Demographic And Clinical Characteristics Of Patients Prescribed Proprotein Convertase Subtilisin/kexin Type 9 Inhibitor Therapy And Patients Whose Current Lipid-Lowering Therapy Was Modified

Seth J Baum,1,2 Rolin L Wade,3 Pin Xiang,4 Jorge Arellano,4 Cesar Cerezo Olmos,5 Sasikiran Nunna,6 Chi-Chang Chen,6 Cathryn M Carter,7 Nihar R Desai8 1Department of Integrated Medical Sciences, Charles E Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA; 2Preventive Cardiology Inc, Boca Raton, FL, USA; 3Medical and Scientific Services, IQVIA, Plymouth Meeting, PA, USA; 4Global Health Economics, Amgen Inc, Thousand Oaks, CA, USA; 5US Medical, Amgen Inc, Thousand Oaks, CA, USA; 6Real-World Evidence Solutions, IQVIA, Plymouth Meeting, PA, USA; 7Global Publications, Amgen Inc, Thousand Oaks, CA, USA; 8Section of Cardiovascular Medicine, Center for Outcomes Research and Evaluation, Yale School of Medicine, New Haven, CT, USACorrespondence: Rolin L WadeIQVIA, One IMS Drive, Plymouth Meeting, PA 19462, USATel +1 215 434 812 2958Email Rolin.Wade@iqvia.comPurpose: Our objective was to describe the demographic and clinical characteristics of real-world patients in the US with elevated low-density lipoprotein cholesterol (LDL-C) whose lipid-lowering therapy (LLT) ─ both proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor and non-PCSK9 inhibitor ─ was actively modified.Methods: This retrospective cohort study used linked laboratory (Prognos), pharmacy (IMS Formulary Impact Analyzer), and medical claims (IQVIA Dx/LRx or PharMetrics Plus) data. PCSK9 inhibitor–prescribed patients with LDL-C ≥70 mg/dL (multiply by 0.02586 for mmol/L) at the time of prescription were matched by LDL-C test date to patients whose non-PCSK9 inhibitor therapy was modified by intensifying statin therapy, switching statins without intensification, or augmenting with ezetimibe (N=12,345 in each cohort). Baseline demographics, use of LLT, LDL-C values, atherosclerotic cardiovascular disease (ASCVD) diagnoses and cardiovascular comorbidities, and occurrence of major adverse cardiovascular events (MACE) were assessed during the 2-year pre-index period.Results: Mean age was 66.2 years in the PCSK9 inhibitor cohort and 64.1 years in the cohort whose LLT regimen was otherwise modified. Respectively, mean baseline LDL-C values were 150 and 121 mg/dL; 60.3% and 39.0% of patients had ASCVD diagnoses, and 9.6% and 5.1% had experienced a recent MACE. Prevalence of ASCVD diagnoses in the PCSK9 inhibitor and modified non-PCSK9 inhibitor cohorts, respectively, was 15.5% vs 9.1% for acute coronary syndrome, 20.7% vs 8.7% for coronary revascularization, and 22.2% vs 5.1% for possible familial hypercholesterolemia. In addition, 19.8% of patients in the PCSK9 inhibitor cohort were receiving both statins and ezetimibe vs 5.0% in the modified LLT cohort.Conclusion: Physicians are prescribing PCSK9 inhibitor therapy to patients with markedly elevated LDL-C levels who also have comorbid risk factors for adverse cardiovascular events. These results may be of interest to payers and policymakers involved in devising access strategies for PCSK9 inhibitors.Keywords: cardiovascular risk, lipid-lowering therapy, low-density lipoprotein, PCSK9 inhibitor, real-world treatment patterns