Repatha (evolocumab) / Dr. Reddy’s, Amgen, Astellas - LARVOL DELTA

Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov) - P1/2 | N=314 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Break Away From the Hemodynamic "Gray Zone": Plaque Regression in a Non-Culprit Lesion of an NSTE-ACS. (PubMed, JACC Case Rep) - "A shared decision with the patient was made to defer intervention and instead commence intensive optimal medical therapy including dual antiplatelet therapy, a beta-blocker, and intensive lipid-lowering therapy with atorvastatin and evolocumab. At the 3-month follow-up, the patient reported complete relief of chest tightness, with a 73.6% reduction in his low-density lipoprotein cholesterol, accompanied by remarkable plaque regression, stabilization, and functional improvement."

Journal • Acute Coronary Syndrome • Cardiovascular • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders

Obesity-Associated Cardiovascular Risk and Benefit From PCSK9 Inhibition: A Prespecified Analysis From FOURIER. (PubMed, J Am Coll Cardiol) - "Individuals with obesity and atherosclerotic cardiovascular disease face an elevated risk of MACE compared with those without obesity, and evolocumab helps to attenuate this risk."

Journal • Atherosclerosis • Cardiovascular • Genetic Disorders • Myocardial Infarction • Obesity

Impact of PCSK9 inhibitor on T lymphocyte subsets and cytokines in patients with acute ischemic stroke: an exploratory analysis of a randomized clinical trial. (PubMed, Front Neurol) - P4 | "In this study, a total of 100 patients with AIS were included for the current analysis (n = 50 for combination therapy of evolocumab and atorvastatin, PI group, n = 50 for atorvastatin monotherapy, AT group). http://www.chictr.org.cn; Identifier: ChicTR2200059445. Date of registration: 29 April 2022."

Clinical • Journal • Cardiovascular • Ischemic stroke • Oncology • CXCL8 • IL6 • TNFA

Effectiveness of PCSK9 inhibitors versus statins in type 2 diabetes and dyslipidemia: a propensity-matched study. (PubMed, Front Endocrinol (Lausanne)) - "The association was significant for alirocumab and evolocumab, but not for inclisiran, likely due to limited sample size. Among patients with T2D and dyslipidemia, PCSK9i use was associated with reduced incidences of cardiovascular and renal events and all-cause mortality compared to statin therapy. These findings support the promising role of PCSK9is in high-risk diabetic populations."

Clinical • Journal • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Cost-utility analysis of PCSK9 inhibitors for hypercholesterolemia: a Chinese healthcare perspective. (PubMed, Front Pharmacol) - "In the base-case analysis, evolocumab 140 mg every 2 weeks (Q2W) was the most cost-effective option, dominating all other active regimens...All other regimens were dominated, and inclisiran showed the least favorable cost-utility profile (ICUR $113,800.14 per QALY)...Alirocumab 75 mg Q2W and tafolecimab 150 mg Q2W also represent cost-effective alternatives. These findings provide important evidence to support clinical decision-making and optimize resource allocation in China."

HEOR • Journal • Cardiovascular • Dyslipidemia • Metabolic Disorders

Sex differences in inflammatory biomarkers during long-term evolocumab therapy. (PubMed, J Clin Lipidol) - "Our findings reveal pronounced biological sex differences in inflammatory responses to long-term evolocumab therapy, highlighting the need to incorporate sex-specific considerations in cardiovascular risk management and treatment monitoring. These novel insights pave the way for personalized therapeutic strategies and call for further investigation into the clinical significance of inflammation in lipid-lowering treatment outcomes."

Biomarker • Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Inflammation • Metabolic Disorders

AACE Updates Guidelines for Pharmacologic Management of Dyslipidemia in Adults (Endocrinology Advisor) - "Among adults with dyslipidemia receiving treatment with statins who have ASCVD or are at increased risk for ASCVD and have less than 70 mg/dL of low-density cholesterol (LDL-C), evolocumab or alirocumab may be added to standard care; Among adults with dyslipidemia without ASCVD, the task force recommended against the use of evolocumab or alirocumab along with standard care; Among adults with dyslipidemia with statin intolerance who have ASCVD or are at increased risk for ASCVD, the use of bempedoic acid may be considered in addition to standard care."

Clinical guideline • Cardiovascular • Dyslipidemia

High levels of serum cholesterol increase the risk of developing vessel co-opting tumors in colorectal cancer liver metastases. (PubMed, FEBS J) - "We also demonstrate, in an in vivo mouse model, that inhibition of key modulators of cholesterol metabolism, using antiproprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, attenuated the development of CRCLM tumors, as well as the formation of vessel co-opting lesions. Our findings underscore the importance of cholesterol in CRCLM and the potential clinical application of evolocumab to mitigate the growth of these histological types of tumors in CRCLM."

