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Chapter 2A Fluoroquinolones for Tuberculosis: a PK/PD Approach University of Groningen Therapeutic drug monitoring Pranger, Anna Diewerke IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2018 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Pranger, A. D. (2018). Therapeutic drug monitoring: How to improve moxifloxacin exposure in tuberculosis patients. Rijksuniversiteit Groningen. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license. More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne- amendment. Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 29-09-2021 2A Chapter Fluoroquinolones, the cornerstone of treatment of drug-resistant tuberculosis: a pharmacokinetic and pharmacodynamic approach A.D. Pranger, J.W.C. Alffenaar, and R.E. Aarnoutse Current Pharmeutical Design 2011;17(27):2900-2930 Chapter 2a Fluoroquinolones for tuberculosis: a PK/PD approach Abstract Introduction Fluoroquinolones (FQs) are important drugs to treat drug-resistant tuberculosis. In this The global extent in multidrug resistant tuberculosis (MDR-TB) cases is very alarming (1-6). review we integrated pharmacokinetic properties (PK) and microbiological susceptibility The proportion of MDR-TB among new TB cases has nearly tripled to about 3% since 2004, against M. tuberculosis and eventually evaluated the pharmcodynamic (PD) properties, as with high rates up to 22% in certain countries (7). In addition, it should be recognized that well as the influence of co-administered agents on these characteristics, for the currently rates of MDR-TB could become even 4-fold higher than currently assumed, if new used FQs (ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin and moxifloxacin) in TB susceptibility breakpoints for first-line TB drugs were used, based on current treatment. Future FQs that are being developed may overcome the problems with FQs that pharmacokinetic/pharmacodynamic science and variability in exposure to these drugs (8). are used in daily practice. Therefore PK and pharmacodynamic (PD) properties of novel FQs Fluoroquinolones (FQs) are key players in the field of MDR-TB treatment (1;9). (clinafloxacin, garenoxacin, lomefloxacin, sitafloxacin, sparfloxacin, trovafloxacin, Unfortunately, FQ resistance or “pre-extensively drug resistant TB” is upcoming and reported gemifloxacin, grepafloxacin and DC-159a) were evaluated in TB treatment as well. worldwide for ciprofloxacin (CFX), levofloxacin (LFX), moxifloxacin (MFX) and particularly for Integrating both excellent PK and PD properties, moxifloxacin, possibly at a higher dosage, ofloxacin (OFX) (2;4;6;10-30), but a lack of resistance have been reported for may fulfil a far more important role in the treatment of multi-drug and early-generation FQ aforementioned agents as well (19;31-38). Furthermore, extensively drug-resistant resistant TB than proposed in the current WHO guideline. Sparfloxacin, trovafloxacin and tuberculosis (XDR-TB), is becoming more of a global health concern, predominantly due to sitafloxacin are upcoming novel FQs that may be useful for drug-resistant TB based on their inadequate management of MDR-TB (1;2;12;15;17;23;25;39-45). favourable PK properties or microbiological susceptibility against M. tuberculosis. Finally, the 8-methoxy moiety, as present in the chemical structure of MFX, will possibly provide DC- In daily practice, there are several guidelines and publications on how to manage drug- 159a with promising PK/PD characteristics and consequently this FQ may develop into a key resistant TB (1;15). According to the current WHO guideline (46), TB drugs are divided into FQ in future drug-resistant TB treatment. five groups to be of help for a practicing physician to make a choice for the right drug. MDR- TB treatment regimens should be designed with a systematic approach based on a hierarchy in these groups. Together with injectable TB drugs (i.e. group 2), FQs (i.e. designated as group 3) are considered to be the cornerstone of MDR-TB regimens. The further classification of FQs in generations is based on integration of both microbiological susceptibilities and pharmacokinetic (PK) data (47). Drugs that are active against M. tuberculosis belong to the second (CFX and OFX), third (LFX and GFX) and fourth generation (MFX) of FQs. According to the current WHO guidelines for programmatic management of drug-resistant tuberculosis, CFX should be no longer part of an MDR-TB regimen as time to achieve sputum conversion will prolong and the relapse rate will increase (46;48). Despite its moderate anti-mycobacterial activity, the low cost drug OFX is still widely used in resource-limited countries (41;46). OFX