Safety and Effectiveness of Roxadustat in Dialysis-Dependent Patients With Renal Anemia: A Hospital-Based Cohort Study

Abstract

Background Randomized controlled trials (RCTs) have shown the efficacy and safety of Roxadustat and conclude that it has the potential to change the treatment for anemia associated with chronic kidney disease. However, the experience of its use from clinical perspectives post-approval is lacking. Aim Using a clinical practice context, this study aims to compare Roxadustat's effectiveness and tolerability with Erythropoietin (EPO) in patients with renal anemia undergoing dialysis. Methods We examined the clinical records of patients with a diagnosis of renal anemia on dialysis who were prescribed Roxadustat or Erythropoietin at the department of nephrology of the First Affiliated Hospital of Gannan Medical University from January 2021 to December 2021. Eligible hemodialysis (HD) or peritoneal dialysis (PD) patients with renal anemia, aged >18 or <75 years, without infection, active bleeding, and malignancy were recruited. These patients received Roxadustat or EPO based on the preferential prescription choice made by the nephrologists of the department. We retrospectively attempted to determine the treatment response measured by the change in hemoglobin rate, from baseline up to six months. We also explored the impact of various factors on the treatment response and reported adverse events. Results A total of 106 patients have been included in the final analysis, with 53 patients in each group. The mean age of the study group was 49.9 ± 13.6 years with the main Hb level at the baseline of 8.1 g/dL ± 1.23 g/dl. The gain of hemoglobin from the baseline averaged over six months was 2.2 ± 2.11 g/dl in the Roxadustat group compared with 1.1 ± 1.67 g/dL in the EPO group ( p=0.01 ) . As compared to EPO,Roxadustat reduced the total cholesterol level by -0.59 ± 1.08 mmol/l versus -0.01 ± 1.28 mmol/l ( p=0012 ) and the low-density lipoprotein (LDL) cholesterol by -0.48 ± 1.07 mmol/l versus -0.47 ± 1.05 ( p=0.017 ) in the first three months. Associated factors with a non-response to treatment were age greater than 65 years (OR=6, 95% CI: 1.23-32.46, p=0.02 ), hypertension (OR=3.5, 95%CI: 0.89-13.25, p=0.060 ), and heart failure (OR=4.18, 95%CI:4.18 1.04-20.39, p=0.040 ). Although the proportion of hospitalization and infection was higher in the EPO group and the incidences of gastrointestinal symptoms (vomiting, nausea) and blood transfusions were higher in the Roxadustat group, there were no statistically significant differences. Conclusion Roxadustat improved hemoglobin compared to erythropoietin in patients undergoing dialysis with a safe profile but precautions should be taken for old patients with a cardiovascular medical history.

Correlation between blood concentration of roxadustat and clinical efficacy in patients with anemia of chronic kidney disease

“…[ 1 ] The overall prevalence of CKD in China is 10.8% and is expected to increase in the coming decades, particularly in rural areas. [ 2 ] Anemia is one of the most severe and inevitable complications associated with CKD. [ 3 ] Currently, the standard of care includes oral or intravenous iron supplementation, erythropoiesis-stimulating agents, and red blood cell transfusion.…”

Involuntary Falls in Patients with Chronic Kidney Diseases on Nephrology Wards: Research Advances and Future Perspectives

“…36,37 Second, vomiting and nausea are prevalent among CKD patients, often caused by metabolite buildup and medication side effects. [38][39][40] Third, digestive complications, including diarrhea and constipation, frequently afflict CKD patients. Arising from electrolyte imbalances, medication side effects, or disrupted bowel function, these complications obstruct the effective absorption and digestion of vital nutrients.…”

“…First, Impaired kidney function leads to reduced erythropoietin (EPO) secretion, which is an essential hormone governing erythropoiesis, resulting in decreased erythropoiesis and subsequent anemia. 39,44 Second, CKD patients often exhibit iron metabolism disorders, including impaired iron absorption, abnormal transportation, and reduced storage, leading to inadequate iron supply and affecting erythropoiesis. 44,45 Third, CKD patients frequently experience chronic inflammatory responses, which can encumber erythropoiesis and truncate the lifespan of red blood cells.…”

A real-world analysis of roxadustat effectiveness and safety in managing renal anemia among patients on maintenance hemodialysis: An observational study

“…By enhancing endogenous erythropoietin (EPO) production and regulating iron metabolism, roxadustat has demonstrated efficacy in correcting anemia in CKD patients. In 2018, China became the first country to approve its use in treating anemia associated with CKD, [2] a testament to its potential clinical value. Clinical research [5][6][7][8] suggests that some patients, due to inflammatory reactions causing functional iron deficiency, exhibit inadequate responses to ESAs, necessitating increased dosage.…”

“…[ 1 ] The overall prevalence of CKD in China is approximately 10.8%, with an upward trend observed in recent years. [ 2 ] Renal anemia, a common clinical manifestation of CKD, exacerbates multi-organ damage and is a crucial risk factor for increased incidence and mortality of CVD in these patients. [ 3 ] Despite advancements in treatment options, including erythropoiesis-stimulating agents (ESAs) and iron therapy, suboptimal management of renal anemia persists, particularly in hemodialysis patients.…”