Clinical Utilization and Performance of Bempedoic Acid in an Italian Real-World Setting: Insight from Campania Region
Open accessAbstract
Background/Objectives: Bempedoic acid (BA) is a novel lipid-lowering agent that reduces low-density lipoprotein cholesterol (LDL-c) and cardiovascular events. Limited real-world data on its effectiveness and safety are available. This study aimed to evaluate the utilization and clinical performance of BA in routine clinical practice. Moreover, an explorative pharmacoeconomic analysis was performed. Methods: We prospectively enrolled consecutive patients with dyslipidemia who started 180 mg BA, alone or with 10 mg ezetimibe, across five outpatient clinics in Campania Region, Italy from September to December 2023. Clinical and laboratory assessments, including lipid profile, hepatic function, and creatine phosphokinase levels, were performed at baseline and at least after one month follow-up. Side effects were recorded. Results: 111 patients (age 65 ± 9 years, 61% male) were included. At BA initiation, 70.3% were on maximally tolerated statin dosage and ezetimibe, 16.2% on ezetimibe alone, and 13.5% on PCSK9 inhibitors due to statin intolerance. BA significantly reduced LDL-c serum levels (89.9 ± 33.0 vs. 56 ± 27.6 mg/dL; p < 0.0001), with 46% achieving therapeutic targets. LDL-c decreased by 28% in patients on intensive statins/ezetimibe and by 45% in statin-intolerant patients, with reduced healthcare costs. Side effects were infrequent (10%) and reversible. Adherence was 99%, and persistence 90%. Conclusions: In our clinical pratice, BA was primarily used in high-risk patients with dyslipidemia who failed to reach LDL-c therapeutic target with statins/ezetimibe, and to a lesser extent, in statin-intolerant individuals. BA treatment enabled 54% to reach LDL-c therapeutic target. BA was well tolerated, and showed high adherence and persistence, contributing to cost savings.
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In a prospective study on patients with dyslipidemia and mixed prevention status, adding bempedoic acid to ongoing high-intensity atorvastatin and ezetimibe achieved a 26.3% LDL-C reduction at 2 months.
“In a prospective study on patients with dyslipidemia and mixed prevention status, the initiation of bempedoic acid to ongoing high-intensity atorvastatin and ezetimibe achieved a 26.3% LDL-C reduction at 2 months (baseline LDL-C = 78 mg/dL) [30].”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [30]
The Results and Subgroup Analysis (sections 3 and 3.2; page not available) identify 25 patients taking 40 mg atorvastatin plus ezetimibe and report a 26.3% LDL-C reduction after bempedoic acid was added, from 77.5 mg/dL at baseline. The Follow-Up section (3.1; page not available) gives a median follow-up of 60 days, supporting the approximate two-month timing. Our copy describes high and very high cardiovascular risk but does not establish that the atorvastatin subgroup had mixed primary- and secondary-prevention status. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn a small subgroup (n=18) from a prospective study on patients with dyslipidemia and mixed prevention status, patients on ongoing ezetimibe who initiated bempedoic acid achieved an LDL-C reduction of 42.0% at 2 months.
“In a small subgroup of patients (n = 18) from a prospective study on patients with dyslipidemia and mixed prevention status, patients on ongoing ezetimibe who initiated bempedoic acid achieved an LDL-C reduction of 42.0% at 2 months (baseline LDL-C = 84 mg/dL) [30].”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [30]
The Subgroup Analysis reports that adding bempedoic acid for 18 patients on ezetimibe monotherapy reduced LDL-C by 42.0%, from 83.9 to 48.6 mg/dL. The Follow-Up section gives a median of 60 days for the overall cohort, not specifically this subgroup. Our copy does not establish the claimed mixed prevention status. (LLM, conf=0.84)
Experimental — accuracy not yet measuredHigher 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 [30]
The Discussion reports a higher discontinuation figure from a prior real-world study of statin-intolerant patients, while the Results (section 3.1) report 9.0% discontinuation in this paper’s cohort. Our copy does not report a rate of 36% or suggest that broader inclusion of patients with statin or lipid-lowering-therapy intolerance explains higher discontinuation rates. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn all-comer populations with mixed statin-intolerance and varied background LLTs, LDL-C reductions with bempedoic acid ranged from 18% to 42%.
