of SOS are similar by the jejunal, nasogastric, or duodenal route. SOS suspension offers an alternative acid control measure when patients are unable to take oral medications, yet have an enteral tube in place.

Original languageEnglish (US)
Pages (from-to)367-372
Number of pages6
JournalAmerican Journal of Gastroenterology
Volume96
Issue number2
DOIs
StatePublished - Mar 13 2001

Fingerprint

Omeprazole
Cross-Over Studies
Ulcer
Suspensions
Pharmacokinetics
Critical Illness
Sodium Bicarbonate
Small Intestine
Acids

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

A randomized, pharmacokinetic and pharmacodynamic, cross-over study of duodenal or jejunal administration compared to nasogastric administration of omeprazole suspension in patients at risk for stress ulcers. / Phillips, Jeffrey O.; Olsen, Keith Melvin; Rebuck, Jill A.; Rangnekar, Nick J.; Miedema, Brent W.; Metzler, Michael H.

In: American Journal of Gastroenterology, Vol. 96, No. 2, 13.03.2001, p. 367-372.

Research output: Contribution to journalArticle

Phillips, Jeffrey O. ; Olsen, Keith Melvin ; Rebuck, Jill A. ; Rangnekar, Nick J. ; Miedema, Brent W. ; Metzler, Michael H. / A randomized, pharmacokinetic and pharmacodynamic, cross-over study of duodenal or jejunal administration compared to nasogastric administration of omeprazole suspension in patients at risk for stress ulcers. In: American Journal of Gastroenterology. 2001 ; Vol. 96, No. 2. pp. 367-372.
@article{483604947db347af8330e1706d45ca68,
title = "A randomized, pharmacokinetic and pharmacodynamic, cross-over study of duodenal or jejunal administration compared to nasogastric administration of omeprazole suspension in patients at risk for stress ulcers",
abstract = "OBJECTIVES: The aim of this study was to characterize absorption and pH control of simplified omeprazole suspension (SOS), 2 mg/ml in 8.4{\%} sodium bicarbonate, administered via the nasogastric versus jejunal or duodenal route. METHODS: Nine critically ill surgical patients, NPO and mechanically ventilated, were enrolled in this randomized cross-over study. Patients received a single 40 mg dose of SOS by the nasogastric and either the jejunal or duodenal route. Twenty-four-hour continuous intragastric pH monitoring was performed during the study period. Sequential blood samples were collected over 24 h to characterize SOS absorption and pharmacokinetic parameters. RESULTS: Nasogastric administration of SOS resulted in lower maximum mean ± SD serum concentrations compared to jejunal/duodenal dosing (0.970 ± 0.436 vs 1.833 ± 0.416/ag/ml, p = 0.006). SOS absorption was significantly slower when administered via nasogastric tube (108.3 ± 42.0 vs 12.1 ± 7.9 min, p < 0.001). However, all routes of administration resulted in similar SOS area under the serum concentration-time curves (AUC0.∞) (415.1 ± 291.8 vs 396.7 ± 388.1 μg · h/ml, p = 0.91). Mean intragastric pH values remained >4 at 1 h after SOS administration and remained >4 for the entire 24-h study (6.32 ± 1.04, 5.57 ± 1.15, nasogastric vs jejunal/duodenal, p = 0.015), regardless of administration route. CONCLUSIONS: In critically ill surgical patients, pharmaco-kinetic parameters and subsequent pH control after the administration of SOS are similar by the jejunal, nasogastric, or duodenal route. SOS suspension offers an alternative acid control measure when patients are unable to take oral medications, yet have an enteral tube in place.",
author = "Phillips, {Jeffrey O.} and Olsen, {Keith Melvin} and Rebuck, {Jill A.} and Rangnekar, {Nick J.} and Miedema, {Brent W.} and Metzler, {Michael H.}",
year = "2001",
month = "3",
day = "13",
doi = "10.1016/S0002-9270(00)02315-7",
language = "English (US)",
volume = "96",
pages = "367--372",
journal = "American Journal of Gastroenterology",
issn = "0002-9270",
publisher = "Nature Publishing Group",
number = "2",

}

TY - JOUR

T1 - A randomized, pharmacokinetic and pharmacodynamic, cross-over study of duodenal or jejunal administration compared to nasogastric administration of omeprazole suspension in patients at risk for stress ulcers

AU - Phillips, Jeffrey O.

