Side Effects of bedaquiline: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Major Research Findings

Bedaquiline is a new anti-tuberculosis drug that has been approved by the FDA for the treatment of drug-resistant tuberculosis. 12 , 6 It inhibits the ATP synthase of Mycobacterium tuberculosis, a key enzyme in the bacteria's energy production. 14 However, bedaquiline is highly lipophilic, which can lead to serious side effects. 14 , 23 For example, bedaquiline can cause heart rhythm problems by inhibiting the hERG channel in the heart. 23 This side effect can lead to QT interval prolongation and may even result in cardiac arrhythmia. 23 Additionally, bedaquiline has been associated with adverse events such as liver dysfunction, skin reactions, and neurological effects. 10 , 9 Furthermore, a case report from Nepal detailed a severe cutaneous reaction to a regimen that included bedaquiline. 9 This highlights the importance of recognizing and managing such reactions.

Reasons for Side Effects

The side effects of bedaquiline are primarily attributed to its high lipophilicity and its ability to inhibit the hERG channel, a potassium channel in the heart. 23 Because of its high lipophilicity, bedaquiline can easily accumulate in various tissues and organs in the body, potentially leading to adverse effects. 23 The hERG channel plays a vital role in regulating heart rhythm, and inhibition by bedaquiline can disrupt this regulation, leading to side effects like heart rhythm disturbances. 23

Common Side Effects

Heart rhythm disturbances

Bedaquiline can cause heart rhythm disturbances by inhibiting the hERG channel, a potassium channel in the heart. 23 This can lead to QT interval prolongation, tachycardia, and atrial fibrillation. 23 , 18 A particularly concerning case involved a patient experiencing grade III severe QT prolongation, a serious heart rhythm disturbance. 18

Liver dysfunction

Bedaquiline can impact liver function, potentially leading to elevated levels of liver enzymes like AST (aspartate aminotransferase) and ALT (alanine aminotransferase). 10

Skin reactions

Bedaquiline may trigger skin reactions such as rash, itching, and hives. 9 In severe cases, these reactions can progress to skin peeling or even toxic epidermal necrolysis. 9

Neurological effects

Bedaquiline has been associated with neurological effects like dizziness, headache, and fatigue. 10

Other side effects

Other side effects associated with bedaquiline include gastrointestinal symptoms such as loss of appetite, nausea, vomiting, and diarrhea. Additionally, it can cause metabolic abnormalities like weight gain. 10

Measures to Counter Side Effects

Heart rhythm disturbances

If heart rhythm disturbances are suspected, it is essential to stop taking bedaquiline and seek immediate medical attention. 18 Before starting bedaquiline treatment, patients with pre-existing heart conditions should consult with their doctor to assess the risks. 23

Liver dysfunction

Prior to initiating bedaquiline treatment, individuals with known liver problems should consult with their doctor. 10 Regular monitoring of liver function is crucial during bedaquiline therapy, and any abnormalities should be reported to the physician for appropriate management. 10

Skin reactions

If skin reactions occur, immediate discontinuation of bedaquiline is advised, and medical evaluation is essential. 9

Neurological effects

If neurological effects are experienced, stopping bedaquiline and seeking medical attention are recommended. 10

Other side effects

If any other side effects are observed, bedaquiline should be stopped, and a medical evaluation is necessary. 10

Comparison Between Studies

Common points of studies

Multiple studies have demonstrated the efficacy of bedaquiline in treating multidrug-resistant tuberculosis. 12 , 6 , 22 Across these studies, there's a consistent finding that bedaquiline can cause side effects such as heart rhythm disturbances, liver dysfunction, and skin reactions. 23 , 10 , 9 , 18

Differences between studies

The incidence and severity of bedaquiline side effects can vary across different studies. 10 , 9 Furthermore, the extent to which these side effects impact treatment outcomes can also differ between studies. 10

Cautions for Real-life Applications

While bedaquiline is a valuable tool in the treatment of multidrug-resistant tuberculosis, it is crucial to remember its potential for serious side effects. 23 Before considering bedaquiline treatment, patients should consult with their physician to carefully assess the risks and benefits. 23 During treatment, regular medical checkups are essential to monitor for any side effects and to ensure appropriate management. 10

Limitations of Current Research

The research on bedaquiline's side effects is still ongoing and not yet comprehensive. 10 Furthermore, the long-term implications of bedaquiline use are not fully understood. 23

Future Research Directions

Continued research is crucial to develop safer administration methods and potentially new drugs that could mitigate the side effects of bedaquiline. 23 Furthermore, extensive research is needed to fully understand the long-term effects of bedaquiline use. 23

Conclusion

Bedaquiline is a significant advance in the treatment of drug-resistant tuberculosis, but it comes with the possibility of serious side effects. 23 Before embarking on bedaquiline therapy, a thorough discussion with a doctor about the risks and benefits is essential. 23 Research into the side effects of bedaquiline continues to be a priority, and continued efforts are needed to address these challenges. 10

Literature analysis of 25 papers
Positive Content
21
Neutral Content
3
Negative Content
1
Article Type
2
0
0
7
22
1.

