[Medicines, sex and gender]

Area of Science:

• Pharmacology
• Pharmacokinetics
• Pharmacodynamics

Background:

• Sex-related differences in pharmacokinetics and pharmacodynamics are influenced by body composition, organ function, and hormonal regulation.
• Historical gender biases in clinical trials have hindered the recognition of these sex-based pharmacological variations.
• These differences impact prescription patterns and therapeutic outcomes, with women experiencing a higher rate of adverse drug reactions.

Purpose of the Study:

• To explore the impact of sex-related differences on drug efficacy and safety.
• To highlight the need for sex-specific dosage adjustments in certain medications.
• To emphasize the importance of personalized medicine beyond sex-based considerations.

Main Methods:

• Review of existing literature on sex differences in drug metabolism and response.
• Analysis of clinical trial data and prescription patterns.
• Examination of physiological and hormonal factors influencing drug disposition and action.

Main Results:

• Sex dimorphisms in body composition, liver, and kidney function significantly affect drug processing.
• Hormonal regulation plays a key role in modulating drug-metabolizing enzymes, transporters, and receptors.
• Evidence suggests that men and women may require different standard dosages for specific anti-infective and anticancer agents to minimize adverse events.

Conclusions:

• Acknowledging and addressing sex-related differences in drug response is essential for improving patient safety and therapeutic effectiveness.
• Sex-specific dosage adjustments can help mitigate the disproportionate burden of adverse drug reactions in women.
• Individual variability in pharmacological response underscores the necessity of personalized therapeutic strategies that go beyond broad sex-based categorizations.