Publications by authors named "Dennis L Vargo"
Article Synopsis
- Vadadustat is being studied as an oral alternative to injectable treatments for anemia in patients on peritoneal dialysis, showing comparable safety and efficacy to darbepoetin alfa in clinical trials.
- A post hoc analysis of the INNO2VATE trials indicated that for patients on peritoneal dialysis, the rates of major cardiovascular events and changes in hemoglobin levels were similar for both treatments.
- Adverse events were reported less frequently in the vadadustat group compared to the darbepoetin alfa group, suggesting a potentially safer profile for vadadustat in this population.
Article Synopsis
- - Anemia is common in chronic kidney disease (CKD) and affects patients' quality of life, but current treatments like erythropoiesis-stimulating agents require ongoing injections, which can be inconvenient and have safety concerns related to cardiovascular risks.
- - The study analyzed the safety of vadadustat, a new oral treatment for CKD-related anemia, by pooling data from four clinical trials involving over 7,300 patients.
- - Results showed that vadadustat had comparable rates of treatment-emergent adverse events, serious adverse events, and fatal events to darbepoetin alfa, the standard injectable treatment, indicating it may be a safe alternative for managing anemia in CKD patients.
Article Synopsis
- * A clinical trial showed that vadadustat, a new treatment, was as effective as darbepoetin alfa in raising and maintaining hemoglobin levels in CKD patients, while also increasing EPO levels and circulating red blood cells.
- * Vadadustat improved iron availability for erythroid cells and altered iron markers in the blood, suggesting it may help enhance red blood cell production more effectively than darbepoetin alfa.
Article Synopsis
- Vadadustat is a medication that stimulates the production of erythropoietin, helping treat anemia in patients with chronic kidney disease on dialysis.
- Two large phase 3 trials compared its safety and effectiveness to darbepoetin alfa, focusing on cardiovascular events and hemoglobin levels over time.
- Results showed similar rates of major adverse cardiovascular events between the two treatments, but vadadustat led to slightly lower increases in hemoglobin levels in both incident and prevalent dialysis-dependent chronic kidney disease patients.
Article Synopsis
- * The study involved two large Phase 3 clinical trials focusing on patients with low hemoglobin levels; the main goal was to assess the safety of vadadustat compared to darbepoetin, specifically looking at major cardiovascular events.
- * Results showed that vadadustat did not meet the safety benchmark compared to darbepoetin, as indicated by a higher hazard ratio for major adverse cardiovascular events, and there was minimal difference in hemoglobin improvement between the two treatments.
Article Synopsis
- Current guidelines recommend using erythropoiesis-stimulating agents (ESAs) for managing anemia in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD), with vadadustat being an investigational oral treatment that boosts erythropoietin production.
- The PROTECT program consists of two Phase 3 clinical trials comparing the safety and efficacy of vadadustat to darbepoetin alfa in adult patients with anemia due to NDD-CKD, focusing on different patient groups based on their prior ESA treatment status.
- Both trials assess primary outcomes like changes in hemoglobin levels and major cardiovascular events over defined treatment periods, aiming to provide valuable insights into vadadustat's role in
Tivozanib hydrochloride (tivozanib) is a potent, selective tyrosine kinase inhibitor of all three vascular endothelial growth factor receptors, with a long half-life. Tivozanib's effects on the QTc interval in patients with advanced solid tumors were assessed. Patients received 1.
View Article and Find Full Text PDFThe effect of food on the pharmacokinetics of tivozanib hydrochloride.
Clin Pharmacol Drug Dev
March 2014
Tivozanib hydrochloride (tivozanib) is a potent, selective tyrosine kinase inhibitor of the vascular endothelial growth factor receptors 1, 2, and 3, with a long half-life. This Phase I study evaluated the effect of food on tivozanib pharmacokinetics (PK). A single oral dose of tivozanib was administered to healthy subjects in a fasted/fed and a fed/fasted state.
View Article and Find Full Text PDFObjective: To evaluate the absorption, metabolism, and excretion of tivozanib, a new investigational drug for renal cell carcinoma and solid malignancies.
Methods: Eight healthy male participants received a single 1.5-mg (˜160 μCi) dose of oral [(14) C]-tivozanib.