Safety Profile of Roxadustat in Anemic Patients: A Meta-Analysis of 21 RCTs

Roxadustat demonstrated a SAE profile generally comparable to that of ESA, with no significant differences in cardiac SAEs, serious infections, azotemia, hypertension, or pneumonia. Hyperkalemia was more frequent compared with placebo, and withdrawals due to adverse events were more frequent compared with ESA. TEAEs leading to death were similar to ESA but higher than with placebo, whereas all-cause mortality was lower than with placebo and comparable to ESA. Taken together, current evidence supports the overall non-inferiority of roxadustat to ESA in terms of safety.