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Dergiler / Turkish Journal of Hematology / 2021 / Cilt: 38 - Sayı: 3

Post-Marketing Analysis of Peripheral Neuropathy Burden with New-Generation Proteasome Inhibitors Using the FDA Adverse Event Reporting System

Yeni Jenerasyon Proteozom İnhibitörleriyle Olan Çevresel Nöropati Yükünün FDA Yan Etki Raporlama Sistemi Kullanılarak Pazarlama Sonrası Analizi

Syeda A. MİNA
Ibrahim N. MUHSEN
Ethan A. BURNS
Humaira SARFRAZ
Sai Ravi PİNGALİ
Jiaqiong XU
Shahrukh K. HASHMİ
Sayfa
218–221
DOI
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⚡ TL;DR(1 Cümlede Hızlı Çıkarım)

Compared to BTZ, CFZ and IZB have lower rates of reported PN, with RORs of 0.19 (0.16- 0.22) and 0.48 (0.43-0.54), respectively.

📌 3 Maddede Bu Makale

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Amaç & Hipotez:Proteasome inhibitors (PIs) are an integral component of multiple myeloma therapies.
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Temel Bulgular & Veri:Signal disproportionality analysis was reported using the reporting odds ratio (ROR) with 95% confidence interval (CI).
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Sonuç & Katkı:Compared to BTZ, CFZ and IZB have lower rates of reported PN, with RORs of 0.19 (0.16- 0.22) and 0.48 (0.43-0.54), respectively.
🔬Tür:Araştırma Makalesi
📍Kapsam:Genişletilmiş Akademik Örneklem
⚙️Değişkenler:Alan Parametreleri

Özet

Proteasome inhibitors (PIs) are an integral component of multiple myeloma therapies. Peripheral neuropathy (PN) is a well-known consequence of PIs, most frequently reported with earlier generations such as bortezomib (BTZ). There is a paucity of data highlighting the risk of developing PN with the new-generation PIs carfilzomib (CFZ) and ixazomib (IZB). This study evaluated reports of PN encountered with all three PIs using the Food and Drug Administration Adverse Event (AE) Reporting System (FAERS). Signal disproportionality analysis was reported using the reporting odds ratio (ROR) with 95% confidence interval (CI). PN was reported in a total of 2.1%, 5.0%, and 10.9% of AEs with CFZ, IZB, and BTZ, respectively. The ROR (95% CI) for PN secondary to BTZ, CFZ, and IZB was 34.10 (32.76-35.49), 6.37 (5.50-7.37), and 14.97 (13.63-16.44), respectively. Compared to BTZ, CFZ and IZB have lower rates of reported PN, with RORs of 0.19 (0.16- 0.22) and 0.48 (0.43-0.54), respectively.

Abstract

Proteozom inhibitörleri (Pİ) multipl myelom tedavilerinin integral parçalarındandır. Çevresel nöropatiler (ÇN) Pİ’nin iyi bilinen bir sonucudur, bortezomib (BTZ) gibi önceki jenerasyonlarla daha sık bildirilmiştir. Yeni jenerasyon PI olan karfilzomib (KFZ) ve iksazomib (IZB) ile gelişen ÇN riskini vurgulayan çalışmalar yetersizdir. Bu çalışmada, Gıda ve İlaç İdaresi Olumsuz Olay (OO) Raporlama Sistemini (FAERS) kullanarak her üç PI ile karşılaşılan ÇN raporları değerlendirildi. Sinyal orantısızlık analizi, raporlama olasılık oranı (ROO) %95 güven aralığı (GA) kullanılarak yapıldı. ÇN; KFZ, IZB, BTZ ile sırasıyla OO’nun toplamında %2,1, %5,0, ve %10,9’unda rapor edilmişti. BTZ, KFZ, ve IZB’ye ikincil ÇN için ROO (%95 GA) sırasıyla 34,10 (32,76-35,49), 6,37 (5,50-7,37), ve 14,97 (13,63-16,44) idi. KFZ ve IZB ile, BTZ ile karşılaştırıldığında daha az ÇN rapor edilmişti, ROO sırasıyla 0,19 (0,16-0,22) ve 0,48 (0,43-0,54) id

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Bu Makaleye Atıf Yap

MİNA, S. A., MUHSEN, I. N., BURNS, E. A., SARFRAZ, H., PİNGALİ, S. R., XU, J., HASHMİ, S. K. (2021). Post-Marketing Analysis of Peripheral Neuropathy Burden with New-Generation Proteasome Inhibitors Using the FDA Adverse Event Reporting System. Turkish Journal of Hematology, Cilt: 38 - Sayı: 3, 218–221. https://ajindex.com/articles/405611

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