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Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study
Clinical Lymphoma Myeloma and Leukemia, 16 (2016), 8; 472-476. https://doi.org/10.1016/j.clml.2016.04.003
Ostojić, Alen; Sertić, Dubravka; Rončević, Pavle; Perić, Zinaida; Granić, Paula; Matić, Nikolina; Bašić-Kinda, Sandra; Serventi-Seiwerth, Ranka; Radman, Ivo; Zadro, Renata; Nemet, Damir

Institucijski repozitorij: Dr Med - digitalni repozitorij Medicinskog fakulteta Sveučilišta u Zagrebu

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Ostojić, A., Sertić, D., Rončević, P., Perić, Z., Granić, P., Matić, N. ... Nemet, D. (2016). Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study. Clinical Lymphoma Myeloma and Leukemia, 16. (8), 472-476. doi: 10.1016/j.clml.2016.04.003

Ostojić, Alen, et al. "Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study." Clinical Lymphoma Myeloma and Leukemia, vol. 16, br. 8, 2016, str. 472-476. https://doi.org/10.1016/j.clml.2016.04.003

Ostojić, Alen, Dubravka Sertić, Pavle Rončević, Zinaida Perić, Paula Granić, Nikolina Matić, Sandra Bašić Kinda, et al. "Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study." Clinical Lymphoma Myeloma and Leukemia 16, br. 8 (2016): 472-476. https://doi.org/10.1016/j.clml.2016.04.003

Ostojić, A., et al. (2016) 'Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study', Clinical Lymphoma Myeloma and Leukemia, 16(8), str. 472-476. doi: 10.1016/j.clml.2016.04.003

Ostojić A, Sertić D, Rončević P, Perić Z, Granić P, Matić N, i sur.. Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study. Clinical Lymphoma Myeloma and Leukemia [Internet]. 08.2016. [pristupljeno 26.11.2024.];16(8):472-476. doi: 10.1016/j.clml.2016.04.003

A. Ostojić, et al., "Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study", Clinical Lymphoma Myeloma and Leukemia, vol. 16, br. 8, str. 472-476, Kolovoz 2016. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:105:528120. [Citirano: 26.11.2024.]

Za citiranje koristite ovu mrežnu adresu: https://urn.nsk.hr/urn:nbn:hr:105:528120
Podaci o radu
Naslov (engleski)Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study
AutorAlen Ostojić
AutorDubravka Sertić
AutorPavle Rončević
AutorZinaida Perić
AutorPaula Granić
AutorNikolina Matić
AutorSandra Bašić-Kinda
AutorRanka Serventi-Seiwerth
AutorIvo Radman
AutorRenata Zadro
AutorDamir Nemet
Autorova ustanovaSveučilište u Zagrebu
Medicinski fakultet
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Sažetak (engleski)
INTRODUCTION: For over a decade, imatinib has been the first-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML). Doubts on the bioequivalence and bioavailability of emerging generic compounds have been expressed. Adequate imatinib plasma concentration ([IPC] ≥1000 μmol/L) is associated with a better chance of optimal treatment response in patients with CML. In this study, we compared the achieved IPCs between the branded compound and its 2 generic forms. ----- PATIENTS AND METHODS: IPCs were compared in 24 consecutive patients with CML in the first chronic phase who changed from branded to generic imatinib. The median age was 49 years (range, 22-76 years). Fifteen of them were male. Six patients were switched to Neopax, 13 to Imakrebin, and 5 patients received both generics consecutively. All compounds were used in an equivalent dose of 400 mg orally once daily for at least 1 month before plasma concentrations were measured. High-performance liquid chromatography was used to determine imatinib plasma concentration from a specimen collected 21 to 24 hours after the last dose. ----- RESULTS: The median IPC achieved with branded imatinib was 1454 μmol/L (range, 485-2707 μmol/L) with 18 patients (75%) having IPC ≥ 1000 μmol/L. For Neopax and Imakrebin, median IPCs were 1717 μmol/L (range, 1249-3630 μmol/L) and 1458 μmol/L (range, 707-880 μmol/L), respectively, with 11 of 11 (100%) and 16 of 18 (89%) patients having IPC ≥ 1000 μmol/L. No significant difference in measured IPCs between all 3 compounds was found (P > .257). ----- CONCLUSION: When taken at equivalent doses, imatinib generics are bioequivalent and comparable in clinical efficacy and have the potential for substantial savings in the treatment cost for CML.
Ključne riječi (engleski)
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran
Verzija publikacijeZavršna verzija rukopisa prihvaćena za objavljivanje (postprint)
Naslov časopisaClinical Lymphoma Myeloma and Leukemia
Brojčani podacivol. 16, br. 8, str. 472-476
p-ISSN2152-2650
DOIhttps://doi.org/10.1016/j.clml.2016.04.003
URN:NBNurn:nbn:hr:105:528120
Datum objave publikacije2016-08
URL dokumentahttps://doi.org/10.1016/j.clml.2016.04.003
Vrsta resursaTekst
Prava pristupaOtvoreni pristup
Uvjeti korištenjaIkona licence Zaštićeno autorskim pravom.
Datum i vrijeme pohrane2024-03-28 09:00:14