Journal • Colorectal Cancer • Developmental Disorders • Oncology • Solid Tumor

Effect of PCSK9 inhibitors on the quality of life in patients with acute coronary syndromes - exploratory analysis of the EMSIACS trial. (PubMed, Sci Rep) - P4 | "Patients were randomly assigned in a 1:1 ratio to receive Evolocumab plus statin therapy or statin-only therapy...In the long term, PCSK9i sustained quality of life improvements. The occurrence of MACE in ACS patients may associate with emotional problems.Clinical trial registration number: NCT04100434."

Clinical • HEOR • Journal • Acute Coronary Syndrome • Cardiovascular • Fatigue • Pain

Relative Efficacy of Alirocumab, Evolocumab, Inclisiran, and Bempedoic Acid on Lipids in Patients with Cardiovascular Disease or Familial Hypercholesterolaemia. (PubMed, J Clin Med) - "Methods and This observational study evaluated the impact of novel lipid-lowering therapies (alirocumab, evolocumab, inclisiran, and bempedoic acid) in patients with a history of atherosclerotic cardiovascular disease or familial hypercholesterolaemia treated with maximum-tolerated doses of high-intensity statin therapy with or without ezetimibe. Strength and limitations: This was the first study to comprehensively compare the efficacy of novel lipid-lowering therapies in achieving guideline-recommended LDL targets within a high-risk cardiovascular population. The sample size was relatively small, especially for patients treated with bempedoic acid."

Journal • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia

Real-World Evidence [RWE] Demonstrates Repatha’s Long-Term Cardiovascular Benefits (Businesswire) - "Patients treated with Repatha experienced a 20% lower relative risk of composite MACE of MI, stroke and coronary revascularization (RR = 0.80; 95% CI: 0.73–0.86) and a 29% lower relative risk of composite MACE of MI, stroke and cardiovascular death (RR = 0.71; 95% CI: 0.64-0.78) at four years compared to those not treated, underscoring Repatha’s sustained, real-world impact on cardiovascular outcomes. The analysis drew on Komodo’s Healthcare Map®, a database of de-identified, real-world patient data, representing the individual healthcare experiences of more than 330 million de-identified U.S. patients, and included 87,102 Repatha treated and 24,609 non-treated patients identified between 2017 and 2023."

Real-world evidence • Atherosclerosis • Cardiovascular

EVACS: Evolocumab in Acute Coronary Syndrome (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Johns Hopkins University | Trial completion date: Oct 2024 ➔ Mar 2025

Trial completion date • Acute Coronary Syndrome • Cardiovascular

Lipid-Lowering Therapy Is Underutilized Across LDL-C Levels in Autoimmune Disease Compared to Diabetes: A Nationwide Analysis (AHA 2025) - "Statins included atorvastatin, rosuvastatin, simvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin. Non-statin therapies included icosapent ethyl, colesevelam, alirocumab, evolocumab, Bempedoic acid, cholestyramine, Inclisiran, colestipol, ezetimibe, gemfibrozil, omega-3 acid, fenofibrate...Non-statin lipid-lowering therapy use was significantly lower in autoimmune patients compared to those with diabetes across all LDL-C tertiles, with the largest differences observed at LDL <70 mg/dL (6.19% vs 10.24%, p<0.0001) and 70–99 mg/dL (4.05% vs 7.06%, p<0.0001).ConclusionDespite comparable ASCVD risk, patients with autoimmune disease are significantly less likely to receive statins or non-statin lipid-lowering therapy than those with DM across LDL-C levels. These findings show a need for improved cardiovascular prevention in this high-risk population."

Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Hepatology • Immunology • Inflammatory Arthritis • Lupus • Metabolic Disorders • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

CT.MDP.24: Closing the LDL Gap: Innovations, Access, and Adherence in Lipid-Lowering Therapy (AHA 2025) - "Discover the real-world impact of evolocumab, cost and utilization trends in under-treated populations, and access inequities driven by socioeconomic deprivation. With new evidence on emerging agents like bempedoic acid, obicetrapib, and zodasiran, this session brings together cutting-edge science and pragmatic solutions to confront one of cardiology's most persistent challenges: getting LDL down and keeping it there. This is not a CE accredited session."

Adherence • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders

Severe angioedema requiring airway intervention following evolocumab administration: a case report. (PubMed, Am J Cardiovasc Dis) - "She received intravenous corticosteroids and antihistamines in the intensive care unit, with symptoms resolving within 48 hours, allowing for extubation and discharge after three days. This case highlights a rare but potentially life-threatening adverse effect of evolocumab."

Journal • Cardiovascular • Critical care • Dyslipidemia • Endocrine Disorders • Hypertension • Immunology • Myocardial Infarction • Pain

Fair pricing, fair access; a systematic review of cost-effectiveness of new hyperlipidemia injectable medication in developing countries. (PubMed, Cost Eff Resour Alloc) - "Cost-effectiveness of PCSK9 inhibitors and inclisiran varies across developing countries, driven by drug prices, WTP thresholds, and healthcare perspectives. Evolocumab may be cost-effective in high-risk subgroups or in Mexico and Saudi Arabia but remains largely unaffordable elsewhere. Ezetimibe was consistently more favorable. Price reductions, tiered pricing, pooled procurement, and context-specific thresholds are essential to improve access and equity."

