Pharmacokinetics and pharmacodynamics of intravenous dexmedetomidine in healthy Korean subjects
Summary What is known and Objective: Dexmedetomidine is a selective alpha2‐adrenoreceptor agonist used for sedation in critically ill patients. The current study aimed to evaluate the pharmacokinetics (PKs), pharmacodynamics and tolerability of intravenous dexmedetomidine in healthy Korean subjects...
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| Published in | Journal of clinical pharmacy and therapeutics Vol. 37; no. 6; pp. 698 - 703 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.12.2012
Blackwell John Wiley & Sons, Inc |
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| Abstract | Summary
What is known and Objective: Dexmedetomidine is a selective alpha2‐adrenoreceptor agonist used for sedation in critically ill patients. The current study aimed to evaluate the pharmacokinetics (PKs), pharmacodynamics and tolerability of intravenous dexmedetomidine in healthy Korean subjects.
Methods: A randomized, double‐blind, placebo‐controlled study with three parallel dosage groups was conducted. Twenty‐four subjects were randomly assigned to placebo or one of three dexmedetomidine dosing regimens, 3 μg/kg/h for 10 min followed by 0·17 μg/kg/h for 50 min (low dose), 6 μg/kg/h for 10 min followed by 0·34 μg/kg/h for 50 min (middle dose) and 3·7 μg/kg/h for 35 min followed by 0·7 μg/kg/h for 25 min (high dose). Serial blood samples for PK analysis were taken up to 12 h. PK parameters were determined using non‐compartmental methods (WinNonlin®), and a population PK model was developed using nonmem®. The sedative effect of dexmedetomidine was assessed by Ramsay sedation score and visual analogue scales/sedation. Adverse events, clinical laboratory tests, electrocardiograms, physical examinations and vital signs were monitored for tolerability assessment.
Results: Six subjects were assigned to each of the three active treatment group or placebo group. The AUClast of the low‐, middle‐ and high‐dose group were 1096·8 ± 119·9 (mean ± SD) ng*h/L, 2643·0 ± 353·2 ng*h/L and 5600·6 ± 411·0 ng*h/L, respectively. PK of dexmedetomidine was best described using a two‐compartment model. The typical value of the population model can be calculated using the following equations: central volume of distribution (L) = 19·9 (age/27)0·954, peripheral volume of distribution (L) = 59·4, clearance (L/h) = 33·7 (albumin level/4·3)1·42 and inter‐compartment clearance (L/h) = 67·7. Sedative effects were significantly increased by dexmedetomidine compared to placebo. The blood pressure and heart rate were decreased, but oxygen saturation was maintained stable.
What is new and Conclusion: Dexmedetomidine shows linear PK characteristics and dose‐dependent sedative effects. A two‐compartment population PK model was developed for healthy Korean subjects. The PK parameter estimates are similar in Koreans and Caucasians. |
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| AbstractList | Summary
What is known and Objective: Dexmedetomidine is a selective alpha2‐adrenoreceptor agonist used for sedation in critically ill patients. The current study aimed to evaluate the pharmacokinetics (PKs), pharmacodynamics and tolerability of intravenous dexmedetomidine in healthy Korean subjects.
Methods: A randomized, double‐blind, placebo‐controlled study with three parallel dosage groups was conducted. Twenty‐four subjects were randomly assigned to placebo or one of three dexmedetomidine dosing regimens, 3 μg/kg/h for 10 min followed by 0·17 μg/kg/h for 50 min (low dose), 6 μg/kg/h for 10 min followed by 0·34 μg/kg/h for 50 min (middle dose) and 3·7 μg/kg/h for 35 min followed by 0·7 μg/kg/h for 25 min (high dose). Serial blood samples for PK analysis were taken up to 12 h. PK parameters were determined using non‐compartmental methods (WinNonlin®), and a population PK model was developed using nonmem®. The sedative effect of dexmedetomidine was assessed by Ramsay sedation score and visual analogue scales/sedation. Adverse events, clinical laboratory tests, electrocardiograms, physical examinations and vital signs were monitored for tolerability assessment.
