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Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors
Blood pressure measurements form a critical component of adverse event monitoring for tyrosine kinase inhibitors, but might also serve as a biomarker for dose titrations. This study explored the impact of various sources of within‐individual variation on blood pressure readings to improve measuremen...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9841306/ https://www.ncbi.nlm.nih.gov/pubmed/36152309 http://dx.doi.org/10.1111/cts.13423 |
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author | Centanni, Maddalena Thijs, Abel Desar, Ingrid Karlsson, Mats O. Friberg, Lena E. |
author_facet | Centanni, Maddalena Thijs, Abel Desar, Ingrid Karlsson, Mats O. Friberg, Lena E. |
author_sort | Centanni, Maddalena |
collection | PubMed |
description | Blood pressure measurements form a critical component of adverse event monitoring for tyrosine kinase inhibitors, but might also serve as a biomarker for dose titrations. This study explored the impact of various sources of within‐individual variation on blood pressure readings to improve measurement practices and evaluated the utility for individual‐ and population‐level dose selection. A pharmacokinetic–pharmacodynamic modeling framework was created to describe circadian blood pressure changes, inter‐ and intra‐day variability, changes from dipper to non‐dipper profiles, and the relationship between drug exposure and blood pressure changes over time. The framework was used to quantitatively evaluate the influence of physiological and pharmacological aspects on blood pressure measurements, as well as to compare measurement techniques, including office‐based, home‐based, and ambulatory 24‐h blood pressure readings. Circadian changes, as well as random intra‐day and inter‐day variability, were found to be the largest sources of within‐individual variation in blood pressure. Office‐based and ambulatory 24‐h measurements gave rise to potential bias (>5 mmHg), which was mitigated by model‐based estimations. Our findings suggest that 5–8 consecutive, home‐based, measurements taken at a consistent time around noon, or alternatively within a limited time frame (e.g., 8.00 a.m. to 12.00 p.m. or 12.00 p.m. to 5.00 p.m.), will give rise to the most consistent blood pressure estimates. Blood pressure measurements likely do not represent a sufficiently accurate method for individual‐level dose selection, but may be valuable for population‐level dose identification. A user‐friendly tool has been made available to allow for interactive blood pressure simulations and estimations for the investigated scenarios. |
format | Online Article Text |
id | pubmed-9841306 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-98413062023-01-19 Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors Centanni, Maddalena Thijs, Abel Desar, Ingrid Karlsson, Mats O. Friberg, Lena E. Clin Transl Sci Research Blood pressure measurements form a critical component of adverse event monitoring for tyrosine kinase inhibitors, but might also serve as a biomarker for dose titrations. This study explored the impact of various sources of within‐individual variation on blood pressure readings to improve measurement practices and evaluated the utility for individual‐ and population‐level dose selection. A pharmacokinetic–pharmacodynamic modeling framework was created to describe circadian blood pressure changes, inter‐ and intra‐day variability, changes from dipper to non‐dipper profiles, and the relationship between drug exposure and blood pressure changes over time. The framework was used to quantitatively evaluate the influence of physiological and pharmacological aspects on blood pressure measurements, as well as to compare measurement techniques, including office‐based, home‐based, and ambulatory 24‐h blood pressure readings. Circadian changes, as well as random intra‐day and inter‐day variability, were found to be the largest sources of within‐individual variation in blood pressure. Office‐based and ambulatory 24‐h measurements gave rise to potential bias (>5 mmHg), which was mitigated by model‐based estimations. Our findings suggest that 5–8 consecutive, home‐based, measurements taken at a consistent time around noon, or alternatively within a limited time frame (e.g., 8.00 a.m. to 12.00 p.m. or 12.00 p.m. to 5.00 p.m.), will give rise to the most consistent blood pressure estimates. Blood pressure measurements likely do not represent a sufficiently accurate method for individual‐level dose selection, but may be valuable for population‐level dose identification. A user‐friendly tool has been made available to allow for interactive blood pressure simulations and estimations for the investigated scenarios. John Wiley and Sons Inc. 2022-10-18 /pmc/articles/PMC9841306/ /pubmed/36152309 http://dx.doi.org/10.1111/cts.13423 Text en © 2022 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Research Centanni, Maddalena Thijs, Abel Desar, Ingrid Karlsson, Mats O. Friberg, Lena E. Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors |
title | Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors |
title_full | Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors |
title_fullStr | Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors |
title_full_unstemmed | Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors |
title_short | Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors |
title_sort | optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine‐kinase inhibitors |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9841306/ https://www.ncbi.nlm.nih.gov/pubmed/36152309 http://dx.doi.org/10.1111/cts.13423 |
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