Data mining study on adverse events of cinacalcet based on JADER database

Abstract Background Cinacalcet is the first calcium-sensing receptor agonist (calcimimetic) primarily indicated for the management of secondary hyperparathyroidism in patients with chronic kidney disease. This study aims to evaluate the safety profile of cinacalcet in real-world clinical settings. Methods Data on adverse events (AEs) associated with cinacalcet, reported from the second quarter of 2004 to the fourth quarter of 2023, were extracted from the Japanese Adverse Drug Event Report (JADER) database. Data mining was performed using the reporting odds ratio (ROR) method, and the time to onset was analyzed using the Weibull Shape Parameter (WSP). Results A total of 663 AE reports related to cinacalcet were identified, involving 284 Preferred Terms (PTs) and 24 System Organ Classes (SOCs). Six noteworthy SOCs qualified based on criteria. Additionally, 67 AEs were identified with positive signals, comprising 41 significant AEs and 36 unexpected AEs. Notable signals that warrant particular attention include parathyroid haemorrhage, electrocardiogram QT shortened, sphincter of Oddi dysfunction, nephrolithiasis, intestinal obstruction, pancreatitis, ascites, gastrointestinal necrosis. The majority of AEs occurred within the first month of treatment. The WSP was calculated to be 0.66, indicating an early failure type. Conclusion This study has identified several significant and unexpected AEs associated with cinacalcet use, highlighting the need for careful monitoring, especially during the early stages of therapy.