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  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
    [VIRTUAL] Treatment Patterns and Disease Burden of Triple Therapy in Asthma (ATS 2020 Virtual) -  Jul 6, 2020 - Abstract #ATSI2020ATS-I_2195;    
    Patients using triple therapy had low adherence and persistence to MITT. Adherence to each individual triple therapy component was demonstrably higher, suggesting that patients are not using all three therapy components simultaneously.
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva
    [VIRTUAL] Trioptimize VI: The Use of Extrafine Single Inhaler Triple Therapy Improves Adherence to Treatment in Patients with COPD - Real-World Evidence (ATS 2020 Virtual) -  Jul 6, 2020 - Abstract #ATSI2020ATS-I_1326;    
    Summary and Conclusion These results indicate that in a real-world setting, switching patients with moderate to severe COPD symptomatic on ICS/LABA or MITT to extrafine SITT with BDP/FF/G is associated with improved adherence to treatment. Further in-depth analysis is planned to describe the different types of adherence impairment (e.g. sporadic/deliberate/unconscious) and to better understand the relationship between improved TAI scores and clinical and health status endpoints.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Review, Journal:  Fenofibrate-induced renal dysfunction, yes or no? (Pubmed Central) -  Jun 27, 2020   
    In patients with normal renal function, follow-up of serum creatinine would be necessary after FEN, but the discontinuation of FEN is not recommended. In addition, in diabetic patients with hypertriglyceridemia, FEN treatment would be suggested for protecting the kidney from diabetes-induced renal injury.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, metformin / Generic mfg.
    [VIRTUAL] Lipodystrophy, a Forgotten Syndrome () -  Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_1083;    
    The diagnosis of lipodystrophy is based on history, abnormal body fat distribution, and metabolic profile. The metabolic disturbances seen in these patients are mainly due to the lack of adipose tissue, which results in impaired energy storage.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, metformin / Generic mfg.
    [VIRTUAL] Asparaginase Induced Severe Hypertriglyceridemia Requiring Multiple Plasmapheresis Sessions () -  Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_771;    
    This side effect may be explained by multiple mechanisms including increased synthesis of very low-density lipoprotein (VLDL), decreased LPL activity as a result of an increase in the apoCIII/apoCII ratio, and increase in serum chylomicrons. Studies have shown patients who had extreme HTG had a higher frequency of ApoE3/4 phenotype, suggesting that screening for ApoE polymorphism may identify patients at high risk for developing this.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    [VIRTUAL] Hypertriglyceridem...From Mild to Fatal!... Is Time for Awareness () -  Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_758;    
    Triglycerides 7,444mg/dL on Gemfibrozil started due to previous levels found >4,000 mg/dL on outpatient evaluation...Awareness of hypertriglyceridemia management and adverse effects is necessary to avoid complications and fatal outcomes. Is time!
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Clinical, Journal:  Treatment with fibrates is associated with higher LAL activity in dyslipidemic patients. (Pubmed Central) -  Jun 19, 2020   
    In a subset of patients tested after 3 months of treatment with micronized fenofibrate, LAL activity raised by 21%; the increase was negatively correlated with baseline LAL activity. Thus, the use of fibrates is independently associated with higher LAL activity in dyslipidemic patients, suggesting that the positive effects of PPAR-α activation on cellular and systemic lipid homeostasis can also include an improved LAL activity.
  • ||||||||||  Formoterol Clickhaler (formoterol dry-powder inhaler) / Vectura, Foradil Aerolizer (formoterol dry powder inhaler) / Novartis, budesonide / Generic mfg.
    Journal:  Variability in airway inflammation, symptoms, lung function and reliever use in asthma: anti-inflammatory reliever hypothesis and STIFLE study design. (Pubmed Central) -  Jun 19, 2020   
    Daily data will be captured for fractional exhaled nitric oxide, spirometry, asthma symptoms and medication use using devices connected to a smartphone via the STIFLE application. STIFLE will thereby enable not only characterisation of the variability of airway inflammation and clinical outcomes in relation to asthma worsening, but also elucidate the effect of as-needed budesonide/formoterol on airway inflammation against a background of daily maintenance therapy.
