Residents and Fellows Research in Progress
Tuesday, November 14, 2023
08:30 AM–10:00 AM
Abstract
Introduction:
Drug dosing is regularly marketed as a “one size fits all” regimen. However, an important factor that may influence the dose is sex. Despite the efforts of regulatory agencies, females have been underrepresented in clinical trials thus differences in drug concentrations and adverse drug reactions are not readily detected during drug development, leading to the current dosing standard.
Research Question or Hypothesis:
Are there dosing discrepancies between sexes in regular practice for commonly used drugs? Does sex remain a significant factor for dosing after adjusting for known predictors (anthropometric, socioeconomic and genetic factors and medical history)?
Study Design:
We performed a cross-sectional study that included 10,090 participants of European ancestry aged = 18 years from the Montreal Heart Institute Hospital Cohort regularly taking at least one of 47 medications selected to be investigated in this study.
Methods:
At the time of recruitment, the participants completed a questionnaire regarding anthropometric and socioeconomic factors, and medical history. A blood sample was collected and used for genotyping using a custom ADME assay developed on the MassArray® System (Agena Bioscience, San Diego, CA).
For descriptive statistics, quantitative variables were presented as means and standard deviations whereas categorical variables were presented as counts and percentages. To compare between sexes, Kruskal-Wallis test was applied for quantitative variables and chi-square test was used for categorical characteristics. Statistical tests are two-sided and a p-value <0.05 is considered statistically significant. We will perform a multiple linear regression analysis to identify the association between sex and drug dosing and a stepwise regression in which sex is the variable of interest. Entry criteria are p<0.15 and exit criteria p>0.05. All statistical analyses will be performed using SAS version 9.4 (SAS Institute).
Results:
This research is in progress, results will be presented at the meeting.
Conclusion:
This study will help shed light on sex differences in drug dosing in clinical practice.
Presenting Author
Jessica Hindi B.Sc., M.Sc.Montreal Heart Institute
Authors
David Busseuil Ph.D.
Martin Jutras B.Sc.
Grégoire Leclair B.Pharm, Ph.D.
Ian Mongrain M.Sc.
Essaïd Oussaid M.Sc.
Marc-Olivier Pilon PharmD
Marie-Christyne Cyr Ph.D.
Simon de Denus B.Pharm, Ph.D.
Marie-Pierre Dubé Ph.D.
Jean-Claude Tardif MD
Isabelle St-Jean M.Sc.