HEOR • Journal • Pricing • Review • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders • Myocardial Infarction

VESALIUS Keeps Revolutionizing Medicine: The Case of Evolocumab in Primary Prevention. (PubMed, Eur Heart J Cardiovasc Pharmacother) - No abstract available

Journal

A disproportionality analysis on proprotein convertase subtilisin/kexin type 9 inhibitors and hypersensitivity and anaphylaxis. (PubMed, Sci Rep) - "We calculated reporting odds ratios (ROR), proportional reporting ratios, and information components (IC) as measures of disproportionate reporting of hypersensitivity or anaphylaxis with PCSK9 inhibitors overall and with specific compounds (alirocumab, evolocumab) using the entire FAERS as comparator. Our large pharmacovigilance study showed no signal of disproportionate reporting for hypersensitivity or anaphylaxis with PCSK9 inhibitors overall. The inconsistencies in alirocumab related findings argue against a compound specific signal."

Journal • Immunology

Rituximab (RTX): Not Only Effective in Anti-Phospholipase A2 Receptor (PLA2R)-Associated Membranous Nephropathy (MN) (KIDNEY WEEK 2025) - "Case Description 66 years old man with history of T-cell lymphoblastic lymphoma status post allogenic HSCT 2 years before presentation, complicated by chronic GVHD with skin and liver involvement, chronically on ruxolitinib and briefly on belumosudil, presented with acute onset lower extremity edema, proteinuria 7600 mg in 24 hours, serum albumin 2.1 g/dL, serum creatinine 1.3 mg/dL (base 1.1)...Irbesartan started, apixaban for DVT prophylaxis, atorvastatin and evolocumab for dyslipidemia...Clinically doing excellent in complete remission, remains on irbesartan, dapagliflozin, atorvastatin, and evolocumab. Discussion Treatment of MN post allogenic HSCT is based on case report and case series, and different agents have been used including calcineurin inhibitors, mycophenolate mofetil, cyclophosphamide, and more recently rituximab...The lack of serological markers (i.e. antiPLA2R antibody) made the decision to continue with RTX and not changing to a different agent..."

Bone Marrow Transplantation • Chronic Graft versus Host Disease • Dyslipidemia • Glomerulonephritis • Graft versus Host Disease • Hematological Malignancies • Immunology • Lymphoma • Metabolic Disorders • Renal Disease

Evolocumab and Saphenous Vein Graft Patency Following Coronary Artery Bypass Graft (CABG) Surgery in People with and without Diabetes: A Pre-Specified Analysis of the Randomized Placebo Controlled NEWTON-CABG CardioLink-5 Trial (AHA 2025) - P4 | "NEWTON-CABG is the first randomized trial to assess the effect of intensive LDL-C lowering with a PCSK9 inhibitor initiated early after CABG on SVG patency. This pre-specified analysis will provide pivotal insights into whether diabetes is an independent risk factor for SVG failure and whether evolocumab modifies this risk. These findings will have important implications for the large cohort of post-CABG patients with diabetes."

Clinical • Surgery • Diabetes • Hematological Disorders • Metabolic Disorders • Thrombosis

EVOLocumab Very Early after Myocardial Infarction (EVOLVE-MI): A Pragmatic Randomized Multicenter International Trial - Design and Baseline Characteristics (AHA 2025) - "For the index event, 92% and 91% received aspirin and P2Y12 inhibition, respectively. This pragmatic randomized trial is evaluating the hypothesis that early administration of potent LDL-C lowering with evolocumab in patients with MI improves outcomes. The trial is ongoing to obtain the planned number of events to determine if this strategy reduces cardiovascular events."

Clinical • Atherosclerosis • Cardiovascular • CNS Disorders • Diabetes • Hypertension • Ischemic stroke • Metabolic Disorders • Myocardial Infarction • Peripheral Arterial Disease • Vascular Neurology

LBS.ID.01: LBS In Depth - The VESALIUS-CV Trial (AHA 2025) - "Description: Hear more from the presenter of Effect of Evolocumab in Patients at High Cardiovascular Risk without Prior Myocardial Infarction or Stroke: Primary Results of the VESALIUS-CV trial"

Late-breaking abstract • Cardiovascular • Myocardial Infarction

Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov) - P1/2 | N=314 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2026 ➔ Nov 2025

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Protective Effects of PCSK9 Inhibitors on Renal Function in ASCVD Patients at High Risk for Contrast-Associated Acute Kidney Injury. (PubMed, Angiology) - "These results were consistent across the subgroups of individuals with varying risk scores. Evolocumab administration effectively reduces the incidence of CA-AKI in inpatients with ASCVD, with a notable effect in high-risk individuals with CA-AKI."

Journal • Acute Kidney Injury • Atherosclerosis • Cardiovascular • Nephrology • Renal Disease