Key result
PCSK9 inhibitor initiation is linked to ~29 mg/dL higher baseline LDL-C versus standard therapy.
Why the study?
There is a need to describe the demographic and clinical characteristics of US patients with elevated LDL-C whose lipid-lowering therapy, including PCSK9 inhibitors and non-PCSK9 inhibitors, was actively modified in real-world practice.
Cohort (n=24,690)
Highlights preferential PCSK9 inhibitor use in higher-risk patients; leaves open whether unadjusted observational outcomes reflect efficacy or confounding.
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.
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Baum et al. (2019) conducted a cohort in Elevated low-density lipoprotein cholesterol (LDL-C) (n=24,690). PCSK9 inhibitor therapy vs. Modification of non-PCSK9 inhibitor lipid-lowering therapy (intensified, switched, or augmented with ezetimibe) was evaluated on Mean baseline LDL-C (mg/dL). Patients prescribed PCSK9 inhibitors had higher baseline LDL-C levels (150 mg/dL vs 121 mg/dL) and greater cardiovascular risk compared to patients whose non-PCSK9 lipid-lowering therapy was modified.
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