Aims: While genetic and biological studies indicated a potential association between proprotein-convertase subtilisin/kexin type 9 inhibitors (PCSK9i) and hyperglycaemia, real-world data are limited. Therefore, we sought to investigate this association using the FDA adverse event reporting system (FAERS).
Methods And Results: The FAERS database (2015-2020) was retrospectively queried to characterize reporting of hyperglycaemic adverse events (AEs) with PCSK9i. Disproportionality analyses were performed using the adjusted reporting odds ratio (adj.ROR), and the lower bound of the information component (IC) 95% credibility interval (IC025 > 0 is deemed significant). Among 7 295 624 eligible patients, 71 748 reports of evolocumab and 15 976 of alirocumab were identified. Compared to the full database, PCSK9i treatment was associated with increased reporting of hyperglycaemic AEs [n = 1841, adj.ROR = 1.14 (1.07-1.22), IC025 = 0.13]. Hyperglycaemic AEs were primarily mild hyperglycaemia [n = 1469, adj. ROR = 1.48 (1.36-1.62), IC025 = 0.51] rather than diabetes [n = 372, adj. ROR = 0.67 (0.60-0.74), IC025 = -0.90]. Among PCSK9i agents, evolocumab, but not alirocumab, was associated with hyperglycaemic AEs [n = 1587, adj. ROR = 1.24 (1.15-1.32), IC025 = 0.20; n = 254, adj. ROR = 0.73 (0.60-0.88), IC025 = -0.38, respectively]. Hyperglycaemic AEs were reported more often with PCSK9i compared to ezetimibe [adj.ROR = 1.99 (1.35-2.94)], and less often compared to statins [adj.ROR = 0.26 (0.25-0.28)]. Notably, hyperglycaemic AEs were reported more frequently by diabetic than by non-diabetic patients (P < 0.001), mostly occurred within 6 months of treatment and were reversible upon drug discontinuation.
Conclusion: In a real-world setting, PCSK9i treatment was associated with increased reporting of mild hyperglycaemia, but not diabetes. While initial monitoring is warranted, the favourable glycaemic safety profile compared to statins supports their essential role in the management of lipid disorders.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1093/eurjpc/zwab209 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Once-Weekly Tirzepatide Versus Once-Daily Basal Insulin in Managing Type 2 Diabetes Inadequately Controlled With Oral anti-Hyperglycemic Drugs: A Systematic Review and Meta-Analysis.
Endocr Pract
December 2024
Department of Endocrinology, CEDAR Superspeciality Clinics, Dwarka, New Delhi, India.
Objective: No meta-analysis has been published comparing the efficacy and safety of tirzepatide vs once-daily basal insulins in subjects with type 2 diabetes (T2D) inadequately controlled with oral anti-hyperglycemic drugs. This meta-analysis was conducted to address this knowledge gap.
Methods: Randomized controlled trials involving subjects with T2D inadequately controlled with oral anti-hyperglycemic drugs and receiving tirzepatide in intervention arm and basal insulins in control arm as add-on therapy were searched throughout the electronic databases.
Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment.
J Clin Endocrinol Metab
December 2024
Division of Thyroid Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.
Context: Teprotumumab, which targets the insulin-like growth factor-1 receptor, is the only drug approved by the US Food and Drug Administration (FDA) for the treatment of thyroid eye disease (TED).
Objective: This study aimed to identify potential safety signals of teprotumumab by analyzing postmarketing safety data from the FDA Adverse Event Reporting System (FAERS) database in 2023.
Methods: The case/noncase approach was used to estimate the reporting odds ratio (ROR) and information component (IC) with relevant 95% CI for adverse events (AEs) that numbered 3 or more.
Insulin infusion sets associated with adverse events: strategies for improved diabetes education.
Front Med (Lausanne)
November 2023
Department of Science and Technology, Institute of Science and Technology, Federal University of São Paulo, São Paulo, Brazil.
Introduction: Insulin Infusion Sets (IIS) play a crucial role in ensuring the safe delivery of insulin through a Continuous Subcutaneous Insulin Infusion (CSII) for individuals with Type 1 Diabetes (T1D). Recent advancements in therapy have highlighted the need to address issues such as unexplained hyperglycemia and IIS occlusion.
Objective: To investigate the adverse events (AEs) associated with IIS that impact the treatment of T1D, with a specific focus on promoting effective educational practices.
Risk factors for hyperglycemia in COVID-19 patients treated with remdesivir.
Clin Transl Sci
January 2024
College of Pharmacy, Chungbuk National University, Cheongju-si, Korea.
The primary objective of this study was to investigate the factors contributing to hyperglycemic adverse events (AEs) associated with the administration of remdesivir in hospitalized patients diagnosed with coronavirus disease 2019 (COVID-19). Furthermore, the study aimed to develop a risk score model employing various machine learning approaches. A total of 1262 patients were enrolled in this investigation.
View Article and Find Full Text PDFHyperglycaemic disorders associated with PCSK9 inhibitors: a real-world, pharmacovigilance study.
Eur J Prev Cardiol
July 2022
Sackler Faculty of Medicine, Tel-Aviv University, Ramat Aviv, Tel Aviv 69978, Israel.
Aims: While genetic and biological studies indicated a potential association between proprotein-convertase subtilisin/kexin type 9 inhibitors (PCSK9i) and hyperglycaemia, real-world data are limited. Therefore, we sought to investigate this association using the FDA adverse event reporting system (FAERS).
Methods And Results: The FAERS database (2015-2020) was retrospectively queried to characterize reporting of hyperglycaemic adverse events (AEs) with PCSK9i.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!