The relationship between the success rate of empirical antifungal therapy with intravenous itraconazole and clinical parameters, including plasma levels of itraconazole, in immunocompromised patients receiving itraconazole oral solution as prophylaxis: A multicenter, prospective, open-label, observational study in Korea

Jin Seok Kim, June Won Cheong, Yeo Kyeoung Kim, Jinny Park, Yeung Chul Mun, Hye Jin Kang, Hyeon Gyu Yi, Je Hwan Lee, Yang Soo Kim, Hun Mo Ryoo, Sung Hyun Kim, Ho Young Kim, Jin Young Kim, Dong Gun Lee, Hoon Gu Kim, Hawk Kim, Young Don Joo, Yoo Hong Min

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

To identify the role of therapeutic drug monitoring of itraconazole (ITZ) in the setting of empirical antifungal therapy with intravenous (IV) ITZ, we performed a multicenter, prospective study in patients with hematological malignancies who had received antifungal prophylaxis with ITZ oral solution (OS). We evaluated the plasma levels of ITZ and hydroxy (OH) ITZ both before initiation of IV ITZ and on days 5-7 of IV ITZ. A total of 181 patients showed an overall success rate of 68.0 %. Prolonged baseline neutropenia and accompanying cardiovascular comorbidity were significantly associated with poor outcomes of the empirical antifungal therapy (P = 0.005 and P = 0.001, respectively). A significantly higher trough plasma level of OH ITZ per body weight was found in the patients who achieved success with empirical antifungal therapy (P = 0.036). There were no significant correlations between plasma concentrations of ITZ/OH ITZ (baseline or trough levels) and toxicities. Seven patients had a discontinuation of ITZ therapy due to toxicity. This study demonstrated that IV ITZ as empirical antifungal therapy was effective and therapeutic drug monitoring was helpful to estimate the outcome of empirical antifungal therapy in patients receiving antifungal prophylaxis with ITZ OS. To predict the outcome of empirical antifungal therapy with IV ITZ, we should evaluate baseline clinical characteristics and also perform the therapeutic drug monitoring of both ITZ and OH ITZ.

Original languageEnglish
Pages (from-to)33-42
Number of pages10
JournalAnnals of Hematology
Volume93
Issue number1
DOIs
Publication statusPublished - 2014 Jan 1

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Itraconazole
Immunocompromised Host
Korea
Observational Studies
Therapeutics
Drug Monitoring
Hematologic Neoplasms
Neutropenia

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Kim, Jin Seok ; Cheong, June Won ; Kim, Yeo Kyeoung ; Park, Jinny ; Mun, Yeung Chul ; Kang, Hye Jin ; Yi, Hyeon Gyu ; Lee, Je Hwan ; Kim, Yang Soo ; Ryoo, Hun Mo ; Kim, Sung Hyun ; Kim, Ho Young ; Kim, Jin Young ; Lee, Dong Gun ; Kim, Hoon Gu ; Kim, Hawk ; Joo, Young Don ; Min, Yoo Hong. / The relationship between the success rate of empirical antifungal therapy with intravenous itraconazole and clinical parameters, including plasma levels of itraconazole, in immunocompromised patients receiving itraconazole oral solution as prophylaxis : A multicenter, prospective, open-label, observational study in Korea. In: Annals of Hematology. 2014 ; Vol. 93, No. 1. pp. 33-42.
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abstract = "To identify the role of therapeutic drug monitoring of itraconazole (ITZ) in the setting of empirical antifungal therapy with intravenous (IV) ITZ, we performed a multicenter, prospective study in patients with hematological malignancies who had received antifungal prophylaxis with ITZ oral solution (OS). We evaluated the plasma levels of ITZ and hydroxy (OH) ITZ both before initiation of IV ITZ and on days 5-7 of IV ITZ. A total of 181 patients showed an overall success rate of 68.0 {\%}. Prolonged baseline neutropenia and accompanying cardiovascular comorbidity were significantly associated with poor outcomes of the empirical antifungal therapy (P = 0.005 and P = 0.001, respectively). A significantly higher trough plasma level of OH ITZ per body weight was found in the patients who achieved success with empirical antifungal therapy (P = 0.036). There were no significant correlations between plasma concentrations of ITZ/OH ITZ (baseline or trough levels) and toxicities. Seven patients had a discontinuation of ITZ therapy due to toxicity. This study demonstrated that IV ITZ as empirical antifungal therapy was effective and therapeutic drug monitoring was helpful to estimate the outcome of empirical antifungal therapy in patients receiving antifungal prophylaxis with ITZ OS. To predict the outcome of empirical antifungal therapy with IV ITZ, we should evaluate baseline clinical characteristics and also perform the therapeutic drug monitoring of both ITZ and OH ITZ.",
author = "Kim, {Jin Seok} and Cheong, {June Won} and Kim, {Yeo Kyeoung} and Jinny Park and Mun, {Yeung Chul} and Kang, {Hye Jin} and Yi, {Hyeon Gyu} and Lee, {Je Hwan} and Kim, {Yang Soo} and Ryoo, {Hun Mo} and Kim, {Sung Hyun} and Kim, {Ho Young} and Kim, {Jin Young} and Lee, {Dong Gun} and Kim, {Hoon Gu} and Hawk Kim and Joo, {Young Don} and Min, {Yoo Hong}",
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The relationship between the success rate of empirical antifungal therapy with intravenous itraconazole and clinical parameters, including plasma levels of itraconazole, in immunocompromised patients receiving itraconazole oral solution as prophylaxis : A multicenter, prospective, open-label, observational study in Korea. / Kim, Jin Seok; Cheong, June Won; Kim, Yeo Kyeoung; Park, Jinny; Mun, Yeung Chul; Kang, Hye Jin; Yi, Hyeon Gyu; Lee, Je Hwan; Kim, Yang Soo; Ryoo, Hun Mo; Kim, Sung Hyun; Kim, Ho Young; Kim, Jin Young; Lee, Dong Gun; Kim, Hoon Gu; Kim, Hawk; Joo, Young Don; Min, Yoo Hong.

