Fenofibrate 145mg / Simvastatin 40mg tablets
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Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 10 · 1992–2026
Showing the 50 most relevant studies, sorted by most relevant.
Birdal O, Saygı M, Doğan R, et al.
2023
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Venous Thromboembolism
- Fenofibrate
BackgroundAnticoagulants are the mainstay of treatment for venous thromboembolism (VTE). Studies have shown conflicting results regarding statins ability to reduce the incidence of VTE.AimsTo perform a network meta-analysis to determine which lipid-lowering agent was more efficacious in and had more evidence regarding reducing the VTE risk.Study designNetwork meta-analysis of the randomized controlled trials (RCTs).MethodsRCTs that assessed the effectiveness and safety of statins or fibrates and compared them to a placebo or another statin were eligible for the study. The outcomes examined in the study were deep vein thrombosis, pulmonary embolism, and/or VTE. We conducted a comprehensive search of the Medline database from 1966 to February 2017, using specific search terms related to VTE and statins. Additionally, we screened, and cross-checked relevant systematic reviews and meta-analyses. We performed a network meta-analysis to compare the different lipid-lowering agents to each other and the placebo and their effectiveness.ResultsTwenty-seven RCTs were included in the network meta-analysis (n = 137,940). Pairwise meta-analysis revealed a statistically significant lower incidence of VTE with statins than with placebos (0.79% vs 0.99%, respectively; risk ratios: 0.87, 0.77-0.98; p = 0.022). Rosuvastatin had the most favorable effect in reducing VTE risk than the other statins, fenofibrate, and placebo. Fenofibrate was ranked the worst drug choice, because it increased risk of VTE when compared with the other statins. Rosuvastatin was the best choice for reducing the VTE risk when compared with the placebo (OR: 0.56, 0.42-0.75), atorvastatin (OR: 0.64, 0.44-0.95), pravastatin (OR: 0.50, 0.34-0.74), simvastatin (OR: 0.60, 0.42-0.86) and fenofibrate (OR: 0.37, 0.25-0.56). Compared with a placebo, rosuvastatin reduced the VTE risk by around 45% and fenofibrate increased the risk by 65%.ConclusionRosuvastatin is significantly reduces the risk of VTE when compared with a placebo, other statin subtypes, and fibrate. Furthermore, fenofibrate increased the VTE risk when compared with a placebo and statins.
Abstract licence: CC BY-NC-ND
Chen KY, Chan HC, Chan CM
2025
IntroductionMacular edema, a major cause of vision loss in diabetic retinopathy, involves retinal fluid accumulation and retinal thickening due to vascular dysfunction and inflammation. Standard treatments include anti-VEGF agents, corticosteroids, and laser photocoagulation, but limitations such as incomplete response and adverse effects exist. Statins, known for lipid-lowering and pleiotropic anti-inflammatory effects, have emerged as a potential therapeutic option.MethodsWe conducted a systematic review and meta-analysis registered with PROSPERO (CRD420251082672) following PRISMA guidelines. Peer-reviewed studies evaluating statins' efficacy and safety in macular edema were identified via multiple databases up to May 2025. Included studies encompassed randomized controlled trials and observational studies involving patients with macular edema treated with statins versus controls. Key outcomes were hard exudate reduction, retinal thickness, visual acuity, diabetic retinopathy progression, and safety.ResultsTen eligible studies involving atorvastatin and simvastatin showed statins significantly reduced hard exudates (risk ratio 4.42, p=0.03) and retinal thickness, with a 58% reduction in diabetic retinopathy progression. Statins also decreased the need for laser treatment by 32%. Visual acuity improvement was inconsistent, with benefits mainly in dyslipidemic patients. Safety analysis revealed no significant increase in adverse events. Statin effects were more pronounced in patients with elevated lipid levels.ConclusionStatins demonstrate promising anatomical and preventive benefits in diabetic macular edema, particularly in patients with dyslipidemia, by reducing lipid exudation and stabilizing retinal vasculature. Despite limited visual acuity improvement, their favorable safety profile supports considering statins as adjunctive therapy. Further large-scale, long-term trials are warranted to confirm these findings and optimize treatment protocols.
