First clinical experiences with inclisiran in a real-world setting

Janneke W.C.M. Mulder; Annette M.H. Galema-Boers; Jeanine E. Roeters van Lennep

doi:10.1016/j.jacl.2023.09.005

First clinical experiences with inclisiran in a real-world setting

Janneke W.C.M. Mulder, Annette M.H. Galema-Boers, Jeanine E. Roeters van Lennep^*

^*Corresponding author for this work

Internal Medicine

Research output: Contribution to journal › Article › Academic › peer-review

15 Citations (Scopus)

84 Downloads (Pure)

Abstract

Background and objective: Inclisiran is the first-in-class small interfering RNA (siRNA) proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. In clinical trials inclisiran showed effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction of ± 50 %. As data in clinical setting are scarce, we aim to investigate the efficacy and safety in clinical practice. Methods: We describe a registry of consecutive patients who started with inclisiran at a lipid clinic of a university hospital. Patients were eligible if they fulfilled the reimbursement criteria in the Netherlands. Patients were included if they started with inclisiran as first line (group 1) or switched from PCSK9 monoclonal antibody (mAbs) to inclisiran (group 2). LDL-C levels were measured at 3 and 9 months after initiation of inclisiran. Median change of LDL-C levels was calculated on an individual and group level. Results: We analysed 65 patients (36 women), median [25 ^th percentile; 75 ^th percentile] age of 63 [54; 68] years. Of these, 44 patients had both a 3 month and 9 month visit. At 3 months, patients who newly started inclisiran (group 1, n = 45) showed a LDL-C decrease of 38 [-49;-33] %. Patients who used statins as co-medication (n = 15) had a higher median LDL-C decrease compared to those without statin use (n=30; 45 % vs 38 %). However, patients who switched from mAbs to inclisiran (group 2, n = 20) had an increase in LDL-C of 38 [+4; +97] %. Adverse effects associated with inclisiran were mild and consisted of mild injection site reactions. Efficacy was slightly less whereas safety results were similar at 9 months. Conclusion: Our initial experience of inclisiran in a clinical setting showed less reduction in LDL-C levels compared to clinical trials but a similar safety profile. Moreover, patients who switched from PCSK9 mAbs to inclisiran generally showed an increase in LDL-C levels implying that inclisiran is less potent in LDL-C reduction compared to PCSK9 mAbs.

Original language	English
Pages (from-to)	818-827
Number of pages	10
Journal	Journal of Clinical Lipidology
Volume	17
Issue number	6
Early online date	18 Sept 2023
DOIs	https://doi.org/10.1016/j.jacl.2023.09.005
Publication status	Published - 1 Nov 2023

Bibliographical note

Funding Information:
Declaration of Competing Interest: JGB received funding from Sanofi outside the submitted work for education purposes. JRVL received research grants from Novartis and Amryt. JM does not have any disclosures.

Publisher Copyright:
© 2023

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.jacl.2023.09.005Licence: CC BY

First clinical experiences with inclisiran in a real-world settingProof, 973 KBLicence: CC BY

Cite this

@article{671a3ca6123a4466a799e0698af115c7,

title = "First clinical experiences with inclisiran in a real-world setting",

abstract = "Background and objective: Inclisiran is the first-in-class small interfering RNA (siRNA) proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. In clinical trials inclisiran showed effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction of ± 50 %. As data in clinical setting are scarce, we aim to investigate the efficacy and safety in clinical practice. Methods: We describe a registry of consecutive patients who started with inclisiran at a lipid clinic of a university hospital. Patients were eligible if they fulfilled the reimbursement criteria in the Netherlands. Patients were included if they started with inclisiran as first line (group 1) or switched from PCSK9 monoclonal antibody (mAbs) to inclisiran (group 2). LDL-C levels were measured at 3 and 9 months after initiation of inclisiran. Median change of LDL-C levels was calculated on an individual and group level. Results: We analysed 65 patients (36 women), median [25 th percentile; 75 th percentile] age of 63 [54; 68] years. Of these, 44 patients had both a 3 month and 9 month visit. At 3 months, patients who newly started inclisiran (group 1, n = 45) showed a LDL-C decrease of 38 [-49;-33] %. Patients who used statins as co-medication (n = 15) had a higher median LDL-C decrease compared to those without statin use (n=30; 45 % vs 38 %). However, patients who switched from mAbs to inclisiran (group 2, n = 20) had an increase in LDL-C of 38 [+4; +97] %. Adverse effects associated with inclisiran were mild and consisted of mild injection site reactions. Efficacy was slightly less whereas safety results were similar at 9 months. Conclusion: Our initial experience of inclisiran in a clinical setting showed less reduction in LDL-C levels compared to clinical trials but a similar safety profile. Moreover, patients who switched from PCSK9 mAbs to inclisiran generally showed an increase in LDL-C levels implying that inclisiran is less potent in LDL-C reduction compared to PCSK9 mAbs.",

author = "Mulder, {Janneke W.C.M.} and Galema-Boers, {Annette M.H.} and {Roeters van Lennep}, {Jeanine E.}",

note = "Funding Information: Declaration of Competing Interest: JGB received funding from Sanofi outside the submitted work for education purposes. JRVL received research grants from Novartis and Amryt. JM does not have any disclosures. Publisher Copyright: {\textcopyright} 2023",

year = "2023",

month = nov,

day = "1",

doi = "10.1016/j.jacl.2023.09.005",

language = "English",

volume = "17",

pages = "818--827",

journal = "Journal of Clinical Lipidology",

issn = "1933-2874",

publisher = "Elsevier Ltd.",

number = "6",

}

TY - JOUR

T1 - First clinical experiences with inclisiran in a real-world setting

AU - Mulder, Janneke W.C.M.

