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

Real-World Outcomes of Lipoprotein Apheresis in Homozygous Familial Hypercholesterolemia: A Single-Center Longitudinal Experience. (PubMed, J Clin Med) - "However, the limited number of TPE-treated patients, repeated procedures within the same individuals, and overlapping evolocumab exposure preclude conclusions regarding comparative efficacy or safety. TPE may be considered as an individualized interim option when selective lipoprotein apheresis is temporarily unavailable."

Journal • Real-world evidence • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: General Hospital of Shenyang Military Region | N=40 ➔ 60

Enrollment change • Dyslipidemia • Hypertriglyceridemia • Pancreatitis

Lerodalcibep-liga as an Injectable Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)-Targeted Therapy for Patients With Hypercholesterolemia. (PubMed, Ann Pharmacother) - "Lerodalcibep-liga is an additional potent injectable PCSK9-directed treatment for adults requiring substantial LDL-C reduction, including those with HeFH. However, alirocumab or evolocumab may remain preferable when demonstrated cardiovascular event reduction is a major consideration in treatment selection."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • APOB

Evolocumab in Metastatic Castration-Resistant Prostate Cancer (mCRPC) – results of a phase II trial (ESMO 2026) - No abstract available

Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PCSK9 inhibitor evolocumab combined with nivolumab in refractory metastatic renal cell carcinoma: stage I analysis of BOOST-RCC (ESMO 2026) - No abstract available

Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

When the Statin Strikes Twice: Atorvastatin-Induced Autoimmune Hepatitis Confirmed by Inadvertent Rechallenge (ACG 2026) - "Atorvastatin was discontinued, she received steroid with improvement, and she was transitioned to evolocumab. The lesson is twofold: an injury labeled DILI may in fact be drug-induced AIH, particularly with interface activity and low-titer antibodies, and such patients warrant close follow-up rather than reassurance alone. In the post-ACS patient, where high-intensity statins are routine, a prior statin hepatitis should be flagged across care transitions, with early use of a PCSK9 inhibitor to avoid a dangerous rechallenge."

Autoimmune Hepatitis • Hepatitis C • Hepatology • Immunology • Inflammation

PCSK9 Inhibitors Added to Moderate/High-Intensity Statin Therapy Are Associated With Improved Liver-Related Outcomes in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (ACG 2026) - "We compared patients who initiated a PCSK9 inhibitor (alirocumab, evolocumab, or inclisiran) at least 3 months after MASLD diagnosis (n=10,940) versus those on M/HI statins alone (n=604,717). After PSM, 10,216 patients per group were identified (Table 1). Median follow-up was 516 vs. 485 days."

Clinical • CNS Disorders • Dyslipidemia • Familial Hypercholesterolemia • Fibrosis • Gastroenterology • Genetic Disorders • Hepatic Encephalopathy • Hepatocellular Cancer • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Solid Tumor

Impact of Diabetes on Coronary Plaque Stabilization With Evolocumab: Insights From the YELLOW III Trial. (PubMed, Cardiovasc Drugs Ther) - "Despite maximally tolerated statin therapy, patients with diabetes exhibited more adverse plaque features. Evolocumab was associated with similar short-term plaque stabilization regardless of diabetes status, suggesting potential mechanistic insight into PCSK9 inhibition in diabetes."

Journal • Cardiovascular • Diabetes • Metabolic Disorders

Comment on "Lipoprotein(a) reduction with inclisiran, alirocumab, evolocumab, enlicitide, and lerodalcibep: A systematic review and meta-analysis of randomized controlled trials". (PubMed, Int J Cardiol Cardiovasc Risk Prev) - No abstract available

Journal • Retrospective data

YN001-004 in Patients With Coronary Atherosclerosis in Australia (clinicaltrials.gov) - P2 | N=3 | Terminated | Sponsor: Beijing Inno Medicine Co., Ltd. | N=24 ➔ 3 | Recruiting ➔ Terminated; The study was terminated at the request of the Sponsor.

Enrollment change • Trial termination • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Coronary Artery Disease

Effects of Evolocumab on Fatal Outcomes in Patients Without a Prior Myocardial Infarction or Stroke : Pre-specified Analysis of the VESALIUS-CV Trial (ESC 2026) - No abstract available

Clinical • Late-breaking abstract • Cardiovascular • Myocardial Infarction

Evolocumab early reduces Interleukin-1β/Interleukin-17A and improves left ventricular function in ST-segment elevation myocardial infarction: an observational study in the real world (ESC 2026) - "Early evolocumab therapy in STEMI rapidly attenuates inflammation and improves left ventricular function, with partially mediated by IL-1β/IL-17A axis. Our findings support evolocumab's role beyond lipid-lowering, suggesting that early PCSK9 inhibition as a potential strategy to mitigate early inflammation-driven cardiac dysfunction in STEMI management."

