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0091270008323754v1
48/11/1350    most recent
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REVIEW/DRUG METABOLISM

Gender Has a Small but Statistically Significant Effect on Clearance of CYP3A Substrate Drugs

David J. Greenblatt, MD and Lisa L. von Moltke, MD

From the Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine and Tufts Medical Center, Boston, Massachusetts. Dr. Hartmut Derendorf acted as editor for this article.

The role of gender on the disposition of drugs metabolized by cytochrome P4503A (CYP3A) remains controversial. Some sources suggest that CYP3A activity in women exceeds that in men, but evidence to support this position is inconsistent at best. We evaluated 38 data sets in which clearance of CYP3A substrate drugs was studied in healthy young male and young female subjects. None of these drugs was a substrate for transport by P-glycoprotein (P-gp). The overall mean (±SE) for the female/male ratio of weight-normalized clearance was 1.26 (±0.07) for parenteral dosage and 1.17 (±0.07) for oral dosage. Both ratios were significantly different (P < .05) from 1.0. For oral dosage studies, the female/male clearance ratio was unrelated to the drug's absolute oral bioavailability. Thus gender has a small and statistically significant, although most likely clinically unimportant, influence on CYP3A phenotype for substrates not transported by P-gp.

Key Words: Gender effects • cytochrome P4503A • benzodiazepines

Address for reprints: David J. Greenblatt, MD, Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA 02111; e-mail: dj.greenblatt{at}tufts.edu.


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