title: [Gender-related differences in pharmacokinetics and pharmacodynamics].
abstract: Following the negative experience with thalidomide, women were excluded from participation in clinical trials with new pharmaceutical agents as far as possible, especially from phase I studies. However, in the early 1990s a body of evidence accumulated suggesting clinically relevant gender-related differences in the efficacy and safety of drugs. Gender-related differences have been shown for the metabolism and the effects of drugs. Gender differences have been described especially for the enzymes of the cytochrome P 450 family, but also for phase II reactions and most recently for P-glycoprotein. Most of these differences observed are only of minor clinical relevance, however may result in an increased rate of adverse drug reactions. Further differences may be based on different receptor/target sensitivities, e. g. the increased sensitivity for drug-induced torsade de pointes arrhythmia in women. In addition, in complex diseases such as heart failure, men and women may develop different mechanisms of counter- regulation requiring different therapeutic approaches. Population-based approaches demonstrate gender differences in the incidence of adverse drug reactions.
authors.affiliation: Universität, Witten/Herdecke. pthuermann@wuppertal.helios-kliniken.de
authors.forename: P A
authors.initials: PA
authors.lastname: Thürmann
mesh_terms: D002986:Clinical Trials as Topic; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D003577:Cytochrome P-450 Enzyme System / Q000378:metabolism; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D010599:Pharmacokinetics; D010600:Pharmacology; D012737:Sex Factors
chemical_list: D003577:Cytochrome P-450 Enzyme System