Clinical • Observational data • Real-world • Real-world evidence • Cardiovascular • Dyslipidemia • Myocardial Infarction • CCR2 • IL17A • IL18 • IL1B

Impact of evolocumab on coronary plaque stratified by very high-risk ASCVD status: a YELLOW III sub study (ESC 2026) - "Conclusion - Maximal lipid-lowering therapy with Evolocumab achieved similar plaque stabilisation and regression in both VHR and non-VHR ASCVD patients. Morphological improvement was primarily determined by baseline plaque characteristics rather than clinical risk, suggesting coronary plaques are equally responsive to PCSK9 inhibition even in the highest-risk patients defined by contemporary guidelines."

Cardiovascular • Coronary Artery Disease

AMUNDSEN: Evolocumab Before Percutaneous Coronary Intervention for Acute Myocardial Infarction (ESC 2026) - No abstract available

Cardiovascular • Myocardial Infarction

Evolocumab for high cardiovascular risk patients without previous stroke: a network meta-analysis of randomized controlled trials (ESC 2026) - "Purpose: To investigate the efficacy and safety of non-statin treatments—including evolocumab, alirocumab, enlicitide, inclisiran, evinacumab, omega-3 fatty acids, and ezetimibe—in high CV risk patients without previous stroke. Evolocumab had the potential to be the first-line non-statin option for high CV risk patients without previous stroke due to its efficacy in reducing MACE, CV mortality, LDL-C, and Lp(a)."

Retrospective data • Cardiovascular • Dyslipidemia • Myocardial Infarction

Clinical Outcomes of an ApoE Genotype-Guided Lipid-Lowering Strategy in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention. (PubMed, Pharmgenomics Pers Med) - "The control group (n=120) received standard atorvastatin therapy. An ApoE genotype-guided lipid-lowering escalation strategy, in which E4 carriers-who typically respond suboptimally to statin monotherapy and carry a higher residual risk-received add-on PCSK9-inhibitor (evolocumab) therapy, was associated with improved clinical efficacy, cardiac function, and lipid control in ACS patients after PCI. Because the study group received more intensive lipid-lowering therapy, the observed benefits most plausibly reflect the greater treatment intensity achieved through genotype-directed escalation rather than the act of genotyping alone, and require confirmation in prospective randomized trials with longer follow-up."

Clinical data • Journal • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Metabolic Disorders • APOE

A retrospective study of disproportionality analysis signals between proprotein convertase subtilisin/kexin 9 inhibitor use and respiratory, thoracic, and mediastinal disorders. (PubMed, Medicine (Baltimore)) - "The median time to onset for adverse event reports was 7.5 days (interquartile range = 0.5-77.5 days); the median time to onset for reports related to alirocumab was 14.5 days (interquartile range = 1.5-100.5 days), while for evolocumab it was only 6.5 days (interquartile range = 0.5-70.5 days). Among these, rhinorrhea, cough, oropharyngeal pain, nasal congestion, and dysphonia were the most frequently reported preferred terms (PTs). The results of this study indicate the presence of a disproportionate signal of RTMD adverse events associated with PCSK9i in the FAERS database; however, this merely suggests that such events warrant further attention in reports related to PCSK9i and does not establish a causal relationship between the 2."

Journal • Retrospective data • Cough • Dysphonia • Pain • Respiratory Diseases

Contemporary non-statin therapies for dyslipidemia management: achieving current lipid targets. (PubMed, Front Med (Lausanne)) - "Third evidence indicates that non-statin therapies-including ezetimibe, bempedoic acid, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran-provide substantial LDL-C reductions and reduce cardiovascular events...Additionally, the fixed-dose combination of bempedoic acid and ezetimibe produces an approximately 36.2% reduction in LDL-C in high-risk patients...Furthermore, inflammation (measured by hsCRP) provides complementary prognostic information beyond LDL-C. This expert position paper proposes practical algorithms for a precision medicine approach in Latin America, matching treatment intensity to individual risk profiles for the primary and secondary prevention of atherosclerotic cardiovascular disease."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Inflammation • Metabolic Disorders • CRP

Real-world comparative outcomes of evolocumab versus high-intensity statin for primary prevention (ESC 2026) - "Cohorts required initiation of either high-intensity statin therapy (atorvastatin 40–80 mg or rosuvastatin 20–40 mg) or evolocumab; each cohort excluded use of the comparator lipid-lowering agent and alirocumab. In this large propensity score–matched analysis of primary prevention patients with ASCVD risk factors, evolocumab was associated with significantly lower all-cause mortality, acute heart failure, and hospitalization compared with high-intensity statin therapy. However, evolocumab users demonstrated higher rates of acute MI and persistent LDL-C elevation. These findings suggest potential complementary roles for PCSK9 inhibitors in primary prevention but warrant prospective validation."

