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Safety of High-Dose Intravenous Daptomycin Treatment: Three-Year Cumulative Experience in a Clinical Program
Background.There are limited safety data for high-dose and long-term daptomycin treatment (>6mg/kg administered for ⩾14 days). We present our experience in 61 patients. Methods.We performed a retrospective chart review for all patients treated with daptomycin at New York Hospital Queens (Flushing...
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| Published in: | Clinical infectious diseases 2009-07, Vol.49 (2), p.177-180 |
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| creator | Figueroa, D. A. Mangini, E. Amodio-Groton, M. Vardianos, B. Melchert, A. Fana, C. Wehbeh, W. Urban, C. M. Segal-Maurer, S. |
| description | Background.There are limited safety data for high-dose and long-term daptomycin treatment (>6mg/kg administered for ⩾14 days). We present our experience in 61 patients. Methods.We performed a retrospective chart review for all patients treated with daptomycin at New York Hospital Queens (Flushing) from 1 January 2004 through 30 April 2007; patients were identified through a computerized hospital pharmacy database. Results.Sixty-one patients (29 male and 32 female patients; mean age, 66.6 years) received a mean dose of 8 mg/kg of daptomycin for a median of 25 days (range, 14-82 days). Twelve patients (with bone and skin and soft-tissue infections) did not have an identified microbiologic isolate. Gram-positive infections included bloodstream infection with or without infective endocarditis (n=32), skin and soft-tissue infection (n=14), bone and joint infection (n=9), and intra-abdominal infection (n=5), and unidentified infection (n=1). Prosthetic devices were removed from 11 of 20 patients. Grade 1 adverse events occurred in 22 patients and did not lead to daptomycin discontinuation. Fifty-eight patients underwent creatine phosphokinase (CPK) analysis (34 patients had paired CPK analyses at the beginning of and during therapy, and 13 patients had random CPK analysis performed during treatment). Three patients had constitutional and/or musculoskeletal symptoms accompanying CPK levels >10 times upper limit of normal (grade 3). All occurred after 24 days of treatment and improved after daptomycin treatment was discontinued. Two of 3 patients were morbidly obese (body mass index grade III). Conclusions.Daptomycin treatment was well tolerated at a mean dose of 8 mg/kg for a median duration of 25 days. The incidence of symptomatic CPK level elevation was within the range reported with lower doses of daptomycin and/or for shorter treatment durations. |
| doi_str_mv | 10.1086/600039 |
| format | article |
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A. ; Mangini, E. ; Amodio-Groton, M. ; Vardianos, B. ; Melchert, A. ; Fana, C. ; Wehbeh, W. ; Urban, C. M. ; Segal-Maurer, S.</creator><creatorcontrib>Figueroa, D. A. ; Mangini, E. ; Amodio-Groton, M. ; Vardianos, B. ; Melchert, A. ; Fana, C. ; Wehbeh, W. ; Urban, C. M. ; Segal-Maurer, S.</creatorcontrib><description>Background.There are limited safety data for high-dose and long-term daptomycin treatment (>6mg/kg administered for ⩾14 days). We present our experience in 61 patients. Methods.We performed a retrospective chart review for all patients treated with daptomycin at New York Hospital Queens (Flushing) from 1 January 2004 through 30 April 2007; patients were identified through a computerized hospital pharmacy database. Results.Sixty-one patients (29 male and 32 female patients; mean age, 66.6 years) received a mean dose of 8 mg/kg of daptomycin for a median of 25 days (range, 14-82 days). Twelve patients (with bone and skin and soft-tissue infections) did not have an identified microbiologic isolate. Gram-positive infections included bloodstream infection with or without infective endocarditis (n=32), skin and soft-tissue infection (n=14), bone and joint infection (n=9), and intra-abdominal infection (n=5), and unidentified infection (n=1). Prosthetic devices were removed from 11 of 20 patients. Grade 1 adverse events occurred in 22 patients and did not lead to daptomycin discontinuation. Fifty-eight patients underwent creatine phosphokinase (CPK) analysis (34 patients had paired CPK analyses at the beginning of and during therapy, and 13 patients had random CPK analysis performed during treatment). Three patients had constitutional and/or musculoskeletal symptoms accompanying CPK levels >10 times upper limit of normal (grade 3). All occurred after 24 days of treatment and improved after daptomycin treatment was discontinued. Two of 3 patients were morbidly obese (body mass index grade III). Conclusions.Daptomycin treatment was well tolerated at a mean dose of 8 mg/kg for a median duration of 25 days. The incidence of symptomatic CPK level elevation was within the range reported with lower doses of daptomycin and/or for shorter treatment durations.