AU - Olsen, Keith Melvin

AU - Rebuck, Jill A.

AU - Rangnekar, Nick J.

AU - Miedema, Brent W.

AU - Metzler, Michael H.

PY - 2001/3/13

Y1 - 2001/3/13

N2 - OBJECTIVES: The aim of this study was to characterize absorption and pH control of simplified omeprazole suspension (SOS), 2 mg/ml in 8.4% sodium bicarbonate, administered via the nasogastric versus jejunal or duodenal route. METHODS: Nine critically ill surgical patients, NPO and mechanically ventilated, were enrolled in this randomized cross-over study. Patients received a single 40 mg dose of SOS by the nasogastric and either the jejunal or duodenal route. Twenty-four-hour continuous intragastric pH monitoring was performed during the study period. Sequential blood samples were collected over 24 h to characterize SOS absorption and pharmacokinetic parameters. RESULTS: Nasogastric administration of SOS resulted in lower maximum mean ± SD serum concentrations compared to jejunal/duodenal dosing (0.970 ± 0.436 vs 1.833 ± 0.416/ag/ml, p = 0.006). SOS absorption was significantly slower when administered via nasogastric tube (108.3 ± 42.0 vs 12.1 ± 7.9 min, p < 0.001). However, all routes of administration resulted in similar SOS area under the serum concentration-time curves (AUC0.∞) (415.1 ± 291.8 vs 396.7 ± 388.1 μg · h/ml, p = 0.91). Mean intragastric pH values remained >4 at 1 h after SOS administration and remained >4 for the entire 24-h study (6.32 ± 1.04, 5.57 ± 1.15, nasogastric vs jejunal/duodenal, p = 0.015), regardless of administration route. CONCLUSIONS: In critically ill surgical patients, pharmaco-kinetic parameters and subsequent pH control after the administration of SOS are similar by the jejunal, nasogastric, or duodenal route. SOS suspension offers an alternative acid control measure when patients are unable to take oral medications, yet have an enteral tube in place.

AB - OBJECTIVES: The aim of this study was to characterize absorption and pH control of simplified omeprazole suspension (SOS), 2 mg/ml in 8.4% sodium bicarbonate, administered via the nasogastric versus jejunal or duodenal route. METHODS: Nine critically ill surgical patients, NPO and mechanically ventilated, were enrolled in this randomized cross-over study. Patients received a single 40 mg dose of SOS by the nasogastric and either the jejunal or duodenal route. Twenty-four-hour continuous intragastric pH monitoring was performed during the study period. Sequential blood samples were collected over 24 h to characterize SOS absorption and pharmacokinetic parameters. RESULTS: Nasogastric administration of SOS resulted in lower maximum mean ± SD serum concentrations compared to jejunal/duodenal dosing (0.970 ± 0.436 vs 1.833 ± 0.416/ag/ml, p = 0.006). SOS absorption was significantly slower when administered via nasogastric tube (108.3 ± 42.0 vs 12.1 ± 7.9 min, p < 0.001). However, all routes of administration resulted in similar SOS area under the serum concentration-time curves (AUC0.∞) (415.1 ± 291.8 vs 396.7 ± 388.1 μg · h/ml, p = 0.91). Mean intragastric pH values remained >4 at 1 h after SOS administration and remained >4 for the entire 24-h study (6.32 ± 1.04, 5.57 ± 1.15, nasogastric vs jejunal/duodenal, p = 0.015), regardless of administration route. CONCLUSIONS: In critically ill surgical patients, pharmaco-kinetic parameters and subsequent pH control after the administration of SOS are similar by the jejunal, nasogastric, or duodenal route. SOS suspension offers an alternative acid control measure when patients are unable to take oral medications, yet have an enteral tube in place.

UR - http://www.scopus.com/inward/record.url?scp=0035123898&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035123898&partnerID=8YFLogxK

U2 - 10.1016/S0002-9270(00)02315-7

DO - 10.1016/S0002-9270(00)02315-7

M3 - Article

VL - 96

SP - 367

EP - 372

JO - American Journal of Gastroenterology

JF - American Journal of Gastroenterology

SN - 0002-9270

IS - 2

ER -