ezetimibe/simvastatin / Generic mfg. - LARVOL DELTA

Cost-Effectiveness Analysis of Fixed-Dose Combination Rosuvastatin and Ezetimibe vs. Simvastatin Plus Ezetimibe for the Treatment of Hypercholesterolemia in Patients at High Risk and Very High Risk of Cardiovascular Disease in Algeria (ISPOR-EU 2025) - "FDC ROS/EZE is a dominant option for treating hypercholesterolemia in patients at HR and VHR of CVD in Algeria, providing economic cost savings with additional LDL-C lowering benefits and improved adherence."

Clinical • Cost effectiveness • HEOR • Cardiovascular • Dyslipidemia • Metabolic Disorders

Ezetimibe for Improving Post-Intracerebral Hemorrhage Outcomes: A Retrospective Cohort Study (ASA 2025) - "In rat models, it was observed that simvastatin-ezetimibe combination attenuates endothelial inflammation and improves neurological function following ICH, with decreased neuronal loss (Wang K.W. et al. The results of this study suggest that the use of ezetimibe for ICH patients may be beneficial, as demonstrated by statistically significant reductions in post-stroke mortality, severe stroke, and ventilator dependence after ICH. Prospective, randomized trials are needed to confirm these findings."

Retrospective data • Addiction (Opioid and Alcohol) • Atherosclerosis • Cardiovascular • Cerebral Hemorrhage • Coronary Artery Disease • Diabetes • Epilepsy • Hematological Disorders • Hypertension • Inflammation • Metabolic Disorders • Myocardial Infarction • Nicotine Addiction • Pulmonary Embolism • Respiratory Diseases

Association of circulating procollagen 1 N-terminal pro-peptide (P1NP) with clinical outcomes in asymptomatic patients with non-severe aortic valve stenosis: a post-hoc study of the SEAS trial (ESC-WCC 2025) - "Methods We analysed data of 1553 asymptomatic patients who had mild-to-moderate AS, preserved systolic and renal function, no manifest coronary artery disease (CAD), and remained event-free one year after inclusion in the randomised Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial...Conclusions Circulating P1NP remains stable within the reference range in 97% of asymptomatic patients with non-severe AS during a one-year follow-up, regardless of AS severity. An age- and sex-adjusted elevated P1NP was associated with a 2.8-fold increased 4-year CAD risk in patients with moderate-severe AS, supporting its further investigation as a potential therapeutic target."

Clinical • Clinical data • Retrospective data • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Myocardial Infarction • IL6

Screening for Dyslipidemia Among Patients Admitted With Acute Coronary Syndrome at the Jakaya Kikwete Cardiac Institute, Tanzania: A Retrospective Cohort Study. (PubMed, Cureus) - " The findings of this study have mirrored many irregularities in the current practice of dyslipidemia screening among patients with ACS admitted to JKCI. This study also highlighted the local nonadherence to national and international recommended guidelines, which, in turn, undermines secondary prevention of cardiovascular events. Further larger multicentered studies are recommended to assess the scope of the problem to reduce the burden and risk of future events."

Journal • Retrospective data • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Dyslipidemia • Infectious Disease • Metabolic Disorders • Myocardial Infarction

STATIN-INDUCED RHABDOMYOLYSIS IN A PATIENT WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA: A CASE REPORT AND CLINICAL IMPLICATIONS - Henrique T. Bianco (ACC 2025) - "Than, the patient was initiated on a combination therapy of Simvastatin 20/Ezetimibe 10. After 30 days, she was admitted to a hospital with generalized myalgia, She had abdominal pain, and altered mental status. Treatment with inclisiran, which suppresses hepatic PCSK9 synthesis, can dramatically reduce LDL cholesterol fraction levels and can be administered in injectable form every six months. Studies reveal that with just two annual applications, it is possible to reduce LDL levels by an average of 52%."

Case report • Clinical • Dyslipidemia • Endocrine Disorders • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • Musculoskeletal Pain • Pain • MB

Deciphering the Mechanism of Action of Drug Combinations by Boolean Modeling of Transcriptomes: a Case Study of Atorvastatin/Simvastatin and Ezetimibe (AHA 2024) - "Drug-induced transcriptomes are informative in deciphering the MoA of drug combinations using Boolean logical modeling. This framework can be easily extended to the combinations of three drugs."

Case study • Clinical • Gastroenterology • Hepatology

Real-World Statin Use and 10-Year Atherosclerotic Cardiovascular Disease Risk in Patients With Biopsy-Confirmed Metabolic Dysfunction Associated Steatohepatitis in an Integrated Delivery Network (ACG 2024) - "3,442 MASH patients had data available to calculate ASCVD risk – 1,359 (39.5%) statin users and 2,083 (60.5%) nonusers. Baseline type 2 diabetes, smoker, and hypertension rates were 29.4%, 51.1%, and 97.2% in statin users and 22.6%, 30.8%, and 36.7% in nonusers. Identified statins included atorvastatin (n=756), amlodipine/atorvastatin (n=3), fluvastatin (n=1), lovastatin (n=12), pitavastatin (n=1), pravastatin (n=152), rosuvastatin (n=290), simvastatin (n=136), and simvastatin/ezetimibe (n=2)."

