Clinical analysis of 207 patients who developed renal disorders during or after treatment with edaravone reported during post-marketing surveillance.

BACKGROUND: The post-marketing surveillance of edaravone has reported serious adverse reactions, including renal and hepatic disorders. Renal disorders were the most frequently reported serious/important adverse reactions, which led to the evaluation of their causation by edaravone, their severity, and the recovery of renal function.

METHODS: A retrospective review was carried out of 207 Japanese patients with acute stroke who developed renal disorders on edaravone treatment.

RESULTS: No particular factor other than edaravone was found as a possible cause of the renal disorders in 17 patients (8.2%). In 91.8% of the patients evaluated, factors other than edaravone were associated with the development of renal disorders. Severe deterioration of systemic status (e.g., a severe infection or a decrease in blood pressure) was considered to be a highly probable cause of renal disorders that occurred before or during treatment with edaravone in 135 patients (65.2%). Fifty-nine patients (28.5%) underwent blood purification treatment (BPT). In the remaining 148 patients without BPT, the peak serum creatinine (SCr) level during follow-up was 3 mg/dl or more in 93 patients (44.9%) and less than 3 mg/dl in 55 patients (26.6%). The severity of renal disorders was moderate to severe in 73.3% of the 207 patients, and renal function recovered in 43%.

CONCLUSIONS: Appropriate treatment of deteriorated systemic status and the discontinuation of edaravone administration following the early discovery of renal disorders are recommended to reduce the development of severe renal disorders during edaravone treatment. The precise role(s) of edaravone in the pathogenesis of renal disorders should be evaluated in the future.