ArticleClinical drug investigation2016
Safety of Overnight Switch from Brand-Name to Generic Levetiracetam.
Article in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Effects of generic exchange of solid oral dosage forms in neurological disorders: a systematic review.International journal of clinical pharmacy · 2020Pooled it
- Nocebo in Biosimilars and Generics in Neurology: A Systematic Review.Frontiers in pharmacology · 2019Pooled it
- Commentary: Consensus Guidelines on the Appropriate Use of Brand-Name and Generic Anti-Seizure Medication for the Management of Epilepsy in the Gulf Region.Neurology and therapy · 2023Article
- Efficacy and safety of switching from brand-name to domestic generic levetiracetam in children with epilepsy.Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2022Article
- Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study.Neurology international · 2022Article
- The Efficacy and Safety Profile of Generic Intravenous Levetiracetam in a Real-World Setting.Current therapeutic research, clinical and experimental · 2021Article
- Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.Pharmacotherapy · 2017Article
- Does substitution of brand name medications by generics differ between pharmacotherapeutic classes? A population-based cohort study in France.European journal of clinical pharmacology · 2017Article
- Safety of switching from brand-name to generic levetiracetam in patients with epilepsy.Drug design, development and therapy · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveConcerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. The objective of this study was to evaluate the safety and tolerability of the brand-to-generic levetiracetam switch in patients with focal or generalized epilepsy.
methodsA prospective study in patients with primary, cryptogenic or symptomatic epilepsy, who were taking branded levetiracetam and were switched to generic levetiracetam. Patients were consecutively recruited from January 2013 to January 2015. We evaluated efficacy, tolerability and compliance before switching (T0) and after 6 months of therapy (T1). Evaluations were scheduled as follows: baseline, 7 and 15 days, 1, 3 and 6 months. At each visit clinical diary seizures, physical and neurological examination, laboratory parameters and electroencephalogram were evaluated.
resultsFifty-nine patients, equally mixed by sex, were included in the study. Mean age was 26.1 years. Forty-seven per cent of the patients enrolled received levetiracetam as monotherapy. One patient was lost during the follow-up: so at T1 we had 58 patients (28 monotherapy and 30 polytherapy). At T0 and at T1, there was no statistically significant difference in terms of seizure frequency and intensity, occurrence of adverse events, laboratory parameters and electroencephalographic features. Two patients stopped treatment with the generic (both at 3 months after the switch) and restarted therapy with brand levetiracetam because of seizure increase. At the end of the study, the switchback rate was 3.4%.
conclusionsNo increase of seizures and adverse effects were observed when branded levetiracetam was interchanged to a generic equivalent. More studies should be conducted with a larger series of patients to confirm these results.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.