Efficacy and safety of short- and long-term treatment of itraconazole on chronic necrotizing pulmonary aspergillosis in multicenter study
In the respiratory field, chronic pulmonary aspergillosis, such as chronic necrotizing pulmonary aspergillosis (CNPA) or aspergilloma, is important. We examined the efficacy and safety of short- and long-term itraconazole (ITCZ) administration, involving a switch from injection to an oral preparatio...
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| Published in | Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy Vol. 18; no. 3; pp. 378 - 385 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Japan
Elsevier Ltd
01.06.2012
Springer Japan |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1341-321X 1437-7780 1437-7780 |
| DOI | 10.1007/s10156-012-0414-7 |
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| Abstract | In the respiratory field, chronic pulmonary aspergillosis, such as chronic necrotizing pulmonary aspergillosis (CNPA) or aspergilloma, is important. We examined the efficacy and safety of short- and long-term itraconazole (ITCZ) administration, involving a switch from injection to an oral preparation, in patients with CNPA. In all hospitals participating in this study, the protocol was approved by the ethics review board. This study started after UMIN registration (UMIN000001727). Subjects enrolled in this study were patients who were clinically or definitively diagnosed with CNPA in the respiratory field, according to the diagnostic criteria of the Japanese “Guidelines for management of deep-seated mycosis 2007,” in 16 hospitals that participated in this study between May 2008 and March 2011. Treatment was started with ITCZ injection. Subsequently, the agent was switched to an oral preparation. Efficacy was evaluated with major items (clinical symptoms, fever, imaging findings) and minor items (nutritional status, inflammatory markers). Twenty-nine patients were enrolled; safety was evaluated in 24 and efficacy in 23. Of the 23 patients, 10 (43.5%) responded. With respect to the administration period, the response rates in 8 patients treated for a short period and 15 treated for a long period were 25.0% and 53.3%, respectively. Trough blood concentration of ITCZ reached a level at which ITCZ may be effective for aspergillosis at 3 days after the start of ITCZ injection therapy. After changing to high-dose capsules, its level was also maintained. Adverse events such as liver dysfunction and heart failure were observed in 9 of the 24 patients. Furthermore, 6 patients died. However, there was no relationship between these events and ITCZ. Step-down therapy from ITCZ injection to oral administration may be a useful treatment option in CNPA patients requiring long-term treatment. |
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| AbstractList | In the respiratory field, chronic pulmonary aspergillosis, such as chronic necrotizing pulmonary aspergillosis (CNPA) or aspergilloma, is important. We examined the efficacy and safety of short- and long-term itraconazole (ITCZ) administration, involving a switch from injection to an oral preparation, in patients with CNPA. In all hospitals participating in this study, the protocol was approved by the ethics review board. This study started after UMIN registration (UMIN000001727). Subjects enrolled in this study were patients who were clinically or definitively diagnosed with CNPA in the respiratory field, according to the diagnostic criteria of the Japanese "Guidelines for management of deep-seated mycosis 2007," in 16 hospitals that participated in this study between May 2008 and March 2011. Treatment was started with ITCZ injection. Subsequently, the agent was switched to an oral preparation. Efficacy was evaluated with major items (clinical symptoms, fever, imaging findings) and minor items (nutritional status, inflammatory markers). Twenty-nine patients were enrolled; safety was evaluated in 24 and efficacy in 23. Of the 23 patients, 10 (43.5 %) responded. With respect to the administration period, the response rates in 8 patients treated for a short period and 15 treated for a long period were 25.0 % and 53.3 %, respectively. Trough blood concentration of ITCZ reached a level at which ITCZ may be effective for aspergillosis at 3 days after the start of ITCZ injection therapy. After changing to high-dose capsules, its level was also maintained. Adverse events such as liver dysfunction and heart failure were observed in 9 of the 24 patients. Furthermore, 6 