Biopsy • Clinical • Real-world • Real-world evidence • Atherosclerosis • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Diabetes • Dyslipidemia • Heart Failure • Hepatology • Hypertension • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus

Impact of sex-specific thresholds for low flow in assessment of prognosis in concordantly and discordantly graded aortic valve stenosis. (PubMed, Eur Heart J Cardiovasc Imaging) - "Identification of low flow by the proposed sex-specific thresholds of SVi needs more prognostic validation before application in clinical practice."

Discordant • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension

Interleukin 6 in asymptomatic patients with nonsevere aortic valve stenosis: a post-hoc study of the SEAS trial (ESC 2024) - " We analyzed data of 1574 asymptomatic patients who had mild-to-moderate AS, preserved systolic and kidney function, no overt cardiovascular diseases, and an event-free follow-up one year after enrollment in the randomized Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial... In asymptomatic patients with nonsevere AS, circulating IL-6 remains stable within the reference range in 7 out of 8 patients during a 1-year follow-up, regardless of AS severity. An elevated IL-6 was associated with a 1.4-fold increased 4-year MACE-risk in patients with mild AS, suggesting its possible role as an early risk marker."

Clinical • Retrospective data • Cardiovascular • Congestive Heart Failure • Heart Failure • Ischemic stroke • Myocardial Infarction • IL6

Analysis of composite time-to-event endpoints in cardiovascular outcome trials. (PubMed, Clin Trials) - "For example, the IMPROVE-IT trial comparing ezetimibe+simvastatin to placebo+simvastatin in 18,144 patients with acute coronary syndrome used a primary composite endpoint with five component outcomes: (1) cardiovascular death, (2) non-fatal stroke, (3) non-fatal myocardial infarction, (4) coronary revascularization ≥30 days after randomization, and (5) unstable angina requiring hospitalization...This approach ignores information for subsequent outcome(s), possibly leading to reduced power to demonstrate the benefit of the test versus the control treatment. We use real data examples and simulations to contrast the traditional approach with several alternative approaches that use data for all the intra-patient component outcomes, not just the first."

Journal • Acute Coronary Syndrome • Cardiovascular • Myocardial Infarction

Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Cedars-Sinai Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8

OUTCOME OF NON-CRYOPRESERVED PERIPHERAL BLOOD STEM CELLS IN AUTOLOGOUS STEM CELL TRANSPLANT IN MULTIPLE MYELOMA (EHA 2024) - " This is a retrospective study of MM patient who underwent ASCT at Oncology Center, Mansoura University inEgypt from December 2019 to June 2023... ** NC preservation is a safe and effective method compared to cryopreservation inboth short-term outcomes and survival."

Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Transplantation

Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: Cedars-Sinai Medical Center

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8

Pharmacokinetics and Bioequivalence of Fixed-Dose Combination of Simvastatin and Ezetimibe Tablets: A Randomized, Crossover, Open-Label Study in Healthy Volunteers. (PubMed, Clin Pharmacol Drug Dev) - "The 90% confidence intervals of unconjugated ezetimibe, total ezetimibe, and simvastatin natural log-transformed under the concentration-time curve from time 0 to the last quantifiable concentration, and maximum concentration were in the range of 80%-125% as per the bioequivalence acceptance criteria. Therefore, the test formulation was bioequivalent to the reference formulation."

Journal • PK/PD data

Degree of serum LDL cholesterol reduction by simvastatin and ezetimibe is dependent on baseline LDL cholesterol concentration but not on baseline values and changes of cholesterol synthesis and absorption parameters. (PubMed, Int J Clin Pharmacol Ther) - "Under ezetimibe, simvastatin, and combination treatment, ΔLDL-C is predominantly dependent on the baseline LDL-C concentration. We hypothesize that the concentration gradient between serum LDL-C and hepatic cellular cholesterol determines the efficiency of serum LDL-C lowering. Combination treatment is the preferred treatment."

Journal • Dyslipidemia

To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects (clinicaltrials.gov) - P=N/A | N=20 | Completed | Sponsor: University at Buffalo | Unknown status ➔ Completed | Phase classification: P3 ➔ PN/A

Phase classification • Trial completion • Inflammation • Obesity • CD68

Rapid screening of ternary amorphous formulations byaspray drying robot. (PubMed, Int J Pharm) - "The practical use of the spray drying robot in formulation development was demonstrated on a case study of poorly water-soluble model drugs simvastatin and ezetimibe. The ability to populate the formulation design space rapidly and automatically made it possible to construct maps of physico-chemical properties such as glass transition temperature or dissolution rate. The spray drying robot thus enables the acceleration of early formulation development and a deeper understanding of composition-property relationships for multi-component spray dried powders."

