{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T16:45:36Z","timestamp":1783788336837,"version":"3.55.0"},"reference-count":26,"publisher":"American Society for Microbiology","issue":"3","license":[{"start":{"date-parts":[[2016,3,1]],"date-time":"2016-03-01T00:00:00Z","timestamp":1456790400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2016,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            The choice of an antimicrobial agent must balance optimization of efficacy endpoints with the minimization of safety events. The risk versus benefit of daptomycin for patients with\n            <jats:named-content xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" content-type=\"genus-species\" xlink:type=\"simple\">Staphylococcus aureus<\/jats:named-content>\n            bacteremia with or without infective endocarditis receiving daptomycin at 6, 8, and 10 mg\/kg of body weight\/day was assessed. The relationships between the area under the concentration-time curve over 24 h (AUC)\/MIC ratio and both clinical response and time to decreased susceptibility were evaluated using data from patients with such infections who received daptomycin at 6 mg\/kg\/day. Using these relationships, plus the previously identified relationship between the minimum concentration and an elevation in the creatine phosphokinase (CPK) concentration (CPK elevation) (S. M. Bhavnani, C. M. Rubino, P. G. Ambrose, and G. L. Drusano, Clin Infect Dis 50:1568\u20131574, 2010) and Monte Carlo simulation, the probability of each outcome by MIC for daptomycin at 6, 8, and 10 mg\/kg\/day was calculated. The function for exposure-response relationships for clinical response (\n            <jats:italic>P<\/jats:italic>\n            = 0.06) and time to decreased susceptibility (\n            <jats:italic>P<\/jats:italic>\n            = 0.01) resembled U and inverted U shapes, respectively. Multivariable analyses demonstrated AUC\/MIC ratio, creatinine clearance, albumin concentration, and disease category to be predictors of clinical response. The results of simulations failed to demonstrate large improvements in the probabilities of clinical success among cohorts of simulated patients defined by the above-described predictive factors or the probability of decreased susceptibility at 30 days when the daptomycin dose was increased from 6 to 10 mg\/kg\/day. The probability of CPK elevation increased from 0.073 to 0.156 over this dose range. These data can be used to inform risk-versus-benefit decisions for daptomycin dose selection in patients with\n            <jats:named-content xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" content-type=\"genus-species\" xlink:type=\"simple\">S. aureus<\/jats:named-content>\n            bacteremia with or without infective endocarditis. The risk of CPK elevation, which is reversible, should be weighed in the context of the mortality and severe morbidity associated with these types of serious staphylococcal infections.\n          <\/jats:p>","DOI":"10.1128\/aac.02967-15","type":"journal-article","created":{"date-parts":[[2015,12,29]],"date-time":"2015-12-29T03:23:15Z","timestamp":1451359395000},"page":"1600-1607","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":37,"title":["Evaluation of Daptomycin Exposure and Efficacy and Safety Endpoints To Support Risk-versus-Benefit Considerations"],"prefix":"10.1128","volume":"60","author":[{"given":"Sujata M.","family":"Bhavnani","sequence":"first","affiliation":[{"name":"Institute for Clinical Pharmacodynamics, Latham, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul G.","family":"Ambrose","sequence":"additional","affiliation":[{"name":"Institute for Clinical Pharmacodynamics, Latham, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey P.","family":"Hammel","sequence":"additional","affiliation":[{"name":"Institute for Clinical Pharmacodynamics, Latham, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher M.","family":"Rubino","sequence":"additional","affiliation":[{"name":"Institute for Clinical Pharmacodynamics, Latham, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George L.","family":"Drusano","sequence":"additional","affiliation":[{"name":"Institute for Therapeutic Innovation, College of Medicine, University of Florida, Lake Nona, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1086\/520991"},{"key":"e_1_3_3_3_2","volume-title":"Cubicin\u00ae (daptomycin for injection) for intravenous use full prescribing information","author":"Merck & Co., Inc","year":"2015","unstructured":"Merck & Co., Inc. 2015. Cubicin\u00ae (daptomycin for injection) for intravenous use full prescribing information. Merck & Co., Inc., Whitehouse Station, NJ."},{"key":"e_1_3_3_4_2","doi-asserted-by":"crossref","first-page":"2269","DOI":"10.1001\/archinte.1989.00390100083020","article-title":"Evaluation of intravenous ciprofloxacin in patients with nosocomial lower respiratory tract infections. Impact of plasma concentrations, organism, minimum inhibitory concentration, and clinical condition on bacterial eradication","volume":"149","author":"Peloquin CA","year":"1989","unstructured":"Peloquin CA, Cumbo TJ, Nix DE, Sands MF, Schentag JJ. 1989. Evaluation of intravenous ciprofloxacin in patients with nosocomial lower respiratory tract infections. Impact of plasma concentrations, organism, minimum inhibitory concentration, and clinical condition on bacterial eradication. Arch Intern Med 149:2269\u20132273.","journal-title":"Arch Intern Med"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/31.5.783"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa053783"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1086\/652767"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.3.845-851.2001"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.44.11.2948-2953.2000"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1159\/000180580"},{"key":"e_1_3_3_11_2","unstructured":"Development Core Team R. 2010. R: a language and environment for statistical computing. R Foundation for Statistical Computing Vienna Austria. https:\/\/www.R-project.org. Accessed 3 October 2013."},{"key":"e_1_3_3_12_2","volume-title":"ADAPT II user's guide: pharmacokinetic\/pharmacodynamic systems analysis software","author":"D'Argenio DZ","year":"1997","unstructured":"D'Argenio DZ, Schumitzky A. 1997. ADAPT II user's guide: pharmacokinetic\/pharmacodynamic systems analysis software. Biomedical Simulations Resource, Los Angeles, CA."},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2011.02.008"},{"key":"e_1_3_3_14_2","volume-title":"CLSI document M100-S25","author":"Clinical and Laboratory Standards Institute","year":"2015","unstructured":"Clinical and Laboratory Standards Institute. 2015. Performance standards for antimicrobial susceptibility testing. 25th informational supplement. CLSI document M100-S25. Clinical and Laboratory Standards Institute, Wayne, PA."},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00334-06"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00182-09"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00064-11"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.1.63-68.2004"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1172\/JCI200316814"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00038-12"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2008.01854.x"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1M085"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1P333"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2334-13-66"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1179\/joc.2009.21.4.414"},{"key":"e_1_3_3_26_2","volume-title":"Abstr 19th Eur Congr Clin Microbiol Infect Dis","author":"Lamp KC","year":"2009","unstructured":"Lamp KC, Friedrich LV. 2009. Safety and clinical outcomes of high-dose daptomycin (>6 mg\/kg), abstr P1790. Abstr 19th Eur Congr Clin Microbiol Infect Dis, Helsinki, Finland."},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01563-13"}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02967-15","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02967-15","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T20:42:16Z","timestamp":1645476136000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.02967-15"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,3]]},"references-count":26,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2016,3]]}},"alternative-id":["10.1128\/AAC.02967-15"],"URL":"https:\/\/doi.org\/10.1128\/aac.02967-15","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,3]]},"assertion":[{"value":"2015-12-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2015-12-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2016-02-26","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}