Factors affecting creatine phosphokinase elevation during daptomycin therapy using a combination of machine learning and conventional methods.
creatine phosphokinase
daptomycin
drug-drug interaction
electronic medical record database
statin
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
revised:
10
08
2021
received:
28
05
2021
accepted:
16
08
2021
pubmed:
27
8
2021
medline:
27
4
2022
entrez:
26
8
2021
Statut:
ppublish
Résumé
Musculoskeletal toxicity is a typical side effect of daptomycin (DAP). However, the risk factors have not been well established. Here, we aimed to identify independent factors affecting DAP-induced musculoskeletal toxicity using a combination of machine learning and conventional statistical methods. A population-based, retrospective, observational cohort study was conducted using the Japanese electronic medical record database. Patients who received DAP between October 2011 and December 2020 were enrolled. Two definitions of musculoskeletal toxicity were employed: (1) elevation of creatine phosphokinase (CPK) value more than twice from baseline and >200 IU/L, and (2) >1000 IU/L. First, multiple logistic regression analyses (a conventional statistical method) were performed to identify independent factors affecting CPK elevation. Then, decision tree analyses, a machine learning method, were performed to detect combinations of factors that change CPK elevation risk. Of the 2970 patients who received DAP, 706 were included. Elevation of CPK values >200 IU/L and >1000 IU/L occurred in 83 (11.8%) and 17 (2.41%) patients, respectively. In multiple logistic regression analysis, baseline CPK value and concomitant use of hydrophobic statins were commonly extracted as independent factors affecting each CPK elevation, but concomitant use of hydrophilic statins was not. In decision tree analysis, patients who received hydrophobic statins and had high baseline CPK values were classified into the high-risk group. Our novel approach revealed new risk factors for CPK elevation. Our findings suggest that high-risk patients require frequent CPK monitoring.
Substances chimiques
Anti-Bacterial Agents
0
Hydroxymethylglutaryl-CoA Reductase Inhibitors
0
Creatine Kinase
EC 2.7.3.2
Daptomycin
NWQ5N31VKK
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1211-1222Informations de copyright
© 2021 British Pharmacological Society.
Références
Gould IM. Treatment of bacteraemia: meticillin-resistant Staphylococcus aureus (MRSA) to vancomycin-resistant S. aureus (VRSA). Int J Antimicrob Agents. 2013;42(Suppl):S17-S21.
Golightly LK, Barber GR, Barron MA, Page RL 2nd. Statins and daptomycin: safety assessment of concurrent use and evaluation of drug interaction liability. Drug Metabol Drug Interact. 2013;28(1):49-58.
Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI. Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis. 2004;38(12):1673-1681.
Bland CM, Bookstaver PB, Lu ZK, Dunn BL, Rumley KF, Southeastern Research Group Endeavor. Musculoskeletal safety outcomes of patients receiving daptomycin with HMG-CoA Reductase Inhibitors. Antimicrob Agents Chemother. 2014;58(10):5726-5731.
Dare RK, Tewell C, Harris B, et al. Effect of Statin Coadministration on the Risk of Daptomycin-Associated Myopathy. Clin Infect Dis. 2018;67(9):1356-1363.
Katz DE, Lindfield KC, Steenbergen JN, et al. A pilot study of high-dose short duration daptomycin for the treatment of patients with complicated skin and skin structure infections caused by gram-positive bacteria. Int J Clin Pract. 2008;62(9):1455-1464.
Pertel PE, Eisenstein BI, Link AS, et al. The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas. Int J Clin Pract. 2009;63(3):368-375.
Dvorchik BH, Brazier D, DeBruin MF, Arbeit RD. Daptomycin pharmacokinetics and safety following administration of escalating doses once daily to healthy subjects. Antimicrob Agents Chemother. 2003;47(4):1318-1323.
Kullar R, Davis SL, Levine DP, et al. High-dose daptomycin for treatment of complicated gram-positive infections: a large, multicenter, retrospective study. Pharmacotherapy. 2011;31(6):527-536.
Parra-Ruiz J, Dueñas-Gutiérrez C, Tomás-Jiménez C, Linares-Palomino JP, Garrido-Gomez J, Hernández-Quero J. Safety analysis of high dose (>6 mg/kg/day) daptomycin in patients with concomitant statin therapy. Eur J Clin Microbiol Infect Dis. 2012;31(8):1771-1774.
