OBJECTIVES: To investigate lipid-modifying therapy (LMT) and LDL-C achievements in statin intolerant patients at very high cardiovascular (VHCV) risk managed by general practitioners in Italy.

METHODS: Retrospective analysis on Real World Data from IQVIA Italian Longitudinal Patient Database. VHCV risk statin intolerant patients with an LDL-C measurement during the period May 2016 - April 2017 (Index Date) were included. Statin intolerance was defined by simultaneous occurrence of the following conditions: 1) non-statin LMT prescription at the Index Date or in the previous six months, 2) no statin LMT prescriptions after the non-statin one, and until six months after the Index Date, 3) at least two statin prescriptions (one at the lower dosage) during the 2-year period preceding the non-statin LMT. VHCV risk was evaluated during the five-year period preceding the Index Date; patients were hierarchically classified into mutually exclusive groups: coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral artery disease (PAD), diabetes mellitus (DM). Non-statin LMT use and LDL-C level at the Index Date were assessed.

RESULTS: Patients included were 413: 178 (43%) had CAD, 96 (23%) CVD, 19 (5%) PAD, 120 (29%) DM. The most prescribed treatment was ezetimibe alone (50%), followed by fibrates alone (25%) and omega-3 fatty acids alone (22%). Few patients received combinations. The highest proportion of patients with above optimal LDL-C levels was observed among those receiving fibrates (21%) for CAD, ezetimibe for CVD (11%), omega-3 for DM (17%). In general, patients achieving above optimal or optimal LDL-C values represented 8% and 23% of the cohort, respectively.

CONCLUSIONS: Despite treatment with non-statin LMTs, statin intolerant patients at VHCV risk with sub-optimal LDL-C levels were still 69% of the total cohort , suggesting an unmet need in the treatment of such patients.