Results: Six subjects were assigned to each of the three active treatment group or placebo group. The AUClast of the low‐, middle‐ and high‐dose group were 1096·8 ± 119·9 (mean ± SD) ng*h/L, 2643·0 ± 353·2 ng*h/L and 5600·6 ± 411·0 ng*h/L, respectively. PK of dexmedetomidine was best described using a two‐compartment model. The typical value of the population model can be calculated using the following equations: central volume of distribution (L) = 19·9 (age/27)0·954, peripheral volume of distribution (L) = 59·4, clearance (L/h) = 33·7 (albumin level/4·3)1·42 and inter‐compartment clearance (L/h) = 67·7. Sedative effects were significantly increased by dexmedetomidine compared to placebo. The blood pressure and heart rate were decreased, but oxygen saturation was maintained stable.
What is new and Conclusion: Dexmedetomidine shows linear PK characteristics and dose‐dependent sedative effects. A two‐compartment population PK model was developed for healthy Korean subjects. The PK parameter estimates are similar in Koreans and Caucasians. Summary What is known and Objective: Dexmedetomidine is a selective alpha2-adrenoreceptor agonist used for sedation in critically ill patients. The current study aimed to evaluate the pharmacokinetics (PKs), pharmacodynamics and tolerability of intravenous dexmedetomidine in healthy Korean subjects. Methods: A randomized, double-blind, placebo-controlled study with three parallel dosage groups was conducted. Twenty-four subjects were randomly assigned to placebo or one of three dexmedetomidine dosing regimens, 3 µg/kg/h for 10 min followed by 0·17 µg/kg/h for 50 min (low dose), 6 µg/kg/h for 10 min followed by 0·34 µg/kg/h for 50 min (middle dose) and 3·7 µg/kg/h for 35 min followed by 0·7 µg/kg/h for 25 min (high dose). Serial blood samples for PK analysis were taken up to 12 h. PK parameters were determined using non-compartmental methods (WinNonlin), and a population PK model was developed using nonmem. The sedative effect of dexmedetomidine was assessed by Ramsay sedation score and visual analogue scales/sedation. Adverse events, clinical laboratory tests, electrocardiograms, physical examinations and vital signs were monitored for tolerability assessment. Results: Six subjects were assigned to each of the three active treatment group or placebo group. The AUClast of the low-, middle- and high-dose group were 1096·8 ± 119·9 (mean ± SD) ng*h/L, 2643·0 ± 353·2 ng*h/L and 5600·6 ± 411·0 ng*h/L, respectively. PK of dexmedetomidine was best described using a two-compartment model. The typical value of the population model can be calculated using the following equations: central volume of distribution (L) = 19·9 (age/27)0·954, peripheral volume of distribution (L) = 59·4, clearance (L/h) = 33·7 (albumin level/4·3)1·42 and inter-compartment clearance (L/h) = 67·7. Sedative effects were significantly increased by dexmedetomidine compared to placebo. The blood pressure and heart rate were decreased, but oxygen saturation was maintained stable. What is new and Conclusion: Dexmedetomidine shows linear PK characteristics and dose-dependent sedative effects. A two-compartment population PK model was developed for healthy Korean subjects. The PK parameter estimates are similar in Koreans and Caucasians. [PUBLICATION ABSTRACT] Dexmedetomidine is a selective alpha2-adrenoreceptor agonist used for sedation in critically ill patients. The current study aimed to evaluate the pharmacokinetics (PKs), pharmacodynamics and tolerability of intravenous dexmedetomidine in healthy Korean subjects. A randomized, double-blind, placebo-controlled study with three parallel dosage groups was conducted. Twenty-four subjects were randomly assigned to placebo or one of three dexmedetomidine dosing regimens, 3 μg/kg/h for 10 min followed by 0.17 μg/kg/h for 50 min (low dose), 6 μg/kg/h for 10 min followed by 0.34 μg/kg/h for 50 min (middle dose) and 3.7 μg/kg/h for 35 min followed by 0.7 μg/kg/h for 25 min (high dose). Serial blood samples for PK analysis were taken up to 12 h. PK parameters were determined using non-compartmental methods (WinNonlin(®)), and a population PK model was developed using nonmem(®). The sedative effect of dexmedetomidine was assessed by Ramsay sedation score and visual analogue scales/sedation. Adverse events, clinical laboratory tests, electrocardiograms, physical examinations and vital signs were monitored for tolerability assessment. Six subjects were assigned to each of the three active treatment group or placebo