Pre-medication practices and incidence of infusion-related reactions in patients receiving AMPHOTEC®: data from the Patient Registry of Amphotericin B Cholesteryl Sulfate Complex for Injection Clinical Tolerability (PRoACT) registry
Background Clinical studies have suggested that rates of infusion-related reactions (IRRs) may be higher with amphotericin B colloidal dispersion (ABCD) versus other forms of amphotericin B. However, these studies did not permit the use of pre-medications upfront, which are now commonly used. Object...
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| Veröffentlicht in: | Journal of antimicrobial chemotherapy 2008-12, Vol.62 (6), p.1392-1400 |
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| creator | Paterson, David L. David, Kristin Mrsic, Mirando Cetkovsky, Petr Weng, Xin-Hua Sterba, Jaroslav Krivan, Gregerly Boskovic, Darinka Lu, Minqiang Zhu, Li-Ping |
| description | Background Clinical studies have suggested that rates of infusion-related reactions (IRRs) may be higher with amphotericin B colloidal dispersion (ABCD) versus other forms of amphotericin B. However, these studies did not permit the use of pre-medications upfront, which are now commonly used. Objectives To describe the use of pre-medications and determine the rate of IRRs in the real-world setting. Methods PRoACT, a multicentre, worldwide observational registry, captured real-world data about pre-medication practices and IRRs in patients receiving ABCD. Eligible patients were those beginning treatment with ABCD; treatment was according to the site's standard treatment practice. Incidence of IRRs was collected during the first 10 days of ABCD therapy. Clinical response data were collected 12 weeks after treatment start. Results One hundred and seventy patients from 21 worldwide sites were included (median age 37 years; 52% male). There were a total of 1230 ABCD infusions (mean dose 2.8 mg/kg/day); 90% of the infusions (1105/1230) had pre-medication. Common pre-medications included corticosteroids, antihistamines, paracetamol (acetaminophen) and metamizole. The overall IRR rate was 12% (147/1230) and was lower in infusions with pre-medication (11%) versus no pre-medication (22%), P < 0.001. Corticosteroids were associated with a decreased incidence of IRRs (P < 0.05), while paracetamol and antihistamines were not. The most common IRRs were chills (7%), fever (7%) and rigors (5%). Clearance of the fungal infection occurred in 52% of the participants. Conclusions These data suggest a lower rate of IRRs with ABCD than previously reported. Pre-medication is associated with decreased IRR incidence. Corticosteroids in particular appear to decrease IRRs while paracetamol and antihistamines, though commonly used, do not. |
| doi_str_mv | 10.1093/jac/dkn394 |
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However, these studies did not permit the use of pre-medications upfront, which are now commonly used. Objectives To describe the use of pre-medications and determine the rate of IRRs in the real-world setting. Methods PRoACT, a multicentre, worldwide observational registry, captured real-world data about pre-medication practices and IRRs in patients receiving ABCD. Eligible patients were those beginning treatment with ABCD; treatment was according to the site's standard treatment practice. Incidence of IRRs was collected during the first 10 days of ABCD therapy. Clinical response data were collected 12 weeks after treatment start. Results One hundred and seventy patients from 21 worldwide sites were included (median age 37 years; 52% male). There were a total of 1230 ABCD infusions (mean dose 2.8 mg/kg/day); 90% of the infusions (1105/1230) had pre-medication. Common pre-medications included corticosteroids, antihistamines, paracetamol (acetaminophen) and metamizole. The overall IRR rate was 12% (147/1230) and was lower in infusions with pre-medication (11%) versus no pre-medication (22%), P < 0.001. Corticosteroids were associated with a decreased incidence of IRRs (P < 0.05), while paracetamol and antihistamines were not. The most common IRRs were chills (7%), fever (7%) and rigors (5%). Clearance of the fungal infection occurred in 52% of the participants. Conclusions These data suggest a lower rate of IRRs with ABCD than previously reported. Pre-medication is associated with decreased IRR incidence. Corticosteroids in particular appear to decrease IRRs while paracetamol and antihistamines, though commonly used, do not.