TO DISCONTINUE OR TO WAIT?: INDICATIONS FOR DISCONTINUATION OF ANTI-TUBERCULOSIS DRUGS DUE TO ADVERSE EVENTS
https://doi.org/10.21292/2075-1230-2018-96-2-47-54
Abstract
The objective of the study: to define indications for discontinuation of a drug causing adverse reactions during chemotherapy in tuberculosis patients. The frequency, severity, and outcomes of adverse reactions with anti-tuberculosis drugs discontinued and not were analyzed in 435 new tuberculosis patients. The severity of AE was assessed using modified criteria of NCI CTCAE version 4.0 and DMID. In 69.2% of patients (95% CI 64.7-73.3%) AE resulted in the discontinuation of at least one drug and it was associated with the significant increase of the intensive phase duration. Severe AE (severity grades 3-4) were observed in 54.3% of patients (95% CI 49.6-58.9%). In 17.0% of cases, the discontinuation of drugs could have been avoided, in 20.9% the drug had to be discontinued due to the risk of complications and irreversible damage of organs as per the signs of grade 2 of severity. The continued in-take of anti-tuberculosis drugs in case of AE of severity grade 3-4 was associated with negative changes in 20 out of 62 cases (32.2%). Indications for discontinuation of anti-tuberculosis drugs in the intensive phase of treatment include grades 3-4 of severity, the risk of irreversible damage of an organ and life-threatening conditions. Discontinuation of the drug can be discussed in case of some moderate adverse events should all available conservative measures fail.
About the Authors
D. A. Ivаnovа
Moscow Municipal Scientific Practical Center of Tuberculosis Control, Moscow
Russian Federation
Candidate of Medical Sciences, Academic Secretary
Russian Federation
Candidate of Medical Sciences, Academic Secretary
S. E. Borisov
Moscow Municipal Scientific Practical Center of Tuberculosis Control, Moscow
Russian Federation
Doctor of Medical Sciences, Professor, Deputy Director for Research and Therapy
Russian Federation
Doctor of Medical Sciences, Professor, Deputy Director for Research and Therapy
References
1. Аstakhova А.V., Lepakhin V.K. Lekarstva: neblagopriyantye pobochnye effekty i kontrol bezopasnosti. [Drugs: adverse reactions and safety control.] 5th ed., Moscow, RUDN Publ., 2008, 255 p.
2. Lecheniye tuberkuleza: rekomendatsii. [Guidelines for treatment of tuberculosis]. 4th ed., WHO, Regional Office for Europe, 2011, 183 p.
3. Mordyk А.V., Kondrya А.V., Gaponenko G.E. Frequency of adverse reactions to tuberculosis drugs in new respiratory tuberculosis patients older than 18 years and factors influencing on their development. Tuberculosis and Lung Diseases,
4. , no. 2, pp. 44-48. (In Russ.)
5. Smirnov А.V., Dobronravov V.А., Rumyantsev А.Sh. et al. National recommendations. Acute renal injury: main diagnostic principles of diagnostics, prevention and therapy. Part I. Nephrologiya, 2016, vol. 20, no. 1, pp. 79-104. (In Russ.)
6. Sterlikov S.А., Nechaeva O.B., Kucheryavaya D.А.et al. Otraslevye i ekonomicheskye pokazateli protivotuberkuleznoy raboty v 2015-2016 gg. Analitichesky obzor osnovnykh pokazateley i statisticheskiye materialy. [Economic rates for TB control in 2015-2016. Analysis of main rates and statistic materials]. Moscow, RIO TsNIIOIZ Publ., 2017, 54 p.
