ArticleBiomedicines2024
Safety Profiles Related to Dosing Errors of Rapid-Acting Insulin Analogs: A Comparative Analysis Using the EudraVigilance Database.
Article in Biomedicines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Comparative Pharmacovigilance Analysis of Selected Cardiotoxicity Signals Associated with Doxorubicin and Epirubicin Based on EudraVigilance Data.Journal of clinical medicine · 2026Article
- Incretin-Based Drugs for Obesity: Common and Drug-Specific Reporting Patterns of Adverse Drug Reactions-A Comparative Disproportionality Analysis Using EudraVigilance Reports Integrating SmPC Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Enhancing insulin administration safety in inpatient care: findings from a root cause analysis and continuous improvement intervention.Open medicine (Warsaw, Poland) · 2026Article
- Biological and Biosimilar Medicines in Contemporary Pharmacotherapy for Metabolic Syndrome.Pharmaceutics · 2025Review
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Insulin is essential for treating type 1 diabetes and insulin-requiring type 2 diabetes. BACKGROUND/
objectivesDiabetes is a widespread condition that can lead to multiple and severe complications. Rapid-acting insulin analogs (RAIAs) and long-acting insulin analogs are prescribed for the effective management of diabetes. RAIAs are expected to be associated with a higher number of dosing errors because of their rapid onset, short duration of action, and the need for frequent dosing, compared to other insulin analogs. There are three approved RAIAs on the market: insulin lispro (LIS), insulin aspart (ASP), and insulin glulisine (GLU). The aim of this study is to evaluate the real-world evidence on dosing errors reported for RAIAs in EudraVigilance (EV), an established pharmacovigilance database, in comparison to other insulin analogs and human insulins.
methodsA descriptive analysis and a disproportionality analysis were conducted.
resultsASP and LIS were associated with high percentages of adverse drug reactions (ADRs) (22% and 17%, respectively), with over 70% of the reports involving serious ADRs. A higher frequency of cardiac and eye disorder ADRs was observed for LIS compared with ASP and GLU. GLU showed a higher frequency of ADRs in the skin and subcutaneous tissue disorders category. LIS dosing errors accounted for 5% of the total number of cases, while dosing errors for ASP and GLU were less than 3%. The most frequently reported dosing errors involved improper dosing (49%).
conclusionsAlthough there were fewer dosing errors of RAIAs in comparison to other insulins, the severity of the potential outcome highlights the importance of precise dosing and timing. Improved the monitoring and reporting of these dosing errors could enhance diabetes patient care. Additionally, smart medical devices could improve therapeutic outcomes.
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