Evidence map›Paper›PMID 28814836›Full record

ArticleDrug design, development and therapy2017

Safety of switching from brand-name to generic levetiracetam in patients with epilepsy.

Magdalena Bosak, Agnieszka Słowik, Wojciech Turaj

Abstract read
In one paragraph

Article in Drug design, development and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. 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 · 2022
    Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Magdalena BosakDepartment of Neurology, Jagiellonian University Medical College, Kraków, Poland.
Agnieszka SłowikDepartment of Neurology, Jagiellonian University Medical College, Kraków, Poland.
Wojciech TurajDepartment of Neurology, Jagiellonian University Medical College, Kraków, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe approach to the use of generic antiepileptic drugs has recently evolved from major concern to general acceptance, but the evidence related specifically to the safety of switching from brand-name to generic levetiracetam (LEV) is scarce. The aim of the study was to assess the risk of increased frequency of seizures or other adverse events after replacement of a brand-name LEV with a generic one. PATIENTS AND

methodsThis retrospective analysis included 159 patients treated with LEV in a tertiary outpatient epilepsy clinic. We included all patients diagnosed with epilepsy who were treated with LEV as at March 1, 2013. Most patients were forced to switch to the generic LEV because of the sudden rise in cost of the branded LEV. We recorded data on age, sex, age at onset of epilepsy, type of epilepsy, and its treatment. We analyzed data from one visit before potential switching and from two visits after the potential switching. The interval between visits was typically 3 months. We registered an increase in the frequency of seizures and in the occurrence of adverse events.

resultsAmong 151 subjects who switched to generic LEV after March 1, 2013, increased frequency of seizures was noted in 9 patients (6%) during the first follow-up visit. Patients with increased frequency of seizures did not differ from other patients regarding sex, age, age at the onset of epilepsy, and the median dose of LEV before switching or the median duration of treatment with LEV before switching. Two patients returned to brand-name LEV. Adverse events were noted in six other patients (4%) and included somnolence, irritability, or dizziness.

conclusionSwitching from brand-name to generic LEV is generally safe.

Indexed as

AdultAnticonvulsantsEpilepsyFemaleHumansLevetiracetamMalePiracetamRetrospective StudiesAnticonvulsantsLevetiracetamPiracetamadverse eventbrandedepilepsygenericlevetiracetamswitching

Identifiers

PMID28814836
PMCPMC5546726

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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.