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. 2021 Sep 1;6(9):1060-1068.
doi: 10.1001/jamacardio.2021.1810.

Use of Lipid-Lowering Therapies Over 2 Years in GOULD, a Registry of Patients With Atherosclerotic Cardiovascular Disease in the US

Christopher P Cannon  1   2 , James A de Lemos  3 , Robert S Rosenson  4 , Christie M Ballantyne  5   6 , Yuyin Liu  2 , Qi Gao  2 , Tamara Palagashvilli  7 , Shushama Alam  7 , Katherine E Mues  7 , Deepak L Bhatt  8 , Mikhail N Kosiborod  9   10 ; GOULD Investigators
Collaborators, Affiliations

Use of Lipid-Lowering Therapies Over 2 Years in GOULD, a Registry of Patients With Atherosclerotic Cardiovascular Disease in the US

Christopher P Cannon et al. JAMA Cardiol. .

Abstract

Importance: Guidelines for patients with atherosclerotic cardiovascular disease (ASCVD) recommend intensive statin therapy and adding nonstatin therapy if low-density lipoprotein cholesterol (LDL-C) levels are 70 mg/dL or more. Compliance with guidelines is often low.

Objective: To track LDL-C treatment patterns in the US over 2 years.

Design, setting, and participants: GOULD is a prospective observational registry study involving multiple centers. Patients with ASCVD receiving any lipid-lowering therapy (LLT) were eligible. Between December 2016 and July 2018, patients were enrolled in 1 of 3 cohorts: (1) those currently receiving proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) and 2 groups not receiving PCSK9i drugs, with (2) LDL-C levels of 100 mg/dL or more or (3) LDL-C levels of 70 to 99 mg/dL. Patients had medical record reviews and telephone interviews every 6 months. Analysis was done on data collected as of October 5, 2020.

Main outcomes and measures: The primary outcome was the change in LLT use in 2 years. Secondary outcomes included the number of LDL-C measurements, LDL-C levels, and responses to structured physician and patient questionnaires over 2 years.

Results: A total of 5006 patients were enrolled (mean [SD] age, 67.8 [9.9] years; 1985 women [39.7%]; 4312 White individuals [86.1%]). At 2 years, 885 (17.1%) had LLT intensification. In the cohorts with LDL-C levels of 100 mg/dL or more and 70 to 99 mg/dL, LLT intensification occurred in 403 (22.4%) and 383 (14.4%), respectively; statins were intensified in 115 (6.4%) and 168 (6.3%), ezetimibe added in 123 (6.8%) and 118 (4.5%), and PCSK9i added in 114 (6.3%) and 58 (2.2%), respectively. In the PCSK9i cohort, 508 of 554 (91.7%) were still taking PCSK9i at 2 years. Lipid panels were measured at least once over 2 years in 3768 patients (88.5%; PCSK9i cohort, 492 [96.1%]; LDL-C levels ≥100 mg/dL or more, 1294 [85.9%]; 70-99 mg/dL, 1982 [88.6%]). Levels of LDL-C fell from medians (interquartile ranges) of 120 (108-141) mg/dL to 95 (73-118) mg/dL in the cohort with LDL-C levels of 100 mg/dL or more, 82 (75-89) to 77 (65-90) mg/dL in the cohort with LDL-C levels of 70 to 99 mg/dL, and 67 (42-104) mg/dL to 67 (42-96) mg/dL in the PCSK9i cohort. Levels of LDL-C less than 70 mg/dL at 2 years were achieved by 308 patients (21.0%) and 758 patients (33.9%) in the cohorts with LDL-C levels of 100 mg/dL or more and 70 to 99 mg/dL, respectively, and 272 patients (52.4%) in the PCSK9i cohort. At 2 years, practice characteristics were associated with more LLT intensification (teaching vs nonteaching hospitals, 148 of 589 [25.1%] vs 600 of 3607 [16.6%]; lipid protocols or none, 359 of 1612 [22.3%] vs 389 of 2584 [15.1%]; cardiology, 452 of 2087 [21.7%] vs internal or family medicine, 204 of 1745 [11.7%] and other, 92 of 364 [25.3%]; all P < .001) and achievement of LDL-C less than 70 mg/dL (teaching vs nonteaching hospitals, 173 of 488 [35.5%] vs 823 of 2986 [27.6%]; lipid protocols vs none, 451 of 1411 [32.0%] vs 545 of 2063 [26.4%]; both P < .001; cardiology, 523 of 1686 [30.1%] vs internal or family medicine, 377 of 1472 [25.6%] and other, 96 of 316 [30.4%]; P = .003).