Abstract licence: CC BY
Luo J, Dai Y, Wu C, et al.
2026
- Diabetic Nephropathies
- Dyslipidemias
- Hypolipidemic Agents
BackgroundIn diabetic kidney disease (DKD), dyslipidemia accelerates renal decline and heart failure risk, making Cardio-Renal-Metabolic (CRM) risk reduction critical. The bidirectional relationship between cardiac and renal dysfunction further highlights the necessity of lipid-lowering therapy as a common intervention pathway; however, its comparative efficacy remains unclear.ObjectiveTo compare the Cardio-Renal-Metabolic (CRM) outcomes of various lipid-lowering agents.MethodsWe searched PubMed, Embase, Web of Science, and Cochrane Library for Randomized Controlled Trials (RCTs) up to May 10, 2025; a Bayesian network meta-analysis compared their effects.ResultsFrom 20 RCTs, Cerivastatin best reduced Total Cholesterol (TC) (Mean Difference (MD): -94.03, 95% CI: -185.37 to -2.16), while Simvastatin best lowered Low-Density Lipoprotein Cholesterol (LDL-C) (MD: -56.05, 95% CI: -101.64 to -11.66). For cardiorenal outcomes, Atorvastatin, Rosuvastatin, and Fenofibrate potentially improved Urine Albumin-to-Creatinine Ratio (UACR). Atorvastatin (MD: -3.19, 95% CI: -5.12 to -1.27) and Fenofibrate (MD: -1.44, 95% CI: -2.78 to -0.09) most robustly reduced cardiovascular event rates (CVER) in hyperlipidemic DKD.ConclusionLipid-lowering agents have divergent effects; Atorvastatin and Fenofibrate best reduce CVER despite variable renal effects, supporting a phenotype-driven CRM strategy prioritizing residual cardiovascular risk reduction.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/, identifier CRD420251049719.
Abstract licence: CC BY
Huang J, Meng K, Qiu H
2026
- Diabetes Mellitus
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Hyperlipidemias
ObjectiveTo systematically assess the clinical effectiveness of combining fenofibrate with statins in treating patients with diabetes mellitus and hyperlipidemia.MethodsClinical randomized controlled trials assessing the efficacy of fenofibrate and statins in patients with diabetes mellitus and hyperlipidemia were identified from both Chinese and international databases. The experimental group received fenofibrate combined with statins, while the control group received either statins or fenofibrate alone, statins or fenofibrate with placebo, placebo alone, or lifestyle interventions.ResultsThe analysis incorporated 18 randomized controlled trials with a combined participant count of 2113. The analysis showed that patients in the experimental group had a higher overall efficacy rate than those in the control group (OR = 5.42, 95% CI = 3.11 to 9.45, P ConclusionThis meta-analysis shows that the combination of fenofibrate and statins is superior to statin monotherapy in improving lipid and glycemic profiles (surrogate markers) in patients with diabetes and hyperlipidemia. However, its long-term benefits on cardiovascular hard endpoints need further confirmation, and combination therapy may increase the risk of adverse reactions such as muscular and hepatic events. Clinical application requires balancing benefits and risks, accompanied by enhanced monitoring.
Abstract licence: CC BY
S. Grundy, G. Vega, Zhong Yuan, et al.
The American journal of cardiology, 2005
G. Vega, P. Ma, N. Cater, et al.
The American journal of cardiology, 2003
Budiman A, Mutmainah L, Anjelina M, et al.