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkn394</identifier><identifier>PMID: 18812423</identifier><identifier>CODEN: JACHDX</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Acetaminophen - therapeutic use ; Adolescent ; Adrenal Cortex Hormones - therapeutic use ; Adult ; Aged ; Aged, 80 and over ; Amphotericin B - administration & dosage ; Amphotericin B - adverse effects ; Amphotericin B - therapeutic use ; Anti-Inflammatory Agents - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antifungal Agents - administration & dosage ; Antifungal Agents - adverse effects ; Antifungal Agents - therapeutic use ; Biological and medical sciences ; Cholesterol Esters - administration & dosage ; Cholesterol Esters - adverse effects ; Cholesterol Esters - therapeutic use ; Drug Combinations ; Female ; fungal infections ; Fungi ; Histamine Antagonists - therapeutic use ; Humans ; Infections ; Infusions, Intravenous ; liposomal ; Male ; Medical sciences ; Middle Aged ; Mycoses - drug therapy ; Pharmacology ; Pharmacology. Drug treatments ; Side effects ; Steroids ; tolerability</subject><ispartof>Journal of antimicrobial chemotherapy, 2008-12, Vol.62 (6), p.1392-1400</ispartof><rights>The Author 2008. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org 2008</rights><rights>2009 INIST-CNRS</rights><rights>The Author 2008. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c477t-7894891e0d0f068521f9678c294d3d175e81466c5381703f548b8d9d4b6b60023</citedby><cites>FETCH-LOGICAL-c477t-7894891e0d0f068521f9678c294d3d175e81466c5381703f548b8d9d4b6b60023</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1584,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20923071$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18812423$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Paterson, David L.</creatorcontrib><creatorcontrib>David, Kristin</creatorcontrib><creatorcontrib>Mrsic, Mirando</creatorcontrib><creatorcontrib>Cetkovsky, Petr</creatorcontrib><creatorcontrib>Weng, Xin-Hua</creatorcontrib><creatorcontrib>Sterba, Jaroslav</creatorcontrib><creatorcontrib>Krivan, Gregerly</creatorcontrib><creatorcontrib>Boskovic, Darinka</creatorcontrib><creatorcontrib>Lu, Minqiang</creatorcontrib><creatorcontrib>Zhu, Li-Ping</creatorcontrib><creatorcontrib>PRoACT Investigators</creatorcontrib><title>Pre-medication practices and incidence of infusion-related reactions in patients receiving AMPHOTEC®: data from the Patient Registry of Amphotericin B Cholesteryl Sulfate Complex for Injection Clinical Tolerability (PRoACT) registry</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Background Clinical studies have suggested that rates of infusion-related reactions (IRRs) may be higher with amphotericin B colloidal dispersion (ABCD) versus other forms of amphotericin B. However, these studies did not permit the use of pre-medications upfront, which are now commonly used. Objectives To describe the use of pre-medications and determine the rate of IRRs in the real-world setting. Methods PRoACT, a multicentre, worldwide observational registry, captured real-world data about pre-medication practices and IRRs in patients receiving ABCD. Eligible patients were those beginning treatment with ABCD; treatment was according to the site's standard treatment practice. Incidence of IRRs was collected during the first 10 days of ABCD therapy. Clinical response data were collected 12 weeks after treatment start. Results One hundred and seventy patients from 21 worldwide sites were included (median age 37 years; 52% male). There were a total of 1230 ABCD infusions (mean dose 2.8 mg/kg/day); 90% of the infusions (1105/1230) had pre-medication. Common pre-medications included corticosteroids, antihistamines, paracetamol (acetaminophen) and metamizole. The overall IRR rate was 12% (147/1230) and was lower in infusions with pre-medication (11%) versus no pre-medication (22%), P < 0.001. Corticosteroids were associated with a decreased incidence of IRRs (P < 0.05), while paracetamol and antihistamines were not. The most common IRRs were chills (7%), fever (7%) and rigors (5%). Clearance of the fungal infection occurred in 52% of the participants. Conclusions These data suggest a lower rate of IRRs with ABCD than previously reported. Pre-medication is associated with decreased IRR incidence. Corticosteroids in particular appear to decrease IRRs while paracetamol and antihistamines, though commonly used, do not.