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

LDL-C Reduction with Evolocumab Among Patients with ASCVD in China: Real-World Evidence from Tianjin Metropolitan Area. (PubMed, Adv Ther) - "LDL-C reductions in patients who added evolocumab to statin therapy in real-world clinical practice in China align with reductions observed in clinical trials."

HEOR • Journal • Real-world evidence • Atherosclerosis • Cardiovascular • Dyslipidemia

Impact of GLP-1 Analogs vs. Lipid Lowering Agents on Risk for Acute Pancreatitis in Hypertriglyceridemia: A TriNetX Analysis (ENDO 2025) - "There were 21,106 patients receiving treatment with a GLP-1 analog (Cohort A) and 296,961 patients taking lipid lowering agents which we defined as atorvastatin, rosuvastatin, pravastatin, simvastatin, fenofibrate, ezetimibe, icosapent ethyl, evolocumab (Cohort B). Ongoing research is essential to understand the long-term outcomes of GLP-1 analog therapy.*. .*"

Dyslipidemia • Genetic Disorders • Hypertriglyceridemia • Obesity • Pancreatitis • Severe Hypertriglyceridemia

Evinacumab as an Effective Treatment Option for Refractory Hypertriglyceridemia (ENDO 2025) - "Despite using atorvastatin 80 mg daily, fenofibrate 162 mg daily, icosapent ethyl 2 g twice daily, and evolocumab 140 mg every 2 weeks, she continued to have hypertriglyceridemia. Evinacumab may be an effective alternative agent for the management of chronic hypertriglyceridemia based on the robust effects seen in our patient. Future research is needed to explore evinacumab's therapeutic targets beyond LDL-C to better modify risk factors for atherosclerosis, as well as CAV progression in heart transplant recipients.*. .*"

Atherosclerosis • Cardiomyopathy • Cardiovascular • Diabetes • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Hypertriglyceridemia • Metabolic Disorders • Pancreatitis • Severe Hypertriglyceridemia • Type 2 Diabetes Mellitus • ANGPTL3 • APOB

A Case Series of Heterozygous Familial Hypercholesteremia With PCSK9 Inhibitor Failure (ENDO 2025) - "Evolocumab was switched to alirocumab which initially reduced her LDL-C to 2.65 mmol/L (102.5 mg/dL), but it later rose again. Ezetimibe 10mg daily was added and patient is awaiting approval for inclisiran.CASE 2: An 18-year-old woman with type 1 diabetes and celiac disease was seen in September 2012 for dyslipidemia...Pravastatin 40 mg was started but discontinued due to myalgias...These cases also highlight the need for ongoing vigilance in patients with high cholesterol and HeFH to ensure optimal cardiovascular protection.*. .*"

Clinical • Cardiovascular • Celiac Disease • Diabetes • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Immunology • Metabolic Disorders • Musculoskeletal Pain • Pain • Type 1 Diabetes Mellitus

Breaking the Triglyceride Barrier: A Case of Severe Hypertriglyceridemia Management (ENDO 2025) - "Pharmacologic therapy included continuation of rosuvastatin 40 mg, fenofibrate 160 mg, and ezetimibe 10 mg. Patient was also started on Icosapent ethyl 2 g twice daily and Levothyroxine (LTX) was increased from 125 mcg to 150 mcg due to an elevated TSH level of 10.4 µIU/mL with a free T4 of 1.0 ng/dL...The patient was also prescribed evolocumab, but insurance restrictions required specialist approval...Further research is needed to assess long-term outcomes and the role of emerging therapies in severe HTG management.*. .*"

Clinical • Cardiovascular • Dyslipidemia • Endocrine Disorders • Hypertension • Hypertriglyceridemia • Obesity • Pancreatitis • Severe Hypertriglyceridemia

TOP2101: A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC (clinicaltrials.gov) - P2 | N=38 | Active, not recruiting | Sponsor: Scott Antonia | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2025 ➔ Sep 2024

Enrollment closed • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Intensive Lowering of LDL Cholesterol Levels With Evolocumab in Autoimmune or Inflammatory Diseases: An Analysis of the FOURIER Trial. (PubMed, Circulation) - P3 | "Intensive lowering of low-density lipoprotein cholesterol levels with evolocumab may lead to greater relative reduction in cardiovascular events in patients with an AIID. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01764633."