Bedaquiline-Pretomanid-Linezolid Regimens for Drug-Resistant Tuberculosis.

Author: ConradieFrancesca, BagdasaryanTatevik R, BorisovSergey, HowellPauline, MikiashviliLali, NgubaneNosipho, SamoilovaAnastasia, SkornykovaSergey, TudorElena, VariavaEbrahim, YablonskiyPetr, EverittDaniel, WillsGenevieve H, SunEugene, OlugbosiMorounfolu, EgiziErica, LiMengchun, HolstaAlda, TimmJuliano, BatesonAnna, CrookAngela M, FabianeStella M, HuntRobert, McHughTimothy D, TweedConor D, ForaidaSalah, MendelCarl M, SpigelmanMelvin,

Drug-resistant TB efficacy
Adverse events

This study aimed to determine the appropriate dose and duration of linezolid treatment to minimize toxic effects while maintaining efficacy against highly drug-resistant tuberculosis in the bedaquiline-pretomanid-linezolid regimen.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

4.

Tuberculosis drug discovery: Progression and future interventions in the wake of emerging resistance.

Author: PerveenSummaya, KumariDiksha, SinghKuljit, SharmaRashmi

Nanoparticles-drug delivery
TB drug discovery
Drug resistance

Drug resistance in tuberculosis (TB) is a significant public health concern. This review explores the challenges and strategies involved in the discovery of new anti-mycobacterial drugs, focusing on current clinical candidates in the TB drug discovery pipeline.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Bioenergetic Inhibitors: Antibiotic Efficacy and Mechanisms of Action in <i>Mycobacterium tuberculosis</i>.

Author: HasenoehrlErik J, WigginsThomas J, BerneyMichael

TB treatment

This review discusses the development of new anti-tuberculosis drugs that target the electron transport chain (ETC) of Mycobacterium tuberculosis (Mtb). It explains how these drugs can disrupt the energy metabolism of Mtb and suggests ways to improve the development of new combination therapies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

New developments in the treatment of drug-resistant tuberculosis: clinical utility of bedaquiline and delamanid.

Author: BrigdenGrania, HewisonCathy, VaraineFrancis

MDR-TB treatment
Side effects

This article reviews the evidence for two new drugs, bedaquiline and delamanid, registered for use in multidrug-resistant tuberculosis (MDR-TB). These drugs offer a real opportunity to improve outcomes for patients with MDR-TB and extensively drug-resistant TB.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

New advances in the treatments of drug-resistant tuberculosis.

Author: MahmoudMohanad, TanYurong

New treatment options

This review discusses new advances and alternative drugs in the treatment of drug-resistant TB, a major global health challenge. The review highlights the need for continued research and development of new treatment and management strategies to combat the growing threat of TB resistance.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

TMC207 becomes bedaquiline, a new anti-TB drug.

Author: PalominoJuan Carlos, MartinAnandi

Treatment of TB

This article reviews the development and clinical application of bedaquiline, a new diarylquinoline antibiotic for the treatment of multidrug-resistant tuberculosis. Bedaquiline inhibits ATP synthase, demonstrating efficacy against Mycobacterium tuberculosis and receiving accelerated approval for treating pulmonary multidrug-resistant TB in adults.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Antitubercular polyhalogenated phenothiazines and phenoselenazine with reduced binding to CNS receptors.

Author: NiziMaria Giulia, DesantisJenny, NakataniYoshio, MassariSerena, MazzarellaMaria Angela, ShetyeGauri, SabatiniStefano, BarrecaMaria Letizia, ManfroniGiuseppe, FelicettiTommaso, Rushton-GreenRowena, HardsKiel, LataczGniewomir, SatałaGrzegorz, BojarskiAndrzej J, CecchettiVioletta, KolářMichal H, HandzlikJadwiga, CookGregory M, FranzblauScott G, TabarriniOriana

Anti-TB activity
Reduced CNS side-effects
Off-target effects

New anti-tuberculosis (TB) drugs are needed. This study focused on phenothiazines (PTZs), which are known inhibitors of an essential enzyme in Mycobacterium tuberculosis (Mtb). The study aimed to overcome the limitations of PTZs for TB treatment by modifying their structure. The researchers developed new PTZs with improved anti-TB activity and reduced side effects, specifically targeting the central nervous system.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

15.

