Cholib (fenofibrate/simvastatin) / AbbVie - LARVOL DELTA

Beyond Weight Clinical Biochemical Evolution in a Patient With Obesity Treated Comprehensively at a Mexican Clinic (OBESITY WEEK 2025) - "Her pharmacological treatment focused on discontinuing insulin and gradually increasing the use of semaglutide, starting at 0.25 mg and increasing to 0.50 mg, and fenofibrate/simvastatin (145/40 mg); supplementation with omega-3 fatty acids (DHA and EPA) and probiotics ( Bifidobacterium lactis BPL1®); the results are shown below. The results obtained in this clinical case suggest that lifestyle modification, a healthy diet, drug treatment, and supplementation have a positive impact on BMI (kg/m2 ) , body composition, and biochemical values in patients living with obesity. Specialized obesity management clinics that integrate all of these factors into their treatment are essential."

Clinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Innovative methods in evaluating the effects of lipid-lowering medication on bone tissue. (PubMed, Sci Rep) - "Both fenofibrate and simvastatin decrease bone strength, and the effect was more significant with the increase of the duration of treatment. The negative effects on bone tissue are more significant with fenofibrate."

Journal • Cardiovascular

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). Furthermore, it may reduce mortality for patients who have failed other modalities for weight loss, which is consistent with our findings. Ongoing research is essential to understand the long-term outcomes of GLP-1 analog therapy."

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

Assessment of bone tissue cytoarchitectonics by 2D 1H NMR relaxometry maps. (PubMed, J Biol Phys) - "In the presence of estrogen, lipid-lowering medication, both simvastatin and fenofibrate alter bone tissue cytoarchitectonics by reducing pore interconnectivity. In the absence of estrogen, fenofibrate improves bone tissue cytoarchitectonics, the T2-T2 molecular exchange map being similar to that of non-osteoporotic bone tissue."

Journal • Osteoporosis • Rheumatology

Negative LDL-C levels with Detectable Apolipoprotein B: Surrogate Markers of Atherosclerotic Disease and Cardiac Event Risk (NLA 2024) - "Background/Synopsis: Serial LDL-C measurements remain the mainstay of targeted therapy for patients on lipid lowering therapy including statins, ezetimibe as well as PCSK9 inhibitors... A 58-year-old male with severe mixed hyperlipidemia presented on fenofibrate and simvastatin...Evolocumab was added to his medication regimen, along with icosapent ethyl... Aggressive therapy with PCSK9 inhibitors and statins may lead to significant decreases in LDL-C, to undetectable or calculated negative levels. It is important to note however, that at elevated triglyceride levels usually exceeding 300 mg/dL, calculated LDL levels are grossly inaccurate, and will not serve as a reliable marker of atherosclerotic cardiovascular disease (ASCVD) risk. Sniderman et al."

Atherosclerosis • Cardiovascular • Dyslipidemia • APOB

Elevated Baseline Triglycerides As an Independent Risk Factor For Coronary Artery Disease (ENDO 2024) - "His medications included empagliflozin 10 mg daily, repaglinide 1 mg three times a day, atorvastatin 20 mg daily, and amlodipine 10 mg daily...As a result of that, the VLDL triglycerides rise, forming small dense LDL with a strong atherogenic potential.In the 2010 published ACCORD study, the effects of simvastatin alone versus simvastatin and fenofibrate were compared in 5500 Patients with type 2 diabetes... McGarry at the University of Texas Southwestern Medical Center was the first to describe the elevated triglyceride along with low HDL phenotype associated with insulin resistance. They explained this phenotype as a result of hepatic insulin resistance. Elevated insulin levels reduce the activity of lipoprotein lipase (LPL)."

Clinical • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Hypertension • Hypertriglyceridemia • Metabolic Disorders • Type 2 Diabetes Mellitus • LPL

Tailored ASD destabilization - Balancing shelf life stability and dissolution performance with hydroxypropyl cellulose. (PubMed, Int J Pharm X) - "This study assessed the potential of ternary ASDs (one API and two polymers) containing the polymers hydroxypropyl cellulose together with poly(vinylpyrrolidone-co-vinyl acetate) (PVP VA64) or hydroxypropyl cellulose acetate succinate to stabilize the amorphously embedded APIs fenofibrate and simvastatin during storage and to enhance the dissolution performance. The thermodynamically most stable ASDs were found to be the ASDs with deteriorated dissolution performance. Within the investigated polymer combinations, physical stability and dissolution performance opposed each other."

