icosapent ethyl / Generic mfg. 
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  • ||||||||||  icosapent ethyl / Generic mfg.
    Journal:  The sphingosine-1-phosphate receptor 1 mediates the atheroprotective effect of eicosapentaenoic acid. (Pubmed Central) -  Jun 22, 2024   
    Finally, we show that Vascepa, a prescription drug containing highly purified and stable EPA ethyl ester, exerts its cardiovascular protective effect through the 17,18-EEQ-S1PR1 pathway in male and female mice. Collectively, our findings indicate that the anti-inflammatory effect of 17,18-EEQ involves the activation of the S1PR1-Gq-Ca2+-eNOS axis in ECs, offering a potential therapeutic target against atherosclerosis.
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Accelerated Atherosclerosis in a Patient With Multifactorial Chylomicronemia Syndrome (MCS), Elevated Lp(a), APOE2/4 Genotype and Diabetes Mellitus. (Kiosk 9) -  Jun 12, 2024 - Abstract #NLA2024NLA_227;    
    Several smaller studies have suggested MCS is caused by either of the two major mechanisms: (1) some combination of minor genetic polymorphisms, or (2) presence of a single genetic mutation in one of the five genes regulating triglyceride metabolism including LPL, APOC2, APOA5, GPHIBP1, and LMF1. We postulate acceleration of ASCVD in our patient with MCS was multifactorial, including deposition of atherogenic triglyceride rich lipoproteins within blood vessels, in addition to the independent risk factor of elevated Lp(a).
  • ||||||||||  icosapent ethyl / Generic mfg.
    Journal:  Omega-3 Fatty Acids for Cardiovascular Event Lowering. (Pubmed Central) -  Jun 2, 2024   
    Notably, icosapent ethyl, a purified formulation of eicosapentaenoic acid (EPA), has garnered compelling evidence in lowering residual cardiovascular risk in patients with hypertriglyceridemia and treated with statins. In this review, we summarize studies that have investigated omega-3-fatty acids for CV event lowering and discuss the clinical implementation of these agents based on trial data and guidelines.
  • ||||||||||  Nexletol (bempedoic acid) / Esperion Therap, Otsuka, Daiichi Sankyo
    Review, Journal:  Hyperlipidaemia in diabetes: are there particular considerations for next-generation therapies? (Pubmed Central) -  Apr 29, 2024   
    Thus, the efficacy of these drugs in subgroups with diabetes should also be closely considered, as well as any potential effects on glycaemic control. In this review, we describe the efficacy of next-generation therapies targeting lipoprotein metabolism in subgroups of people with diabetes and their effects on glycaemic control in individuals with diabetes and prediabetes and in normoglycaemic individuals.
  • ||||||||||  icosapent ethyl / Generic mfg.
    Journal:  Effects of icosapent ethyl according to baseline residual risk in patients with atherosclerotic cardiovascular disease: results from REDUCE-IT. (Pubmed Central) -  Apr 28, 2024   
    In this review, we describe the efficacy of next-generation therapies targeting lipoprotein metabolism in subgroups of people with diabetes and their effects on glycaemic control in individuals with diabetes and prediabetes and in normoglycaemic individuals. Among patients with ASCVD and elevated triglyceride levels, icosapent ethyl significantly reduces the risk of MACE irrespective of baseline CVD risk, though absolute benefits are largest for patients at the highest risk.
  • ||||||||||  Praluent (alirocumab) / Sanofi, Regeneron, Nexletol (bempedoic acid) / Esperion Therap, Otsuka, Daiichi Sankyo, Repatha (evolocumab) / Amgen, Astellas
    Review, Journal:  Effect of statin add-on therapy on cardiovascular mortality. (Pubmed Central) -  Mar 28, 2024   
    Add-on therapy with proprotein convertase subtilisin/kexin type 9 inhibitors achieved the primary composite CV endpoints in the respective CV outcomes trials for alirocumab (P?<?0.001) and evolocumab (P?<?0.001); however, neither CV outcomes trial found a difference vs. placebo in CV-related mortality...A CV outcomes trial of bempedoic acid monotherapy achieved its primary composite CV endpoint vs. placebo (P?=?0.004) but not the endpoint of death from CV causes...Proprotein convertase subtilisin/kexin type 9 inhibitors and icosapent ethyl have approved indications for CV risk reduction. Only add-on therapy with icosapent ethyl demonstrated a significant reduction in CV mortality in the overall intent-to-treat population, possibly due to the unique pleiotropic mechanisms of eicosapentaenoic acid independent of lipid-lowering effects.
