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

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.

Low‐density lipoprotein cholesterol lowering in real‐world patients treated with evolocumab

“…This real‐world analysis describes the characteristics and LDL‐C outcomes of patients who initiated evolocumab therapy between July 1, 2015, and October 31, 2019, in US healthcare settings, including patients with a recent MI within 12 months (median 130 days) prior to starting evolocumab therapy. Overall, patient clinical characteristics were largely consistent with the recommendation that patients selected for PCSK9 inhibitor therapy are those with high levels of CV risk, 14‐16 and supports a previous real‐world study reporting that physicians were most likely to prescribe PCSK9 inhibitors to patients with elevated LDL‐C levels and additional comorbid risk factors for adverse CV events 34 …”

“…Overall, patient clinical characteristics were largely consistent with the recommendation that patients selected for PCSK9 inhibitor therapy are those with high levels of CV risk, [14][15][16] and supports a previous real-world study reporting that physicians were most likely to prescribe PCSK9 inhibitors to patients with elevated LDL-C levels and additional comorbid risk factors for adverse CV events. 34 At baseline, LDL-C levels were markedly elevated despite the majority of patients receiving background LLT with statins and/or ezetimibe in the 12 months prior to evolocumab initiation. Of note, the 60.6% of patients treated with statins prior to evolocumab initiation in the current study is considerably higher than that reported in a recently published study where only 29.3% of patients filled a statin in the period 31-365 days prior to PCSK9 inhibitor initiation.…”

Patient characteristics and acute cardiovascular event rates among patients with very high‐risk and non‐very high‐risk atherosclerotic cardiovascular disease

“…11 The Prognos LDL-C database has been previously used in retrospective cohort studies. [12][13][14] The aggregated IQVIA PharMetrics Plus database comprises adjudicated claims for patients across the US and is sourced directly from insurance companies, and contains data on patient's health plan claims, demographics, clinical characteristics, and occurrence of CV events.…”

PCSK9 Inhibitor Use and Outcomes Using Concomitant Lipid-Lowering Therapies in the Veterans Health Administration

“…While several real-world studies have assessed the side effects and effectiveness (eg, LDL lowering, CV events) of PCSK9-Is, 7 , 8 , 9 , 10 all involved small numbers of patients. Furthermore, while there are multiple studies on the patterns of use, cost, accessibility, adherence, discontinuation, and overall place in therapy of PCSK9-Is in the treatment of hyperlipidemia, 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 these were conducted in populations outside of the VHA. VHA is the largest integrated health care system in the United States and provides access to needed medications with nominal, or no, copayment.…”