Unmet Patient Need in Statin Intolerance: the Clinical Characteristics and Management
Abstract
Purpose A substantial percentage of patients report intolerance or side effects of statin treatment leading to treatment changes or discontinuation. The purpose of this study was to examine statin therapy changes and subsequent effects on low-density lipoprotein cholesterol (LDL-C) among patients with statin intolerance (SI). Methods We identified 45,037 adults from Kaiser Permanente Southern California with SI documented between 2006 and 2012. Changes in statin therapy in the year before and after the SI index date were examined. We categorized patients into those who initiated statin therapy, discontinued, up-titrated, down-titrated, or did not switch therapy. We calculated the percentage change in LDL-C from the year before to the year after SI, and the percentage of patients attaining LDL-C Results In the year prior to the SI date, 77.8% of patients filled a statin prescription. Following SI, 44.6% had no treatment change, 25.5% discontinued, and 30.0% altered their statin therapy. Of those who altered statin therapy, 52.6% down-titrated and 17.2% up-titrated their dose. Rhabdomyolysis was documented in Conclusions Although adjustments to the statin dosage may be appropriate upon documentation of SI, many of these patients will have high LDL-C. Strategies for LDL-C reduction in patients with SI may be necessary.
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All 8 identified retrospective studies were of low quality, mainly due to concerns regarding residual confounding because of lack of adjustment.
“Notably all 8 identified retrospective studies were of low quality, mainly due to concerns regarding residual confounding because of lack of adjustment (S2 File) [35,36,38,41,42,44,45,50].”
The discontinuation rate was similar across different statin-based therapy intensities.
“When comparing effectiveness and discontinuation rates of different statin-based therapy intensities found that the discontinuation rate was similar across intensities [41,42].”
We included eight retrospective cohort studies and two prospective cohort studies.
“We included eight retrospective cohort studies [35,38,39,41,42,44,45,50] and two cohort prospective studies [36,37] (S4 File, Table 2).”
Three studies reported the incidence of muscle symptoms, five studies provided data on treatment discontinuation due to muscle symptoms, and eight studies reported on effectiveness.
“Three studies reported the incidence of muscle symptoms [36–38], five studies provided data on treatment discontinuation due to muscle symptoms [36,37,39,42,45], and eight studies reported on effectiveness [35–37,39,41,44,45,50].”
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Self-citationOptimizing cholesterol treatment in patients with muscle complaints
Rosenson, R. S., Baker, S., Banach, M., Borow, K. M., Braun, L. T., Bruckert, E., Brunham, L. R., Catapano, A. L., Elam, M. B., Mancini, G. B. J., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.07.752 · Cited by 193 · see citing works
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Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance
Laufs, U., Banach, M., Mancini, G. B. J., Gaudet, D., Bloedon, L. T., Sterling, L. R., Kelly, S., & Stroes, E. S. G. (2019) · Journal of the American Heart Association · doi:10.1161/jaha.118.011662 · Cited by 432 · see citing works
Aebi, P. S., Villoz, F., Bührer, J., Lyko, C., Abolhassani, N., Del Giovane, C., Gencer, B., Rodondi, N., & Blum, M. R. (2025) · PLOS One · doi:10.1371/journal.pone.0338575
“When comparing effectiveness and discontinuation rates of different statin-based therapy intensities found that the discontinuation rate was similar across intensities [41,42].”
- Authors
- Harrison, T. N., Hsu, J.-W. Y., Rosenson, R. S., Levitan, E. B., Muntner, P., Cheetham, T. C., Wei, R., Scott, R. D., & Reynolds, K.
- Affiliations
- Kaiser Permanente (US)
- Icahn School of Medicine at Mount Sinai (US)
- University of Alabama at Birmingham (US)
- Western University of Health Sciences (US)
- Corresponding author
- Reynolds, Kristi
- ORCID
- Venue
- Cardiovascular Drugs and Therapy
- Published
- 2018-02
- Volume
- 32
- Issue
- 1
- Pages
- 29-36
- ISSN
- 0920-3206 (ISSN-L)
- 1573-7241
- OpenAlex
- W2792808126
- Cited by
- 10
- References
- 3
- Citations by year
- 2025: 1 · 2022: 2 · 2020: 2 · 2019: 2 · 2018: 3
- FWCI
- 1.83
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Cardiovascular Drugs and Therapy (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Amgen
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Keywords
- statin intolerance, statin adverse effects, LDL cholesterol, statin dose titration, statin discontinuation, rhabdomyolysis, hypercholesterolemia, lipid-lowering therapy, statin switching
- MeSH terms
- Aged, California, Female, Health Services Needs and Demand, Humans, Cholesterol, LDL, Male, Middle Aged, Time Factors, Biomarkers, Down-Regulation, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Needs Assessment, Dyslipidemias, Drug Substitution
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