Evidence map›Paper›PMID 32103380›Full record

ArticlePharmaceutical research2020

Lack of Association of Generic Brittle Status with Genetics and Physiologic Measures in Patients with Epilepsy.

Sharmila Das, Dong Guo, Xiaohui Jiang, Wenlei Jiang, Yan Shu, Tricia Y Ting, James E Polli

Abstract read
PubMed Publisher
In one paragraph

Article in Pharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 50% of its field
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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
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

7 authors at 2 institutions in 2 countries.

Sharmila DasDepartment of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, Maryland, 21201, USA.
Dong GuoDepartment of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, Maryland, 21201, USA.
Xiaohui JiangFood and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, 10903 New Hampshire Avenue, White Oak, Maryland, 20993, USA.
Wenlei JiangFood and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, 10903 New Hampshire Avenue, White Oak, Maryland, 20993, USA.
Yan ShuDepartment of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, Maryland, 21201, USA.
Tricia Y TingDepartment of Neurology, University of Maryland, 22 South Greene Street, Baltimore, Maryland, 21201, USA.
James E PolliDepartment of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, Maryland, 21201, USA. jpolli@rx.umaryland.edu.ORCID http://orcid.org/0000-0002-5274-4314
University of Maryland, Baltimore · USCenter for Drug Evaluation and Research · US

Funding

U.S. Food and Drug Administration HHSF223201400188C
6 · The paper itself

Abstract

purposeA patient was denoted to be generic brittle (GB) if they had a negative opinion about generics (e.g. prior history of a switch problem) or took the innovator brand of their most problematic anti-epileptic drug (AED) when generic was available. The aim of this hypothesis-generating study was to assess possible genetic and physiologic differences between GB and not GB patients with epilepsy.

methodsPatients (n = 148) with epilepsy were previously characterized as being either GB or not GB. Blood was collected from each subject for genotyping and physiologic testing. Genotyping for 24 single nucleotide polymorphisms (SNPs) and two copy number variants (CNVs) was performed across 12 genes in each patient. Forty-four physiologic tests were conducted in each patient. Chi square analysis was performed to assess for associations between genotyping results and GB status, as well as between physiologic test results and GB status.

resultsNo SNP or CNV discriminated GB status in genetic analysis (genotype or allele frequency). Physiologic test results in this study were not associated with GB status.

conclusionsQuestions from neurologists and patients about generics is frequently based on applicability of generic drug standards to individual subjects. However, findings here in patients with epilepsy did not uncover genetic or physiologic reasons that explained which patients were GB and which were not GB.

Indexed as

Patient Medication KnowledgeAnticonvulsantsChoice BehaviorCytochrome P-450 CYP3ADrugs, GenericEpilepsyGene FrequencyGenotypeHumansPolymorphism, Single NucleotideReceptors, NicotinicTherapeutic EquivalencyAnticonvulsantsCytochrome P-450 CYP3ADrugs, GenericReceptors, Nicotinicanti-epileptic drugepilepsygenericgeneticssubstitution

Identifiers

PMID32103380
OpenAlexW3007770560

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.