Journal

The effects of simvastatin and fenofibrate on malondialdehyde and reduced glutathione concentrations in the plasma, liver, and brain of normolipidaemic and hyperlipidaemic rats. (PubMed, Arh Hig Rada Toksikol) - "In both rat strains fenofibrate significantly decreased liver GSH concentrations, most likely because fenofibrate metabolites bind to GSH. Our findings suggest that simvastatin acts as an antioxidant only in normolipidaemic rats, whereas fenofibrate acts as an antioxidant in both rat strains."

Journal • Preclinical

Frequency and predictors of inappropriate medication dosages for cardiovascular disease prevention in chronic kidney disease patients: A retrospective cross-sectional study in a Malaysian primary care clinic. (PubMed, Heliyon) - "Medications with inappropriate dosages identified in this study include simvastatin, fenofibrate, hydrochlorothiazide, spironolactone, metformin, gliclazide, sitagliptin, dapagliflozin and empagliflozin. Clinicians should consider the predictors of inappropriate medication dosages listed above when prescribing to patients with CKD to reduce the risk of medications-related toxicities and adverse effects. Limitations of this study should be considered when interpreting the findings presented."

Journal • Observational data • Retrospective data • Cardiovascular • Chronic Kidney Disease • Diabetes • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease

Screening of Fenofibrate-Simvastatin Solid Dispersions in the Development of Fixed-Dose Formulations for the Treatment of Lipid Disorders. (PubMed, Pharmaceutics) - "Fenofibrate and simvastatin were processed using the kneading method in different weight ratios, and the resulting solid dispersions were assessed using differential scanning calorimetry (DSC), X-ray powder diffractometry (XRPD), Fourier-transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), contact angle, as well as dissolution tests. The obtained results confirmed the formation of a simple eutectic phase diagram, with a eutectic point containing 79 wt% fenofibrate and 21 wt% simvastatin, lack of chemical interactions between the ingredients, and simvastatin impact on improving fenofibrate dissolution profile, due to the formation of crystalline solid dispersions by the kneading method."

Journal • Dyslipidemia • Metabolic Disorders

Determination of 12 anti-obesity drugs in human plasma by a 96-well protein precipitation plate using HPLC-MS. (PubMed, RSC Adv) - "A good linearity was obtained in the range of 0.1-20.0 ng mL for fenfluramine, bupropion, fluoxetine, sibutramine, bisacodyl, and rimonabant; and 0.5-20.0 ng mL for methylephedrine, amphetamine, bumetanide, lovastatin, simvastatin, and fenofibrate with a correlation coefficient above 0.995. The method was fully validated with an acceptable accuracy of 75.63-108.21%, matrix effect of 80.41-117.71% except for fenofibrate (76.07% at low concentration levels), and precision of 0.32-13.12%. Owing to the advantages of simple operation, high accuracy and sensitivity, this method is suitable for the rapid and simultaneous detection of 12 anti-obesity drugs in human plasma, providing support for clinically monitoring the development of adverse reactions and guiding the rational and appropriate use of weight-loss drugs for obese people."

Journal • Genetic Disorders • Obesity

Fenofibrate and Heart Failure Outcomes in Patients With Type 2 Diabetes: Analysis From ACCORD. (PubMed, Diabetes Care) - "In patients with T2D treated with simvastatin, fenofibrate reduced the composite of HF hospitalizations or cardiovascular mortality, an effect that was seen predominantly in patients with standard background glucose-lowering therapy."

Journal • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Type 2 Diabetes Mellitus

Ternary Eutectic Ezetimibe-Simvastatin-Fenofibrate System and the Physical Stability of Its Amorphous Form. (PubMed, Mol Pharm) - "Thermal properties, molecular dynamics, and physical stability of the obtained amorphous system were thoroughly investigated through various experimental techniques compared to both: neat amorphous active pharmaceutical ingredients (considered separately) and other representative concentrations of ternary mixture. The obtained results open up a new way of selecting the therapeutic concentrations for combined therapies, a path that considers one additional variable: eutecticity."