  • ||||||||||  DV281 / Dynavax
    Trial completion, Trial completion date, Trial primary completion date, Combination therapy, PD(L)-1 Biomarker, Metastases:  Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC (clinicaltrials.gov) -  Jun 17, 2020   
    P1b,  N=26, Completed, 
    A favorable outcome can be achieved by timely diagnosis and prompt treatment. Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> Sep 2019 | Trial primary completion date: Aug 2020 --> Sep 2019
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  The metabolic regulation of fenofibrate is dependent on dietary protein content in male juveniles of Nile tilapia (Oreochromis niloticus). (Pubmed Central) -  Jun 10, 2020   
    The present study suggested that lipid-lowering effect of fenofibrate would be strengthened in the fish fed with HP diet containing high energy, but in the fish fed with the LP diet containing low energy, the fenofibrate treatment would cause adverse effects for metabolism. Taking together, our study showed that the metabolic regulation of fenofibrate in Nile tilapia was not only dependent on feed energy content, but also dependent on dietary nutrient composition, such as dietary protein and/or lipid levels.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Effect of crude Moringa oleifera Lam. seed extract on the blood markers of metabolic syndrome in high-fructose diet-fed growing Sprague-Dawley rats. (Pubmed Central) -  Jun 10, 2020   
    Methods Sixty 21-day old female and male Sprague-Dawley rat pups were randomly allocated to and administered one of the following treatment regimens daily for twelve weeks: group I - plain drinking water (PW)+plain gelatine cube (PC), group II - 20% (w/v) fructose solution (FS)+PC, group III - FS+100 mg/kg body mass fenofibrate in gelatine cube (FN), group IV - FS+low dose (50 mg/kg body mass) of M. oleifera in gelatine cube (LMol) and group V - FS+high dose (500 mg/kg body mass) of M. oleifera in gelatine cube (HMol)...The crude hydroethanolic M. oleifera seed extract prevented the high-fructose diet-induced metabolic derangements in male and female rats. Conclusion Crude hydroethanolic M. oleifera seed extract can potentially be used as a prophylactic intervention for diet-induced MetS in children.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Catalytic Transfer Hydration of Cyanohydrins to α-Hydroxyamides. (Pubmed Central) -  Jun 8, 2020   
    The direct conversion of fenofibrate, a drug bearing a benzophenone moiety, into a functionalized α,α-diaryl-α-hydroxyamide was achieved by means of a hydrocyanation-transfer hydration sequence. The synthesis of a site-specifically 18O-labeled α-hydroxyamide was also achieved through transfer hydration with an 18O-labeled carboxamide, demonstrating that the carbonyl oxygen in the product originates from the carbonyl oxygen of the carboxamide reagent.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Solid-state analysis of amorphous solid dispersions: Why DSC and XRPD may not be regarded as stand-alone techniques. (Pubmed Central) -  Jun 8, 2020   
    In addition, the limiting factors of (m)DSC were defined as the well-described heat-induced sample alteration upon heating, the interfering of residual solvent evaporation with other thermal events and the coinciding of enthalpy recovery with melting events. In all of these cases, the application of a single analytical technique would have led to erroneous conclusions, whilst the combination of (m)DSC and XRPD elucidated the true phases of the ASD.
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Journal:  Synthesis of C-14 labeled Rac-(3R,2S)-Glycopyrronium Bromide. (Pubmed Central) -  Jun 3, 2020   
    During the synthesis, an unexpected decarboxylation of phenylglyoxylate resulted in the loss of much of the radiolabeled compound. Chiral chromatography was utilized to isolate and deliver the proper pair of enantiomers as [ C]-1.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, Ocaliva (obeticholic acid) / Intercept, Lacromid (bezafibrate) / Remedica
    [VIRTUAL] Comparative effects of second-line therapy with obeticholic acid or fibrates in primary biliary cholangitis patients (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1023;    
    Second-line therapy with obeticholic acid or fibrates improve hepatic biochemistry with infrequent adverse events in patients with primary biliary cholangitis non- responders to UDCA. Fibrates are associated with higher decrease in alkaline phosphatase while obeticholic acid with higher transaminases improvement.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  Fenofibrate increases very-long-chain sphingolipids and improves blood glucose homeostasis in NOD mice. (Pubmed Central) -  May 28, 2020   
    These data indicate that fenofibrate alters the pancreatic lipidome to a more anti-inflammatory and anti-apoptotic state. The beneficial effects on islet sympathetic nerve fibres and blood glucose homeostasis indicate that fenofibrate could be used as a therapeutic approach to improve blood glucose homeostasis and prevent diabetes-associated pathologies.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, Lacromid (bezafibrate) / Remedica
    Clinical, Journal, Real-World Evidence:  Delivering Benefits at Speed through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point. (Pubmed Central) -  May 27, 2020   
    Clinical trials to assess efficacy are already underway for famotidine, dipyridamole, and sildenafil, and further trials of all these agents will be important in due course. These examples also reveal the unlimited opportunity to future-proof our healthcare systems by proactively mining, synthesizing, cataloging, and evaluating the off-label treatment opportunities of thousands of safe, well established, and affordable generic drugs.
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
    Trial completion date, Trial initiation date, Trial primary completion date:  XPERTT: Investigating the Effects of QVM149 on MRI Ventilation Defects (clinicaltrials.gov) -  May 20, 2020   
    P3,  N=48, Not yet recruiting, 
    Research to increase our understanding of critical errors with each inhaler and how to overcome them is important for improving care. Trial completion date: Dec 2020 --> May 2021 | Initiation date: Apr 2020 --> Sep 2020 | Trial primary completion date: Dec 2020 --> May 2021
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Emerging Fixed-Dose Combination Treatments for Hyperlipidemia. (Pubmed Central) -  May 19, 2020   
    Statins, ezetimibe, and fibrates have established their efficacy and safety in the treatment of hypercholesterolemia and hypertriglyceridemia...Moreover, complementary mechanisms of action of the combined hypolipidemic drugs may also provide additional benefits such as improvement in carbohydrate metabolism. As a result, fixed-dose combinations of hypolipidemic agents may provide an attractive option for the effective and safe management of hypercholesterolemia.