Evidence map›Paper›PMID 27300651›Full record

ArticleClinical drug investigation2016

Disproportionality Analysis for the Assessment of Abuse and Dependence Potential of Pregabalin in the French Pharmacovigilance Database.

Jean-Baptiste Bossard, Camille Ponté, Julie Dupouy, Maryse Lapeyre-Mestre, Emilie Jouanjus

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In one paragraph

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 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  12. Observational
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  14. Pregabalin dispensing patterns in Amman-Jordan: An observational study from community pharmacies.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2018
    Article
  15. Early signal of diverted use of tropicamide eye drops in France.British journal of clinical pharmacology · 2017
    Article
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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

5 authors at 2 institutions in 1 country.

Jean-Baptiste BossardEquipe de Pharmacoepidemiologie, UMR1027-Université Paul Sabatier Toulouse III, 37 allées Jules Guesde, 31000, Toulouse, France.
Camille PontéCEIP-Addictovigilance, Service de Pharmacologie Médicale et Clinique, CHU Toulouse, 37 allées Jules Guesde, 31000, Toulouse, France.
Julie DupouyEquipe de Pharmacoepidemiologie, UMR1027-Université Paul Sabatier Toulouse III, 37 allées Jules Guesde, 31000, Toulouse, France.
Maryse Lapeyre-MestreEquipe de Pharmacoepidemiologie, UMR1027-Université Paul Sabatier Toulouse III, 37 allées Jules Guesde, 31000, Toulouse, France.
Emilie JouanjusEquipe de Pharmacoepidemiologie, UMR1027-Université Paul Sabatier Toulouse III, 37 allées Jules Guesde, 31000, Toulouse, France. emilie.jouanjus@univ-tlse3.fr.
Université Toulouse III - Paul Sabatier · FRPharmacochimie et Pharmacologie pour le Développement · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivePregabalin abuse and dependence has been increasingly described; however, it is not described in France. Our study aimed to investigate the abuse and dependence potential of pregabalin by a disproportionality analysis, in the French Pharmacovigilance Database (FPVD), in comparison with amitriptyline and clonazepam.

methodsWe performed a case/noncase study in the FPVD. Between January, 1 2010 and December, 31 2015, we identified cases of abuse and or dependence (excluding isolated withdrawal syndromes) using MedDRA (Medical Dictionary for Regular Activities) terms. Exposure to pregabalin was defined as the mention of pregabalin in the report. Clonazepam was used as positive control and amitriptyline as negative control.

resultsAmong the 184,310 reports in the database, 521 were abuse or dependence cases. Exposure to pregabalin was found in eight (1.5 %) of them. We did not find any significant association between exposure to pregabalin and drug abuse or dependence: reporting odds ratio (ROR) = 1.1 95 % confidence interval (CI) (0.6-2.3). ROR for clonazepam was 5.7 95 % CI (3.5-9.2). No case of an amitriptyline-related abuse or dependence was recorded in the FPVD.

conclusionsThe first cases of pregabalin-related abuse or dependence reported in France occurred later than in other European countries, since none had been described before 2010. This analysis in the FPVD did not find a higher proportion of abuse/dependence with pregabalin in comparison with other drugs. Considering evidence of pregabalin abuse worldwide, this analysis underlines the limitations of spontaneous reporting system in the field of addictovigilance.

Indexed as

AdultAdverse Drug Reaction Reporting SystemsAgedAmitriptylineAntidepressive Agents, TricyclicClonazepamDatabases, FactualFemaleFranceGABA ModulatorsHumansMaleMiddle AgedPharmacovigilancePregabalinSubstance-Related DisordersAmitriptylineAntidepressive Agents, TricyclicClonazepamGABA ModulatorsPregabalin

Identifiers

PMID27300651
OpenAlexW2429917404

What OpenQuestion holds

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Registered trials

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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.