Abstract Background The role of lipid management as crucial component in CV risk reduction is well established. However, poor adherence to guideline recommended therapy and poor goal achievement in (very) high risk Atherosclerotic Cardiovascular Disease (ASCVD) patients is observed in clinical practice. Methods In this non-interventional prospective study, data from ASCVD patients at 130 sites in Germany are collected. The primary objective is to provide descriptive data on patient characteristics (demographics, medical history, comorbidity burden and CV events). Patients are enrolled into different treatment arms at the time of lipid lowering therapy (LLT) escalation and followed-up for 21 months. In cohort A, patients initiate one or more oral LLTs (oLLT) on top of max. tolerated statin. Patients in cohort B initiate inclisiran (INCL) according to reimbursement criteria, patients in cohort C initiate INCL on top of lipid apheresis. In this interim analysis (IA), the secondary endpoints effectiveness of LDL-C lowering, LDL-C goal achievement and adherence to LLT are analyzed. Results At the time of this IA, baseline (BL) and 3 months (visit 2) data were available for 1137 patients. Cohort C data were not representative (n=4). Patients initiating additional oLLTs (A, n=561)) or inclisiran (B, n=576) represent distinct populations regarding age, gender, medical history and intensity of LLT. Patients in cohort A represent a very high ASCVD risk population that is intensively treated with oLLTs, with 83% on statins + ezetimibe and/or bempedoic acid at BL. Median (Q1; Q3) baseline LDL-C level is 84.9 (73.0; 104.3) mg/dL. Patients in cohort B escalated therapy with INCL as they could not achieve LLT goals with oLLTs (LDL-C at BL: 105 (81.9; 143.0) mg/dL). 44% receive any statin, 46% ezetimibe and 33% dual oLLT based on statins. LLT escalation with one or more oLLTs shows median LDL-C reduction of -36.4% (-47.4; -20.8) at visit 2. 58.3% of oLLT patients do not reach their LDL-C goal of 55 mg/dL. In PCSK9i naïve patients (B1; n=511) INCL reduces LDL-C by -42.4% (-55.6; -24.2). Patients on intensive combination LLT (n=158) show most pronounced improvement (-51.5% (-60.5; -40.6)). Compatibly, 58.2% of B1 patients on intensive background LLT reach their LDL-C goal, while goal achievement is lower in the overall cohort B (36.5%). Patients initiating INCL after previous PCSK9i with mAbs (B2, n= 65) show a similar median LDL-C at visit 2 compared to BL (-6.8% (-37.0; 30.0)) and 6.3% are below target LDL-C (55 mg/dL) at this time. At 15 months, adherence to INCL (n=279) is 99% and persistence is 95%, while adherence to oLLT (n=423) is 87% and persistence is 86%. Conclusion 58.3% of very high risk ASCVD patients did not achieve their LDL-C goal with oLLT escalation in clinical practice and need further LLT escalation. After the initial dose, INCL lowered LDL-C by 42% in patients not reaching target with max. tolerated oLLT.Table 1
Weingaertner et al. (Sat,) studied this question.