ezetimibe/simvastatin / Generic mfg. - LARVOL DELTA

Targeting the AMPK/SIRT1-NLRP3 Inflammasome Axis: Simvastatin, Ezetimibe, and Their Combination Attenuate 3-Nitropropionic Acid-Induced Striatal Neurodegeneration in Rats. (PubMed, Neuropharmacology) - "The combination regimen consistently produced the most pronounced protective effects. Collectively, Simvastatin and Ezetimibe attenuate 3-NP-induced striatal neurodegeneration, possibly through modulation of AMPK/SIRT1-associated neuroinflammatory and glial signaling pathways, warranting further evaluation in additional experimental models."

Journal • Preclinical • CNS Disorders • Inflammation • AMPK • IL18 • IL1B • NLRP3

Deciphering the Mechanisms of Statin-Ezetimibe Drug Combinations Using Boolean Logical Modeling and Transcriptomic Data. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "To decipher the underlying molecular mechanisms of drugs used alone and in combination, we investigated the combination of a statin (atorvastatin or simvastatin) plus ezetimibe using drug-treated RNA-seq transcriptome data from the human hepatocyte-like SOAT2-only-HepG2 cells and from liver biopsies of non-obese normolipidemic patients with uncomplicated cholesterol gallstone disease in the Stockholm Study. Functional enrichment and disease-association analyses of the downstream genes also provide critical insights into the additional therapeutic actions of the drugs. Our study demonstrates that drug-induced transcriptomes, integrated with the human interactome, are informative in deciphering the MoA of drug combinations using Boolean logical modeling."

Journal • Gastroenterology • Obesity

Impact of adsorption-based solidification on the pharmaceutical performance and antidyslipidemic efficacy of simvastatin-ezetimibe SNEDDS. (PubMed, Int J Pharm ) - "In a Poloxamer 407-induced dyslipidemia model, both formulations significantly reduced total cholesterol, LDL-C, and triglyceride levels compared with the dyslipidemic control and produced greater lipid-lowering effects than the drug suspension, while no significant differences were observed between L-SNEDDS and S-SNEDDS. These findings suggest that adsorption-based solidification preserved the pharmaceutical and therapeutic performance of the optimized L-SNEDDS while providing the practical advantages of a solid dosage form, supporting S-SNEDDS as a promising oral lipid-based delivery system for simvastatin-ezetimibe combination therapy."

Journal • Dyslipidemia • Metabolic Disorders

Drugs for hypercholesterolemia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dyslipidemia • Metabolic Disorders

Comparison chart: Statins. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Tirzepatide Use in Familial Partial Lipodystrophy Type 6: A Case Report (ECO 2026) - "Metreleptin and semaglutide show variable and/or modest effectiveness in people with FPLDs...The patient was evaluated at our outpatient clinic for obesity class I, diabetes mellitus, dyslipidemia, hypertension, and obstructive sleep apnea syndrome...The overnight dexamethasone suppression test was negative...Ongoing therapy included metformin 2 g/day, simvastatin/ezetimibe 40/10 mg/day, omega-3 1 g/day, ramipril/hydrochlorothiazide 5/25 mg/day, and atenolol 50 mg/day... Currently, no curative therapy exists for FPLD, and conventional pharmacologic therapies frequently fail to normalize metabolic complications. This case report extends the promising evidence of the dual incretin tirzepatide in improving metabolic control and body weight in patients with FPLD1-3 also to the rarest FPLD6. These findings warrant further investigations."

Case report • Clinical • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Hepatology • Hypertension • Hypertriglyceridemia • Lipodystrophy • Metabolic Disorders • Obesity • Obstructive Sleep Apnea • Rare Diseases • Respiratory Diseases • Sleep Disorder • LMNA

Formulation and evaluation of a facile oral nanocarrier system Co-Encapsulating simvastatin and ezetimibe for enhanced Lipid-Lowering effect. (PubMed, Eur J Pharm Biopharm) - "In vivo evaluation in a hyperlipidemic rat model demonstrated that the optimized formulation significantly reduced total cholesterol levels compared with both the marketed product (Inegy™) and the drug suspension, indicating enhanced oral absorption. These findings highlight the potential of this nanoparticle system as an effective platform to improve the therapeutic efficacy of the SIM/EZE fixed-dose combination."

Journal • Cardiovascular • Dyslipidemia

Effects of Ezetimibe, Statins, and Their Combination on Nuclear Factor Erythroid 2‑Related Factor 2/Heme Oxygenase-1/Kelch-like ECH-Associated Protein‑1 Signaling and Inflammatory Markers in Indomethacin-Induced Gastric Ulcer in Rats. (PubMed, ACS Pharmacol Transl Sci) - "Rats were assigned into six groups (n = 8, each): (I) normal (control), (II) gastric ulcer induced with a single oral dose of indomethacin (30 mg/kg body weight), (III) rats received oral simvastatin (40 mg/kg/day) for 14 days, (IV) rats received oral ezetimibe (10 mg/kg/day) for 14 days, (V) the combination group received both oral simvastatin and ezetimibe, and (VI) standard group received oral famotidine (20 mg/kg). Simvastatin plus ezetimibe exerted synergistic gastroprotective effects in rats, associated with Nrf2/HO-1 activation and suppression of Keap1, oxidative stress, and pro-inflammatory cytokines. This combination may represent a novel therapeutic approach for preventing NSAID-induced GUs, meriting further mechanistic and translational studies."

Journal • Preclinical • Gastrointestinal Disorder • Inflammation • Oncology • Peptic Ulcer • CRP • HMOX1 • KEAP1 • TNFA

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