group. The AUC(last) of the low-, middle- and high-dose group were 1096.8 ± 119.9 (mean ± SD) ng*h/L, 2643.0 ± 353.2 ng*h/L and 5600.6 ± 411.0 ng*h/L, respectively. PK of dexmedetomidine was best described using a two-compartment model. The typical value of the population model can be calculated using the following equations: central volume of distribution (L) = 19.9 (age/27)(0.954), peripheral volume of distribution (L) = 59.4, clearance (L/h) = 33.7 (albumin level/4.3)(1.42) and inter-compartment clearance (L/h) = 67.7. Sedative effects were significantly increased by dexmedetomidine compared to placebo. The blood pressure and heart rate were decreased, but oxygen saturation was maintained stable. Dexmedetomidine shows linear PK characteristics and dose-dependent sedative effects. A two-compartment population PK model was developed for healthy Korean subjects. The PK parameter estimates are similar in Koreans and Caucasians. Dexmedetomidine is a selective alpha2-adrenoreceptor agonist used for sedation in critically ill patients. The current study aimed to evaluate the pharmacokinetics (PKs), pharmacodynamics and tolerability of intravenous dexmedetomidine in healthy Korean subjects.WHAT IS KNOWN AND OBJECTIVEDexmedetomidine is a selective alpha2-adrenoreceptor agonist used for sedation in critically ill patients. The current study aimed to evaluate the pharmacokinetics (PKs), pharmacodynamics and tolerability of intravenous dexmedetomidine in healthy Korean subjects.A randomized, double-blind, placebo-controlled study with three parallel dosage groups was conducted. Twenty-four subjects were randomly assigned to placebo or one of three dexmedetomidine dosing regimens, 3 μg/kg/h for 10 min followed by 0.17 μg/kg/h for 50 min (low dose), 6 μg/kg/h for 10 min followed by 0.34 μg/kg/h for 50 min (middle dose) and 3.7 μg/kg/h for 35 min followed by 0.7 μg/kg/h for 25 min (high dose). Serial blood samples for PK analysis were taken up to 12 h. PK parameters were determined using non-compartmental methods (WinNonlin(®)), and a population PK model was developed using nonmem(®). The sedative effect of dexmedetomidine was assessed by Ramsay sedation score and visual analogue scales/sedation. Adverse events, clinical laboratory tests, electrocardiograms, physical examinations and vital signs were monitored for tolerability assessment.METHODSA randomized, double-blind, placebo-controlled study with three parallel dosage groups was conducted. Twenty-four subjects were randomly assigned to placebo or one of three dexmedetomidine dosing regimens, 3 μg/kg/h for 10 min followed by 0.17 μg/kg/h for 50 min (low dose), 6 μg/kg/h for 10 min followed by 0.34 μg/kg/h for 50 min (middle dose) and 3.7 μg/kg/h for 35 min followed by 0.7 μg/kg/h for 25 min (high dose). Serial blood samples for PK analysis were taken up to 12 h. PK parameters were determined using non-compartmental methods (WinNonlin(®)), and a population PK model was developed using nonmem(®). The sedative effect of dexmedetomidine was assessed by Ramsay sedation score and visual analogue scales/sedation. Adverse events, clinical laboratory tests, electrocardiograms, physical examinations and vital signs were monitored for tolerability assessment.Six subjects were assigned to each of the three active treatment group or placebo group. The AUC(last) of the low-, middle- and high-dose group were 1096.8 ± 119.9 (mean ± SD) ng*h/L, 2643.0 ± 353.2 ng*h/L and 5600.6 ± 411.0 ng*h/L, respectively. PK of dexmedetomidine was best described using a two-compartment model. The typical value of the population model can be calculated using the following equations: central volume of distribution (L) = 19.9 (age/27)(0.954), peripheral volume of distribution (L) = 59.4, clearance (L/h) = 33.7 (albumin level/4.3)(1.42) and inter-compartment clearance (L/h) = 67.7. Sedative effects were significantly increased by dexmedetomidine compared to placebo. The blood pressure and heart rate were decreased, but oxygen saturation was maintained stable.RESULTSSix subjects were assigned to each of the three active treatment group or placebo group. The AUC(last) of the low-, middle- and high-dose group were 1096.8 ± 119.9 (mean ± SD) ng*h/L, 2643.0 ± 353.2 ng*h/L and 5600.6 ± 411.0 ng*h/L, respectively. PK of dexmedetomidine was best described using a two-compartment model. The typical value of the population model can be calculated using the following equations: central volume of distribution (L) = 19.9 (age/27)(0.954), peripheral volume