Publications by authors named "A R Cobitz"
Article Synopsis
- Daprodustat is an oral medication that has completed phase 3 trials for treating anemia in patients with chronic kidney disease.
- The study had two parts: Part A compared the pharmacokinetics of daprodustat from different manufacturing processes, while Part B evaluated the bioequivalence of these formulations at various doses.
- Results showed that daprodustat’s plasma concentrations were similar over 24 hours regardless of the manufacturing method, and bioequivalence was confirmed for most doses, with no new safety issues detected.
Article Synopsis
- - The ASCEND-NHQ trial investigated the effectiveness of daprodustat in increasing hemoglobin levels and improving fatigue in adults with chronic kidney disease (CKD) stages 3-5, comparing it to a placebo over 28 weeks.
- - Results showed that participants taking daprodustat experienced a significant mean change in hemoglobin (1.58 g/dl) compared to the placebo group (0.19 g/dl), with 77% of daprodustat users achieving a 1 g/dl increase.
- - Additionally, the SF-36 Vitality score (which measures fatigue) improved more for those on daprodustat (7.3 points) than those on placebo (1.
Article Synopsis
- Hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) affects 10-15% of chronic dialysis patients, and a study compared the investigational drug daprodustat with standard ESA treatment to understand the characteristics and predictors of this issue.
- The study recruited 2,964 ESA-treated chronic dialysis patients and defined ESA hyporesponsiveness using specific criteria, finding that about 12% of participants were hyporesponsive.
- Key predictors included geographic region (especially Latin America), lower body mass index, younger age, and certain blood levels, along with additional factors like female sex and a history of heart failure; notably, the geographic finding suggests a need for further research.
Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents-post hoc analyses of the ASCEND-ND and ASCEND-D trials.
Ajay K Singh Finnian R McCausland Brian L Claggett Christoph Wanner Andrzej Wiecek Alexander R Cobitz
Nephrol Dial Transplant
July 2023
Article Synopsis
- The ASCEND-ND trial raised concerns about daprodustat having a higher risk of cancer-related adverse events compared to darbepoetin in patients with anemia due to chronic kidney disease (CKD), but this was not seen in the dialysis-focused ASCEND-D trial.* -
- Both trials involved randomizing patients to receive either daprodustat or various types of erythropoiesis-stimulating agents (ESAs), with different dosing schedules, and used statistical models to analyze the safety of the treatments.* -
- The findings indicated that the perceived increased risk of cancer-related adverse events for daprodustat in ASCEND-ND may have been biased due to under-counting of events in the darbepo
Article Synopsis
- The study compared the effectiveness of daprodustat, a new treatment for anemia in chronic kidney disease (CKD) patients on hemodialysis, with the standard treatment, epoetin alfa, in a noninferiority trial over 52 weeks.
- Results showed that daprodustat was as effective as epoetin in improving hemoglobin levels, with 80% of daprodustat patients responding adequately, compared to 64% with epoetin.
- Both treatments had similar rates of adverse events and impacts on blood pressure, while there was no significant difference in monthly intravenous iron use between the two groups.