2025
- Silicon Dioxide
- Atherosclerosis
- Nanoparticles
Atherosclerosis (AS) is a chronic inflammatory condition of large arteries and a major contributor to cardiovascular disease (CVD) and stroke. The prevention of AS diseases involves numerous anti-atherosclerosis agents, including antihyperlipidemic and antihypertensive drugs. However, these drugs often exhibit poor aqueous solubility, which can affect their bioavailability and therapeutic efficacy. Mesoporous silica nanoparticles (MSNs) have emerged as effective drug delivery systems due to their high surface area, tunable pore sizes, surface functionalization potential, and physicochemical stability. These characteristics enable enhanced drug loading, regulated release, and stabilization of amorphous drug forms, thereby improving solubility, permeability, pharmacokinetics, and therapeutic efficacy. This review offers an in-depth look at MSN-based strategies for optimizing the delivery of anti-atherosclerosis drugs, particularly those targeting cholesterol levels and blood pressure control. Relevant data were sourced from PubMed, Scopus, and Google Scholar using the keywords "mesoporous silica nanoparticle", "atherosclerosis", "antihyperlipidemic", and "antihypertensive." Numerous studies have demonstrated the ability of MSN formulations to significantly enhance drug performance, with reported enhancements in solubility and bioavailability ranging from 1.4-fold to 88-fold, depending on the drug and formulation. For example, nifedipine-loaded MSNs showed an 88-fold increase in solubility compared to the pure drug and a 10-fold improvement over marketed tablets. Simvastatin-loaded MSNs achieved a 6.1-fold enhancement in oral bioavailability, while efonidipine-loaded MSNs exhibited up to a 3.5-fold increase in dissolution and permeability. These advancements may result in decreased dosing frequencies, reduced drug dosages, and fewer adverse effects, ultimately improving patient compliance. However, clinical translation remains limited due to the lack of early-phase clinical trials, insufficient long-term safety data, and challenges associated with large-scale MSN manufacturing. This review highlights the therapeutic potential of MSNs in cardiovascular applications and points out that it requires further research to address translational barriers. With continued development, MSN-based delivery systems hold strong potential to enhance the clinical effectiveness of anti-atherosclerosis therapies.
Abstract licence: CC BY-NC
A. Wright, P. Dodson
Eye, 2011
Hou J, Chen KX, He C, et al.
2024
- Macrophages
- PPAR alpha
- Aging
The accumulation and systemic propagation of senescent cells contributes to physiological aging and age-related pathology. However, which cell types are most susceptible to the aged milieu and could be responsible for the propagation of senescence has remained unclear. Here we found that physiologically aged bone marrow monocytes/macrophages (BMMs) propagate senescence to multiple tissues, through extracellular vesicles (EVs), and drive age-associated dysfunction in mice. We identified peroxisome proliferator-activated receptor α (PPARα) as a target of microRNAs within aged BMM-EVs that regulates downstream effects on senescence and age-related dysfunction. Demonstrating therapeutic potential, we report that treatment with the PPARα agonist fenofibrate effectively restores tissue homeostasis in aged mice. Suggesting conservation to humans, in a cohort study of 7,986 participants, we found that fenofibrate use is associated with a reduced risk of age-related chronic disease and higher life expectancy. Together, our findings establish that BMMs can propagate senescence to distant tissues and cause age-related dysfunction, and they provide supportive evidence for fenofibrate to extend healthy lifespan.
Abstract licence: CC BY-NC-ND
N. Tarantino, F. Santoro, L. De gennaro, et al.
Vascular Health and Risk Management, 2017
- Simvastatin
- Triglycerides
- Lipoproteins, HDL
Lipids disorder is the principal cause of atherosclerosis and may present with several forms, according to blood lipoprotein prevalence. One of the most common forms is combined dyslipidemia, characterized by high levels of triglycerides and low level of high-density lipoprotein. Single lipid-lowering drugs may have very selective effect on lipoproteins; hence, the need to use multiple therapy against dyslipidemia. However, the risk of toxicity is a concerning issue. In this review, the effect and safety of an approved combination therapy with simvastatin plus fenofibrate are described, with an analysis of pros and cons resulting from randomized multicenter trials, meta-analyses, animal models, and case reports as well.
Abstract licence: CC BY-NC 3.0
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Scientific data (pharmacology, interactions, ADME) is not yet available for this medicine. Clinical sections are sourced from the NHS dm+d database.