Being male or female and having more or fewer side effects when taking a medication

Over the years, the participation of women in clinical trials has been very limited. There were several reasons to consider excluding them from the trials, such as the probability of pregnancy or fear of distortion of the study by hormonal changes in the menstrual cycle. In the field of pharmacology, this has meant that side effects, also called adverse effects, of drugs in women were unknown for a long time.

It was not until 1993, when the FDA (Food and Drug Administration of the United States) through the Guide for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Medications, called for the participation of women in trials clinical trials and recommended that both genders be tested separately to assess drug response. It is scientifically known that, due to certain biological processes, the response to drugs does not have to be the same in both genders, but despite this evidence, it is still not very common to differentiate between men and women in the prescription of drugs, nor in what refers to the choice of the drug nor in the dose that is prescribed.

On the other hand, drug repositioning is a novel and very promising technique that seeks to find new uses for existing drugs. This is very useful due to the high cost involved in discovering or designing drugs from scratch and is especially relevant in the case of rare diseases, for which lack of profitability is always a key factor.

In this context, a study led by Alejandro Rodríguez González, professor at the Higher Technical School of Computer Engineering of the Polytechnic University of Madrid (UPM) in Spain, and Belén Otero Carrasco, researcher at the UPM Biomedical Technology Center (CTB), and Aurora Pérez Pérez, professor at the UPM School of Computer Science, has focused on investigating repositioning from a gender perspective with the aim of verifying whether there are differences in the number of side effects suffered by men and women when take the same drug repositioned.

The study was carried out within the framework of the DISNET project (Drug repositioning and disease understanding through complex networks creation and analysis) which aims to provide mechanisms to improve and broaden knowledge about diseases, which help to understand the relationships between them, as well as as well as the repositioning of drugs through the integration of biomedical data on a large scale. DISNET is directed by Professor Alejandro Rodríguez González.

Search for a more efficient medicine for each gender

The researchers collected information from different sources and obtained a set of drug repositioning cases, the percentage of adverse effects that these drugs produce in each gender, and the global prevalence by gender of the diseases covered in the study repositioning cases. Firstly, it was analyzed if any of the genders presented a greater number of adverse effects than the other when taking the same medication. Secondly, the prevalence was also considered, analyzing the cases for which the gender that presented the highest percentage of side effects when taking a certain drug was not the gender that had the highest prevalence for the disease treated with said drug.

The results of the study showed that there is a significant difference between the side effects seen in women compared to those seen in men when taking the same medication. This indicates the need and importance of considering the gender variable when repositioning a new drug. Therefore, in repositioning strategies, the possible adverse effects that a drug may have in each of the genders should be considered and the prevalence of the disease should be taken into account. This may help reduce the number of drugs withdrawn from the market for causing major adverse effects in either gender, as well as reduce the overall number of adverse effect cases.

The low participation of women in pharmacological clinical trials over the years may be related to the fact that a greater number of side effects occur in this gender. (Image: UPM)

Likewise, the authors of the study emphasize that the reuse of drugs entails great savings in economic and temporal terms, making it possible for the treatment to be available to the patient in a much shorter period, with greater safety and at a lower cost. For this reason, they consider it very important to introduce the concept of gender perspective in this field.

Based on the results obtained in this first study, the future line in which these researchers are working is based on seeking a more personalized medicine where it is known which drugs are most appropriate for each gender. (Source: UPM)