Tsuji Y, Hiraki Y, Matsumoto K, Mizoguchi A, Kobayashi T, Sadoh S, et al. The pharmacokinetic (PK)/pharmacodynamic parameter of linezolid associated with effectiveness is the area under the concentration curve (AUC)/minimum inhibitory concentration [17, 18]. 2011;17:705. Additionally, advanced age [68] and the duration of administration [69] are also considered risk factors; therefore, this difference in the patients backgrounds may explain the higher incidence of hematotoxicity. The incidence of thrombocytopenia was higher when the Cmin of linezolid exceeded 67g/mL (Tables 4 and 5). To avoid adverse events, we also performed a systematic review to evaluate linezolids monitoring parameters and ranges. The study period, study design, country of the study, age andweight of the patients, definition of hematotoxicity, definition of DRF, and patients with and without DRF (patients with or without hematotoxicity were counted separately) were extracted according to the predefined eligibility criteria. Furthermore, Matsumoto et al. YE organized and coordinated the study. Thrombocytopenia occurred more frequently among patients with renal impairment (42.9% versus 16.8%; P < 0.001), and renal impairment was independently associated with this toxicity in multivariable analysis (adjusted hazard ratio [aHR], 2.37; 95% confidence interval [CI], 1.52 to 3.68). GRADE specifies that the quality of the evidence can be classified into four categories according to the corresponding evaluation criteria: (1) high (); (2) moderate (); (3) low (); and (4) very low (). Recent studies revealed that during linezolid therapy, the incidence of treatment-related hematological toxicity is significantly higher in patients with decreased renal function (DRF) than in those with normal renal function. Linezolid: the first oxazolidinone antimicrobial. Assessment of the risks of bias for studies included in systematic review. Nagoya J Med Sci. Plachouras D, Giannitsioti E, Athanassia S, Kontopidou F, Papadopoulos A, Kanellakopoulou K, et al. Antibiotics. Diamond shapes and horizontal lines indicate odds ratios and 95% confidence intervals, respectively. The .gov means its official. However, it is difficult to measure the AUC in clinical settings; therefore, Cmin may be a surrogate index of AUC in clinical practice. Google Scholar. These studies included 3831 patients, 1240 of whom had DRF. 2). The monitoring of vancomycin: a systematic review and meta-analyses of area under the concentration-time curve-guided dosing and trough-guided dosing. 2019;124:22834. Hematologic effects of linezolid: summary of clinical experience. Thrombocytopenia occurs more frequently in patients with renal impairment receiving standard linezolid doses. Linezolid-a new option for treating gram-positive infections. Int J Antimicrob Agents. 2010;36:846. A woman has told how she feared she'd never become a mum but gave birth to a boy at age 45 after taking Viagra to get pregnant.. Carin Rockind, 48, welcomed a "miracle" baby after trying to have a . Qin Y, Liu Y, Chen Z, Cao M, Shen Y, Ye Y. Squares indicate point estimates and the size of each square indicates the weight of each study. We similarly searched PubMed, Web of Sciences, Cochrane Register of Controlled Trials, and ClinicalTrials.gov databases for relevant studies published before June 24, 2022. In this meta-analysis, no significant differences were observed in the incidence of pancytopenia. 2015;4:2725. Int J Antimicrob Agents. Linezolid-induced thrombocytopenia increases mortality risk in intensive care unit patients, a 10 year retrospective study. Jones SJ, Nichols KR, DeYoung HL, Cox EG, Knoderer CA. Inclusion in an NLM database does not imply endorsement of, or agreement with, 10.1016/j.ijantimicag.2016.08.023. 2011. http://training.cochrane.org/handbook. Methods. Han X, Wang J, Zan X, Peng L, Nie X. A risk factor-based predictive model for linezolid-induced anaemia: a 7-year retrospective study. Farm Hosp. Attassi K, Hershberger E, Alam R, Zervos MJ. Most studies were conducted in Asian countries (16 of 25 studies). Dosage strategy of linezolid according to the trough concentration target and renal function in Chinese critically ill patients. The monitoring of vancomycin: a systematic review and meta-analyses of area under the concentration-time curve-guided dosing and trough-guided dosing. The incidences of thrombocytopenia (OR=2.45; 95% CI: 1.953.09; p<0.001; I2=36%) and anemia (OR=2.31; 95% CI: 1.274.21; p=0.006; I2=29%) were significantly higher in patients with DRF than in those without DRF (Fig. 5 through 11 years: 10 mg/kg orally every 12 hours. Clin Pharmacokinet. Part of 2023 Feb 13;12(2):383. doi: 10.3390/antibiotics12020383. J Antimicrob Chemother. In a couple of weeks, rock overlords Queens Of The Stone Age will return with their new album In Times New Roman; we've already posted the singles "Emotion Sickness" and "Carnavoyeur Rabon AD, Fisher JP, MacVane SH. 2015;39:32032. The definitions of DRF and hematotoxicity in each study are shown in Table1. Duplicate articles were excluded from the study. Linezolid dosing in patients with liver cirrhosis: standard dosing risk toxicity. 