Journal • Dyslipidemia

Interdependent Impact of Lipoprotein Receptors and Lipid-Lowering Drugs on HCV Infectivity. (PubMed, Cells) - "Strikingly, whereas lipid‑lowering drugs such as simvastatin or fenofibrate did not affect HCV entry or infection of immortalized hepatoma cells expressing SR-B1 and/or LDLr or primary human hepatocytes, ablation of these receptors rendered cells more susceptible to these drugs. Interestingly, statin treatment, which blocks the mevalonate pathway leading to decreased cholesterol levels, was associated with mild but appreciable lower levels of liver damage markers before HCV therapy. Overall, our findings confirm the role of lipid homeostasis in HCV infection and highlight the importance of the mevalonate pathway in the HCV replication cycle."

Journal • Dyslipidemia • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Cancer • Metabolic Disorders • Solid Tumor

Drug-drug-gene interactions as mediators of adverse drug reactions to diclofenac and statins: a case report and literature review. (PubMed, Arh Hig Rada Toksikol) - "In that light, we present a case of a 46-year-old woman who had been experiencing acute renal and hepatic injury and myalgia over two years of concomitant treatment with diclofenac, atorvastatin, simvastatin/fenofibrate, and several other drugs, including pantoprazole and furosemide. We also discuss the importance of CYP polymorphisms in the biotransformation of endogenous substrates such as arachidonic acid and their modulating role in pathophysiological processes. Yet even though the risks of ADRs related to the above mentioned drugs are substantially evidenced in literature, pre-emptive pharmacogenetic analysis has not yet found its way into common clinical practice."

Adverse drug reaction • Clinical • Journal • Review • Hepatology • Liver Failure • Musculoskeletal Pain • Pain

REP1-deficiency causes systemic dysfunction of lipid metabolism and oxidative stress in choroideremia. (PubMed, JCI Insight) - "Targeted lipidomics of the chmru848 zebrafish provided further evidence for dysfunction, with the use of Fenofibrates over Simvastatin circumventing the prenylation pathway to improve the lipid profile and increase survival. This study provides strong evidence for systemic manifestations of CHM and proposes novel pathomechanisms and targets for therapeutic consideration."

Journal • Inherited Retinal Dystrophy • Metabolic Disorders • Ophthalmology • Retinal Disorders

Inflammatory Activities in Type 2 Diabetes Patients With Co-morbid Angiopathies and Exploring Beneficial Interventions: A Systematic Review. (PubMed, Front Public Health) - "Use of drugs such as salsalate, pioglitazone, simvastatin, and fenofibrate but not glimepiride or benfotiamine reported a significant decrease in inflammatory events. Regular exercise and consumption of dietary supplements such as ginger, hesperidin which have anti-inflammatory properties, and those containing prebiotic fibers (e.g., raspberries) revealed a consistent significant (p < 0.05) reduction in inflammatory activities. Inflammatory activities are implicated in diabetes-related angiopathies; regular exercise, the intake of healthy dietary supplements, and medications with anti-inflammatory properties could result in improved protective risk outcome for diabetes patients by suppressing inflammatory activities and elevating anti-inflammatory events."

Clinical • Review • Diabetes • Immunology • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • AGER • IL10 • IL6 • TNFA

Legacy effect of fibrate add-on therapy in diabetic patients with dyslipidemia: a secondary analysis of the ACCORDION study. (PubMed, Cardiovasc Diabetol) - P3 | "Fibrate treatment during the initial trial period was associated with a legacy benefit of improved survival over a post-trial follow-up. These findings support re-evaluation of fibrates as an add-on strategy to statins in order to reduce cardiovascular risk in diabetic patients with dyslipidemia. Trial registration clinicaltrials.gov, Identifier: NCT00000620."

Clinical • Journal • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Dyslipidemia • Heart Failure • Metabolic Disorders • Myocardial Infarction • Type 2 Diabetes Mellitus

Safety considerations with fenofibrate/simvastatin combination. (PubMed) - "Furthermore, a decrease in albuminuria was observed with fenofibrate in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and ACCORD Lipid trials. Overall, the combined administration of fenofibrate with simvastatin appears to be safe, unless clinicians give fenofibrate/simvastatin combination to patients with predisposing risk factors for the occurrence of adverse events."