AU - Galema-Boers, Annette M.H.

AU - Roeters van Lennep, Jeanine E.

N1 - Funding Information: Declaration of Competing Interest: JGB received funding from Sanofi outside the submitted work for education purposes. JRVL received research grants from Novartis and Amryt. JM does not have any disclosures. Publisher Copyright: © 2023

PY - 2023/11/1

Y1 - 2023/11/1

N2 - Background and objective: Inclisiran is the first-in-class small interfering RNA (siRNA) proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. In clinical trials inclisiran showed effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction of ± 50 %. As data in clinical setting are scarce, we aim to investigate the efficacy and safety in clinical practice. Methods: We describe a registry of consecutive patients who started with inclisiran at a lipid clinic of a university hospital. Patients were eligible if they fulfilled the reimbursement criteria in the Netherlands. Patients were included if they started with inclisiran as first line (group 1) or switched from PCSK9 monoclonal antibody (mAbs) to inclisiran (group 2). LDL-C levels were measured at 3 and 9 months after initiation of inclisiran. Median change of LDL-C levels was calculated on an individual and group level. Results: We analysed 65 patients (36 women), median [25 th percentile; 75 th percentile] age of 63 [54; 68] years. Of these, 44 patients had both a 3 month and 9 month visit. At 3 months, patients who newly started inclisiran (group 1, n = 45) showed a LDL-C decrease of 38 [-49;-33] %. Patients who used statins as co-medication (n = 15) had a higher median LDL-C decrease compared to those without statin use (n=30; 45 % vs 38 %). However, patients who switched from mAbs to inclisiran (group 2, n = 20) had an increase in LDL-C of 38 [+4; +97] %. Adverse effects associated with inclisiran were mild and consisted of mild injection site reactions. Efficacy was slightly less whereas safety results were similar at 9 months. Conclusion: Our initial experience of inclisiran in a clinical setting showed less reduction in LDL-C levels compared to clinical trials but a similar safety profile. Moreover, patients who switched from PCSK9 mAbs to inclisiran generally showed an increase in LDL-C levels implying that inclisiran is less potent in LDL-C reduction compared to PCSK9 mAbs.

AB - Background and objective: Inclisiran is the first-in-class small interfering RNA (siRNA) proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. In clinical trials inclisiran showed effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction of ± 50 %. As data in clinical setting are scarce, we aim to investigate the efficacy and safety in clinical practice. Methods: We describe a registry of consecutive patients who started with inclisiran at a lipid clinic of a university hospital. Patients were eligible if they fulfilled the reimbursement criteria in the Netherlands. Patients were included if they started with inclisiran as first line (group 1) or switched from PCSK9 monoclonal antibody (mAbs) to inclisiran (group 2). LDL-C levels were measured at 3 and 9 months after initiation of inclisiran. Median change of LDL-C levels was calculated on an individual and group level. Results: We analysed 65 patients (36 women), median [25 th percentile; 75 th percentile] age of 63 [54; 68] years. Of these, 44 patients had both a 3 month and 9 month visit. At 3 months, patients who newly started inclisiran (group 1, n = 45) showed a LDL-C decrease of 38 [-49;-33] %. Patients who used statins as co-medication (n = 15) had a higher median LDL-C decrease compared to those without statin use (n=30; 45 % vs 38 %). However, patients who switched from mAbs to inclisiran (group 2, n = 20) had an increase in LDL-C of 38 [+4; +97] %. Adverse effects associated with inclisiran were mild and consisted of mild injection site reactions. Efficacy was slightly less whereas safety results were similar at 9 months. Conclusion: Our initial experience of inclisiran in a clinical setting showed less reduction in LDL-C levels compared to clinical trials but a similar safety profile. Moreover, patients who switched from PCSK9 mAbs to inclisiran generally showed an increase in LDL-C levels implying that inclisiran is less potent in LDL-C reduction compared to PCSK9 mAbs.

UR - http://www.scopus.com/inward/record.url?scp=85173094674&partnerID=8YFLogxK

U2 - 10.1016/j.jacl.2023.09.005

DO - 10.1016/j.jacl.2023.09.005

M3 - Article

C2 - 37775462

AN - SCOPUS:85173094674

SN - 1933-2874

VL - 17

SP - 818

EP - 827

JO - Journal of Clinical Lipidology

JF - Journal of Clinical Lipidology

IS - 6

ER -

First clinical experiences with inclisiran in a real-world setting

Abstract

Bibliographical note

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this