PK/PD Analysis of Empagliflozin in Healthy Egyptian Males
Start Date
April 2025
Location
3rd floor - Library
Abstract
Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is commonly used to treat Type 2 Diabetes by reducing renal glucose reabsorption. This study aimed to develop a stable pharmacokinetic/pharmacodynamic (PK/PD) model of empagliflozin and establish an optimal dosing regimen to reduce systolic blood pressure (SBP) by 10 mmHg. A dataset from 16 healthy Egyptian male participants was used, where each individual received a 10 mg morning and evening dose of empagliflozin, with a seven-day washout period between. Blood, urine, and vitals were collected for PK/PD analysis.
Model development included Monolix for base model fitting, Sycomore for model evolution tracking, and Simulx for dosing simulations. GraphPad Prism was used to determine EC50 values. A visual predictive check and observed vs. predicted plots confirmed model stability and predictive capability. A stable model was successfully created and can be confidently used in future dosing simulations. The EC50 for SBP reduction was calculated, and simulations supported a dosing regimen of 1.5 mg twice daily to maintain concentrations above the therapeutic goal of 0.007587 mg/L.
Results indicated that reduced doses of empagliflozin could effectively lower blood pressure with potentially fewer side effects. No relevant covariates were identified, and the findings aligned with previous studies. This study contributes to literature by focusing on Egyptian males, an underrepresented population in clinical research.
PK/PD Analysis of Empagliflozin in Healthy Egyptian Males
3rd floor - Library
Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is commonly used to treat Type 2 Diabetes by reducing renal glucose reabsorption. This study aimed to develop a stable pharmacokinetic/pharmacodynamic (PK/PD) model of empagliflozin and establish an optimal dosing regimen to reduce systolic blood pressure (SBP) by 10 mmHg. A dataset from 16 healthy Egyptian male participants was used, where each individual received a 10 mg morning and evening dose of empagliflozin, with a seven-day washout period between. Blood, urine, and vitals were collected for PK/PD analysis.
Model development included Monolix for base model fitting, Sycomore for model evolution tracking, and Simulx for dosing simulations. GraphPad Prism was used to determine EC50 values. A visual predictive check and observed vs. predicted plots confirmed model stability and predictive capability. A stable model was successfully created and can be confidently used in future dosing simulations. The EC50 for SBP reduction was calculated, and simulations supported a dosing regimen of 1.5 mg twice daily to maintain concentrations above the therapeutic goal of 0.007587 mg/L.
Results indicated that reduced doses of empagliflozin could effectively lower blood pressure with potentially fewer side effects. No relevant covariates were identified, and the findings aligned with previous studies. This study contributes to literature by focusing on Egyptian males, an underrepresented population in clinical research.
