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Prednisolone Pharmacokinetics and Pharmacodynamics in Relation to Sex and Race
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Prednisolone pharmacokinetics (PK) and pharmacyodynamics (PD) were investigated in relation to sex and race in white males, black males, white females, and black females (n = 8/group) after a single oral dose (0.27 mg/kg) of prednisone. The study consisted of baseline and prednisone phases with 32‐hour sampling in each phase. Women were studied during the luteal phase of their menstrual cycle. Total and free plasma prednisolone concentrations were assayed by HPLC and ultrafiltration, and pharmacokinetic data were analyzed by compartmental fitting using WinNonlin. Plasma cortisol concentrations were assayed by HPLC; T‐helper, T‐suppressor lymphocyte, and neutrophil cell counts were determined by FACS and hemocytometry, and these pharmacodynamic data were evaluated by basic and extended indirect response models using ADAPT II. Total body weight‐normalized free prednisolone oral clearance and apparent volume of distribution were higher in men compared with women, regardless of race (by 22% in whites and 40% in blacks for oral clearance, p < 0.01; by 32% in whites and 38% in blacks for apparent volume of distribution, p < 0.01). The 50% inhibitory concentration (IC50) values for T‐suppressor cell‐trafficking inhibition were higher in whites than in blacks, regardless of sex (by 125% in men and 208% in women, p < 0.01). The IC50 or SC50 values for effects of prednisolone on cortisol secretion and T‐helper lymphocyte or neutrophil trafficking were not statistically different between men and women, blacks and whites. The findings of this study suggest that there are some prednisolone PK/PD differences related to sex and race. However, these differences do not suggest the need for dosage adjustments, and additional experiments with repeat dosing are needed to fully evaluate the clinical implication of these findings.
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“This pattern is consistent with evidence that other biologic effects of similar doses of orally administered prednisone reach a peak between 4 and 8 hours and have a duration of action lasting in the range of 12 to 16 hours.26”
From Twenty‐four‐hour profiles of plasma glucose, insulin, C‐peptide and free fatty acid in subjects with varying degrees of glucose tolerance following short‐term, medium‐dose prednisone (20 mg/day) treatment: evidence for differing effects on insulin secretion and action (2012) · cites this paper as [26]
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Metadata
- Authors
- Magee, M. H., Blum, R. A., Lates, C. D., & Jusko, W. J.
- Affiliations
- Kaleida Health (US)
- Corresponding author
- Jusko, William J.
- Venue
- The Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2001-11
- Volume
- 41
- Issue
- 11
- Pages
- 1180-1194
- ISSN
- 0021-9754 (ISSN-L)
- 0091-2700
- 1552-4604
- PMC
- PMC4207281
- OpenAlex
- W2065913585
- Cited by
- 125
- References
- 44
- Citations by year
- 2026: 2 · 2025: 7 · 2024: 8 · 2023: 8 · 2022: 5 · 2021: 9 · 2020: 4 · 2019: 13 · 2018: 5 · 2017: 4 · 2016: 6 · 2015: 2 · 2014: 3 · 2013: 6 · 2012: 5
- FWCI
- 4.14
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Clinical Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of General Medical Sciences (R37GM024211, GM 24211, R01GM024211)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- prednisolone, pharmacokinetics, pharmacodynamics, sex differences, racial differences, prednisone, oral clearance, volume of distribution, cortisol secretion, T helper cells, T suppressor lymphocytes, neutrophil trafficking, indirect response model, dose adjustment
- MeSH terms
- Adolescent, Adult, Anti-Inflammatory Agents, Female, T-Lymphocytes, Helper-Inducer, Humans, Hydrocortisone, Male, Middle Aged, Neutrophils, Prednisolone, Sex Factors, Black People, White People, T-Lymphocytes, Regulatory
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