</description><subject>Acetaminophen - therapeutic use</subject><subject>Adolescent</subject><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amphotericin B - administration & dosage</subject><subject>Amphotericin B - adverse effects</subject><subject>Amphotericin B - therapeutic use</subject><subject>Anti-Inflammatory Agents - therapeutic use</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antifungal Agents - adverse effects</subject><subject>Antifungal Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cholesterol Esters - administration & dosage</subject><subject>Cholesterol Esters - adverse effects</subject><subject>Cholesterol Esters - therapeutic use</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>fungal infections</subject><subject>Fungi</subject><subject>Histamine Antagonists - therapeutic use</subject><subject>Humans</subject><subject>Infections</subject><subject>Infusions, Intravenous</subject><subject>liposomal</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mycoses - drug therapy</subject><subject>Pharmacology</subject><subject>Pharmacology. Drug treatments</subject><subject>Side effects</subject><subject>Steroids</subject><subject>tolerability</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ktFu0zAUhiMEYmVwwwMgCwkESGF2nNgOdyUadFLZSlckxI3lOs7qLomDnaD1pXgI3oa34JRUm8QFV9axP___8fkdRU8JfktwTk-2Sp-U1y3N03vRhKQMxwnOyf1oginOYp5m9Ch6FMIWY8wyJh5GR0QIkqQJnUS_F97EjSmtVr11Leq80r3VJiDVlsi22pam1Qa5CopqCMDE3tSqNyXyZs-6NsAR6uC-afsAu9rYH7a9QtNPi9nF6rT49fMdKlWvUOVdg_qNQYsRRktzZUPvd3v5adNtXG-81aD2HhUbV5sA9a5Gl0NdgSMqXNPV5gZVzqOzdmv-uqOiti20X6MV3PBqbWvb79CrxdJNi9Vr6Gf0eBw9qFQdzJPDehx9-XC6Kmbx_OLjWTGdxzrlvI-5yFORE4NLXGEmsoRUOeNCJ3la0pLwzAgYMdMZFYRjWmWpWIsyL9M1WzOME3ocvRx1O---D_AE2digTV2r1rghSJJnQiQsB_D5P-DWDb6F3mRCOOM8SRhAb0ZIexeCN5XsvG2U30mC5T59CenLMX2Anx0UhzVkeoce4gbgxQFQASZWeQUBh1sOvk1CMSd3nBu6_xvGIwcTNje3pPLXknHKMzn7-k3S88-X88XyXGL6Bw5A150</recordid><startdate>20081201</startdate><enddate>20081201</enddate><creator>Paterson, David L.</creator><creator>David, Kristin</creator><creator>Mrsic, Mirando</creator><creator>Cetkovsky, Petr</creator><creator>Weng, Xin-Hua</creator><creator>Sterba, Jaroslav</creator><creator>Krivan, Gregerly</creator><creator>Boskovic, Darinka</creator><creator>Lu, Minqiang</creator><creator>Zhu, Li-Ping</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QO</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope></search><sort><creationdate>20081201</creationdate><title>Pre-medication practices and incidence of infusion-related reactions in patients receiving AMPHOTEC®: data from the Patient Registry of Amphotericin B Cholesteryl Sulfate Complex for Injection Clinical Tolerability (PRoACT) registry</title><author>Paterson, David L. ; David, Kristin ; Mrsic, Mirando ; Cetkovsky, Petr ; Weng, Xin-Hua ; Sterba, Jaroslav ; Krivan, Gregerly ; Boskovic, Darinka ; Lu, Minqiang ; Zhu, Li-Ping</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c477t-7894891e0d0f068521f9678c294d3d175e81466c5381703f548b8d9d4b6b60023</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Acetaminophen - therapeutic use</topic><topic>Adolescent</topic><topic>Adrenal Cortex Hormones - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amphotericin B - administration & dosage</topic><topic>Amphotericin B - adverse effects</topic><topic>Amphotericin B - therapeutic use</topic><topic>Anti-Inflammatory Agents - therapeutic use</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antifungal Agents - adverse effects</topic><topic>Antifungal Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Cholesterol Esters - administration & dosage</topic><topic>Cholesterol Esters - adverse effects</topic><topic>Cholesterol Esters - therapeutic use</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>fungal infections</topic><topic>Fungi</topic><topic>Histamine Antagonists - therapeutic use</topic><topic>Humans</topic><topic>Infections</topic><topic>Infusions, Intravenous</topic><topic>liposomal</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mycoses - drug therapy</topic><topic>Pharmacology</topic><topic>Pharmacology. Drug treatments</topic><topic>Side effects</topic><topic>Steroids</topic><topic>tolerability</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Paterson, David L.