Generic antiepileptic drugs and associated medical resource utilization in the United States

Labiner, David M.; Paradis, Pierre Emmanuel; Manjunath, Ranjani; Duh, Mei Sheng; Lafeuille, M.H.; Latrémouille-Viau, Dominick; Lefèbvre, Patrick; Helmers, Sandra L.

doi:10.1212/wnl.0b013e3181df091b

Cited by 63 publications

(68 citation statements)

References 25 publications

(11 reference statements)

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“…The substitution of Lamictal® for a generic drug in epileptic patients, evaluated by 71 pharmacists and 130 physicians, showed an increase in seizures (Makus, McCormick, 2007). Another study observed that the interchangeability did not reduce cost, because it generally results in an increase and/or addition of another drug to treatment and also increases medical utilization (Labiner et al, 2010).…”

Section: Resultsmentioning

confidence: 99%

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Girolineto

Alexandre

Sakamoto

et al. 2012

Braz. J. Pharm. Sci.

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Epilepsy is the most common serious neurological disorder worldwide. Approximately 70% of patients with epilepsy have their seizures controlled by clinical and pharmacological treatment. This research evaluated the possible influence of interchangeability among therapeutic equivalents of LTG on the clinical condition and quality of life of refractory epileptic patients. The study was divided into three periods of 42 days, and an equivalent therapeutic LTG randomly dispensed for each period (two similars -formulations A and B, and the reference product -formulation C). The mean dose of LTG was 5.5 mg/kg/day. The presence of side effects tends to have a greater deleterious effect on quality of life of refractory epileptics compared to variations in number of seizures or changes in plasma concentrations. The results showed that independently of the drug prescribed, interchangeability among therapeutic equivalents can negatively impact epilepsy control.Uniterms: Epilepsy/treatment. Lamotrigine/therapeutic equivalents. Drugs/interchangeability. Epilepsia é o distúrbio neurológico grave mais comum no mundo todo. Aproximadamente 70% dos pacientes com epilepsia têm suas crises controladas com tratamento clínico e farmacológico. Esta pesquisa avaliou a possível interferência da intercambialidade entre equivalentes terapêuticos da lamotrigina na condição clínica e na qualidade de vida dos pacientes com epilepsia refratária. O estudo foi dividido em três períodos de 42 dias e em cada período foi dispensado um equivalente terapêutico, aleatoriamente (dois similares -formulação A e B e o medicamento de referência -formulação C). A dose média de lamotrigina foi de 5,5 mg/kg/dia. A ocorrência de efeitos colaterais tende a ser mais decisiva para a redução da qualidade de vida em epilepsia refratária em relação às variações no número de crises ou alterações nas concentrações plasmáticas. Os resultados demonstram que, independentemente do medicamento prescrito, a intercambialidade entre equivalentes terapêuticos pode interferir no sucesso do controle da epilepsia.Unitermos: Epilepsia/tratamento. Epilepsia/controle. Lamotrigina/equivalentes terapêuticos. Medicamentos/intercambialidade.

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Section: Resultsmentioning

confidence: 99%

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Girolineto

Alexandre

Sakamoto

et al. 2012

Braz. J. Pharm. Sci.

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“…Lastly, Aptiom can be administered with or without food, and tablets can be administered whole or crushed. [2][3][4] Another key aspect is the frequency of dosing, since most patients prefer medications that are taken less frequently. Tegretol-XR and Trileptal are twice-daily formulations, and the rest of the medications are once daily.…”

Section: Administration Titration Dosingmentioning

confidence: 99%

“…However, because small differences in pharmacokinetics can result in significant side effects or breakthrough seizures, automatic substitutions without notification of the neurologist should not be done routinely. [1,2] …”

Section: Introductionmentioning

confidence: 99%

Carbamazepine-related antiepileptic drugs for the treatment of epilepsy - a comparative review

Gierbolini

Giarratano

Benbadis

2016

Expert Opinion on Pharmacotherapy

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“…have concluded that there really does not seem to be any conclusive association between generic substitution and either loss of seizure control or new, treatment-emergent adverse effects (2), although there clearly is a suggestion that when generic substitution occurs, expenditures of resources goes up (3,4).…”

Section: Generic Antiepileptic Drugs: How Good Is Close Enough?mentioning

confidence: 99%

Generic Antiepileptic Drugs: How Good is Close Enough?

Gidal¹

2012

Epilepsy Curr

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CommentaryIt used to be that cost was only one of the many factors that played into the therapeutic decision-making process. That was then, and this is now. Now, for many individuals, cost is the primary factor governing choice of drug treatment. There are many reasons why a patient might fail to achieve optimal seizure control, including such things as drug interactions, treatment-emergent adverse effects, medication nonadherence, and, of course, lack of drug efficacy. Many of these factors we can modify or control. Clinical experience has taught that, for many patients, optimization of treatment requires careful fine-tuning of medication, and that many antiepileptic drugs (AEDs), especially the poorly soluble ones, will display a certain amount of pharmacokinetic variability between patients. The underlying assumption is made, however, that for a given product, pharmacokinetic performance will remain relatively constant between one dose to another. This very fundamental assumption becomes a bit more tenuous, however, when patients frequently switch between different formulations of a given drug. At least, that is the concern. Skeptics will say that this is an unfounded concern and that the guidelines in place by the regulatory bodies should assure us and our patients.

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Generic antiepileptic drugs and associated medical resource utilization in the United States

Cited by 63 publications

References 25 publications

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Carbamazepine-related antiepileptic drugs for the treatment of epilepsy - a comparative review

Generic Antiepileptic Drugs: How Good is Close Enough?

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