Journal • Biosimilar • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Dyslipidemia

NEAT1 is overexpressed in Parkinson's disease substantia nigra and confers drug-inducible neuroprotection from oxidative stress. (PubMed, FASEB J) - "Furthermore, neuroprotective agents, including fenofibrate and simvastatin, induced NEAT1 up-regulation, whereas RNA interference-mediated depletion of NEAT1 exacerbated death of PQ-exposed cells in a leucine-rich repeat kinase 2-mediated manner. Our findings highlight a novel protective role for NEAT1 in PD and suggest a previously unknown mechanism for the neuroprotective traits of widely used preventive therapeutics.-Simchovitz, A., Hanan, M., Niederhoffer, N., Madrer, N., Yayon, N., Bennett, E. R., Greenberg, D. S., Kadener, S., Soreq, H. NEAT1 is overexpressed in Parkinson's disease substantia nigra and confers drug-inducible neuroprotection from oxidative stress."

Journal • CNS Disorders • Gene Therapies • Movement Disorders • Parkinson's Disease

Nanodiscs bounded by styrene-maleic acid allow trans-cis isomerization of enclosed photoswitches of azobenzene labeled lipids. (PubMed, Chem Phys Lipids) - "Fastest isomerization kinetics were found when azolipids were present in membranes supplemented with lysolipids and slowest in those supplemented with di-unsaturated lipids, suggesting that the isomerization rate is sensitive to the lateral pressure profile in the lipid bilayer and hence may be considered a convenient tool to monitor packing properties of lipids enclosed in nanodiscs. When azolipids were incorporated in SMA-bounded nanodiscs, azolipid isomerization was found to take place readily, indicating that SMA polymers behave as rather flexible belts and allow expansion of the enclosed lipid material."

Journal • Review

Vascular AMPK: enhancer, brake or both? (PubMed, Basic Clin Pharmacol Toxicol) - "The vascular protective effects of certain antidiabetic (metformin and sitagliptin) or lipid-lowering (simvastatin and fenofibrate) therapeutic agents, of active components of Chinese medicinal herbs (resveratrol and berberine), and of pharmacological agents (AICAR, A769662 and PT1) have been attributed to the activation of AMPK (in endothelial cells, vascular smooth muscle cells, and/or perivascular adipocytes), independently of changes in the metabolic profile (e.g. glucose tolerance and/or plasma lipoprotein levels), leading to improved endothelium-derived nitric oxide-mediated vasodilatation and attenuated endothelium-derived cyclooxygenase-dependent vasoconstriction...Therefore, AMPK activation is not necessarily beneficial in terms of endothelial function. The contribution of endothelial AMPK in the regulation of vascular tone, in particular in the microvasculature where EDH plays a more important role, remains to be characterized."

Journal • Review

Rhabdomyolysis risk from the use of two-drug combination of antidyslipidemic drugs with antihypertensive and antidiabetic medications: a signal detection analysis. (PubMed, Fundam Clin Pharmacol) - "We assessed the risk of rhabdomyolysis for the two-drug concomitant use of antidyslipidemic drugs (statin, fibrate, and ezetimibe) with antihypertensive and antidiabetic medications. Concomitant use of pravastatin/fenofibrate, simvastatin/mefruside, fluvastatin/temocapril, bezafibrate/temocapril, bezafibrate/spironolactone, bezafibrate/metoprolol, bezafibrate/losartan, fluvastatin/mitiglinide, or fenofibrate/glibenclamide was detected as the signal of rhabdomyolysis in this analysis. Combination therapy with the drugs listed above has the potential of drug-drug interactions that could result in rhabdomyolysis in patients with dyslipidemia."

Journal

Effects of simvastatin and fenofibrate on butyrylcholinesterase activity in the brain, plasma, and liver of normolipidemic and hyperlipidemic rats. (PubMed, Arh Hig Rada Toksikol) - "In most cases the increase was significant. Considering the important role of BuChE in cholinergic transmission as well as its pharmacological function, it is necessary to continue investigations of the effects of lipid-lowering drugs on BuChE activity."

Journal • Preclinical

FIXED DOSE COMBINATION OF SIMVASTATIN AND FENOFIBRATE VERSUS HIGH DOSE ROSUVASTATIN IN HYPERTRIGLYCERIDEMIA (EAS 2019) - "Combination treatment of simvastatin and fenofibrate was better than high intensity rosuvastatin in control of hypertriglyceridemia and improvement of HDL cholesterol."