  • ||||||||||  Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim, Leqvio (inclisiran) / Novartis, Nexlizet (bempedoic acid/ezetimibe) / Esperion Therap, Otsuka, Daiichi Sankyo
    Enrollment open:  ARTCAP: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) (clinicaltrials.gov) -  Mar 21, 2024   
    P4,  N=200, Recruiting, 
    Importantly, IPE consistently reduced MACE across a range of Lp(a) levels, including Not yet recruiting --> Recruiting
  • ||||||||||  icosapent ethyl / Generic mfg.
    EICOSAPENTAENOIC ACID INHIBITS LIPOPROTEIN(A) OXIDATION DUE TO SCAVENGING MECHANISMS IN VITRO (Moderated Poster Theater 06) -  Jan 26, 2024 - Abstract #ACC2024ACC_3170;    
    EPA inhibited oxidation of Lp(a)-enriched plasma in a time-dependent fashion consistent with a free radical scavenging mechanism. The potent antioxidant actions of EPA may contribute to reduced CV events in REDUCE-IT, including those subjects with elevated Lp(a).
  • ||||||||||  Parmodia (pemafibrate) / Kowa
    Review, Journal:  How to Handle Elevated Triglycerides: Life after PROMINENT. (Pubmed Central) -  Jan 8, 2024   
    Treatment with omega-3 fatty acids was also ineffective in reducing CV risk, with the exception of icosapent ethyl, which, however, appears to have beneficial effects beyond lipids...TG reduction can be achieved by various drugs, but most of them are ineffective in reducing CV risk. The results of outcome studies on new TG-lowering drugs will clarify whether lowering apoB levels is critical to achieve clinical benefit.
  • ||||||||||  icosapent ethyl / Generic mfg.
    Journal, HEOR, Cost-effectiveness, Cost effectiveness:  Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT USA: Results From Patients Randomized in the United States. (Pubmed Central) -  Jan 4, 2024   
    P3
    In this analysis, at $4.59 per day, IPE offers better outcomes than SC at lower costs in trial and over a lifetime and is cost-effective at $11.48 per day for conventional willingness-to-pay thresholds. Treatment with IPE should be strongly considered in US patients like those enrolled in REDUCE-IT USA.
  • ||||||||||  icosapent ethyl / Generic mfg.
    Enrollment closed, Surgery:  EMT2: EPA for Metastasis Trial 2 (clinicaltrials.gov) -  Dec 6, 2023   
    P3,  N=418, Active, not recruiting, 
    Treatment with IPE should be strongly considered in US patients like those enrolled in REDUCE-IT USA. Recruiting --> Active, not recruiting
  • ||||||||||  icosapent ethyl / Generic mfg.
    Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness:  Global eligibility and cost effectiveness of icosapent ethyl in primary and secondary cardiovascular prevention. (Pubmed Central) -  Sep 18, 2023   
    Up to forty-five percent of patients were eligible for IPE, depending on the selection criteria used (ie, REDUCE-IT criteria, US Food and Drug Administration label, Health Canada label, practice guidelines) and the population studied. Overall, eight cost-effectiveness studies across the United States, Canada, Germany, Israel, and Australia were included in this review and findings indicated that IPE is particularly cost effective in patients with established CVD.