Journal • Atherosclerosis • Cardiovascular • Dermatology • Dyslipidemia • Immunology • Inflammation • Inflammatory Arthritis • Myocardial Infarction • Psoriasis • Rheumatoid Arthritis • Rheumatology • CRP

Inadequate Response to PCSK9 Inhibitors. (PubMed, JACC Case Rep) - "A higher rate of suboptimal PCSK9i responses have been reported in real-world data than in randomized clinical trials (7.5% vs 1%), warranting further investigation to understand mechanisms. The use of combination therapy based on individual response and tolerance is essential to assure goal attainment and improve residual risk in patients with suboptimal response."

Clinical • Journal • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Metabolic Disorders • Pain

Consumption and expenditure of drugs used for the treatment of hypercholesterolemia: a governance analysis. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "While statins have long been the cornerstone for lowering LDL cholesterol, their associated side effects have prompted the exploration of alternative treatments, including ezetimibe, bempedoic acid, PCSK9 inhibitors and inclisiran. The landscape of hypercholesterolemia treatment has expanded with several new therapeutic options. Bempedoic acid may mitigate adverse effects and enhance treatment efficacy, potentially delaying the need for costlier injectable medications like evolocumab, alirocumab, and inclisiran."

Journal • Cardiovascular • Dyslipidemia • Metabolic Disorders

Effect of PCSK9 inhibitor usage on coronary endothelial dysfunction in patients with hypercholesterolemia after coronary stenting: the CuVIC-2 trial. (PubMed, J Cardiol) - "Amelioration of CED by evolocumab was not observed in this trial with several limitations."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Infectious Disease • Metabolic Disorders • Myocardial Ischemia • Novel Coronavirus Disease

Safety and effectiveness of proprotein convertase subtilisin/kexin type 9 inhibition: an updated review. (PubMed, Curr Opin Lipidol) - "PCSK9i remain integral in ASCVD risk reduction, given their potent LDL-C-lowering effects, all while maintaining a favorable safety profile. The greatest benefits are observed in patients with AMI, particularly in multivessel disease. Despite high adherence, broader utilization is hindered by persistent challenges, including costs and complex authorization processes."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • Myocardial Infarction

Use of Inclisiran as Lipid-Lowering Therapy in a Heart Transplant Recipient (ISHLT 2025) - "The emergence of novel non-statin therapies (PCSK9 inhibitors such as alirocumab and evolocumab, and more recently, small interfering RNA therapy such as inclisiran) have expanded our repertoire for treatment of dyslipidemia...After transplant, he has been successfully maintained on pravastatin 10 mg daily for CAV prophylaxis without complaints of memory loss...Given the targeted mechanism of action, no drug interactions or interference with immunosuppressive therapy should be anticipated. Future studies should address whether inclisiran may provide CAV risk reduction or cardiovascular mortality benefit in heart transplant recipients."

Clinical • Cardiomyopathy • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Metabolic Disorders • Musculoskeletal Pain • Pain • Transplantation • Type 2 Diabetes Mellitus

Evolocumab Reduces Progression of Cardiac Allograft Vasculopathy in Heart Transplant Recipients with Increased Intimal Thickness at Baseline: A Post-HOC Analysis of the EVOLVD Trial (ISHLT 2025) - "These findings suggest that baseline MIT and PAV may help identify HTx recipients most likely to benefit from PCSK9 inhibition. Further research is needed to confirm these results and inform personalized treatment strategies."

