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Pharmaceuticals
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Sex Differences in Pharmaceutical Practice
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Sex Differences in Pharmaceutical Practice

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Medicinal Chemistry".

Deadline for manuscript submissions: 31 December 2024 | Viewed by 12814

Special Issue Editors

Dr. Silvia De Francia

E-Mail Website
Guest Editor
Department of Biological and Clinical Sciences, University of Turin, S. Luigi Gonzaga Hospital, 10043 Orbassano, Italy
Interests: pharmacology; sex and gender medicine; pharmacokinetics; pharmacodynamics; pharmacogenomics; personalized therapy
Special Issues, Collections and Topics in MDPI journals
Dr. Sarah Allegra

E-Mail Website
Guest Editor
Department of Biological and Clinical Sciences, University of Turin, S. Luigi Gonzaga Hospital, 10043 Orbassano, Italy
Interests: sex and gender pharmacology; gender medicine; pharmacokinetics; pharmacogenomics; personalized therapy.
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Until the last quarter of the 20th century, sex was not recognized as a variable in health research, nor was it believed to be a factor that could affect health and illness. Researchers preferred studying males for a variety of reasons, such as simplicity and low costs, concern about confounding effects of hormones and fear of liability to perinatal exposure in cases of pregnancy. In clinical–scientific research, therefore, the theme of sex differences is a recent historical development. However, it is important to achieve equitable representation in order to provide a non-partial view on the course of diseases and its attainment is necessary for determining the safety, effectiveness, and tolerability of drugs for all consumers. Preclinical and clinical research are two important phases in drug discovery and development process. It takes on average between 12 and 16 years to bring a molecule from the laboratory setting to clinical practice. If, during the early stages of preclinical development, a compound is optimized specifically in one sex model (male or female cells or in male or female mice), then any sex biases inherent in such models may be passed forward into later stages of drug development. Neglecting sex research is paradoxical not only because drugs are less studied in the women that use them the most, but also for the enormous quantities of money wasted on research conducted which is focused on a partial point of view. In this Special Issue, we aim to underline preclinical and clinical research from experts in the field of pharmaceuticals that can highlight therapeutic agents use and clinical strategies focused on sex differences. We are especially keen to publish sex-disaggregated data concerning new and old drugs research in order to try to identify future directions to aid in the design of inclusive trials that benefit all.

Dr. Silvia De Francia
Dr. Sarah Allegra
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • sex
  • differences
  • drugs
  • kinetics
  • dynamics
  • preclinical
  • clinical
  • research

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Published Papers (6 papers)

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Research

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13 pages, 1973 KiB  
Article
Antenatal Magnesium Sulfate Benefits Female Preterm Infants but Results in Poor Male Outcomes
by Ruth M. McLeod, Ted S. Rosenkrantz and R. Holly Fitch
Pharmaceuticals 2024, 17(2), 218; https://doi.org/10.3390/ph17020218 - 7 Feb 2024
Viewed by 1646
Abstract
Magnesium sulfate (MagSul) is used clinically to prevent eclamptic seizures during pregnancy and as a tocolytic for preterm labor. More recently, it has been implicated as offering neural protection in utero for at-risk infants. However, evidence is mixed. Some studies found that MagSul [...] Read more.
Magnesium sulfate (MagSul) is used clinically to prevent eclamptic seizures during pregnancy and as a tocolytic for preterm labor. More recently, it has been implicated as offering neural protection in utero for at-risk infants. However, evidence is mixed. Some studies found that MagSul reduced the incidence of cerebral palsy (CP) but did not improve other measures of neurologic function. Others did not find any improvement in outcomes. Inconsistencies in the literature may reflect the fact that sex effects are largely ignored, despite evidence that MagSul shows sex effects in animal models of neonatal brain injury. The current study used retrospective infant data to assess differences in developmental outcomes as a function of sex and MagSul treatment. We found that on 18-month neurodevelopmental cognitive and language measures, preterm males treated with MagSul (n = 209) had significantly worse scores than their untreated counterparts (n = 135; p < 0.05). Female preterm infants treated with MagSul (n = 220), on the other hand, showed a cognitive benefit relative to untreated females (n = 123; p < 0.05). No significant effects of MagSul were seen among females on language (p > 0.05). These results have tremendous implications for risk–benefit considerations in the ongoing use of MagSul and may explain why benefits have been hard to identify in clinical trials when sex is not considered. Full article
(This article belongs to the Special Issue Sex Differences in Pharmaceutical Practice)
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11 pages, 561 KiB  
Article
Use of Exposure Data to Establish Causality in Drug–Adverse Event Relationships: An Example with Desvenlafaxine
by Andrea Rodríguez-Lopez, Gina Mejía-Abril, Pablo Zubiaur, Sofía Calleja, Manuel Román, Francisco Abad-Santos and Dolores Ochoa
Pharmaceuticals 2024, 17(1), 69; https://doi.org/10.3390/ph17010069 - 3 Jan 2024
Viewed by 1274
Abstract
Causality algorithms help establish relationships between drug use and adverse event (AE) occurrence. High drug exposure leads to a higher likelihood of an AE being classified as an adverse drug reaction (ADR). However, there is a knowledge gap regarding what concentrations are predictive [...] Read more.
Causality algorithms help establish relationships between drug use and adverse event (AE) occurrence. High drug exposure leads to a higher likelihood of an AE being classified as an adverse drug reaction (ADR). However, there is a knowledge gap regarding what concentrations are predictive of ADRs, as this has not been systematically studied. In this work, the Spanish Pharmacovigilance System (SEFV) algorithm was used to define the relationship between the AE occurrence and drug administration in 178 healthy volunteers participating in five desvenlafaxine single-dose clinical trials, a selective serotonin and norepinephrine reuptake inhibitor that may cause dizziness, headache, nausea, dry mouth, constipation and hyperhidrosis. Eighty-three subjects presented 172 AEs that were classified as possible (101), conditional (31), unrelated (24) and probable (16). AUC∞ and Cmax were significantly higher in volunteers with vs. without ADRs (5981.24 ng·h/mL and 239.06 ng/mL and 4770.84 ng·h/mL and 200.69 ng/mL, respectively). Six of 19 subjects with conditional AEs with an SEFV score of 3 points presented an AUC∞ ≥ 6500 ng·h/mL or a Cmax ≥ 300 ng/mL (i.e., above percentile 75) and were summed one point on their SEFV score and classified as “possible” (4 points), improving the capacity of ADR detection. Full article
(This article belongs to the Special Issue Sex Differences in Pharmaceutical Practice)
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Review

