Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes
Abstract Background 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...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | Cardiovascular Diabetology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12933-023-02077-y |
| _version_ | 1797363692185059328 |
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| author | Ana M. González-Lleó Rosa M. Sánchez-Hernández Núria Plana Daiana Ibarretxe Pere Rehues Josep Ribalta Dídac Llop Ana M. Wägner Lluís Masana Mauro Boronat |
| author_facet | Ana M. González-Lleó Rosa M. Sánchez-Hernández Núria Plana Daiana Ibarretxe Pere Rehues Josep Ribalta Dídac Llop Ana M. Wägner Lluís Masana Mauro Boronat |
| author_sort | Ana M. González-Lleó |
| collection | DOAJ |
| description | Abstract Background 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). Methods 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. Results 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. Conclusion 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. |
| first_indexed | 2024-03-08T16:24:37Z |
| format | Article |
| id | doaj.art-c12da2f5cf514766ace3a5b5e220a9af |
| institution | Directory Open Access Journal |
| issn | 1475-2840 |
| language | English |
| last_indexed | 2024-03-08T16:24:37Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Cardiovascular Diabetology |
| spelling | doaj.art-c12da2f5cf514766ace3a5b5e220a9af2024-01-07T12:09:28ZengBMCCardiovascular Diabetology1475-28402024-01-012311810.1186/s12933-023-02077-yImpact of PCSK9 inhibitors in glycaemic control and new-onset diabetesAna M. González-Lleó0Rosa M. Sánchez-Hernández1Núria Plana2Daiana Ibarretxe3Pere Rehues4Josep Ribalta5Dídac Llop6Ana M. Wägner7Lluís Masana8Mauro Boronat9Sección de Endocrinología y Nutrición. Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria (CHUIMI)Sección de Endocrinología y Nutrición. Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria (CHUIMI)Universitat Rovira i Virgili. Unidad de Medicina Vascular y Metabolismo. Unitat de Recerca Lipids i Arteriosclerosi. Hospital Universitari Sant Joan, IISPV: CIBERDEM.Universitat Rovira i Virgili. Unidad de Medicina Vascular y Metabolismo. Unitat de Recerca Lipids i Arteriosclerosi. Hospital Universitari Sant Joan, IISPV: CIBERDEM.Universitat Rovira i Virgili. Unidad de Medicina Vascular y Metabolismo. Unitat de Recerca Lipids i Arteriosclerosi. Hospital Universitari Sant Joan, IISPV: CIBERDEM.Universitat Rovira i Virgili. Unidad de Medicina Vascular y Metabolismo. Unitat de Recerca Lipids i Arteriosclerosi. Hospital Universitari Sant Joan, IISPV: CIBERDEM.Universitat Rovira i Virgili. Unidad de Medicina Vascular y Metabolismo. Unitat de Recerca Lipids i Arteriosclerosi. Hospital Universitari Sant Joan, IISPV: CIBERDEM.Sección de Endocrinología y Nutrición. Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria (CHUIMI)Universitat Rovira i Virgili. Unidad de Medicina Vascular y Metabolismo. Unitat de Recerca Lipids i Arteriosclerosi. Hospital Universitari Sant Joan, IISPV: CIBERDEM.Sección de Endocrinología y Nutrición. Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria (CHUIMI)Abstract Background 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). Methods 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. Results 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. Conclusion 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.https://doi.org/10.1186/s12933-023-02077-yNew-onset Diabetes MellitusPrediabetesPCSK9 inhibitorsReal-life studyHyperglycaemiaFamilial hypercholesterolemia |
| spellingShingle | Ana M. González-Lleó Rosa M. Sánchez-Hernández Núria Plana Daiana Ibarretxe Pere Rehues Josep Ribalta Dídac Llop Ana M. Wägner Lluís Masana Mauro Boronat Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes Cardiovascular Diabetology New-onset Diabetes Mellitus Prediabetes PCSK9 inhibitors Real-life study Hyperglycaemia Familial hypercholesterolemia |
| title | Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes |
| title_full | Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes |
| title_fullStr | Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes |
| title_full_unstemmed | Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes |
| title_short | Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes |
| title_sort | impact of pcsk9 inhibitors in glycaemic control and new onset diabetes |
| topic | New-onset Diabetes Mellitus Prediabetes PCSK9 inhibitors Real-life study Hyperglycaemia Familial hypercholesterolemia |
| url | https://doi.org/10.1186/s12933-023-02077-y |
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