Sex and gender influences on pharmacological response: an overview

Abstract

Research on the specific effects of sex and gender on pharmacokinetics and pharmacodynamics, as well as safety profile tolerability and drug efficacy, of medications remain meager because female animals and women have only recently been included in the pharmacological domain. To date, the influence of sex and gender on access to care and emotional factors, including patients and care provider dyads, the placebo effect, adherence, and safety profiles, are discussed. Furthermore, differences in drug responses, mainly for antidiabetic drugs, have been described. However, further studies are needed to explore the impact of sex and gender on reaching the most appropriate and tailored prescription for each patient, regardless of sex and gender.

Keywords::

• adherence
• antidiabetic drugs
• drug adverse effect
• gender
• medication
• sex

Acknowledgements

We express deep gratitude to Italian Pharmacological Society that provided the Award “Gender Innovation” to Ilaria Campesi. We thank the Mayor of Osilo for the granting of the structure devoted to the National Laboratory of Gender Medicine.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Biological, psychological, social, economic status and care provider influence drug response in men and boys and in women and girls.

• The access to the care and to high-level price drugs depends on sex-gender at least in some fields.

• The care provider–patient dyads should be carefully considered because the sex-gender of physician and patient could affect adherence.

• Adherence is essential to optimize therapy and it seems to be influenced by gender. However, more studies are needed to understand whether women are less adherent than men.

• Bioequivalence studies should enroll women and men because excipients could affect bioavailability in a sexual dimorphic way.

• The influence of sex and gender on placebo effect should be urgently studied because it is mandatory to know this question either in daily clinical practice and for the design or in randomized clinical trials.

• Research with gender approach could reduce adverse drug effects in women and could increase the efficacy in both sexes; sustainability of care is of relevance because cost of care is higher in women than in men.