Sex Differences in Pharmacokinetics, Pharmacodynamics, and Adverse Drug Reactions of Cardiovascular Drugs

Although the number of trials enrolling women has increased, women are still consistently underrepresented. This is especially notable in cardiovascular drug trials, where only 20–30% of participants are women. In addition, sex-specific analyses on the efficacy and safety of drugs are not always performed, or not performed correctly. A consequence of this sex inequality is that most drugs are prescribed to women and men at the same dose, and the information on efficacy and safety at the time of market access is rather limited in women. In the meantime, cardiovascular drugs appear to account for the most pronounced differences in adverse drug reactions between men and women. There are several well-established pharmacokinetic sex differences. Female and male bodies distribute, metabolize and excrete drugs differently, leading to sex differences in drug disposition. Sex-determined variations in pharmacodynamics have traditionally been more difficult to quantify, but several studies have explored these differences for cardiovascular drugs. This chapter examines the biological basis of differences in pharmacokinetics and pharmacodynamics between the sexes for cardiovascular drugs and summarizes studies that have addressed these differences.