Author, as appears in the article.: González-Lleó, AM; Sánchez-Hernández, RM; Plana, N; Ibarretxe, D; Rehues, P; Ribalta, J; Llop, D; Wägner, AM; Masana, L; Boronat, M
Department: Medicina i Cirurgia
URV's Author/s: Ibarretxe Gerediaga, Daiana / Llop Paredes, Dídac / Masana Marín, Luis / Plana Gil, Núria / Rehues Masip, Pere / Ribalta Vives, Josep
Keywords: Real-life study Prediabetes Pcsk9 inhibitors New-onset diabetes mellitus Hyperglycaemia Familial hypercholesterolemia Alirocumab safety risk real-life study prediabetes pcsk9 inhibitors hyperglycaemia familial hypercholesterolemia efficacy association
Abstract: The diabetogenic effect of statins has been well established by clinical trials, Mendelian randomisation studies and meta-analyses. According to large clinical trials, PCSK9 inhibitors (PCSK9i) have no deleterious impact on glucose metabolism. However, few real-life studies have yet evaluated the long-term effects of these drugs on glucose homeostasis and their impact on new-onset diabetes (NODM).We studied 218 patients treated with either alirocumab or evolocumab (70% with familial hypercholesterolemia) for at least three years (PCSK9iG). We studied the NODM rate in the nondiabetic group at baseline (168) and overall glucose metabolism control in the whole group. Incidental DM was compared with two groups. The first was a propensity score matching (PSM)-selected group (n = 168) from the database of patients attending the Reus lipid unit (Metbank, n = 745) who were not on PCSK9i (PSMG). The second was a subgroup with a similar age range (n = 563) of the Di@bet.es study (Spanish prospective study on diabetes development n = 5072) (D@G). The incidence was reported as the percentage of NODM cases per year.The fasting glucose (FG) level of the subjects with normoglycaemia at baseline increased from 91 (86-95.5) to 93 (87-101) mg/dL (p = 0.014). There were 14 NODM cases in the PCSK9i group (2.6%/y), all among people with prediabetes at baseline. The incidence of NODM in PSMG and D@G was 1.8%/y (p = 0.69 compared with the PCSK9iG). The incidence among the subjects with prediabetes was 5.1%/y in the PCSK9iG, 4.8%/y in the PSMG and 3.9%/y in the D@G (p = 0.922 and p = 0.682, respectively). In the multivariate analysis, only the FG level was associated with the development of NODM in the PCSK9iG (OR 1.1; 95% CI: 1.0-1.3; p = 0.027). Neither FG nor A1c levels changed significantly in patients with DM at baseline.A nonsignificant increase in NODM occurred in the PCSK9iG, particularly in patients with prediabetes, compared with the PSMG and D@G groups. Baseline FG levels were the main variable associated with the development of DM. In the subjects who had DM at baseline, glucose control did not change. The impact of PCSK9i on glucose metabolism should not be of concern when prescribing these therapies.© 2023. The Author(s).
Thematic Areas: Saúde coletiva Medicina ii Medicina i Internal medicine Interdisciplinar Farmacia Endocrinology, diabetes and metabolism Endocrinology & metabolism Educação física Ciências biológicas ii Ciências biológicas i Cardiology and cardiovascular medicine Cardiac & cardiovascular systems Biotecnología
licence for use: https://creativecommons.org/licenses/by/3.0/es/
Author's mail: pere.rehues@urv.cat didac.llop@urv.cat daiana.ibarretxe@urv.cat didac.llop@urv.cat pere.rehues@urv.cat luis.masana@urv.cat josep.ribalta@urv.cat
Author identifier: 0000-0002-0789-4954 0000-0002-8879-4719
Record's date: 2024-09-14
Papper version: info:eu-repo/semantics/publishedVersion
Licence document URL: https://repositori.urv.cat/ca/proteccio-de-dades/
Papper original source: Cardiovascular Diabetology. 23 (1): 4-4
APA: González-Lleó, AM; Sánchez-Hernández, RM; Plana, N; Ibarretxe, D; Rehues, P; Ribalta, J; Llop, D; Wägner, AM; Masana, L; Boronat, M (2024). Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes. Cardiovascular Diabetology, 23(1), 4-4. DOI: 10.1186/s12933-023-02077-y
Entity: Universitat Rovira i Virgili
Journal publication year: 2024
Publication Type: Journal Publications
Repositori URV