2022;13:844567. Antimicrob Agents Chemother. Therefore, the patient characteristics and study designs contained various types of bias, hindering their results generalizability. Antimicrob Agents Chemother. Epub 2021 Oct 10. Antibiotics (Basel). In the database search for the evaluation of linezolid-associated hematotoxicity, 1213 articles were screened after duplicates were extracted (Fig. We also conducted a systematic review and determined that hematotoxicity was higher when Cmin exceeded 67g/mL. Moraza L, Leache L, Aquerreta I, Ortega A. Linezolid-induced haematological toxicity. Moellering RC. Thrombocytopenia, anemia, pancytopenia, and reduction in neutrophils corresponded to hematotoxicity. Analysis of thrombocytopenic effects and population pharmacokinetics of linezolid: a dosage strategy according to the trough concentration target and renal function in adult patients. XL, MA, SO, CI, RS, TN, and KT designed the study. Pharmacokinetics of intravenous linezolid in cerebrospinal fluid and plasma in neurointensive care patients with staphylococcal ventriculitis associated with external ventricular drains. Gee T, Ellis R, Marshall G, Andrews J, Ashby J, Wise R. Pharmacokinetics and tissue penetration of linezolid following multiple oral doses. 2015;70:198206. We also conducted a subgroup analysis based on the classification of hematotoxicity. Therapeutic drug monitoring: linezolid too? National Library of Medicine Beer R, Engelhardt KW, Pfausler B, Broessner G, Helbok R, Lackner P, et al. Pharmacokinetic and pharmacodynamic profile of linezolid in healthy volunteers and patients with gram-positive infections. XL, MA, SO, CI, RS, TN, YE, and KT report no conflicts of interest. HR: rate of reduction in the level of hemoglobin; PR: rate of reduction in platelet count; NR: rate of reduction in neutrophil count. Front Pharmacol. Risk factors for linezolid-induced thrombocytopenia in patients without haemato-oncologic diseases. 2022;13:844567. The study period, study design, country of study, age of the patients, and AUC or trough values were extracted. Int J Clin Pharm. 4):715. To ensure safety, linezolid trough concentrations should be 67g/mL. KM received a research grant from Meiji Seika Pharma Co. Ltd. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Two of the four reviewers (MA, CI, RS, and TN) independently searched for literature using the following research terms: linezolid, monitoring, area under the curve, trough, and therapeutic drug monitoring. The publication language was limited to English, and there was no restriction on the publication year. Linezolid is an oxazolidinone antibiotic used to treat infectious diseases caused by drug-resistant gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci. In addition, subgroup analysis revealed a significant difference in the incidence of thrombocytopenia and anemia, but there was no significant difference in the incidence of pancytopenia (Fig. Linezolid versus vancomycin for the treatment of infections caused by methicillin-resistant Staphylococcus aureus in Japan. This study did not receive any grants from funding agencies in the public, commercial, or not-for-profit sectors. Of the 15 adult studies, two were retrospective studies, while 12 were prospective studies, on the analysis of AUC values associated with thrombocytopenia in adults. 2021;65(2):e0161920. To our knowledge, this study is the first systematic review to explore the association of Cmin with linezolid safety. In our meta-analysis, the incidence of thrombocytopenia in patients with and without DRF ranged between 28.9 and 78.6% (except for the study by Hiraki et al. Incidence and risk factors for development of thrombocytopenia in patients treated with linezolid for 7 days or greater. No effect of pyridoxine on the incidence of myelosuppression during prolonged linezolid treatment. Further studies are required to determine the target AUC that correlates with thrombocytopenia. Tables 2 and 3 show studies that evaluated the incidence of thrombocytopenia associated with AUC values in children and adults, respectively. Decreased renal function correlates with an increased risk of thrombocytopenia and anemia due to overexposure. Crossm systematic therapeutic drug monitoring. 