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18 pages, 870 KiB  
Review
Sex-Gender Differences Are Completely Neglected in Treatments for Neuropathic Pain
by Francesco Salis, Salvatore Sardo, Gabriele Finco, Gian Luigi Gessa, Flavia Franconi and Roberta Agabio
Pharmaceuticals 2024, 17(7), 838; https://doi.org/10.3390/ph17070838 - 26 Jun 2024
Viewed by 1312
Abstract
As sex-gender differences have been described in the responses of patients to certain medications, we hypothesized that the responses to medications recommended for neuropathic pain may differ between men and women. We conducted a literature review to identify articles reporting potential sex-gender differences [...] Read more.
As sex-gender differences have been described in the responses of patients to certain medications, we hypothesized that the responses to medications recommended for neuropathic pain may differ between men and women. We conducted a literature review to identify articles reporting potential sex-gender differences in the efficacy and safety of these medications. Only a limited number of studies investigated potential sex-gender differences. Our results show that women seem to achieve higher blood concentrations than men during treatment with amitriptyline, nortriptyline, duloxetine, venlafaxine, and pregabalin. Compared to men, higher rates of women develop side effects during treatment with gabapentin, lidocaine, and tramadol. Globally, the sex-gender differences would suggest initially administering smaller doses of these medications to women with neuropathic pain compared to those administered to men. However, most of these differences have been revealed by studies focused on the treatment of other diseases (e.g., depression). Studies focused on neuropathic pain have overlooked potential sex-gender differences in patient responses to medications. Despite the fact that up to 60% of patients with neuropathic pain fail to achieve an adequate response to medications, the potential role of sex-gender differences in the efficacy and safety of pharmacotherapy has not adequately been investigated. Targeted studies should be implemented to facilitate personalized treatments for neuropathic pain. Full article
(This article belongs to the Special Issue Sex Differences in Pharmaceutical Practice)
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14 pages, 1355 KiB  
Review
The Impact of Sex on the Response to Proton Pump Inhibitor Treatment
by Holmfridur Helgadottir and Einar S. Björnsson
Pharmaceuticals 2023, 16(12), 1722; https://doi.org/10.3390/ph16121722 - 12 Dec 2023
Viewed by 2045
Abstract
Proton pump inhibitor (PPI) treatment is responsible for substantial gastrin elevation secondary to reduced intragastric acidity. Due to the increasing global prevalence of PPI users, concerns have been raised about the clinical significance of continuous gastrin elevation and its potential long-term side effects. [...] Read more.
Proton pump inhibitor (PPI) treatment is responsible for substantial gastrin elevation secondary to reduced intragastric acidity. Due to the increasing global prevalence of PPI users, concerns have been raised about the clinical significance of continuous gastrin elevation and its potential long-term side effects. Hypergastrinemia secondary to PPIs has trophic effects on gastric mucosa, leading to enterochromaffin-like cell hyperplasia and gastric (fundic) polyp formation, and it is believed to provoke acid rebound following PPI withdrawal that induces PPI overutilization. Previous studies have found higher gastrin release following PPI therapy in females compared with males, and sex differences have also been demonstrated in pharmacokinetic parameters and dose requirements for acid reflux. It is conceivable that females might be at increased risk of PPI overuse, because they often receive higher milligram-per-kilogram doses. The prevalence of PPI use is more common among females, and the female sex is a risk factor for adverse drug reactions. This non-systematic review outlines the current knowledge of the impact of biological sex on the response to PPIs. The aim is to highlight the female sex as a potential risk factor that could be a step toward precision medicine and should be considered in future research on the response to PPI treatment. Full article
(This article belongs to the Special Issue Sex Differences in Pharmaceutical Practice)
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19 pages, 380 KiB  
Review
Sex-Related Differences in the Pharmacological Response in SARS-CoV-2 Infection, Dyslipidemia, and Diabetes Mellitus: A Narrative Review