  • ||||||||||  Parmodia (pemafibrate) / Kowa
    Clinical, Review, Journal:  Fibrates, Hypertriglyceridemia, and CVD Risk: Where Do We Stand After the PROMINENT Trial for Triglyceride Lowering? (Pubmed Central) -  Aug 31, 2023   
    The divergent results obtained in patients with hypertriglyceridemia (HTG), a group at particularly high risk of CVD, especially when coupled with other risk factors, indicates that triglyceride lowering in of itself is insufficient to offset CVD risk. Rather, the effectiveness of therapy in this high-risk cohort may be the result of the suppression of the inherent atherogenic properties associated with HTG.
  • ||||||||||  icosapent ethyl / Generic mfg.
    Biomarker, Journal:  Quantitative imaging biomarkers of coronary plaque morphology: insights from EVAPORATE. (Pubmed Central) -  Aug 21, 2023   
    In REDUCE-IT, icosapent ethyl (IPE) reduced total events, but the mechanisms of benefit are not fully understood...Plaques in the IPE-treated patients acquired more characteristics of stability. Reliable assessment using histologically validated analysis of individual response is possible at 9 months, with sustained stabilization at 18 months, providing a quantitative basis to elucidate drug mechanism and assess individual patient response.
  • ||||||||||  icosapent ethyl / Generic mfg.
    CM.APS.P5. Hold the Sugar: Glucose Lowering and Cardioprotective Therapies in Diabetes (Zone 3, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_4660;    
    DESCRIPTION This session will include posters focused on the cardiovascular effects of glucose lowering therapies. Additionally, there will be discussions on statins and icosapent ethyl in the setting of diabetes.
  • ||||||||||  Leqvio (inclisiran) / Alnylam, Novartis
    Review, Journal:  The Effects of Statins, Ezetimibe, PCSK9-Inhibitors, Inclisiran, and Icosapent Ethyl on Platelet Function. (Pubmed Central) -  Aug 2, 2023   
    Finally, in patients with hypertriglyceridemia, the REDUCE-IT study showed that icosapent ethyl (an ethyl ester of eicosapentaenoic acid that reduces triglyceride synthesis and improves triglyceride clearance) resulted in a 25% reduction in ischemic events and cardiovascular death. However, to date, there is not yet clear clinical evidence that the direct antithrombotic effects of the drugs may have a beneficial impact on outcomes independently from the reduction in LDL-C or triglycerides.
  • ||||||||||  Journal:  Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention. (Pubmed Central) -  Jul 24, 2023   
    Established pharmaceutical treatment options include the Niemann-Pick-C1 like-1 protein (NPC1L1) inhibitor ezetimibe, the protein convertase subtilisin-kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab, fibrates as peroxisome proliferator receptor alpha (PPAR-?) activators, and the omega-3 fatty acid icosapent ethyl...For secondary prevention in hypertriglyceridemia, second-line options such as statin add-on or statin-intolerant treatments are icosapent ethyl and fenofibrate...Recent biotechnological advances have led to the development of innovative small molecules (bempedoic acid, lomitapide, pemafibrate, docosapentaenoic and eicosapentaenoic acid), antibodies (evinacumab), antisense oligonucleotides (mipomersen, volanesorsen, pelcarsen, olezarsen), small interfering RNA (inclisiran, olpasiran), and gene therapies for patients with dyslipidemia...Apart from statins, data on new drugs' use in primary cardiovascular prevention remain scarce. For their swift adoption into clinical routine, these treatments must demonstrate safety and efficacy as well as cost-effectiveness in randomized cardiovascular outcome trials.
  • ||||||||||  icosapent ethyl / Generic mfg.
    Trial termination, Trial primary completion date:  MITIGATE: A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (clinicaltrials.gov) -  Jul 20, 2023   
    P4,  N=39600, Terminated, 
    For their swift adoption into clinical routine, these treatments must demonstrate safety and efficacy as well as cost-effectiveness in randomized cardiovascular outcome trials. Active, not recruiting --> Terminated | Trial primary completion date: Feb 2022 --> Dec 2022; The study was suspended by the IRB of record and subsequently terminated