Methods
CKD, anemia
RENAL ANEMIA, THROMBOEMBOLIC EVENT, ANEMIA
Our primary objective was to evaluate the treatment satisfaction with molidustat and darbepoetin alfa versus baseline in non-dialysis CKD patients with renal anemia. This post-hoc analysis employed patient characteristics and TSQM-II data generated in each trial. The MIYABI ND-C and MIYABI ND-M trials have been described in detail elsewhere [Treatment satisfaction was analyzed separately in each trial for the purpose of this post-hoc analysis, as the patient populations differed slightly between the two trials. However, the variables and statistical analysis for patient characteristics and outcomes from both trials were the same. The descriptive patient baseline characteristics of interest were age, sex, body mass index, smoking history, alcohol consumption, Hb level, medical history, history of thromboembolic events, estimated glomerular filtration rate (eGFR) category (mL/min/1.73 mContinuous variables are expressed as the number of non-missing values, median, mean, and standard deviation. Frequency tables were generated for the categorical variables.In both trials, patients who had undergone study treatment at least once were asked to complete the TSQM-II at baseline, week 12, and week 24 (Fig. Overall study design for TSQM-II evaluation in both trials. Changes in the scores from baseline to each time point were compared between the molidustat group and darbepoetin group. The changes from baseline were assessed with paired t-tests. The least square (LS) mean change was estimated using a general linear model (GLM) controlling for baseline TSQM scores, age, sex, CKD duration, duration of anemia due to CKD, CKD etiology, eGFR category, risk of CKD progression, and Hb level. The effect of treatment with molidustat versus darbepoetin alfa was assessed for each questionnaire domain using a generalized estimating equation (GEE) model adjusting for imbalances at baseline. Given the expected correlations between assessments, an autoregressive correlation structure is specified. The covariates in the GEE model were treatment, time, the interaction between time and treatment, and imbalanced variables at baseline that were clinically important. Finally, Pearson correlation coefficients were calculated for the relationship between Hb levels and TSQM scores among patients with high satisfaction at week 24, as well as between the average drug dose (from baseline to week 24) and TSQM scores (at week 24). All analyses were conducted for exploratory purposes, with no multiplicity adjustment for statistical tests.