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Differential musculoskeletal outcome reporting in patients receiving bempedoic acid or atorvastatin: a

Gianluca Gazzaniga1,2, Antonio Romio1, Chiara Galuppi1

  • 1Department of Medical Biotechnology and Translational Medicine, Postgraduate School of Clinical Pharmacology and Toxicology, University of Milano, Milano, Italy.

Frontiers in Pharmacology
|February 9, 2026
PubMed

Insights

Bempedoic acid (BA) shows higher odds of muscle-related adverse drug reactions (ADRs) than atorvastatin (ATO), but these are generally less severe. Increased attention is needed for muscle symptoms with BA, especially when combined with statins.

Area of Science:

  • Cardiology
  • Pharmacology
  • Drug Safety

Background:

  • Elevated low-density lipoprotein cholesterol (LDL-C) is a key risk factor for atherosclerotic cardiovascular disease.
  • Statins are primary LDL-C-lowering drugs but can cause musculoskeletal disorders (MSDs), impacting patient adherence.
  • Bempedoic acid (BA) is an alternative lipid-lowering agent with limited muscle activation, though recent data suggest potential muscle-related adverse drug reactions (ADRs).

Purpose of the Study:

  • To compare muscle-related ADRs between bempedoic acid (BA) and atorvastatin (ATO).
  • To evaluate the safety profile of BA concerning muscle-related adverse events in a real-world setting.

Main Methods:

  • Analysis of ADR reports from the European spontaneous reporting system up to June 2024.
  • Disproportionality analysis using Reporting Odds Ratios (RORs) to compare muscle-related ADRs between BA and ATO.
  • Categorization of ADRs by patient demographics and event type.

Main Results:

  • A total of 78,930 ADR reports were analyzed (2,667 for BA-only, 76,137 for ATO-only).
  • Musculoskeletal disorders were significantly more frequent with BA than ATO (ROR 2.25).
  • Muscle discomfort was more associated with BA, while severe events like rhabdomyolysis were more frequent with ATO; BA-related muscle ADRs were generally less severe.

Conclusions:

  • Bempedoic acid (BA) recipients showed increased odds of muscle-related ADR reports compared to atorvastatin (ATO) recipients.
  • Despite higher reporting odds, BA-associated muscle ADRs were characterized by more favorable clinical outcomes and lower severity.
  • Clinicians should consider drug-induced muscle symptoms when prescribing BA, particularly in combination therapy with statins.
Abstract

Keywords:
adverse drug reactionsatorvastatinbempedoic acidcardiovasculardrug safetypharmacovigilancestatins

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