2014;21:703. XL, MA, SO, CI, RS, TN, YE, and KT report no conflicts of interest. Sato Y, Iguchi M, Kato Y, Morioka H, Hirabayashi A, Tetsuka N, et al. [25]. Pharmacokinetics and tolerance of linezolid for meticillin-resistant Staphylococcus aureus mediastinitis in paediatric patients. Division of Pharmacodynamics, Keio University Faculty of Pharmacy, 1-5-30, Shibakoen, Minato-ku, Tokyo, 105-8512 Japan. 2023 Apr 23;12(5):803. doi: 10.3390/antibiotics12050803. Vertical line indicates no significant differences between the groups. However, this systematic review could not determine the clinically relevant threshold of linezolid in terms of the AUC (Tables 2 and 3). Clinical use and adverse drug reactions of linezolid: a retrospective study in four Belgian hospital centers. Antimicrob Agents Chemother. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. In this meta-analysis of retrospective and prospective studies, the incidence of hematotoxicity was significantly higher in patients with DRF than in those without. Europe PMC Compared with patients without DRF, patients with DRF had a significantly higher incidence of hematotoxicity (OR=2.37; 95% CI: 1.932.90; p<0.001; I2=33%) (Fig. MacGowan AP. Therefore, this meta-analysis aimed to determine whether hematological toxicity has a high incidence in patients with DRF. Thirot H, Briquet C, Frippiat F, Jacobs F, Holemans X, Henrard S, et al. In addition, many studies have focused on thrombocytopenia, which occurs most frequently among the different forms of hematotoxicity (Sheldon et al. Eslam RB, Burian A, Vila G, Sauermann R, Hammer A, Frenzel D, et al. PubMed 2022;88:46475. Age, body surface area, and estimated glomerular filtration rate (eGFR) were identified as covariates of linezolid clearance. Crass RL, Cojutti PG, Pai MP, Pea F. Reappraisal of linezolid dosing in renal impairment to improve safety. 2010;54:460510. Dryden MS. Linezolid pharmacokinetics and pharmacodynamics in clinical treatment. In general, the trough concentration or AUC is used to evaluate the safety of antimicrobials. 1B). The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. YE organized and coordinated the study. Characteristics of the studies included in the systematic review about AUC (children), Characteristics of the studies included in the systematic review AUC (adults), aThree times daily 600mg linezolid was administered, Characteristics of the studies included in the systematic review about Cmin (children), aOne patient Cmin values were measured both after administered intravenously and orally, Characteristics of the studies included in the systematic review about Cmin (adults). No information was available for deviation from the intended intervention and reporting biases. Chemotherapy. We calculated odds ratios (OR) with 95% confidence intervals (CIs) for discrete variables. One patient with a Cmin value of 4.7g/mL received high-dose methotrexate in combination treatment. Cojutti PG, Merelli M, Bassetti M, Pea F. Proactive therapeutic drug monitoring (TDM) may be helpful in managing long-term treatment with linezolid safely: findings from a monocentric, prospective, open-label, interventional study. Rabon AD, Fisher JP, MacVane SH. Eslam RB, Burian A, Vila G, Sauermann R, Hammer A, Frenzel D, et al. Squares indicate point estimates and the size of each square indicates the weight of each study. Matsumoto K, Shigemi A, Takeshita A, Watanabe E, Yokoyama Y, Ikawa K, et al. Twelve of the 14 studies were prospective studies that analyzed Cmin associated with thrombocytopenia in adults. Only four studies reported the AUC values for patients with thrombocytopenia in this study. In our meta-analysis, the incidence of thrombocytopenia in patients with and without DRF ranged between 28.9 and 78.6% (except for the study by Hiraki et al. Alici G, Valerio M, Munoz P, Alcala L, Xandra Garcia G, Burillo A, et al. 2013;57:11449. Information regarding selection bias was unavailable for most studies; few studies identified bias issues. Basic Clin Pharmacol Toxicol. Diamond shapes and horizontal lines indicate odds ratios and 95% confidence intervals, respectively. Two of four reviewers (MA, CI, RS, and TN) independently searched databases for literature using the following research terms: linezolid, renal, kidney, thrombocytopenia, anemia, neutropenia, myelosuppression, leucopenia, and hematotoxicity. The publication language was limited to English, and there was no restriction on the publication year. The difference in AUC values may be accounted for by the difference in the dose per body weight. Kim HS, Lee E, Cho YJ, Lee YJ, Rhie SJ. Tsuji Y, Hiraki Y, Matsumoto K, Mizoguchi A, Kobayashi T, Sadoh S, et al. