TY - JOUR
T1 - Contemporary National Patterns of Eligibility and Use of Novel Lipid-Lowering Therapies in the United States
AU - Shen, Miles
AU - Nargesi, Arash Aghajani
AU - Nasir, Khurram
AU - Bhatt, Deepak L.
AU - Khera, Rohan
N1 - Funding Information:
Dr Bhatt discloses the following relationships: advisory boards of Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Janssen, Level Ex, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys; boards of directors of Boston VA Research Institute, DRS.LINQ (stock options), Society of Cardiovascular Patient Care, and TobeSoft; inaugural chair at American Heart Association Quality Oversight Committee; data monitoring committees of Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute, and Rutgers University (for the National Institutes of Health–funded MINT trial); honoraria from American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org; chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor, Associate Editor), K2P (cochair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and US national coleader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), and Wiley (steering committee). Dr Bhatt also reports the following: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry steering committee (chair), VA CART Research and Publications Committee (chair); research funding from Abbott, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, and 89Bio; royalties from Elsevier (Editor, Braunwald’s Heart Disease); site coinvestigator at Abbott, Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Philips, and Svelte; trustee at American College of Cardiology; and unfunded research at FlowCo and Takeda. Dr Nasir has received research support from the Katz Academy of Translational Research and is an advisory board member for Amgen, Novartis, and Novo Nordisk. Dr Khera also receives support from the Doris Duke Charitable Foundation (under award, 2022060) and from Bristol-Myers Squibb, through Yale. He is a coinventor of U.S. Pending Patent Application No. 63/177,117, “Methods for neighborhood phenomapping for clinical trials”, and U.S. Provisional Patent Application No. 63/346,610, “Articles and methods for format independent detection of hidden cardiovascular disease from printed electrocardiographic images using deep learning”. He is a founder of Evidence2Health, a precision health platform to improve evidence-based cardiovascular care. The remaining authors have no disclosures to report.
Funding Information:
This study is supported by a grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health (1K23HL153775) awarded to Dr Khera. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2022 The Authors.
PY - 2022/9/20
Y1 - 2022/9/20
N2 - BACKGROUND: The emergence of PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitor) and icosapent ethyl (IPE) has expanded the role of lipid-lowering therapies beyond statins. Despite recommendations by clinical practice guidelines, their national eligibility and use rates remain unclear. METHODS AND RESULTS: In the National Health and Nutrition Examination Survey data from 2017 to 2020, we assessed eligibility and the use of statins, PCSK9i, and IPE among US adults according to American College of Cardiology/American Heart Association guideline recommendations. Eligibility for PCSK9i and IPE were determined in the following 2 scenarios: (1) assuming existing lipid-lowering therapy as the maximum tolerated before assessing eligibility for novel therapies and (2) assessing eligibility after assuming initiation and maximal escalation of preexisting lipid-lowering therapies and accounting for expected lipid improvements. Of 2729 sampled individuals, representing 149.3 million adults, 1376 had indications for statins, representing 65.8 million or 44.0% (95% CI, 40.9%– 47.2%) of adults. Current statin use was 45% of those eligible and was low across demographic groups. A total of 9.7 and 11.6 million adults would benefit from PCSK9i and IPE, respectively, based on lipid profiles and existing therapies. Assuming maximal escalation of statins and addition of ezetimibe, 4.1% (95% CI, 2.8%– 5.4%) of adults or 6.1 million would benefit from PCSK9i and 6.8% (95% CI, 5.4%– 8.3%) or 10.2 million from IPE. CONCLUSIONS: Six and 10 million individuals have clinical profiles whereby PCSK9i and IPE, respectively, would be expected to improve cardiovascular outcomes even after maximum escalation of statins and ezetimibe use, but remain undertreated with lipid-lowering therapies. Optimal use of lipid-targeted agents that include these novel agents is needed to improve population health outcomes.
AB - BACKGROUND: The emergence of PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitor) and icosapent ethyl (IPE) has expanded the role of lipid-lowering therapies beyond statins. Despite recommendations by clinical practice guidelines, their national eligibility and use rates remain unclear. METHODS AND RESULTS: In the National Health and Nutrition Examination Survey data from 2017 to 2020, we assessed eligibility and the use of statins, PCSK9i, and IPE among US adults according to American College of Cardiology/American Heart Association guideline recommendations. Eligibility for PCSK9i and IPE were determined in the following 2 scenarios: (1) assuming existing lipid-lowering therapy as the maximum tolerated before assessing eligibility for novel therapies and (2) assessing eligibility after assuming initiation and maximal escalation of preexisting lipid-lowering therapies and accounting for expected lipid improvements. Of 2729 sampled individuals, representing 149.3 million adults, 1376 had indications for statins, representing 65.8 million or 44.0% (95% CI, 40.9%– 47.2%) of adults. Current statin use was 45% of those eligible and was low across demographic groups. A total of 9.7 and 11.6 million adults would benefit from PCSK9i and IPE, respectively, based on lipid profiles and existing therapies. Assuming maximal escalation of statins and addition of ezetimibe, 4.1% (95% CI, 2.8%– 5.4%) of adults or 6.1 million would benefit from PCSK9i and 6.8% (95% CI, 5.4%– 8.3%) or 10.2 million from IPE. CONCLUSIONS: Six and 10 million individuals have clinical profiles whereby PCSK9i and IPE, respectively, would be expected to improve cardiovascular outcomes even after maximum escalation of statins and ezetimibe use, but remain undertreated with lipid-lowering therapies. Optimal use of lipid-targeted agents that include these novel agents is needed to improve population health outcomes.
KW - NHANES
KW - PCSK9 inhibitor
KW - icosapent ethyl
KW - lipid-lowering therapy
KW - United States/epidemiology
KW - Nutrition Surveys
KW - Subtilisins
KW - Humans
KW - Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use
KW - Adult
KW - Ezetimibe/therapeutic use
KW - Proprotein Convertases
UR - http://www.scopus.com/inward/record.url?scp=85138458737&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85138458737&partnerID=8YFLogxK
U2 - 10.1161/JAHA.122.026075
DO - 10.1161/JAHA.122.026075
M3 - Article
C2 - 36102276
AN - SCOPUS:85138458737
SN - 2047-9980
VL - 11
SP - e026075
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 18
M1 - e026075
ER -