Cited by 5Lipoproteins and Cardiovascular HealthCholesterol and Lipid MetabolismBlood Pressure and Hypertension Studies

A UK multicentre audit of the management of patients with primary hypercholesterolaemia or mixed dyslipidaemia with bempedoic acid against published lipid-lowering treatment targets

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Ramachandran, Sudarshan, Maarouf, Amro, Mitchell, Karen, Avades, Tony, Smith, Peter, Boulton, Lee, Kelly, Jennifer, Vekaria, Nitasha +1 more·2024·Drugs in Context

Abstract

Background: Bempedoic acid, an adenosine triphosphate citrate lyase inhibitor, was introduced to UK practice via a pre-reimbursement access scheme for adults with primary hypercholesterolaemia or mixed dyslipidaemia who are at high risk of cardiovascular disease, in whom statins are either not tolerated or contraindicated, who have not achieved target cholesterol, despite being on ezetimibe therapy, and do not qualify for PCSK9 inhibitor treatment. This retrospective multicentre audit aimed to evaluate the achievement of lipid-lowering targets with bempedoic acid in UK patients based on recommendations in the Joint British Societies (JBS) guidelines for the prevention of cardiovascular disease. Methods: Pseudo-anonymized medical record data for 221 adults treated with bempedoic acid as part of the UK scheme were entered into a bespoke data collection tool at four UK hospitals. Patient demographics, clinical characteristics, treatment pathways and lipid assessment results (against JBS lipid-lowering targets) were collected against pre-specified criteria. Results: Overall, 54% (99/184) of patients achieved the JBS2 audit standard (total cholesterol (TC) <5 mmol/L and low-density lipoprotein cholesterol (LDL-C) <3 mmol/L or ≥25% reduction in TC and ≥30% reduction in LDL-C) at 12 weeks post-initiation. At week 12, the mean absolute change in LDL-C was -1.0 mmol/L; the mean percentage reduction from baseline was 22.0%. Additionally, 52% (96/185) of patients had an LDL-C of <3 mmol/L and 10% (18/185) an LDL-C of <1.8 mmol/L at 12 weeks (as per JBS3). Conclusion: This audit highlights the role of bempedoic acid as part of combination therapy for a population with previously limited treatment options.

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Crossref · 10.7573/dic.2024-2-4

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  • In a study of patients with primary hypercholesterolemia or mixed dyslipidemia, most of whom were statin intolerant (93%), 58.0% on bempedoic acid, initiated in line with the Summary of Product Characteristics, achieved an LDL-C target of <70 mg/dL (baseline LDL-C = 155 mg/dL).

    “A second study in patients with primary hypercholesterolemia or mixed dyslipidemia, most of whom were statin intolerant (93%) found that 58.0% on bempedoic acid, initiated in line with the Summary of Product Characteristics achieved a target of <70 mg/dL (baseline LDL-C = 155 mg/dL) [40].”

    From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [40]

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  • In that study, over half (54%) of patients continued statins, the majority on low- (74%) or medium-intensity statins (13%).

    “over half (54%) of patients continued statins, the majority on low- (74%) or medium-intensity statins (13%), while others received background LLTs including ezetimibe [40].”

    From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [40]

    The Results (Patient demographics and clinical characteristics; page unavailable) report that 74% (40/54) of patients receiving concomitant statins were on low-intensity statins, and that ezetimibe was a common ongoing therapy. The Discussion (Summary of main results; page unavailable) says 51% of patients with documented ongoing lipid-lowering therapy remained on statins—not 54% of all patients. The passages found do not substantiate the stated 13% on medium-intensity statins. (LLM, conf=0.88)

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  • LDL-C reductions with bempedoic acid in statin-intolerant patients ranged from 22% to 38%.

    “Consistent effects were also seen when bempedoic acid was added to statins (15% to 39%) [25,30,32,38,39,44], and when used in statin intolerant patients (22% to 38%) [24,29,34,35,37,40,41], despite the latter group having higher baseline LDL-C.”