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. In the analysis of AUC values associated with thrombocytopenia, two studies involved children (Table2), and 15 studies involved adults (Table3). The empirical formula is C16H20FN3O4. Slatter JG, Stalker DJ, Feenstra KL, Welshman IR, Bruss JB, Sams JP, et al. Provided by the Springer Nature SharedIt content-sharing initiative. 2019;74:358895. Yuki Enoki. 2014;59:31924. 0.06-0.84) and absence of renal insufficiency (OR, 0.32; 95% CI, 0.11-0.95). Rubinstein E, Isturiz R, Standiford HC, Smith LG, Oliphant TH, Cammarata S, et al. Linezolid is administered as a fixed dose to all patients despite evidence of overexposure and thrombocytopenia in renal impairment. However, this systematic review could not determine the clinically relevant threshold of linezolid in terms of the AUC (Tables (Tables22 and and3).3). A study was considered eligible for evaluation in this systematic review provided that it met the following inclusion criteria: (1) the study revealed the AUC or trough values of patients; (2) the study included patients who received treatment with linezolid; and (3) the study revealed the outcomes of thrombocytopenia. Careers, Unable to load your collection due to an error. Paladino JA. Drug Metab Dispos. Two of the four reviewers (XL, SO, CI, and RS) independently extracted data from the studies. Richards GA, Brink AJ. Flow chart of A meta-analysis of hematotoxicity associated with linezolid, and B systematic review of hematotoxicity associated with the linezolid area under the concentration curve or Cmin (minimum blood plasma concentration). PubMed Google Scholar. To our knowledge, this study is the first systematic review to explore the association of Cmin with linezolid safety. Ann Transl Med. Cattaneo D, Gervasoni C, Cozzi V, Castoldi S, Baldelli S, Clementi E. Therapeutic drug management of linezolid: a missed opportunity for clinicians? The .gov means its official. 2002;46:147580. The primary outcome was the incidence rate of hematotoxicity. 2020;8:493. Two of the four reviewers (XL, MA, SO, and TN) independently screened the literature. Fig. Effect of renal function on the risk of thrombocytopaenia in patients receiving linezolid therapy: a systematic review and meta-analysis. Linezolid-a new option for treating gram-positive infections; 2000. p. 239. Time-to-event analyses were performed using Cox proportional-hazards models. Studies that met the following criteria were excluded: (1) studies involving cells or animal models; and (2) case reports, case series, or reviews. Forest plot of the hematotoxicity associated with linezolid treatment with or without decreased renal function. The characteristics of the 27 systematically reviewed studies are shown in Tables2, ,3,3, ,44 and and5.5. Two of the four reviewers (XL, SO, CI, and RA) independently assessed the risk of bias based on Cochrane Collaboration (Risk Of Bias In Non-Randomized Studies of Interventions, ROBINS-I) [21]. Linezolid causes hematological toxicity, mostly thrombocytopenia, which leads to treatment discontinuation and failure. Alffenaar JWC, Van Altena R, Harmelink IM, Filguera P, Molenaar E, Wessels AMA, et al. 2006;50:39716. High frequency of linezolid-associated thrombocytopenia among patients with renal insufficiency. The National Institute of Allergy and Infectious Diseases (NIAID) study in 2018 was a clinical trial. Cookies policy. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. 2014;58:233443. Three studies [30, 33, 40] had a moderate risk of measurement of outcome bias. Twenty-three studies were retrospective, and two studies [25, 37] were prospective studies with a small number of cases conducted in Japan. First, most of the analyzed studies were observational studies. Bookshelf Forest plot of the hematotoxicity associated with linezolid treatment with or without decreased renal function. No problems in intervention bias were identified, and moderate missing data bias was identified in the study by Choi 2019. Hiraki Y, Tsuji Y, Hiraike M, Misumi N, Matsumoto K, Morita K, et al. Bhalodi AA, Papasavas PK, Tishler DS, Nicolau DP, Kuti JL. Generally, linezolid was administered twice daily (600mg2) and the dose was not adjusted by body weight. Wu F, Zhang X-S, Dai Y, Zhou Z-Y, Zhang C-H, Han L, et al. Colitis Bone marrow suppression Acidosis Carcinoid syndrome Hemodialysis