Harnessing Clinical Trial and Real-World Data Towards an Understanding of Sex Effects on Drug Pharmacokinetics, Pharmacodynamics and Efficacy
Increasing clinical data on sex-related differences in drug efficacy and toxicity has highlighted the importance of understanding the impact of sex on drug pharmacokinetics and pharmacodynamics. Intrinsic differences between males and females, such as different CYP enzyme activity, drug transporter...
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| Published in: | Frontiers in pharmacology Vol. 13; p. 874606 |
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| Main Authors: | , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Frontiers Media S.A
06-06-2022
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| Subjects: | |
| Online Access: | Get full text |
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| Summary: | Increasing clinical data on sex-related differences in drug efficacy and toxicity has highlighted the importance of understanding the impact of sex on drug pharmacokinetics and pharmacodynamics. Intrinsic differences between males and females, such as different CYP enzyme activity, drug transporter expression or levels of sex hormones can all contribute to different responses to medications. However, most studies do not include sex-specific investigations, leading to lack of sex-disaggregated pharmacokinetic and pharmacodynamic data. Based available literature, the potential influence of sex on exposure-response relationship has not been fully explored for many drugs used in clinical practice, though population-based pharmacokinetic/pharmacodynamic modelling is well-placed to explore this effect. The aim of this review is to highlight existing knowledge gaps regarding the effect of sex on clinical outcomes, thereby proposing future research direction for the drugs with significant sex differences. Based on evaluated drugs encompassing all therapeutic areas, 25 drugs demonstrated a clinically meaningful sex differences in drug exposure (characterised by ≥ 50% change in drug exposure) and this altered PK was correlated with differential response. |
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| Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1 Jiao Zheng, Shanghai Jiao Tong University, China Edited by: Rose Hayeshi, North-West University, South Africa This article was submitted to Pharmacology of Anti-Cancer Drugs, a section of the journal Frontiers in Pharmacology Reviewed by: Pascal Le Corre, University of Rennes 1, France |
| ISSN: | 1663-9812 1663-9812 |
| DOI: | 10.3389/fphar.2022.874606 |