    From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [40]

    The Results (Patient demographics and clinical characteristics; page not available) report a mean 22.0% LDL-C reduction at 12 weeks in the overall audit cohort, of whom 93% were documented as statin intolerant. The Discussion (Summary of main results; page not available) describes the cohort as largely statin intolerant, but the paper does not report a 38% reduction or establish the stated 22%–38% range. (LLM, conf=0.86)

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  • Higher discontinuation rates observed (up to 36%) likely reflect the broader inclusion of patients with statin intolerance or LLT non-tolerance.

    “An increased incidence of gout was observed with bempedoic acid [28,29]; higher discontinuation rates observed (up to 36%) [23,28,30,40] likely reflect the broader inclusion of patients with statin intolerance or LLT non-tolerance, although reasons for discontinuation were not consistently reported.”

    From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [40]

    The Results report 33% discontinuation, within the cited sentence’s ‘up to 36%,’ and describe a cohort in which 93% were documented as statin intolerant. The Discussion suggests this high-risk cohort may be more likely to report treatment intolerance, but says the higher discontinuation rate can be partially explained by longer follow-up and that further research is needed to determine its cause. It does not establish broader inclusion of patients with treatment intolerance as the likely explanation. (LLM, conf=0.86)

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  • In patients with primary hypercholesterolemia or mixed dyslipidemia, most of whom were statin intolerant (93%), bempedoic acid produced a 22% LDL-C reduction at 3 months.

    “In patients with primary hypercholesterolemia or mixed dyslipidemia, most of whom were statin intolerant (93%), bempedoic acid, initiated in line with the Summary of Product Characteristics, produced a 22% LDL-C reduction at 3 months (baseline LDL-C = 155 mg/dL);”

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1 of the 19 references couldn’t be matched to a known paper.

Research works printed but not linked: 3

  1. [3]National Institute for Health and Care Excellence (NICE) Cardiovascular disease: risk assessment and reduction, including lipid modification Clinical guideline [CG181] http://www.nice.org.uk/Guidance/CG181 Accessed December 2023 36952507
  2. [11]National Institute for Health and Care Excellence (NICE) Bempe acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia (TA694) https://www.nice.org.uk/guidance/ta694/resources/bempedoic-acid-with-ezetimibe-for-treating-primary-hypercholesterolaemia-or-mixed-dyslipidaemia-pdf-82609440519877 Accessed December 2023 40743376
  3. [22]National Institute for Health and Care Excellence (NICE) Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia (TA733) NICE 2021 https://www.nice.org.uk/guidance/TA733 Accessed May 2, 2024 40802800

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Authors
Ramachandran, S., Maarouf, A., Mitchell, K., Avades, T., Smith, P., Boulton, L., Kelly, J., Vekaria, N., & Hughes, E.
Affiliations
  • University Hospitals Birmingham NHS Foundation Trust (GB)
  • Calderdale and Huddersfield NHS Foundation Trust (GB)
  • University Hospitals Plymouth NHS Trust (GB)
  • Daiichi Sankyo (United Kingdom) (GB)
  • Sandwell & West Birmingham Hospitals NHS Trust (GB)
Corresponding author
Ramachandran, Sudarshan
Venue
Drugs in Context
Publisher
BioExcel
Published
2024-08-08
Volume
13
Pages
1-11
ISSN
1740-4398 (ISSN-L)
OpenAlex
W4401364989
Cited by
5
References
19
Citations by year
2026: 2 · 2025: 2 · 2024: 1
FWCI
2.11
Type
journal article
Language
en
Open access
Licence
cc-by-nc-nd
Locations
  • Drugs in Context (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Daiichi Sankyo Europe
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
Keywords
bempedoic acid, primary hypercholesterolemia, mixed dyslipidemia, lipid-lowering targets, LDL cholesterol lowering, statin intolerance, ezetimibe, combination lipid-lowering therapy, ATP-citrate lyase inhibitor

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