Discussion
anemia
SIDE EFFECT, DISEASE, ANEMIA, MYELODYSPLASTIC SYNDROME (MDS), COMPLICATIONS
The findings from this analysis suggest that when the results of both clinical trials are considered together, patients receiving molidustat reported improved treatment satisfaction over time. Patient-reported scores from both trials improved remarkably in terms of the convenience and global satisfaction domains when receiving molidustat. In contrast, the scores for darbepoetin alfa showed only numerical changes. Considering patient satisfaction in decision-making regarding CKD-related anemia treatment options may allow healthcare providers to better align care to holistically improve patient outcomes.In the MIYABI ND-C trial, the molidustat group demonstrated significant improvements from baseline in all domain scores at week 24, whereas notable improvements in effectiveness and side effect domain scores were observed in the darbepoetin group. Upon further investigation, there was a significant difference in LS mean changes, as evaluated with a GLM, between molidustat and darbepoetin alfa in the convenience domain at week 12, and a significant difference for this domain was also observed in the GEE analysis in that trial. Enhanced improvement in the convenience domain with molidustat could be attributed to the different routes of administration of molidustat (daily oral tablets) and darbepoetin alfa (SC injection at a hospital). In the MIYABI ND-M trial of patients who received ESAs prior to enrollment, global satisfaction and convenience improved more with molidustat. However, given the small sample sizes, improvements observed with darbepoetin alpha did not reach significance in any domain. In the GLM and GEE analyses, an impact of molidustat on the convenience domain was found at all follow-up time points. It cannot be ruled out that the considerable differences in the frequency and route of administration impacted patient convenience with these treatments.A preference among patients for oral administration over subcutaneous injection has been demonstrated in other disease areas with blood-related complications, such as long-term treatment of myelodysplastic syndrome (MDS) [It is also possible that patients found treatment schedules to be more convenient for molidustat. Patients taking molidustat required dose-control visits once every 4 weeks, whereas dose-control visits for darbepoetin alfa users were required every 2 weeks until Hb levels stabilized in the target range as per the study protocol. Furthermore, the frequency of darbepoetin alfa administration and dosage were changed from once every 2 weeks to once every 4 weeks when Hb levels were considered stable. A clinical trial focused on treatment satisfaction for people living with HIV requiring long-term treatment management found that patients preferred less frequent treatment and concluded that the mode of administration is one characteristic that accounts for improved treatment satisfaction [Other domains of the TSQM-II showed remarkable improvement in both trials, albeit less consistently than changes in the convenience domain. Both studies showed better outcomes for perceived effectiveness, in the form of absolute value increases, at weeks 12 and 24 for both the molidustat and darbepoetin groups. These increments were nominally significant for both treatments in patients who had not previously received ESAs. Previous structural equation modeling of responses to the TSQM-II found that the effectiveness and convenience domains contributed significantly to global satisfaction among patients using generic medication [Although this study had several strengths, several limitations should be noted. First, this post-hoc analysis of data from multiple trials did not aim to statistically compare the outcomes of each trial. Furthermore, since both the MIYABI-ND-C and ND-M were open-label, the participants to the trials might be more interested in a HIF-PH inhibitor as a newer treatment compared to an ESA. There was a concern that the open-label design of the study might have introduced bias and partially confounded the outcomes of the trial, but as TSQM data were collected up to week 24th (half of the study period), there were no significant dropouts for both treatment groups. Descriptive comparisons were complicated by slightly different inclusion criteria and patient characteristics. While they are not directly comparable, regardless of prior ESA usage, patients who received molidustat reported higher satisfaction in terms of convenience at the earlier evaluation time point compared with those who received darbepoetin alfa. Overall, perceptions of convenience and global satisfaction with their treatment significantly improved for patients who received molidustat, whereas no significant improvement was seen in those who received darbepoetin alfa. Second, the duration of this study was 24 weeks; therefore, studies with a longer study period are warranted to ascertain long-term effects. Owing to the chronic nature of complications and the long-term treatment for CKD-related anemia, treatment satisfaction may be a key differentiator for patients with CKD-related anemia and their healthcare providers.
