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  • ||||||||||  Retrospective data, Journal:  Drug-induced vasculitis (Pubmed Central) -  Dec 29, 2019   
    Anamnestic, clinical, biological and histopathological findings allow the early recognition of drug-induced vasculitis. Adequate treatment prevents systemic spreading and a worse prognosis.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, danazol oral / Generic mfg.
    Preclinical, Journal:  A lipolysis-permeation setup for simultaneous study of digestion and absorption in vitro. (Pubmed Central) -  Dec 21, 2019   
    The drug transfer across the Caco-2 membrane accurately reflected in vivo drug exposure upon administration of three different LBFs loaded with fenofibrate, where the traditional lipolysis set up failed to predict in vivo performance. As the new setup reflects the dynamic processes occurring in the gastrointestinal tract, it is a valuable tool that can be used in the development of LBFs prior to in vivo studies.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  β-hydroxybutyrate protects hepatocytes against endoplasmic reticulum stress in a sirtuin 1-independent manner. (Pubmed Central) -  Dec 21, 2019   
    In human hepatoma HepG2 cells, the protein expression levels of ER stress responsive genes were increased by the partial inhibition of BHB production with siRNA targeting endogenous 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) lyase, whereas they were decreased by promoting BHB production with fenofibrate. These findings revealed that BHB helps to suppress hepatic ER stress via a SIRT1-independent pathway, and it might be possible to manipulate ER stress by regulating BHB production genetically or pharmacologically.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Retrospective data, Journal:  Fibrates as drugs with senolytic and autophagic activity for osteoarthritis therapy. (Pubmed Central) -  Dec 19, 2019   
    FUND: This study was supported by Instituto de Salud Carlos III- Ministerio de Ciencia, Innovación y Universidades, Spain, Plan Estatal 2013-2016 and Fondo Europeo de Desarrollo Regional (FEDER), "Una manera de hacer Europa", PI14/01324 and PI17/02059, by Innopharma Pharmacogenomics platform applied to the validation of targets and discovery of drugs candidates to preclinical phases, Ministerio de Economía y Competitividad, by grants of the National Instiutes of Health to PDR (P01 AG043376 and U19 AG056278). We thank FOREUM Foundation for Research in Rheumatology for their support.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Lipid-lowering agents for concurrent cardiovascular and chronic kidney disease. (Pubmed Central) -  Dec 19, 2019   
    The use of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, cholesterol-reducing nutraceuticals, bempedoic acid and apabetalone in such patients should be investigated. Patients with concomitant CVD and CKD should be treated, in terms of lipid-lowering therapy, early and intensively to minimize their very high risk and possibly, progression of CKD.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Long-Term Effects of Intensive Glycemic and Blood Pressure Control and Fenofibrate Use on Kidney Outcomes. (Pubmed Central) -  Dec 6, 2019   
    Patients with concomitant CVD and CKD should be treated, in terms of lipid-lowering therapy, early and intensively to minimize their very high risk and possibly, progression of CKD. In people with type 2 diabetes at high risk for cardiovascular disease, intensive glycemic control may result in a long-term reduction in macroalbuminuria; however, intensive BP control and fenofibrates may increase the risk for adverse kidney events.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Solubility of Pharmaceutical Ingredients in Triglycerides. (Pubmed Central) -  Nov 29, 2019   
    The fatty-acid chain length of TGs only slightly affects the solubility of ibuprofen and fenofibrate, but strongly influences the eutectic temperature of the API/TG mixtures. API solubilities in TGs and TG mixtures (mixtures of tricaprylin and tricaprin) were successfully modeled using the Perturbed-Chain Statistical Associating Fluid Theory (PC-SAFT) accounting for the intermolecular API/TG interactions providing a deep understanding of the energetic and structural impact of the TGs on API solubility.
  • ||||||||||  Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi
    Journal:  LABAs and p38MAPK Inhibitors Reverse the Corticosteroid-Insensitivity of IL-8 in Airway Smooth Muscle Cells of COPD. (Pubmed Central) -  Nov 29, 2019   
    Fluticasone/formoterol, fluticasone/salmeterol, and fluticasone/BIRB796, but not fluticasone/SB203580 combinations, reduced TNFα-induced IL-8 stronger than single treatments...Our pre-clinical data indicate a utility for also adding ICS in non-type 2 inflammatory COPD phenotypes to bronchodilator therapy. Depending on phenotype and disease stage, isoform-specific p38MAPK blockers might also reverse corticosteroid-resistance in COPD.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Improvement of the dissolution rate and bioavailability of fenofibrate by the supercritical anti-solvent process. (Pubmed Central) -  Nov 24, 2019   
    In a pharmacodynamic study to evaluate the efficacy of the drug in hyperlipidemic rat models, SAS-SD showed strong lipid-lowering effects including cholesterol (1.9-fold) and triglycerides (3.3-fold), than CSE-SD. Taken together, these results suggested that SAS-SD has excellent potential as a formulation for the poorly soluble drug fenofibrate.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Unusual cases of acute abdomen () -  Nov 24, 2019 - Abstract #APDW2019APDW_1514;    
    Use of insulin and heparin is a novel modality in treating hypertriglyceridemic pancreatitis. Along with the supportive treatment of acute pancreatitis,treating the precipitating cause is important as well.
