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; Rolin L Wade; Pin Xiang; Jorge Arellano; Cesar Cerezo Olmos; Sasikiran Nunna; Chi-Chang Chen; Cathryn M Carter; Nihar R Desai

doi:10.2147/TCRM.S216606

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

Ther Clin Risk Manag. 2019 Nov 13:15:1325-1332. doi: 10.2147/TCRM.S216606. eCollection 2019.

Authors

Seth J Baum^{1

2}, Rolin L Wade³, Pin Xiang⁴, Jorge Arellano⁴, Cesar Cerezo Olmos⁵, Sasikiran Nunna⁶, Chi-Chang Chen⁶, Cathryn M Carter⁷, Nihar R Desai⁸

Affiliations

¹ Department of Integrated Medical Sciences, Charles E Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA.
² Preventive Cardiology Inc, Boca Raton, FL, USA.
³ Medical and Scientific Services, IQVIA, Plymouth Meeting, PA, USA.
⁴ Global Health Economics, Amgen Inc, Thousand Oaks, CA, USA.
⁵ US Medical, Amgen Inc, Thousand Oaks, CA, USA.
⁶ Real-World Evidence Solutions, IQVIA, Plymouth Meeting, PA, USA.
⁷ Global Publications, Amgen Inc, Thousand Oaks, CA, USA.
⁸ Section of Cardiovascular Medicine, Center for Outcomes Research and Evaluation, Yale School of Medicine, New Haven, CT, USA.

Abstract

Purpose: 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: PCSK9 inhibitor; cardiovascular risk; lipid-lowering therapy; low-density lipoprotein; real-world treatment patterns.

Grants and funding

This study was sponsored by Amgen Inc. The sponsor provided funding for the study and, via employee coauthors, input into the design of the study and interpretation of the data. The sponsor reviewed the manuscript prior to submission, but the coauthors prepared, approved, and decided to submit the manuscript for publication.