Abstract
AimStatin‐associated muscle symptoms (SAMS) are a major determinant of poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study was an observational retrospective study aimed to assess the prevalence of reported SAMS in a cohort of dyslipidaemic patients.MethodsDemographic/anamnestic data, biochemical values and occurrence of SAMS were collected by 23 Italian Lipid Clinics. Adjusted logistic regression was performed to estimate odds ratio (OR) and 95% confidence intervals for association between probability of reporting SAMS and several factors.ResultsAnalyses were carried out on 16 717 statin‐treated patients (mean ± SD, age 60.5 ± 12.0 years; 52.1% men). During statin therapy, 9.6% (N = 1599) of patients reported SAMS. 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), whist age ≥ 65 (OR 0.79 [0.70–0.89]), presence of type 2 diabetes mellitus (OR 0.62 [0.51–0.74]), use of concomitant nonstatin lipid‐lowering drugs (OR 0.87 [0.76–0.99]), use of high‐intensity statins (OR 0.79 [0.69–0.90]) and use of potential interacting drugs (OR 0.63 [0.48–0.84]) were associated with lower probability of reporting SAMS. Amongst patients reporting SAMS, 82.2% underwent dechallenge (treatment interruption) and/or rechallenge (change or restart of statin therapy), with reappearance of muscular symptoms in 38.4% (3.01% of the whole cohort).ConclusionsThe reported prevalence of SAMS was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re‐evaluation.
Highlights
Statins are the cornerstone of pharmacological therapy for low-density lipoprotein cholesterol (LDL-C) lowering and play a pivotal role in the prevention and treatment of coronary heart disease and other cardiovascular (CV) diseases [1]
The reported prevalence of Statin-associated muscle symptoms (SAMS) was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re-evaluation
Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine Journal of Internal Medicine and only clinical variables collected in daily practice by physicians were recorded in the electronic case report form (eCRF)
Summary
Statins are the cornerstone of pharmacological therapy for low-density lipoprotein cholesterol (LDL-C) lowering and play a pivotal role in the prevention and treatment of coronary heart disease and other cardiovascular (CV) diseases [1]. Statins are generally safe and well tolerated, not all patients are able to use them at the recommended dose [2]. All statins are associated with some adverse effects (AE) including muscle-related AE, hepatic or gastrointestinal AE, especially at higher doses, which could lead patients to discontinue or interrupt the statin a 2020 The Authors.
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