Bookstaver PB, Bland CM, Qureshi ZP, et al. Safety and effectiveness of daptomycin across a hospitalized obese population: results of a multicenter investigation in the southeastern United States. Pharmacotherapy. 2013;33(12):1322-1330.
Moise PA, Amodio-Groton M, Rashid M, et al. Multicenter evaluation of the clinical outcomes of daptomycin with and without concomitant β-lactams in patients with Staphylococcus aureus bacteremia and mild to moderate renal impairment. Antimicrob Agents Chemother. 2013;57(3):1192-1200.
Berg ML, Estes LL, Dierkhising RA, Curran B, Enzler MJ. Evaluation of impact of statin use on development of CPK elevation during daptomycin therapy. Ann Pharmacother. 2014;48(3):320-327.
McConnell HL, Perris ET, Lowry C, Lodise T, Patel N. Effect of concomitant 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor therapy on creatine phosphokinase levels and mortality among patients receiving daptomycin: retrospective cohort study. Infect Dis Ther. 2014;3(2):225-233.
Figueroa DA, Mangini E, Amodio-Groton M, et al. Safety of high-dose intravenous daptomycin treatment: three-year cumulative experience in a clinical program. Clin Infect Dis. 2009;49(2):177-180.
Corona Pérez-Cardona PS, Barro Ojeda V, Rodriguez Pardo D, et al. Clinical experience with daptomycin for the treatment of patients with knee and hip periprosthetic joint infections. J Antimicrob Chemother. 2012;67(7):1749-1754.
Casapao AM, Kullar R, Davis SL, et al. Multicenter study of high-dose daptomycin for treatment of enterococcal infections. Antimicrob Agents Chemother. 2013;57(9):4190-4196.
Pharmaceuticals and Medical Devices Agency [Internet]. Cubicin (daptomycin) [package insert] (in Japanese). MSD KK, Japan; 2021 [cited 2021 March 12]. Available from: https://www.info.pmda.go.jp/go/pack/6119402D1021_1_10/?view=frame&style=XML&lang=ja
US Food and Drug Administration [Internet]. Merck & Co., Inc. Cubicin (daptomycin) [label]; 2020 [cited 2021 March 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021572s063,064lbl.pdf
European Medicines Agency website [Internet]. Cubicin (daptomycin) [summaries of product characteristics]. Merck Sharp & Dohme B.V. The Netherlands; 2021 [cited 2021 July 28]. Available from: https://www.ema.europa.eu/en/documents/product-information/cubicin-epar-product-information_en.pdf
Health Canada website [Internet]. Cubicin (daptomycin) [product monograph]. Cubist Pharmaceuticals LLC. Switzerland; 2020 [cited 2021 July 28]. Available from: https://pdf.hres.ca/dpd_pm/00056534.PDF
Lehman B, Neuner EA, Heh V, Isada C. A retrospective multisite case-control series of concomitant use of daptomycin and statins and the effect on creatine phosphokinase. Open Forum Infect Dis. 2019;6(11):ofz444.
Vlashyn OO, Lorenz AM, Sobhanie MM, Smith JM, Bond M, Wardlow L. Safety outcomes with high-dose daptomycin in patients with acute kidney injury and/or end-stage renal disease. J Clin Pharm Ther. 2021;46(2):363-368.
Kido K, Oyen AA, Beckmann MA, Brouse SD. Musculoskeletal toxicities in patients receiving concomitant statin and daptomycin therapy. Am J Health Syst Pharm. 2019;76(4):206-210.
Chou R, Dana T, Blazina I, Daeges M, Bougatsos C, Grusing S & Jeanne TL Statin use for the prevention of cardiovascular disease in adults: A systematic review for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality; 2016. Report No.: 14-05206-EF-2.
Imai S, Yamada T, Kasashi K, Kobayashi M, Iseki K. Usefulness of a decision tree model for the analysis of adverse drug reactions: evaluation of a risk prediction model of vancomycin-associated nephrotoxicity constructed using a data mining procedure. J Eval Clin Pract. 2017;23(6):1240-1246.
