Erythropoiesis-stimulating agents (ESAs) are a standard treatment for patients with renal anemia to increase hemoglobin (Hb) levels and reduce their need for blood transfusions. However, treatments targeting high Hb levels require high doses of ESAs by the intravenous injection which are associated with an elevated risk of adverse cardiovascular events. In response to this key limitation other erythropoietin-promoting medications have been developed such as hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PH inhibitor). This post-hoc analysis of two clinical trials evaluates patients’ treatment satisfaction with a HIF-PH inhibitor, molidustat, compared to a standard ESA, darbepoetin alfa, as part of therapy for patients with non-dialysis chronic kidney disease (CKD) and renal anemia. Exploratory outcome data using the Treatment Satisfaction Questionnaire for Medicine version II (TSQM-II) showed that both arms in both trials had increased treatment satisfaction over the course of the study period as well as improvements in most TSQM-II domains at week 24. Molidustat was associated with convenience domain scores at multiple timepoints depending on the trial and more patients were highly satisfied with the convenience of molidustat compared to darbepoetin alfa. Patients treated with molidustat also had increases in global satisfaction domain scores compared to darbepoetin alfa, but the differences s in global satisfaction domain scores were not significant. These patient-reported satisfaction outcomes provide findings supporting the use of molidustat as a patient-centered treatment option for CKD-related anemia.

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. Registration of clinical trials ClinicalTrials.gov Identifier: NCT03350321 (November 22, 2017). ClinicalTrials.gov Identifier: NCT03350347 (November 22, 2017).