PEARL: A Non-interventional Study of Real-World Alirocumab Use in German Clinical Practice

Abstract

BackgroundSeveral lipid guidelines recommend that proprotein convertase subtilisin/kexin type 9 inhibitors should be considered for patients with atherosclerotic cardiovascular disease who are inadequately treated with maximally tolerated lipid-lowering treatment.ObjectivesThe PEARL study assessed the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab in patients with hypercholesterolemia in a real-world setting.MethodsPEARL was an open, prospective, multicenter, non-interventional study conducted in Germany. Patients (n\u2009=\u2009619) for whom treating physicians decided to use alirocumab 75 or 150\xa0mg every 2\xa0weeks according to German guidelines (low-density lipoprotein cholesterol >\u20091.8/2.6\xa0mmol/L [>\u200970/100\xa0mg/dL], depending on cardiovascular risk, despite maximally tolerated statin therapy with/without other non-alirocumab lipid-lowering therapy) were enrolled and followed for 24\xa0weeks. Physicians could adjust the alirocumab dose based on their clinical judgment. The primary efficacy endpoint was low-density lipoprotein cholesterol reduction from baseline (prior to alirocumab therapy) to week 24.ResultsOverall, 72.8% of patients reported complete or partial statin intolerance. Mean low-density lipoprotein cholesterol was 4.7\xa0mmol/L (180.5\xa0mg/dL) and 2.3\xa0mmol/L (89.8\xa0mg/dL) at baseline and week 24, respectively. Least-squares mean percentage change from baseline to week 24 in low-density lipoprotein cholesterol was −\u200948.6%. Initial alirocumab dose was 75\xa0mg in 72.9% of patients and 150\xa0mg in 24.5% of patients; 19.6% of patients received an alirocumab dose increase (75\xa0to 150\xa0mg) and 1.6% of patients received a dose decrease. Adverse events were reported in 10.3% of patients, with myalgia being the most common.ConclusionsIn a real-world setting in Germany, alirocumab was used in patients who had high baseline low-density lipoprotein cholesterol levels with/without statin intolerance. Efficacy and safety were consistent with findings observed in the ODYSSEY Phase III program.