Bedaquiline inhibits the yeast and human mitochondrial ATP synthases.

Author: LuoMin, ZhouWenchang, PatelHiral, SrivastavaAnurag P, SymerskyJindrich, BonarMichał M, Faraldo-GómezJosé D, LiaoMaofu, MuellerDavid M

Tuberculosis treatment
Cardiac arrhythmias
Death

This study demonstrates that bedaquiline (BDQ), a drug approved to treat multidrug resistant tuberculosis, is a potent inhibitor of yeast and human mitochondrial ATP synthases. The authors suggest that BDQ derivatives should be developed to increase specificity for the mycobacterial enzyme and reduce side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, N.I.H., IntramuralFunding provided by the NIH for research projects within the NIH.

Language : English

16.

Combating Tuberculosis Infection: A Forbidding Challenge.

Author: RawalTejal, ButaniShital

Improved efficacy
New drug development
Drug resistance

New drugs are needed to combat tuberculosis, especially drug-resistant strains, which are more prevalent in developing countries.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles.

Author: IessaNoha, Macolic SarinicViola, GhazaryanLilit, RomanovaNaira, AlemuAsnakech, RungapiromnanWatcharee, JiamsuchonPorntip, PokhagulPattreya, CastroJose Luis, Macias Saint-GeronsDiego, GhukasyanGayane, TeferiMengistab, GuptaMadhur, PalShanthi Narayan

Improved pharmacovigilance

The Smart Safety Surveillance (3S) concept recommends countries to invest judiciously in pharmacovigilance, focusing on new priority products, sharing work and resources with other countries, and building national competence for non-delegatable activities.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

An All-Oral 6-Month Regimen for Multidrug-Resistant Tuberculosis: A Multicenter, Randomized Controlled Clinical Trial (the NExT Study).

Author: EsmailAliasgar, OelofseSuzette, LombardCarl, PerumalRubeshan, MbuthiniLinda, Goolam MahomedAkhter, VariavaEbrahim, BlackJohn, OluboyoPatrick, GwentshuNelile, NgamEric, AckermanTertius, MaraisLinde, MottayLynelle, MeierStuart, PooranAnil, TomasicchioMichele, Te RieleJulian, DerendingerBrigitta, NdjekaNorbert, MaartensGary, WarrenRobin, MartinsonNeil, DhedaKeertan

Improved treatment outcome
Shorter treatment duration
Drug toxicity

This study compared a 6-month all-oral regimen of levofloxacin, bedaquiline, and linezolid to the standard of care (SOC) 9-month injectable-based regimen for the treatment of multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB). The authors found that the all-oral regimen was associated with a significantly improved 24-month treatment outcome, primarily due to toxicity-related drug substitutions in the SOC arm. However, drug toxicity was frequent in both arms. The authors conclude that while the all-oral regimen offers potential benefits, further research is needed to develop less toxic and more effective regimens for MDR/RR-TB.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

A disseminated Mycobacterium marinum infection in a renal transplant HIV-infected patient successfully treated with a bedaquiline-containing antimycobacterial treatment: A case report.

Author: MeybeckAgnès, TetartMacha, BacletVéronique, AlcarazIsabelle, BlondiauxNicolas, PeytavinGilles, VeyzirisNicolas, RobineauOlivier, SennevilleEric

Infection treatment
Adverse effects

Disseminated Mycobacterium marinum infection is rare and is difficult to treat. The first case of disseminated M. marinum infection successfully treated with a bedaquiline-containing regimen is reported.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

22.

High treatment success rate for multidrug-resistant and extensively drug-resistant tuberculosis using a bedaquiline-containing treatment regimen.

Author: NdjekaNorbert, SchnippelKathryn, MasterIqbal, MeintjesGraeme, MaartensGary, RomeroRodolfo, PadanilamXavier, EnweremMartin, ChotooSunitha, SinghNalini, HughesJennifer, VariavaEbrahim, FerreiraHannetjie, Te RieleJulian, IsmailNazir, MohrErika, BantubaniNonkqubela, ConradieFrancesca

Successful treatment outcomes
Adverse events
QT prolongation

A clinical access program in South Africa provided bedaquiline to patients with rifampicin-resistant tuberculosis who also had resistance to fluoroquinolones and/or injectable drugs. The results showed that bedaquiline was effective in treating these patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Selective drug deposition in lungs through pulmonary drug delivery system for effective management of drug-resistant TB.

Author: SankheKaksha, KhanTabassum, BhavsarChintan, MominMunira, OmriAbdelwahab

TB treatment
MDR-TB
XDR-TB

This study addressed the emergence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) as a global health concern. The study highlighted the challenges of targeting tuberculosis reservoirs in the alveoli and the need for innovative treatment modalities.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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