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  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Polymeric Precipitation Inhibitors Promote Fenofibrate Supersaturation and Enhance Drug Absorption from a Type IV Lipid-Based Formulation. (Pubmed Central) -  Jul 5, 2019   
    Improved in vitro- in vivo correlation was apparent when comparing the same formulation under different supersaturation conditions. These observations directly exemplify the potential utility of PPIs in promoting drug absorption from LBF, via stabilization of supersaturation, and further confirm that relatively brief periods of supersaturation may be sufficient to promote drug absorption, at least for highly permeable drugs such as fenofibrate.
  • ||||||||||  glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva
    Review, Journal:  Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. (Pubmed Central) -  Jul 4, 2019   
    ...Of the five main fixed triple studies completed so far, three evaluated the efficacy and safety of an extrafine formulation of beclometasone dipropionate, formoterol fumarate, and glycopyrronium; the other two studies evaluated fluticasone furoate, vilanterol, and umeclidinium...The evidence suggests that triple therapy is the most effective treatment in moderate/severe symptomatic patients with COPD at risk of exacerbations, with marginal if any risk of side effects including pneumonia. Ongoing studies are examining the role of triple therapy in less severe symptomatic patients with COPD and asthma-COPD overlap.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, TriptoSar (triptolide) / Pierre Fabre
    Biomarker, Journal:  The Protective Roles of PPARα Activation in Triptolide-induced Liver Injury. (Pubmed Central) -  Jun 27, 2019   
    In agreement with these observations in mice, the increase of long-chain acylcarnitines was observed in the serum of patients with cholestatic liver injury compared to heathy volunteers. These data demonstrated the role of PPARα and long-chain acylcarnitines in TP-induced hepatotoxicity, and suggest that modulation of PPARα may protect against drug-induced liver injury.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Shortening of telomere length by metabolic factors in diabetes: protective effects of fenofibrate. (Pubmed Central) -  Jun 17, 2019   
    However knockdown of Trf1 and Trf2 expression using specific siRNA did not prevent HO effects to lower RTL, thus implicating factors other than these Trfs alone in the fenofibrate protection against the HO induction of RTL lowering. These in vitro findings demonstrate that diabetic conditions can induce telomere shortening and that fenofibrate has protective effects on telomere attrition, through as yet undefined mechanisms.
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
    Enrollment closed, Head-to-Head:  ARGON: Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (clinicaltrials.gov) -  Jun 13, 2019   
    P3,  N=1432, Active, not recruiting, 
    These in vitro findings demonstrate that diabetic conditions can induce telomere shortening and that fenofibrate has protective effects on telomere attrition, through as yet undefined mechanisms. Recruiting --> Active, not recruiting
  • ||||||||||  DV281 / Dynavax
    Enrollment closed, Enrollment change, Combination therapy, PD(L)-1 Biomarker, Metastases:  Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC (clinicaltrials.gov) -  Jun 12, 2019   
    P1b,  N=26, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=167 --> 26
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Review, Journal:  Management of diabetic dyslipidemia: An update. (Pubmed Central) -  May 30, 2019   
    Attractive adjunctive therapies include Ezetimibe which is more cost effective and PCSK9 inhibitors which display potent LDL-cholesterol lowering and ASCVD event reduction. For severe hypertriglyceridemia, to avert the risk of pancreatitis, both fish oil and fenofibrate in concert with diet is the best strategy.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Zoledronate dysregulates fatty acid metabolism in renal tubular epithelial cells to induce nephrotoxicity. (Pubmed Central) -  May 29, 2019   
    Conversely, fatty acid transport protein Slc27a2 deficiency or co-administration of PPARA agonist fenofibrate (20 mg/kg) prevented zoledronate-induced lipid accumulation and kidney fibrosis in mice, indicating that over-expression of fatty acid transporter SLC27A2 and defective fatty acid β-oxidation following zoledronate treatments were significant factors contributing to its nephrotoxicity. These pharmacological and genetic studies provide an important mechanistic insight into zoledronate-associated kidney toxicity that will aid in development of therapeutic prevention and treatment options for this nephropathy.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Retrospective data, Journal:  Metabolic Syndrome as a Predictor of Adrenal Functional Status: A Discriminant Multivariate Analysis Versus Logistic Regression Analysis. (Pubmed Central) -  May 26, 2019   
    ...Diabetes, impaired glucose tolerance, impaired fasting glucose, hypertension, body mass index, HDL-cholesterol levels, triglyceride levels, drug treatment for lipid disorder (statins, fenofibrate, and fish oils, alone or in combination), and maximal adrenal lesion diameter were used as discriminating covariates...MetS components exhibit a good predictive feature of hormonal hypersecretion in patients with adrenal tumors. Predictive functions may help in the search for an easy and generally available algorithm to validly predict the functional activity of adrenal masses.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Chemically Modified Variants of Fenofibrate with Antiglioblastoma Potential. (Pubmed Central) -  May 13, 2019   
    In addition, one of the lead compounds, PP1, has improved water solubility and is significantly more stable when exposed to human blood in comparison to fenofibrate. Importantly, mice bearing large intracranial glioblastoma tumors demonstrated extensive areas of tumor cell death within the tumor mass following oral administration of PP1, and the treated mice did not show any major signs of distress, and accumulated PP1 at therapeutically relevant concentrations in several tissues, including brain and intracranial tumors.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Sleep Deprivation Induces Dry Eye Through Inhibition of PPARα Expression in Corneal Epithelium. (Pubmed Central) -  May 13, 2019   
    In cultured corneal epithelial sheets, fenofibrate increased PPARα and TRPV6 gene and protein expression levels and restored microvilli morphology, whereas MK886 attenuated these changes. Sleep deprivation induces dry eye through abnormal SCEC microvilli morphology, which is caused by sequential downregulation of PPARα, TRPV6 expression, and Ezrin phosphorylation status in mice.