patients died. However, there was no relationship between these events and ITCZ. Step-down therapy from ITCZ injection to oral administration may be a useful treatment option in CNPA patients requiring long-term treatment.In the respiratory field, chronic pulmonary aspergillosis, such as chronic necrotizing pulmonary aspergillosis (CNPA) or aspergilloma, is important. We examined the efficacy and safety of short- and long-term itraconazole (ITCZ) administration, involving a switch from injection to an oral preparation, in patients with CNPA. In all hospitals participating in this study, the protocol was approved by the ethics review board. This study started after UMIN registration (UMIN000001727). Subjects enrolled in this study were patients who were clinically or definitively diagnosed with CNPA in the respiratory field, according to the diagnostic criteria of the Japanese "Guidelines for management of deep-seated mycosis 2007," in 16 hospitals that participated in this study between May 2008 and March 2011. Treatment was started with ITCZ injection. Subsequently, the agent was switched to an oral preparation. Efficacy was evaluated with major items (clinical symptoms, fever, imaging findings) and minor items (nutritional status, inflammatory markers). Twenty-nine patients were enrolled; safety was evaluated in 24 and efficacy in 23. Of the 23 patients, 10 (43.5 %) responded. With respect to the administration period, the response rates in 8 patients treated for a short period and 15 treated for a long period were 25.0 % and 53.3 %, respectively. Trough blood concentration of ITCZ reached a level at which ITCZ may be effective for aspergillosis at 3 days after the start of ITCZ injection therapy. After changing to high-dose capsules, its level was also maintained. Adverse events such as liver dysfunction and heart failure were observed in 9 of the 24 patients. Furthermore, 6 patients died. However, there was no relationship between these events and ITCZ. Step-down therapy from ITCZ injection to oral administration may be a useful treatment option in CNPA patients requiring long-term treatment. In the respiratory field, chronic pulmonary aspergillosis, such as chronic necrotizing pulmonary aspergillosis (CNPA) or aspergilloma, is important. We examined the efficacy and safety of short- and long-term itraconazole (ITCZ) administration, involving a switch from injection to an oral preparation, in patients with CNPA. In all hospitals participating in this study, the protocol was approved by the ethics review board. This study started after UMIN registration (UMIN000001727). Subjects enrolled in this study were patients who were clinically or definitively diagnosed with CNPA in the respiratory field, according to the diagnostic criteria of the Japanese “Guidelines for management of deep-seated mycosis 2007,” in 16 hospitals that participated in this study between May 2008 and March 2011. Treatment was started with ITCZ injection. Subsequently, the agent was switched to an oral preparation. Efficacy was evaluated with major items (clinical symptoms, fever, imaging findings) and minor items (nutritional status, inflammatory markers). Twenty-nine patients were enrolled; safety was evaluated in 24 and efficacy in 23. Of the 23 patients, 10 (43.5 %) responded. With respect to the administration period, the response rates in 8 patients treated for a short period and 15 treated for a long period were 25.0 % and 53.3 %, respectively. Trough blood concentration of ITCZ reached a level at which ITCZ may be effective for aspergillosis at 3 days after the start of ITCZ injection therapy. After changing to high-dose capsules, its level was also maintained. Adverse events such as liver dysfunction and heart failure were observed in 9 of the 24 patients. Furthermore, 6 patients died. However, there was no relationship between these events and ITCZ. Step-down therapy from ITCZ injection to oral administration may be a useful treatment option in CNPA patients requiring long-term treatment. In the respiratory field, chronic pulmonary aspergillosis, such as chronic necrotizing pulmonary aspergillosis (CNPA) or aspergilloma, is important. We examined the efficacy and safety of short- and long-term itraconazole (ITCZ) administration, involving a switch from injection to an oral preparation, in patients with CNPA. In all hospitals participating in this study, the protocol was approved by the ethics review board. This study started after UMIN registration (UMIN000001727). Subjects enrolled in this