Background: Anecdotal evidence suggests that there may be sex differences in Drug-drug Interactions (DDI) involving specific drugs. Regulators have provided general guidance for the inclusion of females in clinical studies. Some clinical studies have reported sex differences in the Pharmacokinetics (PK) of CYP3A4 substrates, suggesting that DDI involving CYP3A4 substrates could potentially show sex differences.
Objective: The aim of this review was to investigate whether recent prospective DDI studies have included both sexes and whether there was evidence for the presence or absence of sex differences with the DDIs.
Methods: The relevant details from 156 drug interaction studies within 124 papers were extracted and evaluated.
Results: Only eight studies (five papers) compared the outcome of the DDI between males and females. The majority of the studies had only male volunteers. Five studies had females only while 60 had males only, with 7.7% of the studies having an equal proportion of both sexes. Surprisingly, four studies did not specify the sex of the subjects. Based on the limited number of studies comparing males and females, no specific trends or conclusions were evident. Sex differences in the interaction were reported between ketoconazole and midazolam as well as clarithromycin and midazolam. However, no sex difference was observed with the interaction between clarithromycin and triazolam or erythromycin and triazolam. No sex-related PK differences were observed with the interaction between ketoconazole and domperidone, although sex-related differences in QT prolongation were observed.
Conclusion: This review has shown that only limited progress had been made with the inclusion of both sexes in DDI studies.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.2174/1389200220666181128160813 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Immunonutrition to improve the quality of life of upper gastrointestinal cancer patients undergoing neoadjuvant treatment prior to surgery (NEOIMMUNE): double-blind randomized controlled multicenter clinical trial.
Dis Esophagus
January 2025
Department of Digestive and Oncological Surgery, Claude Huriez Hospital, Chu Lille, Lille, France.
Background: Malnutrition is common with esophagogastric cancers and is associated with negative outcomes. We aimed to evaluate if immunonutrition during neoadjuvant treatment improves patient's health-related quality of life (HRQOL) and reduces postoperative morbidity and toxicities during neoadjuvant treatment.
Methods: A multicenter double-blind randomized controlled trial (RCT) was undertaken.
A meta-analysis of sex differences in neonatal rodent ultrasonic vocalizations and the implication for the preclinical maternal immune activation model.
Biol Sex Differ
January 2025
Department of Psychology, Memorial University of Newfoundland and Labrador, St. John's NL, Canada.
As the earliest measure of social communication in rodents, ultrasonic vocalizations (USVs) in response to maternal separation are critical in preclinical research on neurodevelopmental disorders (NDDs). While sex differences in both USV production and behavioral outcomes are reported, many studies overlook sex as a biological variable in preclinical NDD models. We aimed to evaluate sex differences in USV call parameters and determine if USVs are differently impacted based on sex in the preclinical maternal immune activation (MIA) model.
View Article and Find Full Text PDFDifferences between private and public primary health care centers and differences between men and women in antihypertensive care and cardiovascular prevention in all patients with hypertension treated in primary care in Stockholm County, Sweden.
BMC Prim Care
January 2025
Division of Family Medicine and Primary Care, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.
Aims: To study differences in cardiovascular prevention and hypertension management in primary care in men and women, with comparisons between public and privately operated primary health care (PHC).
Methods: We used register data from Region Stockholm on collected prescribed medication and registered diagnoses, to identify patients aged 30 years and above with hypertension. Age-adjusted logistic regression was used to calculate odds ratios (ORs) with 99% confidence intervals (99% CIs) using public PHC centers as referents.
Measurement and Assessment of Head-to-Helmet Contact Forces.
Ann Biomed Eng
January 2025
Department of Mechanical and Industrial Engineering, Northeastern University, 360 Huntington Avenue, Boston, MA, 02115, USA.
Purpose: To evaluate the population variation in head-to-helmet contact forces in helmet users.
Methods: Four different size Kevlar composite helmets were instrumented with contact pressure sensors and chinstrap tension meters. A total number of 89 volunteers (25 female and 64 male volunteers) participated in the study.
Association between intraoperative fluid management and postoperative outcomes in living kidney donors: a retrospective cohort study.
Sci Rep
January 2025
Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.
Optimal fluid strategy for laparoscopic donor nephrectomy (LDN) remains unclear. LDN has been a domain for liberal fluid management to ensure graft perfusion, but this can result in adverse outcomes due to fluid overload. We compared postoperative outcome of living kidney donors according to the intraoperative fluid management.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!