ArticleJournal of pharmaceutical policy and practice2025
Adverse events reporting of Etelcalcetide: a real-word analysis from FAERS database.
Article in Journal of pharmaceutical policy and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
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Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
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