  • ||||||||||  micronized fenofibrate / Generic mfg., fenofibrate / Generic mfg.
    Biomarker, Trial completion date:  Fenofibrate in Type 2 Diabetes (clinicaltrials.gov) -  May 9, 2019   
    P4,  N=40, Recruiting, 
    Sleep deprivation induces dry eye through abnormal SCEC microvilli morphology, which is caused by sequential downregulation of PPARα, TRPV6 expression, and Ezrin phosphorylation status in mice. Trial completion date: Jun 2019 --> Nov 2019
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, Lacromid (bezafibrate) / Remedica
    Journal:  Temperature-Induced Surface Effects on Drug Nanosuspensions. (Pubmed Central) -  Apr 30, 2019   
    The combined usage of analytical surface methods provides the basis for a better understanding of phenomena that take place on drug surfaces. Such understanding is of importance for pharmaceutical development to achieve desirable quality attributes of nanosuspensions.
  • ||||||||||  Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi
    Trial completion date, Trial primary completion date:  Efficacy of FLUTIFORM ® vs Seretide® in Moderate to Severe Persistent Asthma in Subjects Aged ≥12 Years (clinicaltrials.gov) -  Apr 29, 2019   
    P3,  N=330, Recruiting, 
    Such understanding is of importance for pharmaceutical development to achieve desirable quality attributes of nanosuspensions. Trial completion date: Dec 2018 --> Mar 2020 | Trial primary completion date: Nov 2018 --> Dec 2019
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  PPARα activation protects against cholestatic liver injury. (Pubmed Central) -  Apr 26, 2019   
    In the end, the disrupted bile acid metabolism in the enterohepatic circulation and the enhanced oxidative stress and inflammation cytokines induced by ANIT exposure were significantly recovered with the improvement of β-FAO using fenofibrate treatment. These findings provide the rationale for the use of PPARα agonists as therapeutic alternatives for cholestatic liver damage.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, Parmodia (pemafibrate) / Kowa
    Biomarker, Retrospective data, Review, Journal:  Efficacy and safety of pemafibrate administration in patients with dyslipidemia: a systematic review and meta-analysis. (Pubmed Central) -  Apr 26, 2019   
    In addition to the pemafibrate group having an improved lipid profile, which was comparable with that of the fenofibrate group, the AEs were significantly lower than in the fenofibrate group and an improvement in hepatobiliary enzyme activity was also recognized. However, we believe that actual clinical data as well as long-term efficacy and safety need to be investigated in the future.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  Obesity-associated exosomal miRNAs modulate glucose and lipid metabolism in mice. (Pubmed Central) -  Apr 24, 2019   
    Importantly, simultaneously reducing free fatty acid plasma levels in MIMIC mice with either the lipolysis inhibitor acipimox or the PPARα agonist fenofibrate partially protects against these metabolic alterations. Overall, our data highlight the central role of obesity-associated exosomal miRNAs in the etiopathogeny of glucose intolerance and dyslipidemia.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal, IO Biomarker:  Beneficial effects of fenofibrate in pulmonary hypertension in rats. (Pubmed Central) -  Apr 17, 2019   
    To conclude, FF prevented MCT-induced PH in rats by various mechanisms. It might be helpful in preventing PH in patients who are likely to develop PH.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Clinical, Review, Journal:  Efficacy of fenofibrate for diabetic retinopathy: A systematic review protocol. (Pubmed Central) -  Apr 16, 2019   
    Thus, fenofibrate may effectively prevent the development of fibrosis in renal allograft and improve the outcome. The findings of this systematic review will provide latest evidence of fenofibrate for patients with DRP.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Variability amongst urine toxicology amphetamine readings with concurrent administration of fenofibrate. (Pubmed Central) -  Apr 11, 2019   
    Despite the relatively high prevalence of substance misuse in the population of psychiatric inpatients, there exists a need for increased vigilance towards the possibility of false-positive amphetamine results owing to likely cross-reactivity of fenofibrate with the test reagents. In cases where there is uncertainty when correlating clinically, or where false positives are suspected, gold-standard urine-sample analysis by mass spectrometry should be considered, particularly when the consequences for patients may include restrictive measures.