7. Federalnye klinicheskiye rekomendatsii po diagnostike i lecheniyu tuberkuleza organov dykhaniya s mnozhestvennoy i shirokoy lekarstennoy ustoichivostyu vozbuditelya. [Federal clinical recommendations for diagnosis and treatment of respiratory tuberculosis with multiple and extensive drug resistance]. Moscow, Tver, Triada Publ., 2014, 72 p. 3. 28 p. http://roftb.ru/netcat_files/doks2015/rec2.pdf
8. Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 / National Cancer Institute, 2009. Available at: www.evs.nci.nih. gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf
9. (Accessed as of 23.03.2011)
10. Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis. Geneva, WHO, 2014. Available at: apps.who.int/iris/bitstream/10665/130918/1/9789241548809_eng.pdf (Accessed as of 14.04.2016)
11. Division of Microbiology and Infection Diseases (DMID) adult toxicity table – DRAFT. Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools / National Institute of Allergy and Infectious Diseases, Bethesda, 2007. Available at: www.niaid.nih. gov/LabsAndResources/resources/DMIDClinRsrch/Documents/dmidadulttox. pdf (Accessed as of 12.02.2012)
12. Fausti S.A. American Speech-Language Hearing Association (1994) Guidelines for the audiologic management of individuals receiving cochleotoxic drug therapy. Am. Speech-Lang Hear. Assoc., vol. 36, pp. 11-19.
13. Francis J. Curry National Nuberculosis Center, California Department of Public
14. Health. Drug-resistant tuberculosis: a survival guide for clinicians. 3rd ed., 2016, Available at: www.currytbcenter.ucsf.edu/products/view/drug-resistant- tub erculosis-survival-guide-clinicians-3rd-edition. (Accessed as of 15.09.2016)
15. ICH Harmonised Tripartite Guideline. The common technical document for the registration of pharmaceuticals for human use: safety – M4S (R2): current Step 4 version 2002. Available at: www.ich.org/fileadmin/Public_Web_Site/ICH_
16. Products/CTD/M4__R2__Safety/M4S_R2_.pdf (Accessed as of 12.01.11)
17. Nahid P., Jarlsberg L.C., Rudoy I. Factors associated with mortality in patients with drug-susceptible pulmonary tuberculosis. BMC Infect. Dis., 2011, no. 11. Available at: www.biomedcentral.com/1471-2334/11/1 (Accessed as of 09.09.2016).
18. Nathanson E., Gupta R., Huamani P. et al. Adverse events in the treatment of multidrug-resistant tuberculosis: results from the DOTS-Plus initiative. Int. J. Tuberc. Lung Dis., 2004, vol. 8, no. 11, pp. 1382-1384.
19. Okada R., Nakachi S., Inokuma S. The severity of peripheral blood eosinophilia indicates an eosinophilia-associated disease corresponding to its level. Allergology Int., 2016, vol. 65, pp. 112-114.
20. PIH Guide to the medical management of multidrug-resistant tuberculosis / Partners In Health. 2nd ed., Boston, Partners In Health, 2013. Avaible at: drtbnetwork.org/91-general-considerations (Accessed as of 15.10.2016)
21. Saukkonen J.J., Cohn D.L., Jasmer, R.M. et al. An official ATS Statement: hepatotoxicity of antituberculosis. Am. J. Respir. Crit. Care Med., 2006, vol. 174, no. 8, pp. 935-952.
22. Van’t Boveneind-Vrubleuskaya N., Daskapan A., Kosterink J.G.W. et al. Predictors of prolonged TB treatment in a Dutch outpatient setting.
23. PLoS ONE, 2016, vol. 11, no. 11 Available at doi.org/10.1371/journal. pone.0166030
24. Weller P.F., Klion A.D. Approach to the patient with unexplained. UpToDate, 2016, Available at: www.uptodate.com/contents/approach-to-the-patient-withunexplained-eosinophilia (Accessed as of 16.05.2017).
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For citations:
Ivаnovа D.A., Borisov S.E. TO DISCONTINUE OR TO WAIT?: INDICATIONS FOR DISCONTINUATION OF ANTI-TUBERCULOSIS DRUGS DUE TO ADVERSE EVENTS. Tuberculosis and Lung Diseases. 2018;96(2):47-54. (In Russ.) https://doi.org/10.21292/2075-1230-2018-96-2-47-54
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