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1086/600039</identifier><identifier>PMID: 19500039</identifier><identifier>CODEN: CIDIEL</identifier><language>eng</language><publisher>Oxford: The University of Chicago Press</publisher><subject>Aged ; Anti-Bacterial Agents - administration & dosage ; Anti-Bacterial Agents - adverse effects ; Anti-Bacterial Agents - therapeutic use ; Antibacterial agents ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Articles and Commentaries ; Bacterial Infections - drug therapy ; Biological and medical sciences ; Body mass index ; Bones ; Creatine Kinase - blood ; Cubism ; Daptomycin - administration & dosage ; Daptomycin - adverse effects ; Daptomycin - therapeutic use ; Dosage ; Drug dosages ; Drug therapy ; Endocarditis ; Female ; Hospitals ; Humans ; Infections ; Infectious diseases ; Injections, Intravenous ; Male ; Medical sciences ; Microbiology ; Musculoskeletal diseases ; New York ; Obesity ; Patients ; Pharmaceutical preparations ; Pharmacology. Drug treatments ; Prosthetics ; Retrospective Studies</subject><ispartof>Clinical infectious diseases, 2009-07, Vol.49 (2), p.177-180</ispartof><rights>Copyright 2009 Infectious Diseases Society of America</rights><rights>2009 by the Infectious Diseases Society of America 2009</rights><rights>2009 INIST-CNRS</rights><rights>Copyright University of Chicago, acting through its Press Jul 15, 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c550t-9f82d8f50d7de3a451d1c84a78bf88f9e5a488e940c62fff62271c4aa5ba26023</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/40308650$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/40308650$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>315,786,790,27957,27958,58593,58826</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21708406$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19500039$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Figueroa, D. A.</creatorcontrib><creatorcontrib>Mangini, E.</creatorcontrib><creatorcontrib>Amodio-Groton, M.</creatorcontrib><creatorcontrib>Vardianos, B.</creatorcontrib><creatorcontrib>Melchert, A.</creatorcontrib><creatorcontrib>Fana, C.</creatorcontrib><creatorcontrib>Wehbeh, W.</creatorcontrib><creatorcontrib>Urban, C. M.</creatorcontrib><creatorcontrib>Segal-Maurer, S.</creatorcontrib><title>Safety of High-Dose Intravenous Daptomycin Treatment: Three-Year Cumulative Experience in a Clinical Program</title><title>Clinical infectious diseases</title><addtitle>Clinical Infectious Diseases</addtitle><addtitle>Clinical Infectious Diseases</addtitle><description>Background.There are limited safety data for high-dose and long-term daptomycin treatment (>6mg/kg administered for ⩾14 days). We present our experience in 61 patients. Methods.We performed a retrospective chart review for all patients treated with daptomycin at New York Hospital Queens (Flushing) from 1 January 2004 through 30 April 2007; patients were identified through a computerized hospital pharmacy database. Results.Sixty-one patients (29 male and 32 female patients; mean age, 66.6 years) received a mean dose of 8 mg/kg of daptomycin for a median of 25 days (range, 14-82 days). Twelve patients (with bone and skin and soft-tissue infections) did not have an identified microbiologic isolate. Gram-positive infections included bloodstream infection with or without infective endocarditis (n=32), skin and soft-tissue infection (n=14), bone and joint infection (n=9), and intra-abdominal infection (n=5), and unidentified infection (n=1). Prosthetic devices were removed from 11 of 20 patients. Grade 1 adverse events occurred in 22 patients and did not lead to daptomycin discontinuation. Fifty-eight patients underwent creatine phosphokinase (CPK) analysis (34 patients had paired CPK analyses at the beginning of and during therapy, and 13 patients had random CPK analysis performed during treatment). Three patients had constitutional and/or musculoskeletal symptoms accompanying CPK levels >10 times upper limit of normal (grade 3). All occurred after 24 days of treatment and improved after daptomycin treatment was discontinued. Two of 3 patients were morbidly obese (body mass index grade III). Conclusions.Daptomycin treatment was well tolerated at a mean dose of 8 mg/kg for a median duration of 25 days. The incidence of symptomatic CPK level elevation was within the range reported with lower doses of daptomycin and/or for shorter treatment durations.