Hypertension Hypoglycemia Liver disease MAOI activity Neuropathy Renal dysfunction Seizures Major Antibiotics (applies to Zyvox) colitis Major Potential Hazard, Moderate plausibility. Linezolid dose reductions improved the probability of achieving optimal exposures in simulated patients with eGFR values of <60 ml/min. This study did not receive any grants from funding agencies in the public, commercial, or not-for-profit sectors. Pea F, Viale P, Cojutti P, Del pin B, Zamparini E, Furlanut M. Therapeutic drug monitoring may improve safety outcomes of long-term treatment with linezolid in adult patients. Thrombocytopenia was defined as a platelet count of <112.510. Twenty-five articles [9,10,11,12,13, 23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42] were included for the evaluation of linezolid-associated hematotoxicity. [. 3AC). The first look at the 'middle aged Love Island' set has been released, which has already been nicknamed the 'Viagra House' by locals after single parents searched for love To avoid hematological toxicity, some studies have suggested that linezolid dose optimization based on its plasma concentration may be effective [14,15,16]. The online version contains supplementary material available at 10.1186/s40360-022-00628-9. Disclaimer. The pharmacokinetic (PK)/pharmacodynamic parameter of linezolid associated with effectiveness is the area under the concentration curve (AUC)/minimum inhibitory concentration [17, 18]. Before Beer R, Engelhardt KW, Pfausler B, Broessner G, Helbok R, Lackner P, et al. Two of the three studies were prospective in the analysis of Cmin associated with thrombocytopenia in children. Tables4 and 5 list studies that evaluated the incidence of thrombocytopenia associated with Cmin in children and adults, respectively. Cattaneo D, Gervasoni C, Cozzi V, Castoldi S, Baldelli S, Clementi E. Therapeutic drug management of linezolid: a missed opportunity for clinicians?. Only four studies reported the AUC values for patients with thrombocytopenia, and the values were 180.5 [44] 243 [49], 280.74 [16], and 175.0 or 345.8 [66] mgh/L. Article Finally, funnel plots were constructed to assess potential publication bias. High frequency of linezolid-associated thrombocytopenia among patients with renal insufficiency. Wu V-C, Wang Y-T, Wang C-Y, Tsai I-J, Wu K-D, Hwang J-J, et al. Cochrane Handbook for systematic reviews of interventions version 5.1.0 (updated March 2011), Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach (Updated October 2013). KM was the chief investigator and data analyst. Antimicrob Agents Chemother. Funnel plots of the incidence of hematotoxicity are shown in Fig. These studies included 3831 patients, 1240 of whom had DRF. Approximately 30% of linezolid is excreted by the kidneys of patients with normal renal function [70]. The site is secure. Luque S, Grau S, Alvarez-Lerma F, Ferrndez O, Campillo N, Horcajada JP, et al. J Antimicrob Chemother. J Infect Chemother. Impact of vancomycin or linezolid therapy on development of renal dysfunction and thrombocytopenia in Japanese patients. Safety of linezolid in patients with decreased renal function and trough monitoring: a systematic review and meta-analysis. Tsutsuura M, Moriyama H, Kojima N, Mizukami Y, Tashiro S, Osa S, et al. 14 to 28. 2002;46:27236. Additionally, advanced age [68] and the duration of administration [69] are also considered risk factors; therefore, this difference in the patients backgrounds may explain the higher incidence of hematotoxicity. Following constitution, each 5 mL contains 100 mg of linezolid. 2021;10(5):530. Tables Tables22 and and33 show studies that evaluated the incidence of thrombocytopenia associated with AUC values in children and adults, respectively. Yokoyama Y, Hiraki Y, Liu Y, Chen Z, Cao M, Moriyama H, C. Rate ( eGFR ) were identified, and KT designed the study of renal dysfunction and in. Development of thrombocytopenia associated with AUC values in children be 67g/mL, Zhou Z-Y, Zhang,... The analysis of Cmin with linezolid treatment with or without decreased renal function and monitoring. Vancomycin or linezolid therapy on development of renal function whether hematological toxicity, mostly thrombocytopenia,,., Nicolau DP, Kuti JL no restriction on the classification of hematotoxicity ( et... 4 and 5 ) N, Mizukami Y, Chen Z, Cao M, Kato Y, M! Gram-Positive bacteria, such as methicillin-resistant Staphylococcus aureus mediastinitis in paediatric patients on. Receiving linezolid therapy: a systematic review and meta-analyses of area under the curve-guided. 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