Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With Liver Cirrhosis

Phase 4 Completed 22 enrolled Kafrelsheikh University

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This prospective open-label parallel pilot clinical study evaluated the efficacy and safety of physiologically based pharmacokinetic (PBPK)-guided simvastatin dosing in Child-Pugh A and B cirrhotic patients with portal hypertension over a 3-month period. Twenty-two patients were enrolled following screening, and portal hemodynamic, laboratory, and safety parameters were assessed.

Timeline

Start: 2024-03-15
Primary completion: 2025-03-15
Completion: 2025-06-15

Publications

Background Abraldes JG, Albillos A, Banares R, Turnes J, Gonzalez R, Garcia-Pagan JC, Bosch J. Simvastatin lowers portal pressure in patients with cirrhosis and portal hypertension: a randomized controlled trial. Gastroenterology. 2009 May;136(5):1651-8. doi: 10.1053/j.gastro.2009.01.043. Epub 2009 Jan 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simvastatin	Small molecule	5 mg	—
Subject	Simvastatin	Small molecule	15 mg	—

Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With Liver Cirrhosis

Summary

Timeline

Publications

Drugs

Indications