OBJECTIVES: The aim of this study was to assess the prevalence and characteristics of subjects appropriately treated with high-efficacy statins, and who have inadequate control of LDL-C levels, despite being adherent to treatment METHODS: An observational retrospective cohort analysis based on five Local Health Units administrative databases was conducted, for a total number of 1.2 Million beneficiaries involved. Patients with at least one LDL-C measurement between January 1, 2011 and December 31, 2012 were included. Patients were characterized back 12 months to assess appropriateness and adherence to statin treatment RESULTS: Among patients with LDL-C determination (1’218 patients), 578 (47%) and 640 (53%) displayed LDL-C under control and out of control, respectively. Among patients with uncontrolled LDL-C, 74 (12%) and 566 (88%) were not treated and treated with statins, respectively. Among patients with statins treatment, 188 (33%) and 378 (67%) were treated with low and high efficacy statins, respectively. Finally, among patients treated with high efficacy statins, 225 (60%) and 153 (40%) were non-adherent and adherent to high efficacy statin treatment, respectively. LDL-C uncontrolled high efficacy adherent patients showed different distances from their lipid target: 28% were less than 10% distant, 28.4% were 10-19% distant, 10.5% were 20-29% distant, 11.1% were 30-39% distant and 24.8% were more than 40% distant CONCLUSIONS: These results are topical, as new monoclonal antibodies - PCSK9 inhibitors - are being marketed to address the residual unmet need in cholesterol statin-management of dyslipidaemia for uncontrolled patients. By projecting study percentages to the Italian population, the number of LDL-C patients who are uncontrolled, despite being adherent to a high efficacy statin, would be around 17’825