study were patients who were clinically or definitively diagnosed with CNPA in the respiratory field, according to the diagnostic criteria of the Japanese “Guidelines for management of deep-seated mycosis 2007,” in 16 hospitals that participated in this study between May 2008 and March 2011. Treatment was started with ITCZ injection. Subsequently, the agent was switched to an oral preparation. Efficacy was evaluated with major items (clinical symptoms, fever, imaging findings) and minor items (nutritional status, inflammatory markers). Twenty-nine patients were enrolled; safety was evaluated in 24 and efficacy in 23. Of the 23 patients, 10 (43.5%) responded. With respect to the administration period, the response rates in 8 patients treated for a short period and 15 treated for a long period were 25.0% and 53.3%, respectively. Trough blood concentration of ITCZ reached a level at which ITCZ may be effective for aspergillosis at 3 days after the start of ITCZ injection therapy. After changing to high-dose capsules, its level was also maintained. Adverse events such as liver dysfunction and heart failure were observed in 9 of the 24 patients. Furthermore, 6 patients died. However, there was no relationship between these events and ITCZ. Step-down therapy from ITCZ injection to oral administration may be a useful treatment option in CNPA patients requiring long-term treatment. Abstract In the respiratory field, chronic pulmonary aspergillosis, such as chronic necrotizing pulmonary aspergillosis (CNPA) or aspergilloma, is important. We examined the efficacy and safety of short- and long-term itraconazole (ITCZ) administration, involving a switch from injection to an oral preparation, in patients with CNPA. In all hospitals participating in this study, the protocol was approved by the ethics review board. This study started after UMIN registration (UMIN000001727). Subjects enrolled in this study were patients who were clinically or definitively diagnosed with CNPA in the respiratory field, according to the diagnostic criteria of the Japanese “Guidelines for management of deep-seated mycosis 2007,” in 16 hospitals that participated in this study between May 2008 and March 2011. Treatment was started with ITCZ injection. Subsequently, the agent was switched to an oral preparation. Efficacy was evaluated with major items (clinical symptoms, fever, imaging findings) and minor items (nutritional status, inflammatory markers). Twenty-nine patients were enrolled; safety was evaluated in 24 and efficacy in 23. Of the 23 patients, 10 (43.5 %) responded. With respect to the administration period, the response rates in 8 patients treated for a short period and 15 treated for a long period were 25.0 % and 53.3 %, respectively. Trough blood concentration of ITCZ reached a level at which ITCZ may be effective for aspergillosis at 3 days after the start of ITCZ injection therapy. After changing to high-dose capsules, its level was also maintained. Adverse events such as liver dysfunction and heart failure were observed in 9 of the 24 patients. Furthermore, 6 patients died. However, there was no relationship between these events and ITCZ. Step-down therapy from ITCZ injection to oral administration may be a useful treatment option in CNPA patients requiring long-term treatment. In the respiratory field, chronic pulmonary aspergillosis, such as chronic necrotizing pulmonary aspergillosis (CNPA) or aspergilloma, is important. We examined the efficacy and safety of short- and long-term itraconazole (ITCZ) administration, involving a switch from injection to an oral preparation, in patients with CNPA. In all hospitals participating in this study, the protocol was approved by the ethics review board. This study started after UMIN registration (UMIN000001727). Subjects enrolled in this study were patients who were clinically or definitively diagnosed with CNPA in the respiratory field, according to the diagnostic criteria of the Japanese 'Guidelines for management of deep-seated mycosis 2007,' in 16 hospitals that participated in this study between May 2008 and March 2011. Treatment was started with ITCZ injection. Subsequently, the agent was switched to an oral preparation. Efficacy was evaluated with major items (clinical symptoms, fever, imaging findings) and minor items (nutritional status, inflammatory markers). Twenty-nine patients were enrolled; safety was evaluated in 24 and efficacy in 23. Of the 23 patients, 10 (43.5 %) responded. With respect to the administration period, the response rates in 8 patients treated for a short period and 15 treated for a long period were 25.0 % and 53.3 %, respectively. Trough blood concentration of ITCZ reached a level at which ITCZ may be effective for aspergillosis at 3 days after the start of ITCZ injection therapy. After changing to high-dose capsules, its level was also maintained. Adverse events such as liver dysfunction and heart failure were observed in 9 of the 24 patients. Furthermore, 6 patients died. However, there was no relationship between these events and ITCZ. Step-down therapy from ITCZ injection to oral administration may be a useful treatment option in CNPA patients requiring long-term treatment. |