Conclusions and relevance: Of patients with ASCVD, most with suboptimal LDL-C levels at baseline, only 17.1% had LLT intensification after 2 years, and two-thirds remained at an LDL-C level greater than 70 mg/dL. Further intensive efforts are needed to achieve optimal LDL-C management in patients with ASCVD.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Cannon reported research grants from Amgen during the conduct of this study and Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Merck, Novo Nordisk, and Pfizer outside the submitted work, as well as consulting fees from Amgen during the conduct of this study and Aegerion, Alnylam, Amarin Applied Therapeutics, Ascendia, Boehringer Ingelheim, Bristol Myers Squibb, Corvidia, Eli Lilly, HLS Therapeutics, Innovent, Janssen, Kowa, Merck, Pfizer, Rhoshan, and Sanofi (for advisory board participation) outside the submitted work. Dr de Lemos reported personal fees from Amgen during the conduct of the study and personal fees from Regeneron, Esperion, and Novo Nordisk outside the submitted work. Dr Rosenson reported research grants from Amgen, AstraZeneca, Novartis, and Regeneron; received consulting honoraria from Amgen, Amyrt, C5, CVS Caremark, Novartis, Regeneron, and 89 Bio; received honoraria from Amgen, Kowa, and Regeneron; received royalties from Wolters Kluwer (UpToDate); and owned stock in MediMergent, LLC. Dr Ballantyne reported research grants (all paid to his institution) from Abbott Diagnostic, Akcea, Amgen, Esperion, Ionis, Novartis, Regeneron, Roche Diagnostic, Sanofi-Synthelabo, National Institutes of Health, American Heart Association, ADA; consulting fees from Abbott Diagnostics, Akcea, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Boehringer Ingelheim, Corvidia, Denka Seiken, Esperion, Genentech, Gilead, Intercept, Janssen, Matinas BioPharma Inc, Merck, New Amsterdam, Novartis, Novo Nordisk, Pfizer, Regeneron, Roche Diagnostic, and Sanofi-Synthelabo outside the submitted work. Dr Palagashvili reported employment with and holding stock in Amgen during the conduct of the study. Dr Mues reported employment with and holding stock in Amgen during the conduct of the study. Dr Alam reported being employed by Amgen. Dr Kosiborod reported research grants from AstraZeneca and Boehringer Ingelheim; other research support from AstraZeneca; consulting and advisory board participation for Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Merck (Diabetes), Novo Nordisk, Sanofi, and Vifor Pharma; and honoraria from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk outside the submitted work. Dr Bhatt reported serving on advisory boards for Cardax, Cereno Scientific, Elsevier PracticeUpdate Cardiology, Medscape Cardiology, PhaseBio, and Regado Biosciences and boards of directors for Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; serving as a chair of the American Heart Association Quality Oversight Committee; being on data monitoring committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), and the Population Health Research Institute; receiving honoraria from the American College of Cardiology (as a senior associate editor of Clinical Trials and News [ACC.org] and a vice chair of the ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; for the RE-DUAL PCI clinical trial steering committee, funded by Boehringer Ingelheim, and the AEGIS-II executive committee, funded by CSL Behring), Belvoir Publications (as editor in chief of Harvard Heart Letter), Duke Clinical Research Institute (for clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (as editor in chief of the Journal of Invasive Cardiology), Journal of the American College of Cardiology (as a guest editor and associate editor), Medtelligence/ReachMD (for continuing medical education steering committees), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national coleadership, funded by Bayer), Slack Publications (as chief medical editor of Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (as secretary/treasurer), WebMD (as part of continuing medical education steering committees); having additional commitments with Clinical Cardiology (as a deputy editor), the NCDR-ACTION Registry Steering Committee (as the chair), and VA CART Research and Publications Committee (as the chair); receiving research funding from Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi, Sanofi Aventis, Synaptic, and The Medicines Company; receiving royalties from Elsevier (as an editor of Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); being a site co-investigator for Biotronik, Boston Scientific, St Jude Medical (now Abbott), and Svelte; being a trustee of the American College of Cardiology; conducting unfunded research with involvement from FlowCo, Merck, Novo Nordisk, PLx Pharma, and Takeda; receiving personal fees from MJH Life Sciences, Level Ex, Contego Medical, CellProthera, K2P, and Canadian Medical and Surgical Knowledge Translation Research Group; being part of the ODYSSEY executive steering committee outside the submitted work; receiving grants from PLx Pharma, Lexicon, Owkin, MyoKardia, and HLS Therapeutics; and receiving other support from VA, CSI, and MyoKardia, outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Use of Lipid-Lowering Therapies (LLT) at Baseline and 2 Years Among Patients Enrolled in the GOULD Registry
GOULD indicates Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management; LDL-C, low-density lipoprotein cholesterol; PCSK9i, proprotein convertase subtilisin/kexin type 9 inhibitor. To convert LDL-C levels to millimoles per liter, multiply by 0.0259.
Figure 2.
Figure 2.. Median Low-Density Lipoprotein Cholesterol (LDL-C) Over 2 Years of Follow-up in the GOULD Registry
GOULD indicates Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management; PCSK9i, proprotein convertase subtilisin/kexin type 9 inhibitor. To convert LDL-C levels convert to millimoles per liter, multiply by 0.0259.
Figure 3.
Figure 3.. Follow-up at 2 Years
A, Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) levels less than 70 mg/dL and less than 55 mg/dL (to convert to millimoles per liter, multiply by 0.0259) at baseline and 2 years of follow-up in the Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) registry. B, Percentage of patients who achieved LDL-C levels less than 70 mg/dL and less than 55 mg/dL at 2 years among users of proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) drugs as monotherapy and in combination with a statin drug or ezetimibe.
See this image and copyright information in PMC

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