  • ||||||||||  glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva
    Retrospective data, Review, Journal:  Triple therapy versus single and dual long-acting bronchodilator therapy in chronic obstructive pulmonary disease: a systematic review and meta-analysis. (Pubmed Central) -  Nov 19, 2019   
    The risk of pneumonia did not differ between ICS/LABA/LAMA combination and comparators; the number needed to harm was ≈195 and it decreased to ≈34 when considering the study that included fluticasone furoate in the triple combination. This meta-analysis suggests that patients on single long-acting bronchodilator therapy or LABA/LAMA combination, who still have exacerbations and have blood eosinophil count ≥300 cells per µL, could benefit from ICS/LABA/LAMA combination.
  • ||||||||||  micronized fenofibrate / Generic mfg., fenofibrate / Generic mfg.
    Biomarker, Trial completion date, Trial primary completion date:  Fenofibrate in Type 2 Diabetes (clinicaltrials.gov) -  Nov 8, 2019   
    P4,  N=40, Recruiting, 
    Generic market competition and price negotiation by the UCS led to price reduction. Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Oct 2019 --> Feb 2020
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, allopurinol / Generic Mfg.
    Clinical, Journal:  Effect of fenofibrate on uric acid level in patients with gout. (Pubmed Central) -  Nov 4, 2019   
    There was no difference in the levels of creatinine, blood urea nitrogen, and aminotransferases between patients treated with and without fenofibrate. Fenofibrate additionally reduced uric acid levels without showing any change in the results of renal or liver function tests, suggesting that the addition of fenofibrate is a reasonable option for treating gout in patients having high triglyceride levels.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Retrospective data, Review, Journal:  Impact of fibrates on circulating cystatin C levels: a systematic review and meta-analysis of clinical trials. (Pubmed Central) -  Oct 31, 2019   
    Its downregulation and the pathomorphologic features of steatohepatitis are prevented by co-administration of fenofibrate. The results suggest that fenofibrate treatment adversely affects cystatin C levels and might partially explain the limited efficacy of fenofibrate in reducing cardiovascular events.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Biomarker, Journal:  Neuroprotective effects of PPARα in retinopathy of type 1 diabetes. (Pubmed Central) -  Oct 31, 2019   
    Two independent prospective clinical trials unexpectedly identified that the PPARα agonist fenofibrate had unprecedented therapeutic effects in DR, but gave little insight into the physiological and molecular mechanisms of action...Mitochondrially mediated apoptosis and oxidative stress secondary to mitochondrial dysfunction contribute to neurodegeneration in DR. Taken together, these findings identify a robust neuroprotective effect for PPARα in DR, which may be due to improved mitochondrial function and subsequent alleviation of energetic deficits, oxidative stress and mitochondrially mediated apoptosis.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Adrenoceptor-stimulated inflammatory response in stress-induced serum amyloid A synthesis. (Pubmed Central) -  Oct 29, 2019   
    Hippocampal PPARα is a potential novel antidepressant target which mediates the antidepressant actions of fluoxetine in mice. Taken together, these findings strongly support a critical role of the AR-stimulated inflammatory response in the hepatic SAA production under stressful conditions, highlighting distinct AR type-specific mechanisms that regulate the hepatic synthesis of SAA1/2 and SAA3.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Fenofibrate and telmisartan in the management of abdominal aortic aneurysm. (Pubmed Central) -  Oct 29, 2019   
    Methods / Results Data from preclinical and human studies investigating the efficacy of fenofibrate and telmisartan to limit AAA growth is presented and provides the rationale for three current randomized controlled trials assessing these medications as potential interventions to limit aneurysm growth in AAA patients. Conclusions Fenofibrate and telmisartan have potential as repurposed medications to limit AAA growth and randomized trials for further assessment in AAA patients are ongoing.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Residual cardiovascular risk of lipid origin. Components and pathophysiological aspects. (Pubmed Central) -  Oct 27, 2019   
    The treatment of atherogenic dyslipidemia is based on weight loss and physical exercise. Regarding pharmacological treatment, we have no evidence of cardiovascular benefit with drugs aimed at lowering triglycerides and HDL-c, fenofibrate seems to be effective in situations of atherogenic dyslipidemia.
  • ||||||||||  heparin sodium (VR496) / Vectura, lexgenleucel-T (VRX496) / VIRxSYS Corp
    Trial completion:  Evaluate the Tolerability and Therapeutic Effects of Repeated Doses of Autologous T Cells With VRX496 in HIV (clinicaltrials.gov) -  Oct 26, 2019   
    P1/2,  N=25, Completed, 
    Regarding pharmacological treatment, we have no evidence of cardiovascular benefit with drugs aimed at lowering triglycerides and HDL-c, fenofibrate seems to be effective in situations of atherogenic dyslipidemia. Active, not recruiting --> Completed
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Retinal de novo lipogenesis coordinates neurotrophic signaling to maintain vision. (Pubmed Central) -  Oct 24, 2019   
    Neurotrophic signaling was restored by exogenous cholesterol delivery. These findings implicate de novo lipogenesis in neurotrophin-dependent cell survival by maintaining retinal membrane configuration and lipid composition, and they suggest that ongoing lipogenesis may be required to prevent cell death in many forms of retinopathy.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  Fenofibrate Ameliorates Oxidative Stress-Induced Retinal Microvascular Dysfunction in Diabetic Rats. (Pubmed Central) -  Oct 24, 2019   
    These findings implicate de novo lipogenesis in neurotrophin-dependent cell survival by maintaining retinal membrane configuration and lipid composition, and they suggest that ongoing lipogenesis may be required to prevent cell death in many forms of retinopathy. FA prevents the retinal microvascular dysfunction induced by diabetes, likely by restoring VEGF and P-p65 levels, and possibly by reducing oxidative stress and TXNIP expression.