</creatorcontrib><creatorcontrib>David, Kristin</creatorcontrib><creatorcontrib>Mrsic, Mirando</creatorcontrib><creatorcontrib>Cetkovsky, Petr</creatorcontrib><creatorcontrib>Weng, Xin-Hua</creatorcontrib><creatorcontrib>Sterba, Jaroslav</creatorcontrib><creatorcontrib>Krivan, Gregerly</creatorcontrib><creatorcontrib>Boskovic, Darinka</creatorcontrib><creatorcontrib>Lu, Minqiang</creatorcontrib><creatorcontrib>Zhu, Li-Ping</creatorcontrib><creatorcontrib>PRoACT Investigators</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Paterson, David L.</au><au>David, Kristin</au><au>Mrsic, Mirando</au><au>Cetkovsky, Petr</au><au>Weng, Xin-Hua</au><au>Sterba, Jaroslav</au><au>Krivan, Gregerly</au><au>Boskovic, Darinka</au><au>Lu, Minqiang</au><au>Zhu, Li-Ping</au><aucorp>PRoACT Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pre-medication practices and incidence of infusion-related reactions in patients receiving AMPHOTEC®: data from the Patient Registry of Amphotericin B Cholesteryl Sulfate Complex for Injection Clinical Tolerability (PRoACT) registry</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2008-12-01</date><risdate>2008</risdate><volume>62</volume><issue>6</issue><spage>1392</spage><epage>1400</epage><pages>1392-1400</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><coden>JACHDX</coden><abstract>Background Clinical studies have suggested that rates of infusion-related reactions (IRRs) may be higher with amphotericin B colloidal dispersion (ABCD) versus other forms of amphotericin B. However, these studies did not permit the use of pre-medications upfront, which are now commonly used. Objectives To describe the use of pre-medications and determine the rate of IRRs in the real-world setting. Methods PRoACT, a multicentre, worldwide observational registry, captured real-world data about pre-medication practices and IRRs in patients receiving ABCD. Eligible patients were those beginning treatment with ABCD; treatment was according to the site's standard treatment practice. Incidence of IRRs was collected during the first 10 days of ABCD therapy. Clinical response data were collected 12 weeks after treatment start. Results One hundred and seventy patients from 21 worldwide sites were included (median age 37 years; 52% male). There were a total of 1230 ABCD infusions (mean dose 2.8 mg/kg/day); 90% of the infusions (1105/1230) had pre-medication. Common pre-medications included corticosteroids, antihistamines, paracetamol (acetaminophen) and metamizole. The overall IRR rate was 12% (147/1230) and was lower in infusions with pre-medication (11%) versus no pre-medication (22%), P < 0.001. Corticosteroids were associated with a decreased incidence of IRRs (P < 0.05), while paracetamol and antihistamines were not. The most common IRRs were chills (7%), fever (7%) and rigors (5%). Clearance of the fungal infection occurred in 52% of the participants. Conclusions These data suggest a lower rate of IRRs with ABCD than previously reported. Pre-medication is associated with decreased IRR incidence. Corticosteroids in particular appear to decrease IRRs while paracetamol and antihistamines, though commonly used, do not.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>18812423</pmid><doi>10.1093/jac/dkn394</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of antimicrobial chemotherapy, 2008-12, Vol.62 (6), p.1392-1400 |
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| subjects | Acetaminophen - therapeutic use Adolescent Adrenal Cortex Hormones - therapeutic use Adult Aged Aged, 80 and over Amphotericin B - administration & dosage Amphotericin B - adverse effects Amphotericin B - therapeutic use Anti-Inflammatory Agents - therapeutic use Antibiotics. Antiinfectious agents. Antiparasitic agents Antifungal Agents - administration & dosage Antifungal Agents - adverse effects Antifungal Agents - therapeutic use Biological and medical sciences Cholesterol Esters - administration & dosage Cholesterol Esters - adverse effects Cholesterol Esters - therapeutic use Drug Combinations Female fungal infections Fungi Histamine Antagonists - therapeutic use Humans Infections Infusions, Intravenous liposomal Male Medical sciences Middle Aged Mycoses - drug therapy Pharmacology Pharmacology. Drug treatments Side effects Steroids tolerability |
| title | Pre-medication practices and incidence of infusion-related reactions in patients receiving AMPHOTEC®: data from the Patient Registry of Amphotericin B Cholesteryl Sulfate Complex for Injection Clinical Tolerability (PRoACT) registry |
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