Scientific Sessions 2024  /  Lipids and Management - A Deep Dive  /  Statin Intolerance due to Muscle Symptoms Affects Management of Patients: Insights from the CLEAR Outcomes Trial
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Final ID: MDP467

Statin Intolerance due to Muscle Symptoms Affects Management of Patients: Insights from the CLEAR Outcomes Trial

Abstract Body (Do not enter title and authors here): Background
In CLEAR Outcomes the non-statin bempedoic acid (BA) 180 mg daily reduced MACE-4 (nonfatal MI, nonfatal stroke, coronary revascularization, or CV death) by 13% in 13970 patients at high CV risk with statin intolerance (SI) over a median of 40.6 months. This is the largest prospective database of patients with SI.
Aims
To assess whether there were differences in SI symptom history and whether this influenced the clinical course during CLEAR Outcomes.
Methods
SI symptoms and impact on activities of daily living (ADL) were recorded prior to randomization. Patients were grouped post hoc as reporting only statin associated muscle symptoms (SAMS), only non-muscle adverse effects (NonSAMS), or BOTH.
Results
At baseline 6887 (49.3%) patients reported SAMS, 2485 (18%) NonSAMS, and 4587 (33%) BOTH.
SI symptoms had a moderate/severe impact on ADL in 62% SAMS, 48% NonSAMS, and 69% BOTH. Use of any lipid modifying treatment at baseline was 43% SAMS, 36% NonSAMS, and 42% BOTH. Compared to placebo, BA reduced LDL-C at 6 months by 21% in SAMS, 22% in NonSAMS, and 21% in BOTH. There was no difference in the effect on MACE-4 by SI group. New use of moderate/high intensity statin during the study was relatively infrequent (3.2-8.0%) but higher in PBO than BA in all SI groups and was not generally maintained at study end (Table 1). Muscle adverse events (AE) were more frequent and resulted in higher rates of treatment DC in SAMS/BOTH vs NonSAMS (Table 2). There was no difference between BA and PBO in the rate of muscle related AE.
Conclusion
SAMS are the predominant cause of SI in patients in CLEAR Outcomes. Patients with a history of SAMS had higher rates of muscle AE and study drug DC due to muscle AE versus NonSAMS. Muscle AE rates and study drug DC were balanced between BA and PBO within each SI symptom subgroup. CLEAR Outcomes exhibits the challenges of treating patients with SI. These data also demonstrate that BA can be useful in reducing CV risk in this patient population.
  • Laufs, Ulrich  ( Universitatsklinikum Leipzig , Leipzig , Germany )
  • Lincoff, Abraham  ( CLEVELAND CLINIC , Cleveland , Ohio , United States )
  • Nicholls, Stephen  ( Victorian Heart Hospital , Clayton , Victoria , Australia )
  • Li, Na  ( Esperion Therapeutics , Ann Arbor , Michigan , United States )
  • Sasiela, William  ( Esperion Therapeutics , Ann Arbor , Michigan , United States )
  • Bloedon, Leanne  ( Esperion Therapeutics , Ann Arbor , Michigan , United States )
  • Robinson, Paula  ( Esperion Therapeutics , Ann Arbor , Michigan , United States )
  • Nissen, Steven  ( CLEVELAND CLINIC , Cleveland , Ohio , United States )
  • Thompson, Paul  ( HARTFORD HOSPITAL , Simsbury , Connecticut , United States )
    • Author Disclosures:
    Ulrich Laufs: DO have relevant financial relationships ; Speaker:Amgen, Daiichi, Novartis, Sanofi:Active (exists now) | Abraham Lincoff: DO have relevant financial relationships ; Consultant:Novo Nordisk:Active (exists now) ; Research Funding (PI or named investigator):Novartis:Active (exists now) ; Research Funding (PI or named investigator):Esperion:Active (exists now) ; Research Funding (PI or named investigator):CSL Behring:Active (exists now) ; Research Funding (PI or named investigator):AstraZeneca:Past (completed) ; Research Funding (PI or named investigator):AbbVie:Past (completed) ; Consultant:Fibrogen:Past (completed) ; Consultant:Endologix:Past (completed) ; Consultant:Cadrenal:Active (exists now) ; Consultant:Brainstorm Cell:Past (completed) ; Consultant:Becton Dickson:Past (completed) ; Consultant:Amgen:Active (exists now) ; Consultant:Alnylam:Past (completed) ; Consultant:Akebia:Past (completed) ; Consultant:Eli Lilly:Active (exists now) | Stephen Nicholls: DO have relevant financial relationships ; Researcher:AstraZeneca, Amgen, Anthera, CSL Behring, Cerenis, Cyclarity, Eli Lilly, Esperion, Resverlogix, Novartis, InfraReDx and Sanofi-Regeneron:Active (exists now) ; Consultant:Amgen, Akcea, AstraZeneca, Boehringer Ingelheim, CSL Behring, Cyclarity, Daiichi Sankyo, Eli Lilly, Esperion, Kowa, Merck, Takeda, Pfizer, Sanofi-Regeneron, Novo Nordisk, CSL Seqirus and Vaxxinity:Active (exists now) | Na Li: DO have relevant financial relationships ; Employee:Esperion:Active (exists now) | William Sasiela: DO have relevant financial relationships ; Consultant:Esperion Pharmaceuticals:Active (exists now) ; Individual Stocks/Stock Options:Response Pharmaceuticals:Active (exists now) ; Executive Role:Response Pharmaceuticals:Active (exists now) ; Individual Stocks/Stock Options:Retension Pharmaceuticals:Active (exists now) ; Executive Role:Retension Pharmaceuticals:Active (exists now) ; Individual Stocks/Stock Options:Esperion Pharmaceuticals:Active (exists now) | Leanne Bloedon: DO have relevant financial relationships ; Employee:Esperion Therapeutics:Active (exists now) ; Individual Stocks/Stock Options:Esperion Therapeutics:Active (exists now) | Paula Robinson: No Answer | Steven Nissen: DO have relevant financial relationships ; Research Funding (PI or named investigator):Eli Lilly:Active (exists now) ; Research Funding (PI or named investigator):Arrowhead Pharmaceuticals:Active (exists now) ; Research Funding (PI or named investigator):Bristol Myers Squibb:Active (exists now) ; Research Funding (PI or named investigator):AstraZeneca:Active (exists now) ; Research Funding (PI or named investigator):Silence Therapeutics:Active (exists now) ; Research Funding (PI or named investigator):New Amsterdam Phrma.:Active (exists now) ; Research Funding (PI or named investigator):Novartis:Active (exists now) | Paul Thompson: No Answer
Meeting Info:

Scientific Sessions 2024

2024

Chicago, Illinois

Session Info:

Lipids and Management - A Deep Dive

Saturday, 11/16/2024 , 11:10AM - 12:35PM

Moderated Digital Poster Session

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