Statin-associated muscle symptoms (SAMS) are one of the main reasons for statin non-adherence and/or discontinuation.
The PROSISA is an observational, retrospective and multicenter study aimed at assessing the prevalence of statin intolerance, due to muscolar symptoms, in dyslipidemic patients on statins followed by Italian lipid clinics. 

Anamnestic data, biochemical values, and potential occurence of muscular symptoms were collected. Adjusted logistic regression was fitted to estimate odds ratio (OR) and 95% confidence intervals for the association between SAMS onset and several factors.

In the first six months of activity, the PROSISA database accounted for 6429 patients (mean age 66.7±12 years; 53.9% males) on statins. During statin therapy, 787 patients (12.2%) reported muscular symptoms (63,9% within the first year of treatment): myalgia (74.2%) and cramps (25.8%), mainly. Among them, 375 patients underwent dechallenge, with disappearance of muscular symptoms in 87.2% of cases, while overall 503 patients underwent rechallenge (237 with change of statin/dose reduction without interruption of therapy) mainly with low-intensity statins, with reappearance of muscular symptoms (myalgia 76.2%) in only 151 patients. Risk of SAMS onset was significantly higher for patients with diabetes (OR 1.58 [1.26-1.98]), using high potency statins (OR 1.32 [1.09-1.59]) and with an interacting drugs therapy (OR 1.65 [1.14-2.39]).

This analysis offers a real life outlook of SAMS. The percentage of patients in whom intolerance has been confirmed by dechallenge/rechallenge is between 26-30%, emphasizing the need to deepen the assessment beyond the simple occurrence of muscle symptoms for definitive diagnosis of SAMS and if needed treatment re-evaluation.

03 - PREVALENCE OF STATIN-ASSOCIATED MUSCLE SYMPTOMS IN ITALY: THE PROSISA STUDY