Efficacy and safety of roxadustat for treating anaemia in patients with chronic kidney disease and heart failure: a retrospective cohort study

Abstract

Background. Anaemia is a common comorbidity in patients with chronic kidney disease (CKD) and heart failure (HF). Roxadustat has been approved for the treatment of anaemia in patients with CKD. However, its efficacy and safety in treating anaemia in patients with both CKD and HF remain unclear. We conducted a retrospective study with propensity score matching (PSM) to evaluate the efficacy and safety of roxadustat in this population. Methods. This retrospective study enrolled patients diagnosed with HF comorbid with CKD and anaemia. The patients were divided into two groups: a roxadustat group and a control group. One-to-one PSM was used to balance baseline characteristics between the groups. The primary endpoint was the change in haemoglobin (Hb) at week 8. Secondary endpoints included Hb response, changes in haematocrit, iron parameters, echocardiographic parameters, B-type natriuretic peptides and lipid levels. Exploratory endpoints were mortality and rehospitalization rates over 30 days–2 years. Safety endpoints included the incidence of hyperkalaemia, liver damage and thrombotic events. Results. A total of 1055 patients were screened. After PSM, 206 patients were included. Baseline characteristics were comparable between the matched cohorts. At week 8, the roxadustat group experienced a greater increase in Hb than the control group, with a difference of 0.8 g/dl (95% confidence interval 0.3–1.3; P = .003). The roxadustat group also demonstrated a higher Hb response (60.2% versus 28.2%; P < .001) and a greater increase in haematocrit (4.7 ± 0.9% versus 2.8 ± 0.6%; P = .008) than the control group. No significant differences were observed for other secondary endpoints. Thrombotic events were similar between the two groups and there were no differences in the risks of mortality or rehospitalization. Conclusions. Roxadustat was effective in correcting and maintaining Hb levels in patients with anaemia, HF and CKD. It did not increase thrombotic and other adverse events, mortality or rehospitalization risks, making it a promising treatment option for anaemia in this population.