of distribution (L) = 59.4, clearance (L/h) = 33.7 (albumin level/4.3)(1.42) and inter-compartment clearance (L/h) = 67.7. Sedative effects were significantly increased by dexmedetomidine compared to placebo. The blood pressure and heart rate were decreased, but oxygen saturation was maintained stable.Dexmedetomidine shows linear PK characteristics and dose-dependent sedative effects. A two-compartment population PK model was developed for healthy Korean subjects. The PK parameter estimates are similar in Koreans and Caucasians.WHAT IS NEW AND CONCLUSIONDexmedetomidine shows linear PK characteristics and dose-dependent sedative effects. A two-compartment population PK model was developed for healthy Korean subjects. The PK parameter estimates are similar in Koreans and Caucasians. |
| Author | Yu, K.-S. Stalker, D. Wisemandle, W. Shin, S.-G. Lee, S. Lim, K. Kim, B.-H. Jang, I.-J. |
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| Keywords | α2-Adrenergic receptor Human Population pharmacokinetics Pharmacokinetic pharmacodynamic relationship Agonist Pharmacodynamics Intravenous administration Healthy subject Korean Biological activity Dexmedetomidine pharmacokinetics α-Adrenergic receptor agonist |
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| References_xml | – reference: Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs, 2000;59:263-268; discussion 69-70. – reference: Potts AL, Warman GR, Anderson BJ. Dexmedetomidine disposition in children: a population analysis. Paediatr Anaesth, 2008;18:722-730. – reference: Venn RM, Karol MD, Grounds RM. Pharmacokinetics of dexmedetomidine infusions for sedation of postoperative patients requiring intensive caret. Br J Anaesth, 2002;88:669-675. – reference: Dyck JB, Maze M, Haack C, Azarnoff DL, Vuorilehto L, Shafer SL. Computer-controlled infusion of intravenous dexmedetomidine hydrochloride in adult human volunteers. Anesthesiology, 1993;78:821-828. – reference: Zhang X, Schmidt U, Wain JC, Bigatello L. Bradycardia leading to asystole during dexmedetomidine infusion in an 18 year-old double-lung transplant recipient. J Clin Anesth, 2010;22:45-49. – reference: Esmaoglu A, Ulgey A, Akin A, Boyaci A. Comparison between dexmedetomidine and midazolam for sedation of eclampsia patients in the intensive care unit. J Crit Care, 2009;24:551-555. – reference: Dyck JB, Maze M, Haack C, Vuorilehto L, Shafer SL. The pharmacokinetics and hemodynamic effects of intravenous and intramuscular dexmedetomidine hydrochloride in adult human volunteers. Anesthesiology, 1993;78:813-820. – reference: Hsu YW, Cortinez LI, Robertson KM et al. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology, 2004;101:1066-1076. – reference: Su F, Nicolson SC, Gastonguay MR et al. Population pharmacokinetics of dexmedetomidine in infants after open heart surgery. Anesth Analg, 2010;110:1383-1392. – reference: Lin L, Guo X, Zhang MZ, Qu CJ, Sun Y, Bai J. Pharmacokinetics of dexmedetomidine in Chinese post-surgical intensive care unit patients. 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What is known and Objective: Dexmedetomidine is a selective alpha2‐adrenoreceptor agonist used for sedation in critically ill patients. The current... Dexmedetomidine is a selective alpha2-adrenoreceptor agonist used for sedation in critically ill patients. The current study aimed to evaluate the... Summary What is known and Objective: Dexmedetomidine is a selective alpha2-adrenoreceptor agonist used for sedation in critically ill patients. The current... |
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| SubjectTerms | Adrenergic alpha-2 Receptor Agonists - administration & dosage Adrenergic alpha-2 Receptor Agonists - pharmacokinetics Adrenergic alpha-2 Receptor Agonists - pharmacology Adult Area Under Curve Biological and medical sciences dexmedetomidine Dexmedetomidine - administration & dosage Dexmedetomidine - pharmacokinetics Dexmedetomidine - pharmacology Dose-Response Relationship, Drug Double-Blind Method Humans Hypnotics and Sedatives - administration & dosage Hypnotics and Sedatives - pharmacokinetics Hypnotics and Sedatives - pharmacology Infusions, Intravenous Korean Male Medical sciences Models, Biological Nonlinear Dynamics pharmacodynamics pharmacokinetics Pharmacology. Drug treatments population pharmacokinetics Republic of Korea Tissue Distribution |
| Title | Pharmacokinetics and pharmacodynamics of intravenous dexmedetomidine in healthy Korean subjects |
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