Clinical • Retrospective data • Cardiovascular • Dyslipidemia • Transplantation

LIPID LOWERING THERAPY USE IN HIGH RISK ASCVD PATIENTS WITHOUT PRIOR MI OR STROKE - PRELIMINARY DATA FROM VESALIUS-REAL, US - Swati Sakhuja (ACC 2025) - P3 | "Background: Benefits of lipid lowering therapy (LLT) intervention in high CV risk patients prior to MI/stroke are being investigated in a clinical trial (NCT03872401: Effect of EVolocumab in PatiEntS at High CArdiovascuLar RIsk WithoUt Prior Myocardial Infarction or Stroke - CardioVascular [VESALIUS-CV])...Of these, 37.6%, 1.6% and 0.2% were on statins, ezetimibe and PCSK9i, respectively and 62.4% had no background LLT. Results highlight the treatment gap and a missed opportunity to improve lipid control in this high risk ASCVD population to prevent major ischemic events."

Clinical • Cardiovascular • CNS Disorders • Coronary Artery Disease • Diabetes • Metabolic Disorders • Myocardial Infarction • Peripheral Arterial Disease • Vascular Neurology

EVOLOCUMAB AND RATE OF COMPLEX CORONARY REVASCULARIZUATION DURING 8-YEAR FOLLOW-UP - ANALYSIS OF 6,635 PATIENTS FROM THE FOURIER OLE TRIAL - Paul M. Haller (ACC 2025) - "Compared to delayed treatment initiation (during OLE), earlier treatment with Evo significantly reduced the likelihood of complex revasc. events during long-term follow-up."

Clinical • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Heart Failure • Reperfusion Injury

LOSS OF EFFICACY WITH ALIROCUMAB AFTER TWO YEARS OF TREATMENT IN A PATIENT WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) - Erika Hellenbart (ACC 2025) - "Here, we describe a case showing significant loss of efficacy of alirocumab following two years of therapy.Case: We present a 29 year-old female with HeFH; baseline LDL of 136 mg/dL on rosuvastatin 40 mg daily and ezetimibe 10 mg daily...Given a previously reported rash with evolocumab, no commercial test for antidrug antibodies, alirocumab was changed to inclisiran in March of 2024... Loss of efficacy to alirocumab was overcome by switching to inclisiran which interferes with PCSK9 protein translation rather than blocking the receptor site. We do not expect the oral contraceptive changes to account for such dramatic changes in LDL. This case reinforces ongoing lipid monitoring even when LDL goals are met."

Clinical • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • Polycystic Ovary Syndrome

CHOLESTEROL CONUNDRUM: LIPOPROTEIN X DISGUISED AS LDL IN CHOLESTATIC LIVER DISEASE - Muhammad Hammad (ACC 2025) - "Treatment options, including evolocumab and plasma apheresis, were offered but declined by the patient... This case highlights the importance of recognizing the role of LpX in hypercholesterolemia resulting from liver dysfunction. LpX not only interferes with LDL calculations but can also affect direct LDL assays. An indirect assessment of LpX can be made by measuring the apo-B to total cholesterol ratio, since LpX lack apo-B."

Cardiovascular • Cholestasis • Dyslipidemia • Hepatology • Immunology • Ischemic stroke • Liver Failure • Metabolic Disorders • Sarcoidosis • APOB

BARKING UP THE RIGHT TREE: SIGNIFICANT LP(A) LOWERING WITH MAGNOLIA BARK - Elizabeth S. Epstein (ACC 2025) - "In the integrative lipidology clinic, it has also been noted to have an Lp(a)-lowering effect.Case: A 61 year old female with NSTEMI s/p multi-vessel PCI, HLD, and elevated Lp(a) was on a regimen of Repatha 140mg/mL, ezetimibe 10mg, and rosuvastatin 20mg. Lp(a)-lowering is a frontier for cardiovascular risk reduction. While several drugs are forthcoming, there is a need for additional therapeutics, especially low-risk, low-cost options. Magnolia bark may be a useful supplement to guideline-directed lipid management."

