Statin intolerance in a real word setting of Italian cardiology centers: data from the BRING-UP Prevention study

Abstract Background Statins are commonly prescribed to prevent cardiovascular disease by lowering low-density lipoprotein cholesterol (LDL-C). However, statin intolerance can limit their use or adherence to optimal high-intensity statin therapy. Observational studies have estimated intolerance in 25-30% of patients, while the prevalence in randomised clinical trials has been largely lower. Data on statin intolerance in Italian practice are scarce. Purpose This analysis from the Bring UP Prevention study aims to assess the prevalence of statin intolerance, the clinical characteristics of affected patients, and their pharmacological treatment in a large representative sample of Italian cardiology centers. Methods BRING-UP Prevention is a nationwide, observational, prospective study enrolling patients with a prior atherothrombotic event. The study consists of two 3-month enrolment phases followed by a 6-month follow-up. An educational intervention focused on current guideline recommendations preceded patient enrolment. Statin intolerance was defined as: - Complete intolerance. Relevant CK elevation, severe hepatic or renal disease, myopathy, symptoms improving after statin withdrawal. - Partial intolerance. Clinical or laboratory abnormalities (e.g., muscle pain, CK elevation) during high-dose statin therapy, managed with low doses. Results Over 3 months, the study enrolled 4790 patients from 189 cardiology centers. Follow-up data on LDL-C were available for 4504 patients (96.9%). The Figure shows the rate of patients who did not tolerate statins over the 6 months follow-up and the reasons for total or partial intolerance. Characteristics of patients with/without statin intolerance were not significantly different. 233 pts were not prescribed on statins (58.2% of them for complete intolerance). 234 patients received a low dosage of statins (26.9% of them for partial intolerance). Ezetemibe was prescribed in 71.3% of statin intolerant patients versus 77.6 of the patients on statins. Other lipid lowering drugs were significantly more prescribed in statin intoletant pts: PCSK9-I 43% vs 3.9%, inclisiran 8.0% vs 1.2%, bempedoic acid in 22.7% vs 3.5%. Conclusions This analysis shows that in the context of a trial designed to improve adherence to current guidelines in the secondary prevention setting, complete or partial intolerance to statins occurs in a low proportion of patients, very similar to the incidence described in randomised controlled trials.