Reporting Patterns of Sialorrhea Comparing Users of Clozapine to Users of Other Antipsychotics: A Disproportionality Analysis Using VigiBase
| Autor: | Man, Wai Hong, Wilting, Ingeborg, Souverein, Patrick, Meyboom, Ronald, Egberts, Toine, Heerdink, Eibert R., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
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| Přispěvatelé: | Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Internationality Databases Factual medicine.medical_treatment disproportionality analysis 03 medical and health sciences 0302 clinical medicine Internal medicine Health care medicine Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) Antipsychotic sialorrhea Clozapine Aged adverse drug reactions Sialorrhea clozapine business.industry Case-control study Odds ratio Middle Aged medicine.disease Confidence interval 030227 psychiatry Psychiatry and Mental health Case-Control Studies pharmacovigilance Female Brief Reports business 030217 neurology & neurosurgery Adverse drug reaction Antipsychotic Agents medicine.drug |
| Zdroj: | Journal of Clinical Psychopharmacology, 40(3), 283. Lippincott Williams and Wilkins Journal of Clinical Psychopharmacology |
| ISSN: | 0271-0749 |
| Popis: | Background Sialorrhea is a non–life-threatening, but potentially invalidating adverse drug reaction (ADR) in patients using clozapine. In light of the very serious ADRs (agranulocytosis and myocarditis), sialorrhea is at risk to be overlooked by health care professionals. In this study, the sialorrhea reporting patterns of clozapine compared with other antipsychotics were assessed by evaluating differences in relative reporting frequency and reporter type. Methods A case/noncase disproportionality analysis using data from VigiBase (1968–2016) was performed. Reports of antipsychotics with “salivary hypersecretion” as ADR were considered as cases, and those with ADRs other than salivary hypersecretion were defined as noncases. Relative reporting frequencies were expressed as reporting odds ratios (RORs), and multivariate logistic regression was performed with the drug-ADR pair as unit of analysis to estimate RORs with 95% confidence intervals (CIs). Results A total of 1,169,254 drug-ADR pairs from 425,304 unique Individual Case Safety Reports were identified. Sialorrhea was relatively more frequently reported in clozapine (n = 2732 [1.1%]) compared with other antipsychotics (n = 2911 [0.31%]; ROR, 3.60; 95% CI, 3.41–3.79) and was reported relatively more often by consumers (ROR, 19.8; 95% CI, 15.1–25.9) compared with health care professionals (ROR, 2.44; 95% CI, 2.27–2.63). Conclusions Sialorrhea was reported almost 4 times more often with clozapine use than with other antipsychotic use and was reported 8 times more often by patients than by health care professionals. This provides a signal of disproportion in sialorrhea occurrence among clozapine compared with other antipsychotics and in light of the disproportionality between reporter and an underreporting by health care professionals, underlining the importance to incorporate sialorrhea into the shared decision process when commencing clozapine therapy. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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