Federica Bonaiti, Italy

Epidemiology and Preventive Pharmacology Service, University of Milan Department of Pharmacological and Biomolecular Sciences

Presenter Of 1 Presentation

Statin-associated muscle symptoms in the PROSISA study: prevalence and risk factors

Session Type
Track 4 - Prevention and Treatment of CVD
06.10.2020, Tuesday
Session Time
10:00 - 11:13
Lecture Time
10:40 - 10:50


Background and Aims

Statin associated muscle symptoms (SAMS) are one of the main reasons for poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study is an observational retrospective study aimed at assessing the prevalence of SAMS in dyslipidaemic patients.


Demographic/anamnestic data, biochemical levels, and occurrence of SAMS were collected. Adjusted logistic regression was fitted to estimate OR and 95% confidence intervals for association between probability of reporting SAMS and several factors.


This analysis was carried out on 16,717 statin-treated patients (mean±SD age 60.5±12.0 years; 52.1% men). During statin therapy, 9.6% of patients reported SAMS, mainly myalgia (71.9%). Women and physically active subjects were more likely to report SAMS (OR 1.23 [1.10-1.37] and OR 1.35 [1.14-1.60], respectively), while older patients (OR 0.79 [0.70-0.89]), presence of type II diabetes mellitus (OR 0.62 [0.51-0.74]), use of concomitant non-statin lipid-modifying drugs (OR 0.87 [0.76-0.99]), of high-potency statins (OR 0.79 [0.69-0.90]) and of potential interacting drugs (OR 0.63 [0.48-0.84]) were associated with a lower probability of reporting SAMS. Among patients reporting SAMS, 761 underwent dechallenge, with disappearance of muscular symptoms in 87.2% of cases, while overall 908 patients underwent rechallenge (468 with change of statin/dose reduction without interruption of therapy), with reappearance of muscular symptoms in only 248 patients.


The reported prevalence of SAMS was 9.6%, but the percentage of patients in whom intolerance has been confirmed by dechallenge/rechallenge was between 23-28%, emphasizing the need for a better management of SAMS to provide a definitive diagnosis and treatment re-evaluation.