In: Annals of Hematology, Vol. 93, No. 1, 01.01.2014, p. 33-42.

Research output: Contribution to journalArticle

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T1 - The relationship between the success rate of empirical antifungal therapy with intravenous itraconazole and clinical parameters, including plasma levels of itraconazole, in immunocompromised patients receiving itraconazole oral solution as prophylaxis

T2 - A multicenter, prospective, open-label, observational study in Korea

AU - Kim, Jin Seok

AU - Cheong, June Won

AU - Kim, Yeo Kyeoung

AU - Park, Jinny

AU - Mun, Yeung Chul

AU - Kang, Hye Jin

AU - Yi, Hyeon Gyu

AU - Lee, Je Hwan

AU - Kim, Yang Soo

AU - Ryoo, Hun Mo

AU - Kim, Sung Hyun

AU - Kim, Ho Young

AU - Kim, Jin Young

AU - Lee, Dong Gun

AU - Kim, Hoon Gu

AU - Kim, Hawk

AU - Joo, Young Don

AU - Min, Yoo Hong

PY - 2014/1/1

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N2 - To identify the role of therapeutic drug monitoring of itraconazole (ITZ) in the setting of empirical antifungal therapy with intravenous (IV) ITZ, we performed a multicenter, prospective study in patients with hematological malignancies who had received antifungal prophylaxis with ITZ oral solution (OS). We evaluated the plasma levels of ITZ and hydroxy (OH) ITZ both before initiation of IV ITZ and on days 5-7 of IV ITZ. A total of 181 patients showed an overall success rate of 68.0 %. Prolonged baseline neutropenia and accompanying cardiovascular comorbidity were significantly associated with poor outcomes of the empirical antifungal therapy (P = 0.005 and P = 0.001, respectively). A significantly higher trough plasma level of OH ITZ per body weight was found in the patients who achieved success with empirical antifungal therapy (P = 0.036). There were no significant correlations between plasma concentrations of ITZ/OH ITZ (baseline or trough levels) and toxicities. Seven patients had a discontinuation of ITZ therapy due to toxicity. This study demonstrated that IV ITZ as empirical antifungal therapy was effective and therapeutic drug monitoring was helpful to estimate the outcome of empirical antifungal therapy in patients receiving antifungal prophylaxis with ITZ OS. To predict the outcome of empirical antifungal therapy with IV ITZ, we should evaluate baseline clinical characteristics and also perform the therapeutic drug monitoring of both ITZ and OH ITZ.

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