Cardiovascular • Coronary Artery Disease • APOB • LPL

PREVENTION OF SLOW FLOW/NO REFLOW DURING PERCUTANEOUS CORONARY INTERVENTION BY A SINGLE DOSE OF PCSK9 INHIBITOR THERAPY - Tatsuhiro Kataoka (ACC 2025) - "Among them, 27 patients (PCSK9 inhibitor group) received a single dose of Evolocumab 420mg 2-6 weeks before PCI... A single dose of PCSK9 inhibitor therapy before PCI significantly reduced the incidence of slow flow/no-reflow during PCI."

Cardiovascular • Coronary Artery Disease • Myocardial Ischemia

COMPARATIVE EFFICACY, SAFETY, AND LONG-TERM OUTCOMES OF INJECTABLE CHOLESTEROL-LOWERING AGENTS: A NETWORK META-ANALYSIS OF ALIROCUMAB, EVOLOCUMAB, INCLISIRAN, AND MIPOMERSEN - Rakhshanda Khan (ACC 2025) - "Risk of bias was assessed using ROB 2.0. PCSK9 inhibitors, including Alirocumab, Evolocumab, Bococizumab, and Inclisiran, significantly reduced LDL-C levels, with reductions over 60%. PCSK9 inhibitors, particularly alirocumab and evolocumab, significantly reduce LDL-C and lower the risk of myocardial infarction, stroke, and revascularization. These agents provide a promising adjunct to statin therapy in high-risk patients with a favorable safety profile, supporting their role in improving long-term CV outcomes. Further research is needed on their long-term cost-effectiveness and clinical impact."

Retrospective data • Atherosclerosis • Cardiovascular • Myocardial Infarction

SEX DIFFERENCES IN PLAQUE STABILIZATION IN PATIENTS TREATED WITH EVOLOCUMAB: MECHANISTIC INSIGHTS FROM THE YELLOW III TRIAL - Keisuke Yasumura (ACC 2025) - "In stable CAD patients, evolocumab treatment resulted in comparable plaque stabilization across sexes. PCSK9 inhibitor therapy can be equally effective in stabilizing vulnerable plaques in both women and men. Larger RCT studies are needed to verify these results."

Clinical

DIABETES AND PLAQUE STABILIZATION IN PATIENTS TREATED WITH EVOLOCUMAB: INSIGHTS FROM THE YELLOW III TRIAL - Keisuke Yasumura (ACC 2025) - "Although DM patients had higher-risk plaque characteristics at baseline, evolocumab led to comparable plaque stabilization across groups, supporting its efficacy regardless of diabetes status. Future studies are essential to assess long-term outcomes of intensive lipid-lowering therapy in this population."

Clinical • Diabetes • Metabolic Disorders

THE LONG TERM EFFECT OF EVOLOCUMAB IN PATIENTS TAKING STATIN WITH KNOWN CARDIOVASCULAR RISK FACTORS - Samantha Lo (ACC 2025) - "Patients taking statins with known cardiovascular RFs, the addition of evolocumab significantly reduced lipid parameters without significant adverse events."

Clinical • Cardiovascular • Dyslipidemia • APOB

SATISFACTION WITH EVOLOCUMAB FOR LDL-C MANAGEMENT: INSIGHTS FROM PATIENTS AND PHYSICIANS - Laney Jones (ACC 2025) - "A large majority of patients and physicians report satisfaction about their experience with evolocumab treatment."

Clinical • Cardiovascular

Factors Responsible for Successful Value-Based Agreements and Barriers for Their Adoption in the United States (ISPOR 2025) - "For instance, REPATHA®'s agreement linked payments to its ability to reduce LDL cholesterol, balancing patient benefits with payer costs. 2) Patient-centric approach: Successful agreements, like those for JANUVIA® and JANUMET®, incorporated both clinical outcomes and quality of life improvements. 3) Innovative payment models: LUXTURNA®'s pay-overtime model spread payments based on continued effectiveness, reducing financial risk... VBAs are increasingly enhancing access to innovative medications while ensuring cost-effectiveness. Overcoming adoption barriers requires multifaceted strategies and long-term planning, such as fostering stakeholder alignment and enhancing data collection and analytics capabilities."