Therapeutic Drug Monitoring of Antiepileptic Drugs in a Tertiary Care Hospital in India

Natarajan, Harivenkatesh; Haribalaji, Natarajan; David, Darling Chellathai; Kumar, Ch. Manoj

doi:10.1097/wnf.0000000000000057

Cited by 17 publications

(17 citation statements)

References 18 publications

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“…Harivenkatesh et al, in their study, reported that phenytoin and valproic acid are the most common antiepileptics for which TDM was indicated. Dose adjustment and breakthrough seizures were the most common reasons for which patients were referred for TDM 29 …”

Section: Resultsmentioning

confidence: 99%

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Past, present and future perspectives of therapeutic drug monitoring in India

et al. 2021

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Therapeutic drug monitoring (TDM) is the clinical practice of performing drug assays and interpreting results to maintain constant therapeutic concentrations in patients' bloodstream. Conventional TDM was started way back in the 1960s and served to optimise pharmacotherapy by maximising therapeutic efficacy by evaluating efficacy failure and monitoring drug compliance, while minimising adverse events, in drugs with a narrow therapeutic range. Currently, the scope of TDM has been extended to additional indications which are of importance to India. Apart from the conventional indications, TDM can also help combat drug resistance amongst patients treated with antimicrobials, including anti-tubercular drugs and critically ill patients with compromised pharmacokinetics. TDM is also indicated for patients on antiretroviral drugs under specific clinical scenarios and is of high importance to India. Target concentration intervention (TCI) and apriori TDM (by merging TDM with pharmacogenomics) are emerging fields explored in developed nations. The authors sought to assess the evolution of TDM in India and evaluate the potential impact of newer indications in rationalising pharmacotherapy. In the mid-1980s, TDM was presented to India.Despite showing some initial progress, its use is limited to conventional indications.Its utility is also challenged by cost and higher reliance on conventional prescribing practices. However, the newer indications such as antimicrobial resistance, tuberculosis and HIV, with their high prevalence in developing nations, present an opportunity for the growth of TDM in these countries. Indian clinician's awareness and buoyant demands alongside expert contributions from clinical pharmacologists could widen its scope.

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Section: Resultsmentioning

confidence: 99%

“…Dose adjustment and breakthrough seizures were the most common reasons for which patients were referred for TDM. 29…”

Section: Antiepileptic Drugsmentioning

confidence: 99%

Past, present and future perspectives of therapeutic drug monitoring in India

et al. 2021

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“…The maximum number of studies were found in the antiepileptic drugs category. One study showed that although TDM helped in distinguishing nonresponders due to noncompliance, the "reference range" of the drugs did not reliably predict breakthrough seizures or toxicity (Harivenkatesh et al, 2015). The latter finding had been seen previously in a study in which among patients clinically suspected of having phenytoin toxicity, only 59% had plasma concentrations above the reference levels (Taur et al, 2013).…”

Section: Therapeutic Drug Monitoring (Tdm)mentioning

confidence: 88%

Clinical Pharmacology in India-A Systematic Review of Research in the Past 5 Years

Shafiq

Malhotra²

2017

Proceedings of the Indian National Science Academy

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The Indian National Science Academy has published two Status Reports on Pharmacological Research (1984 & 2000). The International Council for Science (ICSU) National Committee for Pharmacology has commissioned the third status report on Pharmacological Research in India covering the last 5 years. This systematic review covers the status of research in Clinical Pharmacology (excluding pharmacogenomics, pharmacovigilance, pharmaco-economics). We searched PubMed, Scopus and Google Scholar to extract published articles in the various sub-categories like drug discovery and development, clinical trial methodology & biostatistics, medical education, ethics, drug utilization research, therapeutic drug monitoring, pharmacodynamics, therapeutics and systematic reviews. This report presents a summary of the published research in the last 5 years, discusses some of the challenges and how some steps can be taken to raise the standards of clinical pharmacological research in India.

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“…2 However, it is reported that patients having plasma concentrations within therapeutic range show clinical symptoms of toxicity. 3 The plasma concentration of AEDs can be influenced by many factors like age, gender, duration of epileptic disorder, drug interactions with concomitant drugs, compliance, co-morbid conditions of the patient as well as the genetic make-up of the individual. [4][5][6] Phenytoin, phenobarbitone and carbamazepine are inducers of cytochrome enzymes and sodium valproate is an inhibitor of these enzymes.…”

Section: Introductionmentioning

confidence: 99%

Factors Influencing Plasma Concentrations of Phenytoin, Phenobarbitone, Carbamazepine and Sodium Valproate in Epileptic Patients Attending a Tertiary Care Hospital

Jagennath

Raj

Mathaiyan

2019

IJPI

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Objective: The traditional anti-epileptic drugs like phenytoin, sodium valproate and carbamazepine continue to be used widely in the low to middle income countries due to their time tested efficacy and low costs. The factors which affect the AED concentrations in non-toxicity indications has not been reported so far. Hence, we studied the factors that could influence the plasma concentrations of these AEDs. Methods: This is a retrospective record based study and a short term prosepective study. Requisition forms of epileptic patients referred for TDM 2012-2014 were compared with the AED concentrations reported. Epileptic patients who were referred during May-June 2015 for TDM were evaluated for their seizure history and anthropometic measurements for calculation of extracellular volume (V ECW ) and compared with the AED concentrations. Results: Out of the 170 requisitions for TDM, 68.2% were monotherapy and 31.8% received two or more antiepileptic drugs. In 44% of patients, the plasma concentrations of the AED correlated with clinical response. In our study the plasma level of carbamazepine was found to be reduced by phenytoin, sodium valproate concentration was reduced by carbamazepine and phenytoin levels were reduced by sodium valproate. In male, phenytoin levels were significantly lower than in female, Phenytoin decreased carbamazepine levels significantly in female. Carbamazepine significantly decreased sodium valproate concentrations in females. Carbamazepine dose adjusted for weight and V ECW was found to show a trend of correlation to the blood levels, Conclusion: TDM for AEDs is an indispensable investigation that guides the clinicians to tailor dose of drugs in individual patients. Factors such as age, gender, concomitant drugs in general and V ECW in patients on carbamazepine needs to be considered while interpreting AED plasma concentrations for monitoring therapy.

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Therapeutic Drug Monitoring of Antiepileptic Drugs in a Tertiary Care Hospital in India

Cited by 17 publications

References 18 publications

Past, present and future perspectives of therapeutic drug monitoring in India

Past, present and future perspectives of therapeutic drug monitoring in India

Clinical Pharmacology in India-A Systematic Review of Research in the Past 5 Years

Factors Influencing Plasma Concentrations of Phenytoin, Phenobarbitone, Carbamazepine and Sodium Valproate in Epileptic Patients Attending a Tertiary Care Hospital

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