Disproportionality Analysis for the Assessment of Abuse and Dependence Potential of Pregabalin in the French Pharmacovigilance Database
| Autor: | Julie Dupouy, Jean-Baptiste Bossard, Maryse Lapeyre-Mestre, Emilie Jouanjus, Camille Ponté |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Databases Factual Substance-Related Disorders MedDRA Amitriptyline Pregabalin Antidepressive Agents Tricyclic computer.software_genre 030226 pharmacology & pharmacy Clonazepam 03 medical and health sciences Pharmacovigilance 0302 clinical medicine Medicine Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) Psychiatry GABA Modulators Aged Database business.industry General Medicine Odds ratio Middle Aged medicine.disease Confidence interval Substance abuse Female France business computer 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Clinical drug investigation. 36(9) |
| ISSN: | 1179-1918 |
| Popis: | Pregabalin 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. We 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. Among 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. The 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. |
| Databáze: | OpenAIRE |
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