Michael Wilkinson MD, Tommy Chiou MD, Pam Taub MD, Donya Mazdeyasnan BS
{"title":"*Real-World Experience with Inclisiran at a Large Academic Lipid Clinic","authors":"Michael Wilkinson MD, Tommy Chiou MD, Pam Taub MD, Donya Mazdeyasnan BS","doi":"10.1016/j.jacl.2024.04.087","DOIUrl":null,"url":null,"abstract":"<div><h3>Background/Synopsis</h3><p>Inclisiran is an siRNA that targets PCSK9 and lowers LDL-C by approximately 50%. Inclisiran is unique among lipid-lowering therapies (LLTs) available for LDL-C reduction as it is administered via subcutaneous injection by a healthcare professional every 6 months. Real-world data examining inclisiran use in US clinical practice are limited.</p></div><div><h3>Objective/Purpose</h3><p>Examine patient characteristics and LDL-C reduction during the initial two-year experience with inclisiran at a large academic lipid clinic.</p></div><div><h3>Methods</h3><p>We performed a retrospective chart review of 60 patients at a large academic lipid clinic who were prescribed inclisiran between March 2022 to November 2023 and had follow-up LDL-C measurements taken ≥ 30 days after initiating treatment as part of routine care. Background LLT was extracted from the medical record and reflects treatment at time of inclisiran initiation. Absolute and percent LDL-C reduction was examined during follow-up. LDL-C reduction from baseline was assessed within group using a paired samples t-test with two-sided p < 0.05 considered significant.</p></div><div><h3>Results</h3><p>Among 60 patients, mean (± SD) age was 71 ± 9.2 years (52% women, 90% White, 2% Hispanic/Latino, 8% Asian), 87% with history of ASCVD, 70% with statin intolerance, 20% with HeFH, and 50% on background statin therapy (Table). During the 4.4 ± 2.8 months of follow-up from first dose of inclisiran to first LDL-C measurement, 2 patients had received three doses of inclisiran, 34 patients had received two doses, and 24 patients had received one dose. LDL-C decreased from 107 ± 47 mg/dL at baseline to 67 ± 42 mg/dL at first follow up (-37%, p < 0.001). Excluding patients that switched from a PCSK9i monoclonal antibody (mAb) within approximately one month prior to starting inclisiran (n=12) or patients on no background LLT at time of inclisiran initiation (n=9), patients saw a decrease in mean LDL-C from 102 ± 42 mg/dL at baseline to 54 ± 40 mg/dL at first follow-up ((n=39) -47%, p <0.001) (Figure).</p></div><div><h3>Conclusions</h3><p>Patients that remained on background lipid-lowering therapy and did not switch from PCSK9i mAb to inclisiran observed LDL-C reductions of approximately 50%, consistent with inclisiran clinical trials. Additional real-world data examining the impact of inclisiran on LDL-C are needed, across multiple centers and among patients on various background LLT regimens.</p></div>","PeriodicalId":15392,"journal":{"name":"Journal of clinical lipidology","volume":"18 4","pages":"Pages e553-e554"},"PeriodicalIF":3.6000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical lipidology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S193328742400134X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Background/Synopsis
Inclisiran is an siRNA that targets PCSK9 and lowers LDL-C by approximately 50%. Inclisiran is unique among lipid-lowering therapies (LLTs) available for LDL-C reduction as it is administered via subcutaneous injection by a healthcare professional every 6 months. Real-world data examining inclisiran use in US clinical practice are limited.
Objective/Purpose
Examine patient characteristics and LDL-C reduction during the initial two-year experience with inclisiran at a large academic lipid clinic.
Methods
We performed a retrospective chart review of 60 patients at a large academic lipid clinic who were prescribed inclisiran between March 2022 to November 2023 and had follow-up LDL-C measurements taken ≥ 30 days after initiating treatment as part of routine care. Background LLT was extracted from the medical record and reflects treatment at time of inclisiran initiation. Absolute and percent LDL-C reduction was examined during follow-up. LDL-C reduction from baseline was assessed within group using a paired samples t-test with two-sided p < 0.05 considered significant.
Results
Among 60 patients, mean (± SD) age was 71 ± 9.2 years (52% women, 90% White, 2% Hispanic/Latino, 8% Asian), 87% with history of ASCVD, 70% with statin intolerance, 20% with HeFH, and 50% on background statin therapy (Table). During the 4.4 ± 2.8 months of follow-up from first dose of inclisiran to first LDL-C measurement, 2 patients had received three doses of inclisiran, 34 patients had received two doses, and 24 patients had received one dose. LDL-C decreased from 107 ± 47 mg/dL at baseline to 67 ± 42 mg/dL at first follow up (-37%, p < 0.001). Excluding patients that switched from a PCSK9i monoclonal antibody (mAb) within approximately one month prior to starting inclisiran (n=12) or patients on no background LLT at time of inclisiran initiation (n=9), patients saw a decrease in mean LDL-C from 102 ± 42 mg/dL at baseline to 54 ± 40 mg/dL at first follow-up ((n=39) -47%, p <0.001) (Figure).
Conclusions
Patients that remained on background lipid-lowering therapy and did not switch from PCSK9i mAb to inclisiran observed LDL-C reductions of approximately 50%, consistent with inclisiran clinical trials. Additional real-world data examining the impact of inclisiran on LDL-C are needed, across multiple centers and among patients on various background LLT regimens.
期刊介绍:
Because the scope of clinical lipidology is broad, the topics addressed by the Journal are equally diverse. Typical articles explore lipidology as it is practiced in the treatment setting, recent developments in pharmacological research, reports of treatment and trials, case studies, the impact of lifestyle modification, and similar academic material of interest to the practitioner. While preference is given to material of immediate practical concern, the science that underpins lipidology is forwarded by expert contributors so that evidence-based approaches to reducing cardiovascular and coronary heart disease can be made immediately available to our readers. Sections of the Journal will address pioneering studies and the clinicians who conduct them, case studies, ethical standards and conduct, professional guidance such as ATP and NCEP, editorial commentary, letters from readers, National Lipid Association (NLA) news and upcoming event information, as well as abstracts from the NLA annual scientific sessions and the scientific forums held by its chapters, when appropriate.