resistance seems therefore not surprising. Instead, a later-generation FQ (i.e. LFX) is recommended in the drug-resistant regimen. MFX is not yet recommended by the WHO, with the argument that there is insufficient data to substantiate its long-term safety. GFX should only be used as last remedy, in case there is no other later-generation FQ available (46). In this period of emerging FQ resistance, novel FQs are needed for future drug-resistant TB regimens. Based on their molecular structure, the new FQs, sitafloxacin (STX), sparfloxacin (SFX) and clinafloxacin (CLX) are suggested to be highly active, in contrast to grepafloxacin (GPX), gemifloxacin (GMX), trovafloxacin (TFX) 22 23 Chapter 2a Fluoroquinolones for tuberculosis: a PK/PD approach Abstract Introduction Fluoroquinolones (FQs) are important drugs to treat drug-resistant tuberculosis. In this The global extent in multidrug resistant tuberculosis (MDR-TB) cases is very alarming (1-6). review we integrated pharmacokinetic properties (PK) and microbiological susceptibility The proportion of MDR-TB among new TB cases has nearly tripled to about 3% since 2004, against M. tuberculosis and eventually evaluated the pharmcodynamic (PD) properties, as with high rates up to 22% in certain countries (7). In addition, it should be recognized that well as the influence of co-administered agents on these characteristics, for the currently rates of MDR-TB could become even 4-fold higher than currently assumed, if new used FQs (ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin and moxifloxacin) in TB susceptibility breakpoints for first-line TB drugs were used, based on current Chapter treatment. Future FQs that are being developed may overcome the problems with FQs that pharmacokinetic/pharmacodynamic science and variability in exposure to these drugs (8). are used in daily practice. Therefore PK and pharmacodynamic (PD) properties of novel FQs Fluoroquinolones (FQs) are key players in the field of MDR-TB treatment (1;9). (clinafloxacin, garenoxacin, lomefloxacin, sitafloxacin, sparfloxacin, trovafloxacin, Unfortunately, FQ resistance or “pre-extensively drug resistant TB” is upcoming and reported 2a gemifloxacin, grepafloxacin and DC-159a) were evaluated in TB treatment as well. worldwide for ciprofloxacin (CFX), levofloxacin (LFX), moxifloxacin (MFX) and particularly for Integrating both excellent PK and PD properties, moxifloxacin, possibly at a higher dosage, ofloxacin (OFX) (2;4;6;10-30), but a lack of resistance have been reported for may fulfil a far more important role in the treatment of multi-drug and early-generation FQ aforementioned agents as well (19;31-38). Furthermore, extensively drug-resistant resistant TB than proposed in the current WHO guideline. Sparfloxacin, trovafloxacin and tuberculosis (XDR-TB), is becoming more of a global health concern, predominantly due to sitafloxacin are upcoming novel FQs that may be useful for drug-resistant TB based on their inadequate management of MDR-TB (1;2;12;15;17;23;25;39-45). favourable PK properties or microbiological susceptibility against M. tuberculosis. Finally, the 8-methoxy moiety, as present in the chemical structure of MFX, will possibly provide DC- In daily practice, there are several guidelines and publications on how to manage drug- 159a with promising PK/PD characteristics and consequently this FQ may develop into a key resistant TB (1;15). According to the current WHO guideline (46), TB drugs are divided into FQ in future drug-resistant TB treatment. five groups to be of help for a practicing physician to make a choice for the right drug. MDR- TB treatment regimens should be designed with a systematic approach based on a hierarchy in these groups. Together with injectable TB drugs (i.e. group 2), FQs (i.e. designated as group 3) are considered to be the cornerstone of MDR-TB regimens. The further classification of FQs in generations is based on integration of both microbiological susceptibilities and pharmacokinetic (PK) data (47). Drugs that are active against M. tuberculosis belong to the second (CFX and OFX), third (LFX and GFX) and fourth generation (MFX) of FQs. According to the current WHO guidelines for programmatic management of drug-resistant tuberculosis, CFX should be no longer part of an MDR-TB regimen as time to achieve sputum conversion will prolong and the relapse rate will increase (46;48). Despite its moderate anti-mycobacterial activity, the low cost drug OFX is still widely used in resource-limited countries (41;46). OFX resistance seems therefore not surprising. Instead, a later-generation FQ (i.e. LFX) is recommended in the drug-resistant regimen.
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