The association between receptor binding affinity and metabolic side effect profile of antipsychotics and major cardio- and cerebrovascular events: A case/non-case study using VigiBase

Aguiar, João Pedro; Costa, Filipa Alves da; Egberts, Toine C. G.; Leufkens, Hubert G. M.; Souverein, Patrick C.

doi:10.1016/j.euroneuro.2020.03.022

Cited by 6 publications

(4 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Basically, the higher the ROR or IC score, the stronger the disproportion appears to be (13). The ROR allows for adjustment using logistic regression analysis (18,19) and has the advantage of controlling the following covariates: sex, age, and reporting year. The results were expressed as adjusted ROR (aROR).…”

Section: Data Mining Algorithmmentioning

confidence: 99%

Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database

et al. 2021

View full text Add to dashboard Cite

Because of contradictory evidence from clinical trials, the association between angiotensin-converting enzyme inhibitors (ACEIs) and lung cancer needs further evaluation. As such, the current study is to assess disproportionate reporting of primary malignant lung cancer among reports for ACEIs submitted to the FDA adverse event reporting system utilizing a pharmacovigilance approach. We conducted a disproportionality analysis of primary malignant lung cancer adverse events associated with 10 ACEIs by calculating the reported odds ratios (ROR) and information component (IC) with 95% confidence intervals (CI). ROR was adjusted for sex, age, and reporting year by logistic regression analyses. From January 2004 to March 2020, a total of 622 cases of lung cancer adverse event reports were identified for ACEIs users. Significant disproportionate association was found for ACEIs as a drug class (ROR: 1.22, 95% CI: 1.13–1.32; IC: 0.28, 95% CI: 0.17–0.39. adjusted ROR: 1.23, 95% CI: 1.02–1.49). After stratification based on gender, a subset analysis suggested that female patients exhibited a significant disproportionate association, while male patients did not. Sensitivity analyses that limited the data by reporting region, comorbidity, and reporting year also showed similar trends. Statistical significant lung cancer signals were detected among patients who received ACEI, especially female patients. The disproportionality analysis of the FAERS database suggests mildly increased reporting of lung cancer among ACEI users. Further robust epidemiological studies are necessary to confirm this relationship.

show abstract

Section: Data Mining Algorithmmentioning

confidence: 99%

Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database

et al. 2021

View full text Add to dashboard Cite

show abstract

“…The FAERS, which gathers spontaneous reports of adverse events from the entire world, is particularly suited to investigate rare or unexpected adverse events, such as ICDs, related to recently marketed drugs. It is also extensively used in the psychiatric area as a source of evidence, complementary to clinical trials, for safety profiling of antidepressants and antipsychotics ( Poluzzi et al, 2013 ; Mazhar et al, 2019 ; Cepaityte et al, 2021 ; Gastaldon et al, 2021 ; Zazu et al, 2021 ) and for generating hypotheses on the underlying mechanisms ( Aguiar et al, 2020 ; Gahr et al, 2021 ). Given that more than 5 years have passed from the first approval of brexpiprazole and cariprazine, the FAERS should provide enough data for a first in-depth assessment of TGA-related ICDs.…”

Section: Introductionmentioning

confidence: 99%

Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System

Fusaroli

Raschi

Giunchi

et al. 2022

International Journal of Neuropsychopharmacology

View full text Add to dashboard Cite

Background The dopaminergic partial agonism of the so-called third-generation antipsychotics (TGAs: aripiprazole, brexpiprazole, cariprazine) is hypothesized to cause Impulse Control Disorders (ICDs). Relevant warnings by the Food and Drug Administration (FDA) were posted on aripiprazole (2016) and brexpiprazole (2018). Our study investigated the FDA Adverse Event Reporting System (FAERS) and the pharmacodynamic CHEMBL database to further characterize TGA-induced ICDs. Methods We downloaded and pre-processed the FAERS up to December 2020. We adapted Bradford Hill criteria to assess each TGA’s –and secondarily other antipsychotics’– causal role in inducing ICDs (pathological gambling, compulsive shopping, hyperphagia, hypersexuality), accounting for literature and disproportionality. ICDs clinical features were analyzed, and their pathogenesis investigated using receptor affinities. Results 2708 reports of TGA-related ICDs were found, primarily recording aripiprazole (2545 reports, 94%) among the drugs, and gambling (2018 reports, 75%) among the events. Bradford-Hill criteria displayed evidence for a causal role of each TGA, consistent across subpopulations and when correcting for biases. Significant disproportionalities also emerged for lurasidone with compulsive shopping, hyperphagia, and hypersexuality, and olanzapine and ziprasidone with hyperphagia. Time to onset varied between days and years, and positive dechallenge was observed in 20% cases. Frequently co-reported events were economic (50%), obsessive-compulsive (44%), and emotional conditions (34%). 5-HT1A emerged as an additional plausible pathogenetic mechanism. Conclusions We detected an association between TGAs and ICDs and identified a new signal for lurasidone. ICD characteristics are behavior-specific and may impact heavily on life. The role of 5-HT1A-agonism should be further explored.

show abstract

“…Aguiar et al also explored the underlying mechanisms that lead to more serious adverse events associated with psychotropic medications by assessing reports on the World Health Organisation (WHO) Global Individual Case Safety Report (ICSR) database, VigiBase. They found that antipsychotics with high affinity for alpha-1 adrenergic receptors, histamine H1 receptors, muscarinic M1 receptors, and 5-HT2A receptors, and with a high risk of metabolic side effects may explain the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) [ 23 ].…”

Section: Gaps In the Pharmacological Management Of Mental Illnessesmentioning

confidence: 99%

Clinical pharmacy services in mental health in Europe: a commentary paper of the European Society of Clinical Pharmacy Special Interest Group on Mental Health

Stuhec,

Hahn,

Taskova

et al. 2023

Int J Clin Pharm

View full text Add to dashboard Cite

A large proportion of the world’s disease burden is attributable to mental illnesses. Although effective interventions are available, many patients still have limited access to evidence-based treatments. Aside from access, treatment gaps, including inappropriate medication selection and monitoring, are also routinely recognised. Mental health clinical pharmacists can help address these gaps and enable patients to receive optimised pharmaceutical care, particularly appropriate medication selection and monitoring. The European Society of Clinical Pharmacy (ESCP) Special Interest Group on Mental Health was established to improve standardised service provision in mental health settings across Europe. The Special Interest Group identified significant barriers (predominantly associated with reimbursement and position within the multidisciplinary team) to effective pharmaceutical care amongst those with mental illnesses. This commentary presents recommendations to address these gaps through improved mental health clinical pharmacy service provision.

show abstract

The association between receptor binding affinity and metabolic side effect profile of antipsychotics and major cardio- and cerebrovascular events: A case/non-case study using VigiBase

Cited by 6 publications

References 22 publications

Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database

Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database

Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System

Clinical pharmacy services in mental health in Europe: a commentary paper of the European Society of Clinical Pharmacy Special Interest Group on Mental Health

Contact Info

Product

Resources

About