Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Background: Extrapyramidal symptoms (EPS) in association with the long-acting, injectable, atypical antipsychotic aripiprazole once monthly (AOM) have been observed in clinical trials, but information on EPS requiring treatment with anticholinergic drugs in clinical practice is limited.
Objectives: The objective of this European post-authorisation safety study (PASS) was to assess the risk of EPS-related events, as defined by dispensings of anticholinergic drugs, linked to the use of AOM in routine clinical practice.
Design: This European cohort study was based on healthcare databases from Germany (German Pharmacoepidemiological Research Database GePaRD), Italy (Caserta and Palermo healthcare claims databases), and Sweden (National health registers). New users of AOM were followed from their first dispensing for a maximum of 2 years.
Methods: Primary study outcome was an EPS-related event, defined as the first dispensing of an anticholinergic drug. The crude incidence rate (IR) and the cumulative incidence of EPS-related events were estimated. Cox proportional hazard regression modelling was performed to further investigate the effect of potential risk factors for the occurrence of EPS-related events.
Results: A total of = 1748 patients were eligible for inclusion into the primary study populations (Germany = 629; Italy = 519; Sweden = 600). IRs of EPS-related events per 100 patient years were highest in Italy (IR = 18.4; 95% confidence interval (CI) 15.3-22.1), followed by Sweden (IR = 7.7; 95% CI 5.8-10.2) and Germany (IR = 3.4; 95% CI 2.4-4.6). Rates were highest during the first 30 days after treatment initiation. Cumulative incidences after 2 years of treatment were 27.8% (Italy), 11.5% (Sweden), and 10.0% (Germany). Diabetes and previous antipsychotic drug use were identified as risk factors for EPS-related events.
Conclusion: In this observational study, incidence rates of EPS-related events, defined as the first dispensing of an anticholinergic drug during follow-up, were compatible with the known safety profile of AOM but showed substantial regional variation.
Trial Registration: EU PAS number EUPAS21056.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398657 | PMC |
| http://dx.doi.org/10.1177/20451253251368010 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Frequency of anticholinergic drug use in patients treated with aripiprazole once-monthly: a 2-year cohort study using European healthcare databases.
Ther Adv Psychopharmacol
August 2025
H. Lundbeck A/S, Valby, Denmark.
Background: Extrapyramidal symptoms (EPS) in association with the long-acting, injectable, atypical antipsychotic aripiprazole once monthly (AOM) have been observed in clinical trials, but information on EPS requiring treatment with anticholinergic drugs in clinical practice is limited.
Objectives: The objective of this European post-authorisation safety study (PASS) was to assess the risk of EPS-related events, as defined by dispensings of anticholinergic drugs, linked to the use of AOM in routine clinical practice.
Design: This European cohort study was based on healthcare databases from Germany (German Pharmacoepidemiological Research Database GePaRD), Italy (Caserta and Palermo healthcare claims databases), and Sweden (National health registers).
Multi-scale analysis of the foaming mechanism in anaerobic digestion of food waste: From physicochemical parameter, microbial community to metabolite response.
Water Res
June 2022
Key Laboratory of Three Gorges Reservoir Region's Eco-Environment, Ministry of Education, Chongqing University, Chongqing, 400045, China.
Foaming is a key issue that threatens the efficient and stable operation of the anaerobic digestion process. This study introduced three disturbances to induce foaming and explored the responses of physicochemical parameters, microbial communities, and metabolites to reveal the foaming mechanism. Under the three disturbance conditions, extracellular polymeric substances (EPS)-related parameters are significantly positively correlated with foam height, and EPS may cause foam by lowering the surface tension.
View Article and Find Full Text PDFSafety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia.
Schizophr Res
February 2021
Intra-Cellular Therapies, Inc., Alexandria Center for Life Science, 430 East 29(th) Street, Suite 900, New York, NY, USA.
Background: Lumateperone is a mechanistically novel agent FDA-approved for the treatment of schizophrenia. Efficacy and favorable tolerability of lumateperone were demonstrated in 2 short-term placebo-controlled studies in patients with schizophrenia. This open-label study investigated the short-term safety/tolerability of lumateperone in outpatients with stable schizophrenia switched from previous antipsychotic treatment.
View Article and Find Full Text PDFBeyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study.
J Clin Psychiatry
August 2020
Alkermes, Inc, Waltham, Massachusetts, USA.
Objective: To describe the long-term safety, tolerability, and symptom trajectory with the long-acting injectable antipsychotic aripiprazole lauroxil (AL) in patients with DSM-5-diagnosed schizophrenia followed for up to 180 weeks (3.5 years).
Methods: Long-term safety of 2 fixed doses of AL (441 or 882 mg every 4 weeks) was assessed during up to 180 weeks (3.
Efficacy and Safety of Cariprazine in Acute Management of Psychiatric Disorders: a Meta-Analysis of Randomized Controlled Trials.
Psychiatr Danub
April 2020
Midlands Partnership NHS Foundation Trust, Stafford, UK.
Background: Cariprazine is a new atypical antipsychotic drug approved for the treatment of schizophrenia and bipolar disorders.
Methods: we searched the published randomized controlled-trials (RCT) to review cariprazine efficacy and tolerability using the databases (PubMed, EUDRACT, ClinicalTrials.gov and Cochrane Central Register of Controlled Trials) for cariprazine role in managing the following psychiatric conditions (schizophrenia, bipolar mania, bipolar depression and major depressive disorder).