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Genetic Polymorphisms of Cytochrome P450 Enzymes and the Effect on Interindividual, Pharmacokinetic Variability in Extensive Metabolizers

From the Clinical Pharmacology Research Center (Dr. Ma, Dr. Nafziger, Dr. Bertino), Department of Medicine (Dr. Nafziger, Dr. Bertino), and Department of Pharmacy Services (Dr. Bertino), Bassett Healthcare, Cooperstown, New York.

Genetic polymorphisms of cytochrome P450 (CYP) enzymes are one of the factors that contribute to the pharmacokinetic (PK) variability of drugs. PK variability is observed in the bimodal distribution between extensive metabolizers (EMs) and poor metabolizers (PMs). PK variability may also exist between individuals genotyped as homozygous EMs and heterozygous EMs. This may carry implications for drug dosing and drug response (e.g., risk of therapeutic failure or drug toxicity). Studies have reported significant PK differences between homozygous and heterozygous EMs. Some literature suggests that this distinction may be of clinical relevance. Due to study design limitations and data that are either sparse or conflicting, generalizations regarding the potential impact of the CYP genotype, within EMs, are difficult. Optimally designed clinical trials are needed. This review evaluates the potential impact of CYP genetic polymorphisms on interindividual PK variability of drugs within an EM population.

Key Words: Genetic polymorphisms • pharmacokinetics • extensive metabolizers • poor metabolizers • cytochrome P450 enzymes • drug metabolism

Address for reprints: Joseph S. Bertino Jr., PharmD, FCP, Clinical Pharmacology Research Center, Bassett Healthcare, One Atwell Road, Cooperstown, NY 13326-1394.

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