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Gender, ethnicity and genetics in cardiovascular disease: part 1: Basic principles
Benjamin M Schaefer1, Vincent Caracciolo, William H Frishman
1Department of Medicine, Jacobi Medical Center, Brooklyn, NY, USA.
Heart Disease (Hagerstown, Md.)
|April 26, 2003
Summary
Clinical drug trials historically excluded women and minorities, leading to disparities in pharmacodynamics and pharmacokinetics. This review covers genetic and ethnic variations impacting drug efficacy and safety.
Area of Science:
- Pharmacology
- Genetics
- Clinical Trials
Background:
- Historically, drug trials predominantly featured white males, overlooking significant gender and racial variations in drug responses.
- Despite regulatory efforts since 1993, the inclusion of diverse populations in clinical trials remains limited.
- Documented gender and racial differences in pharmacodynamics and pharmacokinetics exist, impacting therapeutic outcomes.
Purpose of the Study:
- To review the fundamental scientific principles behind gender and ethnic differences in drug efficacy and safety.
- To highlight the importance of diverse representation in clinical pharmacology.
- To summarize pharmacodynamic and pharmacokinetic variations across genders and ethnicities.
Main Methods:
- Review of scientific literature on pharmacogenetics and pharmacodynamics.
- Analysis of genetic polymorphisms in cardiovascular genes and drug metabolism pathways.
- Synthesis of data on gender and ethnic variations in drug response.
Main Results:
- Genetic polymorphisms significantly influence drug metabolism and cardiovascular responses.
- Substantial pharmacodynamic and pharmacokinetic variations exist between genders and ethnic groups.
- These variations can lead to differential drug efficacy and safety profiles.
Conclusions:
- Addressing underrepresentation in clinical trials is crucial for personalized medicine.
- Understanding genetic and demographic variations is essential for optimizing drug therapy.
- Further research is needed to fully elucidate and mitigate disparities in drug response.