</description><subject>Aged</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antibacterial agents</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Articles and Commentaries</subject><subject>Bacterial Infections - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Body mass index</subject><subject>Bones</subject><subject>Creatine Kinase - blood</subject><subject>Cubism</subject><subject>Daptomycin - administration & dosage</subject><subject>Daptomycin - adverse effects</subject><subject>Daptomycin - therapeutic use</subject><subject>Dosage</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Endocarditis</subject><subject>Female</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Injections, Intravenous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Musculoskeletal diseases</subject><subject>New York</subject><subject>Obesity</subject><subject>Patients</subject><subject>Pharmaceutical preparations</subject><subject>Pharmacology. 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A.</au><au>Mangini, E.</au><au>Amodio-Groton, M.</au><au>Vardianos, B.</au><au>Melchert, A.</au><au>Fana, C.</au><au>Wehbeh, W.</au><au>Urban, C. M.</au><au>Segal-Maurer, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of High-Dose Intravenous Daptomycin Treatment: Three-Year Cumulative Experience in a Clinical Program</atitle><jtitle>Clinical infectious diseases</jtitle><stitle>Clinical Infectious Diseases</stitle><addtitle>Clinical Infectious Diseases</addtitle><date>2009-07-15</date><risdate>2009</risdate><volume>49</volume><issue>2</issue><spage>177</spage><epage>180</epage><pages>177-180</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><coden>CIDIEL</coden><notes>ark:/67375/HXZ-M71Q2781-V</notes><notes>istex:A74F77DAD9C7311425551FDF19FBCA4D55B5DF24</notes><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-1</notes><notes>content type line 23</notes><abstract>Background.There are limited safety data for high-dose and long-term daptomycin treatment (>6mg/kg administered for ⩾14 days). We present our experience in 61 patients. Methods.We performed a retrospective chart review for all patients treated with daptomycin at New York Hospital Queens (Flushing) from 1 January 2004 through 30 April 2007; patients were identified through a computerized hospital pharmacy database. Results.Sixty-one patients (29 male and 32 female patients; mean age, 66.6 years) received a mean dose of 8 mg/kg of daptomycin for a median of 25 days (range, 14-82 days). Twelve patients (with bone and skin and soft-tissue infections) did not have an identified microbiologic isolate. Gram-positive infections included bloodstream infection with or without infective endocarditis (n=32), skin and soft-tissue infection (n=14), bone and joint infection (n=9), and intra-abdominal infection (n=5), and unidentified infection (n=1). Prosthetic devices were removed from 11 of 20 patients. Grade 1 adverse events occurred in 22 patients and did not lead to daptomycin discontinuation. Fifty-eight patients underwent creatine phosphokinase (CPK) analysis (34 patients had paired CPK analyses at the beginning of and during therapy, and 13 patients had random CPK analysis performed during treatment). Three patients had constitutional and/or musculoskeletal symptoms accompanying CPK levels >10 times upper limit of normal (grade 3). All occurred after 24 days of treatment and improved after daptomycin treatment was discontinued. Two of 3 patients were morbidly obese (body mass index grade III). Conclusions.Daptomycin treatment was well tolerated at a mean dose of 8 mg/kg for a median duration of 25 days. The incidence of symptomatic CPK level elevation was within the range reported with lower doses of daptomycin and/or for shorter treatment durations.</abstract><cop>Oxford</cop><pub>The University of Chicago Press</pub><pmid>19500039</pmid><doi>10.1086/600039</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - therapeutic use Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Articles and Commentaries Bacterial Infections - drug therapy Biological and medical sciences Body mass index Bones Creatine Kinase - blood Cubism Daptomycin - administration & dosage Daptomycin - adverse effects Daptomycin - therapeutic use Dosage Drug dosages Drug therapy Endocarditis Female Hospitals Humans Infections Infectious diseases Injections, Intravenous Male Medical sciences Microbiology Musculoskeletal diseases New York Obesity Patients Pharmaceutical preparations Pharmacology. Drug treatments Prosthetics Retrospective Studies |
| title | Safety of High-Dose Intravenous Daptomycin Treatment: Three-Year Cumulative Experience in a Clinical Program |
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