by Adelina Lombrea, Mirabela Romanescu, Narcisa Jianu, Minodora Andor, Maria Suciu, Dana Emilia Man, Corina Danciu, Cristina Adriana Dehelean and Valentina Buda
Pharmaceuticals 2023, 16(6), 853; https://doi.org/10.3390/ph16060853 - 7 Jun 2023
Cited by 5 | Viewed by 2398
Abstract
Pharmacological responses vary by sex in several illnesses. This narrative review summarizes sex variations in pharmaceutical response in SARS-CoV-2 infection, dyslipidemia, and diabetes mellitus. Infection with SARS-CoV-2 is more severe and deadly in men than women. This may be attributed to immunological responses, [...] Read more.
Pharmacological responses vary by sex in several illnesses. This narrative review summarizes sex variations in pharmaceutical response in SARS-CoV-2 infection, dyslipidemia, and diabetes mellitus. Infection with SARS-CoV-2 is more severe and deadly in men than women. This may be attributed to immunological responses, genetics, and hormones. Some research shows that men may respond better to genomic vaccinations and females to antiviral medications such as remdesivir (Moderna and Pfizer-BioNTech). In dyslipidemia, women tend to have greater HDL-C and lower LDL-C than men. Some studies show that females may need lower statin dosages than men to obtain equal LDL-C reductions. Ezetimibe co-administered with a statin significantly improved lipid profile indicators in men compared to women. Statins reduce dementia risk. Atorvastatin decreased dementia risk in males (adjusted HR 0.92, 95% CI 0.88–0.97), whereas lovastatin lowered dementia risk in women (HR 0.74, 95% CI 0.58–0.95). In diabetes mellitus, evidence suggests that females may have a higher risk of developing certain complications such as diabetic retinopathy and neuropathy, despite having lower rates of cardiovascular disease than males. This could be the result of differences in hormonal influences and genetic factors. Some research shows females may respond better to oral hypoglycemic medications such as metformin. In conclusion, sex-related differences in pharmacological response have been observed in SARS-CoV-2 infection, dyslipidemia, and diabetes mellitus. Further research is needed to better understand these differences and to develop personalized treatment strategies for males and females with these conditions. Full article
(This article belongs to the Special Issue Sex Differences in Pharmaceutical Practice)
19 pages, 394 KiB  
Review
Evaluation of Sex Differences in Preclinical Pharmacology Research: How Far Is Left to Go?
by Sarah Allegra, Francesco Chiara, Daniela Di Grazia, Marco Gaspari and Silvia De Francia
Pharmaceuticals 2023, 16(6), 786; https://doi.org/10.3390/ph16060786 - 24 May 2023
Cited by 10 | Viewed by 3342
Abstract
Until the last quarter of the 20th century, sex was not recognized as a variable in health research, nor was it believed to be a factor that could affect health and illness. Researchers preferred studying male models for a variety of reasons, such [...] Read more.
Until the last quarter of the 20th century, sex was not recognized as a variable in health research, nor was it believed to be a factor that could affect health and illness. Researchers preferred studying male models for a variety of reasons, such as simplicity, lower costs, hormone confounding effects, and fear of liability from perinatal exposure in case of pregnancy. Equitable representation is imperative for determining the safety, effectiveness, and tolerance of therapeutic agents for all consumers. Decades of female models’ underrepresentation in preclinical studies has resulted in inequality in the understanding, diagnosis, and treatment of disease between the sexes. Sex bias has been highlighted as one of the contributing factors to the poor translation and replicability of preclinical research. There have been multiple calls for action, and the inclusion of sex as a biological variable is increasingly supported. However, although there has been substantial progress in the efforts to include more female models in preclinical studies, disparities today remain. In the present review, we consider the current standard practice of the preclinical research setting, why the sex bias exists, why there is the need to include female models, and what risks may arise from continuing this exclusion from experimental design. Full article
(This article belongs to the Special Issue Sex Differences in Pharmaceutical Practice)
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