Comparison of long‐term and short‐term administration of itraconazole for primary antifungal prophylaxis in recipients of allogeneic hematopoietic stem cell transplantation: a multicenter, randomized, open‐label trial

Lin, Ren; Xu, Xiaojun; Li, Y.; Sun, Jing; Zhang, Fan; Jiang, Qianli; Huang, Fen; Zhou, Hongsheng; Nie, Danian; Guo, Ziyue; Mao, Yujing; Xiao, Yang; Liu, Q.

doi:10.1111/tid.12192

Cited by 5 publications

(3 citation statements)

References 26 publications

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“…Of these 29 studies, seven studies used itraconazole for treatment 30 , 46 – 51 and 22 studies used itraconazole for prophylaxis. 16 – 19 , 22 – 24 , 52 – 65 Fourteen were conducted in European countries, six were in Japan, 16 , 48 , 50 , 53 , 55 , 63 three were in China, 61 , 64 , 65 three were in America, 23 , 57 , 59 two in Australia, 18 , 62 and one in South Korea. 20 Among these, two studies were conducted in children who used itraconazole for prophylaxis.…”

Section: Resultsmentioning

confidence: 99%

“… 17 Glasmacher et al, 60 in their study, claimed that there were no severe adverse effects (necessitating an interruption of prophylaxis) clearly attributable to itraconazole, especially no severe hepatotoxicity events. Lin et al’s study 61 showed that drug-related adverse events occurred in 19 (15.7%) of the patients involved, including 15 with gastrointestinal disorders (12.4%), two with abnormal liver function (1.65%), one with hypokalemia (1/121), and one with hydrothorax (0.8%). In Liu’s study there were 16 patients who withdrew from the study due to adverse reactions, including three cases of elevated aminotransferase.…”

Section: Resultsmentioning

confidence: 99%

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Trough concentration of itraconazole and its relationship with efficacy and safety: a systematic review and meta-analysis

Zhang¹,

Liu²,

Nie³

et al. 2018

IDR

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ObjectivesThe optimum trough concentration of itraconazole for clinical response and safty is controversial. The objective of this systematic review and meta-analysis was to determine the optimum trough concentration of itraconazole and evaluate its relationship with efficacy and safety.MethodsWe searched PubMed, EMBASE, Web of Science, the Cochrane Library, Clinical-Trials.gov, and three Chinese literature databases (CNKI, WanFang, and CBM). We included observational studies that compared clinical outcomes below or above the trough concentration cut-off value which we set as 0.25, 0.5, and 1.0 mg/L. The efficacy outcomes were rate of successful treatment, rate of prophylaxis failure and invasive fungal infection (IFI)-related mortality. The safety outcomes included incidents of hepatotoxicity and other adverse events.ResultsThe study included a total of 29 studies involving 2,346 patients. Our meta-analysis showed that compared with itraconazole trough concentrations (Ctrough) of ≥0.25 mg/L, levels of <0.25 mg/L significantly increased the incidence of IFI for prophylaxis (RR =3.279, 95% confidence interval [CI] 1.73–6.206). Moreover, the success rate of treatment decreased significantly at a cut-off level of 0.5 mg/L (RR =0.396, 95% CI 0.176–0.889). An itraconazole trough level of 1.0 mg/L was associated with hepatotoxicity and other adverse events in a review of many studies.ConclusionAn itraconazole trough concentration of 0.25 mg/L should be considered as the lower threshold for prophylaxis, and a target concentration of 0.5 mg/L should be the lower limit for effective treatment. A trough level of 1.0 mg/L is associated with increased hepatotoxicity and other adverse events (using High Performance Liquid Chromatography [HPLC]).

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Trough concentration of itraconazole and its relationship with efficacy and safety: a systematic review and meta-analysis

Zhang¹,

Liu²,

Nie³

et al. 2018

IDR

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“…The only new data supporting the use of intravenous itraconazole or its solution are from a few cohort studies reporting IFD rates of 1-7% for HSCT patients and 5% for patients with AML. 53,57,58…”

Section: Voriconazolementioning

confidence: 99%

Consensus guidelines for antifungal prophylaxis in haematological malignancy and haemopoietic stem cell transplantation, 2021

Teh

Yeoh

Haeusler

et al. 2021

Internal Medicine Journal

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Antifungal prophylaxis can reduce morbidity and mortality from invasive fungal disease (IFD). However, its use needs to be optimised and appropriately targeted to patients at highest risk to derive the most benefit. In addition to established risks for IFD, considerable recent progress in the treatment of malignancies has resulted in the development of new 'at-risk' groups. The changing epidemiology of IFD and emergence of drug resistance continue to impact choice of prophylaxis, highlighting the importance of active surveillance and knowledge of local epidemiology. These guidelines aim to highlight emerging risk groups and review the evidence and limitations around new formulations of established agents and new antifungal drugs. It provides recommendations around use and choice of antifungal prophylaxis, discusses the potential impact of the changing epidemiology of IFD and emergence of drug resistance, and future directions for risk stratification to assist optimal management of highly vulnerable patients.

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Antifungal Drugs

McManus¹

2015

Side Effects of Drugs Annual

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Comparison of long‐term and short‐term administration of itraconazole for primary antifungal prophylaxis in recipients of allogeneic hematopoietic stem cell transplantation: a multicenter, randomized, open‐label trial

Abstract: Long-term and short-term administration of ITCZ both seemed effective in preventing IFD in recipients of allo-HSCT. Further study with large sample size should be performed to evaluate this result. ITCZ shows the same pharmacokinetics in recipients of allo-HSCT as in non-recipients.

Cited by 5 publications

References 26 publications

Trough concentration of itraconazole and its relationship with efficacy and safety: a systematic review and meta-analysis

Trough concentration of itraconazole and its relationship with efficacy and safety: a systematic review and meta-analysis

Consensus guidelines for antifungal prophylaxis in haematological malignancy and haemopoietic stem cell transplantation, 2021

Antifungal Drugs

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