Clinical • Real-world • Real-world evidence • Atherosclerosis • Cardiovascular • Congestive Heart Failure • Dyslipidemia • Heart Failure • Myocardial Infarction

Clinical Study of PCSK9 Inhibitors for Preventing Early Neurological Deterioration in Branch Atheromatous Disease (ChiCTR) - P4 | N=152 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Dalian Medical University; The First Affiliated Hospital of Dalian Medical University

New P4 trial • Cardiovascular • Ischemic stroke

Alirocumab and cardiovascular outcomes in patients without a prior ischemic event (ESC 2026) - "VESALIUS-CV recently showed that evolocumab lowers cardiovascular event rates in patients without prior myocardial infarction (MI) or stroke...Use of lipid-lowering therapy, including statin+ ezetimibe combination, was high in both groups (Table)... In this population-based cohort of patients with ASCVD without prior acute ischemic events, alirocumab was associated with lower 4-year risk of all-cause death, MI, or ischemic stroke, supporting the clinical value of alirocumab in these patients and complementing recent randomized trial evidence."

Clinical • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Ischemic stroke • Myocardial Infarction

Real-World Effectiveness of Evolocumab in Reducing Major Adverse Cardiovascular Events: A Cohort Study. (PubMed, J Am Heart Assoc) - "In a large, diverse, real-world population with atherosclerotic cardiovascular disease, evolocumab use was associated with significant reductions in major adverse cardiovascular events, supporting the effectiveness of guideline-recommended PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor therapy in routine clinical practice."

Adverse events • Journal • Real-world evidence • Atherosclerosis • Cardiovascular • Myocardial Infarction

Sex differences in coronary plaque stabilization with evolocumab: a post hoc analysis of the YELLOW III trial. (PubMed, Int J Cardiovasc Imaging) - "Evolocumab was associated with similar short-term plaque stabilization in women and men with CCD, despite baseline sex-related differences in inflammatory pathways. These findings warrant confirmation in larger prospective studies."

Journal • Retrospective data • Cardiovascular • Dyslipidemia

Evolocumab and risk of a first myocardial infarction: a prespecified analysis of the VESALIUS-CV trial (ESC 2026) - "Among patients without a history of a prior MI or stroke, evolocumab reduced the incidence of a first MI, with a robust early benefit that was maintained over time. These favourable results were observed across subtypes of MI, including for spontaneous Type 1 events, large MIs and both NSTEMI and STEMI. These findings strongly support intensive LDL-C lowering with evolocumab for prevention of a first MI in high-risk patients."

Atherosclerosis • Cardiovascular • Myocardial Infarction

Efficacy of PCSK9 inhibitors in patients with peripheral artery disease: insights from the AT-TARGET-IT Registry (ESC 2026) - "LDL-cholesterol (LDL-C) lowering improves outcomes in PAD, and randomized evidence supports the use of proprotein convertase subtilisin/kexin type-9 inhibitors (PCSK9i) on top of statin ± ezetimibe therapy...The purpose of this subanalysis was to investigate efficacy and safety of PCSK9i in patients with PAD. Patients with PAD initiating evolocumab or alirocumab (75, 150 or 300 mg), according to ESC/EAS Guidelines indications and national reimbursement criteria, were enrolled in the AT-TARGET-IT registry... A total of 124 patients with PAD were enrolled in the AT-TARGET-IT registry (61.3% male, median age 59 years), of whom 118 had at least one follow-up recorded. Of these patients, 61.3% had hypertension, 17.7% had type 2 diabetes mellitus, and 21.8% had a previous history of lower limb revascularization. Baseline median ankle brachial index (ABI) was 0.8 (IQR 0.7-0.9), and most patients had symptomatic PAD, predominantly Fontaine stage IIa (30.6%) and IIb (48.4%),..."

Clinical • Cardiovascular • Hypertension • Peripheral Arterial Disease