Treatment satisfaction with molidustat in CKD-related anemia in non-dialysis patients: a post-hoc analysis of two clinical trials

by Selleckchem | Jul 20 2023

Background: Erythropoiesis-stimulating agents (ESAs) are the standard treatment for patients with renal anemia to increase hemoglobin (Hb) levels and reduce the need for blood transfusions. However, treatments targeting high Hb levels require high doses of ESAs administered intravenously, which is associated with an elevated risk of adverse cardiovascular events. Furthermore, there have been some problems such as hemoglobin variability and low achievement of target hemoglobin due to the shorter half-lives of ESAs. Consequently, erythropoietin-promoting medications, such as hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors, have been developed. This study aimed to evaluate changes in the Treatment Satisfaction Questionnaire for Medicine version II (TSQM-II) domain scores relative to baseline in each trial, to assess patient satisfaction with molidustat versus darbepoetin alfa.

Methods: This post-hoc analysis of two clinical trials compared treatment satisfaction with an HIF-PH inhibitor, molidustat, versus a standard ESA, darbepoetin alfa, as part of therapy in patients with non-dialysis chronic kidney disease (CKD) and renal anemia.

Results: Exploratory outcome data using the TSQM-II showed that both arms in both trials had enhanced treatment satisfaction over the course of the study period, as well as improvements in most TSQM-II domains at week 24 of treatment. Molidustat was associated with convenience domain scores at multiple time points depending on the trial. More patients were highly satisfied with the convenience of molidustat than that of darbepoetin alfa. Patients treated with molidustat had increased global satisfaction domain scores compared with those treated with darbepoetin alfa; however, the differences in global satisfaction domain scores were not significant.

Conclusion: These patient-reported satisfaction outcomes support the use of molidustat as a patient-centered treatment option for CKD-related anemia.

Comments:

The study aimed to assess patient satisfaction with molidustat, an erythropoietin-promoting medication, compared to darbepoetin alfa, a standard erythropoiesis-stimulating agent (ESA), in the treatment of non-dialysis chronic kidney disease (CKD) and renal anemia. The researchers conducted a post-hoc analysis of two clinical trials and evaluated changes in the Treatment Satisfaction Questionnaire for Medicine version II (TSQM-II) domain scores relative to baseline.

The results of the analysis showed that both treatment arms (molidustat and darbepoetin alfa) demonstrated improved treatment satisfaction over the study period, with most TSQM-II domains showing enhancements at week 24 of treatment. In terms of convenience, molidustat had higher domain scores at multiple time points compared to darbepoetin alfa. More patients expressed high satisfaction with the convenience of molidustat compared to darbepoetin alfa. Additionally, patients treated with molidustat exhibited increased global satisfaction domain scores compared to those treated with darbepoetin alfa, although the differences in global satisfaction domain scores did not reach statistical significance.

Based on these patient-reported satisfaction outcomes, the study suggests that molidustat could be considered as a patient-centered treatment option for anemia associated with CKD. By addressing the issues of hemoglobin variability and low achievement of target hemoglobin levels, molidustat offers the potential for improved convenience and treatment satisfaction compared to traditional ESAs like darbepoetin alfa. However, it is important to note that these findings are specific to the patient satisfaction aspect and further research and clinical evaluations are necessary to comprehensively assess the efficacy, safety, and overall benefits of molidustat in the management of CKD-related anemia.