| Author | Yoshida, Koichiro Oritsu, Masaru Ando, Tsunehiro Niki, Yoshihito Kurashima, Atsuyuki Kamei, Katsuhiko Yamamoto, Toshinori |
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| BackLink | https://cir.nii.ac.jp/crid/1574231875493907584$$DView record in CiNii https://www.ncbi.nlm.nih.gov/pubmed/22526387$$D View this record in MEDLINE/PubMed |
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| Keywords | Chronic necrotizing pulmonary aspergillosis Treatment Itraconazole |
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| References_xml | – volume: 61 start-page: 109 year: 1982 end-page: 124 ident: bib0015 article-title: Chronic necrotizing pulmonary aspergillosis: a discrete clinical entity publication-title: Medicine (Baltim) – volume: 58 start-page: 128 year: 2010 end-page: 139 ident: bib0045 article-title: Clinical efficacy and safety of micafungin, a novel echinocandin antifungal drug, in pulmonary aspergillosis in a postmarketing setting publication-title: Jpn J Chemother – volume: 61 start-page: 410 year: 2010 end-page: 418 ident: bib0040 article-title: Intravenous micafungin versus voriconazole for chronic pulmonary aspergillosis: a multicenter trial in Japan. Japan Chronic Pulmonary Aspergillosis Study Group (JCPASG) publication-title: J Infect – volume: 54 start-page: 32 year: 2006 end-page: 47 ident: bib0050 article-title: Efficacy and safety of itraconazole injections and capsules in deep mycosis: uncontrolled multicenter open-label trial. 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Japan Chronic Pulmonary Aspergillosis Study Group (JCPASG) publication-title: J Infect doi: 10.1016/j.jinf.2010.08.005 – volume: 42 start-page: 591 year: 1999 ident: 10.1007/s10156-012-0414-7_bib0060 article-title: Itraconazole trough concentration in antifungal prophylaxis with six different dosing regimens using hydroxypropyl-β-cyclodextrin oral solution or coated-pellet capsules publication-title: Mycoses doi: 10.1046/j.1439-0507.1999.00518.x – volume: 58 start-page: 128 year: 2010 ident: 10.1007/s10156-012-0414-7_bib0045 article-title: Clinical efficacy and safety of micafungin, a novel echinocandin antifungal drug, in pulmonary aspergillosis in a postmarketing setting publication-title: Jpn J Chemother – volume: 61 start-page: 109 year: 1982 ident: 10.1007/s10156-012-0414-7_bib0015 article-title: Chronic necrotizing pulmonary aspergillosis: a discrete clinical entity publication-title: Medicine (Baltim) doi: 10.1097/00005792-198203000-00005 – volume: 23 start-page: 147 year: 2007 ident: 10.1007/s10156-012-0414-7_bib0055 article-title: Serum itraconazole concentrations in the treatment of pulmonary aspergillosis publication-title: Antibiot Chemother – volume: 46 start-page: 864 year: 2008 ident: 10.1007/s10156-012-0414-7_bib0035 article-title: Clinical features of chronic necrotizing pulmonary aspergillosis treated with voriconazole in patients with chronic respiratory disease publication-title: J Jpn Respir Soc – volume: 54 start-page: 32 year: 2006 ident: 10.1007/s10156-012-0414-7_bib0050 article-title: Efficacy and safety of itraconazole injections and capsules in deep mycosis: uncontrolled multicenter open-label trial. Itraconazole-Deep Mycosis Research Group publication-title: Jpn J Chemother – volume: 97 start-page: 135 year: 1994 ident: 10.1007/s10156-012-0414-7_bib0065 article-title: NIAID Mycoses Study Group multicenter trial of oral itraconazole therapy for invasive aspergillosis publication-title: Am J Med doi: 10.1016/0002-9343(94)90023-X – volume: 25 start-page: 397 year: 1991 ident: 10.1007/s10156-012-0414-7_bib0020 article-title: Phase I study on itraconazole (ITZ), an oral triazole antifungal: pharmacokinetics of ITZ in healthy subjects after single and multiple oral administrations publication-title: Kiso to Rinsho |
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