Publications by authors named "D J Jaworowicz"
Article Synopsis
- * Enhanced exposure-response and pharmacokinetic/pharmacodynamic modeling revealed that higher concentrations of sotatercept improve key clinical outcomes including 6MWD and the likelihood of achieving lower NT-proBNP levels, while maintaining safety measures like hemoglobin levels.
- * Key factors influencing the treatment's response include patient age and iron supplementation, but their overall impact on outcomes was minimal, supporting the selected dosing strategy of 0.7 mg/kg administered subcutaneously every three weeks as effective and safe.
Population pharmacokinetic modeling of sotatercept in healthy participants and patients with pulmonary arterial hypertension.
CPT Pharmacometrics Syst Pharmacol
August 2024
Article Synopsis
- Sotatercept is a newly FDA-approved biologic for treating pulmonary arterial hypertension (PAH), which shows promising pharmacokinetic (PK) properties based on clinical studies.
- A population pharmacokinetic model was created using data from various studies, analyzing different dosing methods and durations, which included a total of 350 participants.
- The analysis revealed that body weight and a patient's baseline albumin level influence drug clearance and volume but do not significantly affect sotatercept's overall disposition, supporting its use as a subcutaneous treatment for PAH.
Pimavanserin is a selective serotonin-modulating agent with inverse agonist/antagonist activity at the 5-hydroxytryptamine (5-HT ) receptor. The safety and efficacy of pimavanserin 34 mg once daily were studied in adults with hallucinations and delusions associated with Parkinson's disease psychosis and other neuropsychiatric conditions. This analysis used model-based simulations of pimavanserin steady-state exposures to identify a dose that generated pediatric exposures comparable with adult exposures achieved with 34 mg pimavanserin.
View Article and Find Full Text PDFIn the 10-week, phase 2 CLARITY study of patients with major depressive disorder, adjunctive therapy to antidepressants with pimavanserin 34 mg once daily statistically significantly improved the Hamilton Depression Rating Scale (HAMD-17) total score (primary endpoint) and Sheehan Disability Scale (SDS) score (secondary endpoint) versus placebo. This analysis characterized the exposure-response (E-R) relationships of pimavanserin in this CLARITY patient population. Exposure measures were estimated for each patient based on population-pharmacokinetic empirical Bayesian estimates.
View Article and Find Full Text PDFPurpose/background: Pimavanserin is a selective serotonin 5-HT 2A receptor inverse agonist/antagonist being investigated in patients with negative symptoms of schizophrenia. This analysis aimed to characterize exposure-response relationships of pimavanserin in this population.
Methods/procedures: Exposure-response models were developed using data from ADVANCE.