Journal of pharmaceutical policy and practice · 2025
Adverse events reporting of Etelcalcetide: a real-word analysis from FAERS database.
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Zhang Dongdong, Cai Ying, Sun Yixin, Zeng Peiji, Wang Wei, Wang Wenhui, Cai Chengfu
Аннотация
BACKGROUND: This study's main goal was to closely monitor and record adverse events (AEs) related to the medication Etelcalcetide, which is used to treat secondary hyperparathyroidism (SHPT, which is defined as elevated parathyroid hormone (PTH) levels in response to abnormalities in the calcium, phosphate, and vitamin D homeostasis). Optimising patient safety and offering evidence-based recommendations for the proper use of this medication are the ultimate goals.
METHODS: A thorough collection and analysis of reports from the FDA Adverse Event Reporting System (FAERS) database was conducted, encompassing the first quarter of 2014 to the first quarter of 2024. Robust algorithms including as ROR, PRR, BCPNN, and EBGM were employed for proportional analysis, enabling efficient data mining to measure signals linked to AEs related to Etelcalcetide.
RESULTS: Based on the reports gathered, the number of patients in the Etelcalcetide population was found to be 2,472 (5,435 AEs). As expected, the study's findings revealed the occurrence of Decreased blood calcium, Hypophosphatemia, among other AEs, which are in line with the instructions in the medication insert. Furthermore, unforeseen major AEs were noted at the preferred term (PT) level. These included hunt stenosis, Shunt aneurysm, Shunt occlusion, Shunt infection and Peripheral arterial occlusive disease (PAOD) and so on. These results point to the possibility of AEs that are not presently listed in the medication description.
CONCLUSION: This work successfully identified previously unidentified and novel signals linked to AEs associated with the administration of Etelcalcetide, offering crucial insights into the intricate relationship between AEs and Etelcalcetide use. In the context of Etelcalcetide therapy, the study's findings highlight the vital significance of diligent surveillance and ongoing monitoring for the prompt detection and efficient management of AEs and to enhance overall patient safety and well-being.
METHODS: A thorough collection and analysis of reports from the FDA Adverse Event Reporting System (FAERS) database was conducted, encompassing the first quarter of 2014 to the first quarter of 2024. Robust algorithms including as ROR, PRR, BCPNN, and EBGM were employed for proportional analysis, enabling efficient data mining to measure signals linked to AEs related to Etelcalcetide.
RESULTS: Based on the reports gathered, the number of patients in the Etelcalcetide population was found to be 2,472 (5,435 AEs). As expected, the study's findings revealed the occurrence of Decreased blood calcium, Hypophosphatemia, among other AEs, which are in line with the instructions in the medication insert. Furthermore, unforeseen major AEs were noted at the preferred term (PT) level. These included hunt stenosis, Shunt aneurysm, Shunt occlusion, Shunt infection and Peripheral arterial occlusive disease (PAOD) and so on. These results point to the possibility of AEs that are not presently listed in the medication description.
CONCLUSION: This work successfully identified previously unidentified and novel signals linked to AEs associated with the administration of Etelcalcetide, offering crucial insights into the intricate relationship between AEs and Etelcalcetide use. In the context of Etelcalcetide therapy, the study's findings highlight the vital significance of diligent surveillance and ongoing monitoring for the prompt detection and efficient management of AEs and to enhance overall patient safety and well-being.