Song YY, Lu Y. Decision tree methods: applications for classification and prediction. Shanghai Arch Psychiatry. 2015;27(2):130-135.
Takeuchi M, Ogura M, Minoura T, Inagaki N, Kawakami K. Comparative effectiveness of sodium-glucose Cotransporter-2 inhibitors versus other classes of glucose-lowering medications on renal outcome in Type 2 diabetes. Mayo Clin Proc. 2020;95(2):265-273.
Baxter M, Morimoto Y, Tamiwa M, et al. A Real-World Observational Study Evaluating the Probability of Glycemic Control with Basal Insulin or Glucagon-Like Peptide-1 Receptor Agonist in Japanese Patients with Type 2 Diabetes. Diabetes Ther. 2020;11(7):1481-1496.
Natsuaki M, Furukawa Y, Morimoto T, et al. Kimura T; CREDO-Kyoto PCI/CABG registry cohort-2 investigators. Intensity of statin therapy, achieved low-density lipoprotein cholesterol levels and cardiovascular outcomes in Japanese patients after coronary revascularization. Perspectives from the CREDO-Kyoto registry cohort-2. Circ J. 2012;76(6):1369-1379.
Ichihara K, Satoh K. Disparity between angiographic regression and clinical event rates with hydrophobic statins. Lancet. 2002;359(9324):2195-2198.
Culhane NS, Lettieri SL, Skae JR. Rosuvastatin for the treatment of hypercholesterolemia. Pharmacotherapy. 2005;25(7):990-1000.
US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, et al. Statin use for the primary prevention of cardiovascular disease in adults: US preventive services task force recommendation statement. JAMA. 2016;316(19):1997-2007.
National Clinical Guideline Centre (UK). Lipid Modification: Cardiovascular Risk Assessment and the Modification of Blood Lipids for the Primary and Secondary Prevention of Cardiovascular Disease. London: National Institute for Health and Care Excellence (UK); 2014 Jul.
Pearson GJ, Thanassoulis G, Anderson TJ, et al. Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in Adults. Can J Cardiol. 2021;37(8):1129-1150.
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41.
Portal site of official statistics of Japan [Internet]. National Statistics Center (in Japanese); 2020 [cited 2021 March 12]. Available from: https://www.e-stat.go.jp/stat-search/files?page=1&layout=datalist&toukei=00450171&tstat=000001041744&cycle=7&year=20190&month=0&tclass1=000001148507&tclass2val=0
Kojima S, Sakakibara H, Motani S, et al. Incidence of chronic obstructive pulmonary disease, and the relationship between age and smoking in a Japanese population. J Epidemiol. 2007;17(2):54-60.
Alexander SPH, Kelly E, Mathie A, et al. THE CONCISE GUIDE TO PHARMACOLOGY 2019/20: Introduction and Other Protein Targets. Br J Pharmacol. 2019;176(Suppl 1):S1-S20.
Kurose K, Sugiyama E, Saito Y. Population differences in major functional polymorphisms of pharmacokinetics/pharmacodynamics-related genes in Eastern Asians and Europeans: implications in the clinical trials for novel drug development. Drug Metab Pharmacokinet. 2012;27(1):9-54.
Kostrominova TY, Hassett CA, Rader EP, et al. Characterization of skeletal muscle effects associated with daptomycin in rats. Muscle Nerve. 2010;42(3):385-393.
Chatzizisis YS, Koskinas KC, Misirli G, Vaklavas C, Hatzitolios A, Giannoglou GD. Risk factors and drug interactions predisposing to statin-induced myopathy: implications for risk assessment, prevention and treatment. Drug Saf. 2010;33(3):171-187.
Kobayashi M, Chisaki I, Narumi K, et al. Association between risk of myopathy and cholesterol-lowering effect: a comparison of all statins. Life Sci. 2008;82(17-18):969-975.
Brancaccio P, Maffulli N, Limongelli FM. Creatine kinase monitoring in sport medicine. Br Med Bull. 2007;81-82:209-230.
Bais R, Edwards JB. Creatine kinase. Crit Rev Clin Lab Sci. 1982;16(4):291-335.
Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996;49(12):1373-1379.