Journal

Effect of Ezetimibe combined with Simvastatin in the treatment of coronary heart disease: a retrospective analysis. (PubMed, Eur Rev Med Pharmacol Sci) - "Compared with Simvastatin alone, a combination of Ezetimibe and Simvastatin can more effectively regulate the level of blood lipids, reduce the inflammatory reaction in the body, improve heart function, and lower the risk of MACE."

Journal • Retrospective data • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Heart Failure • CCL19 • CCL2 • CRP

A study on the chemical stability of cholesterol-lowering drugs in concomitant simple suspensions with magnesium oxide. (PubMed, J Pharm Health Care Sci) - "A simple co-suspension with MgO is feasible for atorvastatin, pravastatin, and rosuvastatin, although the rosuvastatin tablet should not be left soaking for a long time. Further it is inadvisable to suspend simvastatin or ezetimibe together with MgO because of their partial degradation."

Journal • Gastrointestinal Disorder

Use of sex-specific thresholds for low flow in assessment of prognosis in concordantly and discordantly graded aortic valve stenosis (ESC 2023) - " Data from 1353 patients (38.6% women) with asymptomatic mild-moderate AS and preserved left ventricular ejection fraction enrolled in the Simvastatin and Ezetimibe in AS study was used... Identification of low flow by the proposed sex-specific thresholds of stroke volume index <40 ml/m² in men and <32 ml/m² in women needs more validation before inclusion in clinical guidelines. Figure. Kaplan-Meier plot of event-free survival from combined death and heart failure hospitalization in groups of patients with mild-moderate AS normal flow, mild-moderate AS low flow, DGASEL with normal flow and DGASEL with low flow."

Discordant • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension

Validation of the developed ASGARD risk score for safe monitoring of asymptomatic patients with non-severe aortic valve stenosis (ESC 2023) - " We have developed the ASGARD risk score using data from 1196/1739 (69%) asymptomatic AS-patients with mild-to-moderate AS who were enrolled in the randomized, multicentre Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial... Without a new echocardiogram, the ASGARD risk score identifies patients at low risk for AS-related events among asymptomatic patients with non-severe AS. The ASGARD risk score also estimates the safe watchful-waiting period of 6, 15, 21, and 24 months for the four ASGARD risk score quartiles in decreasing order."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

ASGARD risk scores for long-term, individualized cardiovascular surveillance of low-risk patients with asymptomatic non-severe aortic valve stenosis: development and internal validation (ESC 2023) - " We analyzed serial measurements from 69% of 1579 patients with mild-to-moderate AS who were asymptomatic and event-free one year after inclusion in the randomized, multicenter Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial... The ASGARD risk scores show promise for long-term, individualized cardiovascular surveillance of low-risk patients with non-severe AS without unnecessary echocardiography. Further studies are warranted for external model validation, continuous optimization, and exploring the potential for implementation in clinical practice."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

A Retrospective Study on the Adoption of Lipid Management Guidelines in Post-Myocardial Infarction Patients in a Tertiary Care Centre. (PubMed, Cureus) - "This retrospective study highlights the need for early sensitisation and the adoption of secondary prevention strategies in acute coronary syndrome (ACS), as recommended by the 2019 ESC guidelines."

Journal • Retrospective data • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Genetic Disorders • Hypertension • Metabolic Disorders • Myocardial Infarction • Obesity • Pulmonary Arterial Hypertension • Type 2 Diabetes Mellitus

Impact of outcome adjudication in kidney disease trials: observations from the Study of Heart and Renal Protection (SHARP). (PubMed, Kidney Int Rep) - "Consequently, randomised comparisons using pre-adjudication reports found almost identical results (pre-adjudication: simvastatin/ezetimibe 1038 vs placebo 1077; risk ratio [RR] 0.95, 95%CI 0.88-1.04; post-adjudicated: 1057 vs 1084; RR=0.97, 95%CI 0.89-1.05)...Secondly, when an event that mimics an atherosclerotic outcome is not expected to be influenced by the treatment under study (e.g. heart failure), the aim of adjudicating atherosclerotic outcomes should be to remove such events. Lastly, restrictive definitions for the remaining suspected atherosclerotic outcomes may reduce statistical power."

Journal • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Dyslipidemia • Heart Failure • Nephrology • Renal Disease • Transplantation

Statin versus ezetimibe-statin for incident atrial fibrillation among patients with type 2 diabetes mellitus with acute coronary syndrome and acute ischemic stroke. (PubMed, Medicine (Baltimore)) - "After controlling for sex, age, comorbidities and medications, the patients coexisting with type 2 diabetes mellitus, acute coronary syndrome and acute ischemic stroke with ezetimibe 10 mg/simvastatin 20 mg treatment were not significantly at risk of AF, compared to the patients with atorvastatin 40 mg treatment (adjusted hazard ratio, 0.85; 95% confidence interval, 0.52-1.38). A similar effect for AF risk between ezetimibe 10 mg/simvastatin 20 mg and atorvastatin 40 mg users was observed in the current investigation."

Journal • Acute Coronary Syndrome • Atrial Fibrillation • Cardiovascular • Diabetes • Ischemic stroke • Metabolic Disorders • Type 2 Diabetes Mellitus