Physicians' Academy for Cardiovascular Education

Worldwide prevalence of statin intolerance

Prevalence of statin intolerance: a meta-analysis

Literature - Bytyçi I, Penson PE, Mikhailidis DP et al., - Eur Heart J 2022,

Introduction and methods


Statin-associated muscle symptoms (SAMS) are the most common cause of discontinuation of statin therapy [1,2]. The estimated prevalence of statin intolerance (SI) ranges from 5-7% in RCTs to 30% in cohort studies [3,4]. However, this prevalence is debated as symptoms may be attributable to a nocebo/drucebo effect [5].

In this meta-analysis, the overall prevalence of SI, the prevalence according to various diagnostic criteria, and in different disease setting are estimated, and possible risk factors for SI are identified.


PubMed-Medline, EMBASE, Scope, Google Scholar, the Cochrane Central Registry of Controlled Trials and were searched. Articles were eligible if they reported the prevalence of SI either in primary or secondary prevention and met the following criteria: trials or cohorts reporting SI; ≥100 participants; and available criteria for SI diagnosis. 176 Studies with 4,143,517 patients and mean follow-up of 19 ± 7.3 months were included; 112 were RCTs and 64 were cohort studies.


Primary endpoint was the overall prevalence and the prevalence based on each of the international diagnostic criteria: NLA [3], EAS [6] and ILEP [7]. Secondary endpoint was the prevalence of SI in groups of patients with different diseases and the analysis of the association between possible risk factors/conditions and risk of SI.

Main results

Prevalence of statin intolerance

Risk factors for statin intolerance


This meta-analysis of 176 studies with 4,143,517 patients demonstrated that the worldwide prevalence of statin intolerance is 9.1%, and is independent of the criteria that are used. Risk factors of SI include older age, female gender, Asian and African-American races, obesity, T2DM, alcohol use, exercise, hypothyroidism, chronic liver and renal diseases, high statin doses, antiarrhymic agents and calcium channel blockers.

The authors conclude: “These results support the concept that the prevalence of complete SI is often overestimated and highlights the need for a very careful assessment of patients with SI to decrease the risk of unnecessary statin discontinuation and suboptimal lipid-lowering therapy. Clinicians should use these results to encourage adherence to statin therapy in their patients”.


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Find this article online at Eur Heart J

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