“In all-comer populations with mixed statin-intolerance and varied background LLTs, LDL-C reductions also ranged from 18% to 42% [23,26,28,30,31,33,43].”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [30]
The Results and Subgroup Analysis (section 3; page unavailable) describe a real-world cohort with varied background lipid-lowering therapies and report a 42% LDL-C reduction in the ezetimibe-only subgroup. They do not establish an 18%–42% range for this cohort: another subgroup had a 50% reduction. The approximately 18% figure in the Discussion (section 4; page unavailable) comes from a pooled analysis of randomized trials, not this all-comer population. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOne study had data that contributed to two treatment groups.
“of note, one study had data that contributed to two groups [30]:”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [30]
In the same study, adding bempedoic acid to high-intensity rosuvastatin and ezetimibe achieved a 29.8% LDL-C reduction at 2 months.
“In the same study, LDL-C reductions were in a similar range (baseline LDL-C = 78 mg/dL; 29.8% reduction) at 2 months after initiation of bempedoic acid to high intensity rosuvastatin and ezetimibe [30].”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [30]
Among the few studies reporting treatment discontinuation (n = 4), rates ranged from 9% to 36% across heterogeneous populations with mixed prevention status, varying degrees of statin intolerance, and different background LLTs.
“Among the few studies reporting treatment discontinuation (n = 4) [23,28,30,40], rates ranged from 9% to 36% across heterogeneous populations with mixed prevention status, varying degrees of statin intolerance, and different background LLTs.”
From Systematic literature review on the real-world effectiveness and safety of bempedoic acid (2026) · cites this paper as [30]
LDL-C reductions with bempedoic acid added to statins ranged from 15% to 39%.
“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 [30]
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Cited by
Sorted by citations
Systematic literature review on the real-world effectiveness and safety of bempedoic acid
Cicero, A. F. G., Cannon, C. P., Gautam, R., Anwar, S., Ghatak, A., Sarnes, E., Powell, H. A., Chhabra, R., & Jawla, S. (2026) · Atherosclerosis Plus · doi:10.1016/j.athplu.2026.100562 · Cited by 1 · see citing works
“…to initiation of bempedoic acid, patients had LDL-C levels ranging from 90 mg/dL to 146 mg/dL. Diabetes was present in 11% to 66% of patients [23,25,29,30,32,38, 39,41,42]; hypertension in 33% to 83% [23,25,29,30,32,39,42,44]; and one study focusing on HIV reported HIV in 100% of patients [28].”
Influential
- Authors
- Russo, V., Ratti, G., Parrella, A., De Falco, A., Crisci, M., Franco, R., Covetti, G., Caturano, A., Napolitano, G., Scotto di Uccio, F., Izzo, G., & Argenziano, L.
- Affiliations
- University of Campania "Luigi Vanvitelli" (IT)
- Cardiology Unit, San Giovanni Bosco Hospital, Health Authority Naples 1, 80144 Naples, Italy
- Ospedale Antonio Cardarelli (IT)
- Cardiology Unit, Department of Medical Translational Sciences, University of Campania “Luigi Vanvitelli”—Monaldi Hospital, 80131 Naples, Italy
- Ospedale Monaldi (IT)
- Cardiology Unit, San Giuliano Hospital, Health Authority Naples 2 North, 80014 Naples, Italy
- San Raffaele University of Rome (IT)
- Cardiology Unit, Ospedale del Mare ASL NA1 Centro, 80147 Naples, Italy
- Cardiology Unit, Pineta Grande Hospital, 81030 Castel Volturno, Italy
- Corresponding author
- Russo, Vincenzo
- Caturano, Alfredo
- Venue
- Journal of Clinical Medicine
- Publisher
- MDPI AG
- Published
- 2025-03-09
- Volume
- 14
- Issue
- 6
- Pages
- 1839
- ISSN
- 2077-0383 (ISSN-L)
- PMC
- PMC11943254
- OpenAlex
- W4408296468
- Cited by
- 8
- References
- 6
- Citations by year
- 2026: 5 · 2025: 3
- FWCI
- 7.53
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Clinical Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- bempedoic acid, LDL cholesterol lowering, dyslipidemia, statin intolerance, ezetimibe, PCSK9 inhibitors, lipid-lowering therapy, medication adherence, treatment persistence, drug safety, pharmacoeconomics, health care costs, Campania Region
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