- |||||||||| glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Seebri (glycopyrronium bromide) / Novartis, Vectura, Sosei
Mechanisms leading to the bronchorelaxant synergy of ICS/LABA/LAMA combination (6C) - Aug 26, 2019 - Abstract #ERS2019ERS_4111;
Methods Human isolated airways undergoing ex vivo asthma and COPD models were treated overnight with the intracellular glucocorticoid receptors antagonist RU486 (1 μM) to assess the role of the genomic mechanisms activated by BDP...Conclusion The synergy elicited by triple ICS/LABA/LAMA combination was related with the genomic effect of intracellular glucocorticoid receptors and the activation of Gsα subunit G-protein of β2-adrenoceptor, at least in human models of asthma and COPD. Funding This study was supported by Chiesi Farmaceutici, Italy.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Fenofibrate is associated with higher risk of mortality in patients with tuberculosis infection (TP-36) - Aug 26, 2019 - Abstract #ERS2019ERS_3108;
In patients with asthma uncontrolled on medium dose ICS/LABA, PAL did not influence the efficacy of extrafine MS BDP/FF/GB in reducing moderate-severe exacerbations and was associated with a greater reduction in annual severe exacerbation rates. Longer use of fenofibrate in patients with TB is associated with higher risk of mortality.
- |||||||||| Seebri (glycopyrronium bromide) / Novartis, Vectura, Sosei
Beclomethasone, formoterol and glycopyrronium: synergism of triple therapy on human airways (RETIRO) - Aug 26, 2019 - Abstract #ERS2019ERS_2163;
Methods Human isolated bronchi were stimulated by histamine or carbachol and treated with BDP, FF and GP, administered alone and in combination at the concentration-ratio of the available fixed-dose combination (FDC; BDP/FF/GB 100:6:12.5)...Conclusion BDP/FF/GB FDC synergistically relaxed human isolated bronchi in ex vivo models of asthma and COPD. Funding This study was supported by Chiesi Farmaceutici, Italy.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
The German Severe Asthma Registry: FeNO values correlate with medical therapy, quality of life and smoking (6B) - Aug 26, 2019 - Abstract #ERS2019ERS_578;
Medical therapy included ICS+LABA+LAMA in 1073, biologics in 1293 and oral steroids (OCS) in 905 of 2582 appointments...Omalizumab treatment leads to reduction in FeNO (therapy start: 43±40ppb; n=181) in ≥3 yearly follow-up (29±23ppb; n=47; p=0,001)... In this carefully selected severe asthma cohort, increased FeNO levels are associated with OCS-dependency, eligibility for biological-therapy, lower FEV1, higher blood eosinophils, lower ICS-doses and lower asthma control, as well as never smoking status.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi, Parmodia (pemafibrate) / Kowa
Differences in Lipoprotein Particle Number Evaluation Between Gel Permeation-High Performance Chromatography and Nuclear Magnetic Resonance: Analysis in Dyslipidemic Patients Treated With a Selective Peroxisome Prolifetator-Activated Receptor α Modulator, Pemafibrate (Zone 1, Science and Technology Hall) - Aug 21, 2019 - Abstract #AHA2019AHA_5279;
From the phase 2 clinical trial, randomizing 212 patients to PEMA 0.025-0.2 mg BID, fenofibrate 100 mg QD, or placebo groups, PEMA reduced the PNs of CM, large VLDL(1-3) and medium VLDL(4), but not small VLDL(5) by GP-HPLC. GP-HPLC evaluates the lipoprotein PNs more accurately than NMR and can be used for assessing the effects of lipid-lowering drugs on lipoprotein subclasses.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Overlap Syndrome of Primary Sclerosing Cholangitis and Primary Biliary Cholangitis: A Case Report (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2361;
He was started on cholestyramine with minimal improvement in pruritus...The patient was subsequently hospitalized for rhabdomyolysis with acute kidney injury in setting of fenofibrate use...At present, there are no consensus guidelines on the diagnosis and management of this syndrome. Given the rarity of this condition, there is currently no available data on long term outcomes in patients with overlap of PBC and PSC.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
A Case of Hypertriglyceridemia Acute Pancreatitis Requiring Plasmapheresis Treatment (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1449;
He reported compliance with his Gemfibrozil and fish oil supplements...He was discharged on Fenofibrate, Atorvastatin and fish oil supplements...Our patient had a 75% reduction in serum triglycerides with PLEX therapy. We believe that there is a need for randomized trials to elucidate the benefits and risks of PLEX in HTG-AP.
- |||||||||| Seebri (glycopyrronium bromide) / Novartis, Vectura, Sosei
Journal: Multiple analytical methods for determination of formoterol and glycopyrronium simultaneously in their novel combined metered dose inhaler. (Pubmed Central) - Aug 7, 2019
...Recently approved combined inhaler of formoterol fumarate (FF) and glycopyrronium bromide (GLY) has been used in very low concentrations (µg level/actuation) doses in COPD patients...The percent recoveries of the inhaled drugs in their MDI were good. The method was successfully established for the quantitative analysis of FF and GLY in their combined pharmaceutical inhaler capsules to validate the therapeutic efficiency of the combined drugs in quality control labs.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Clinical, PK/PD data, Journal: Pharmacokinetics and bioequivalence of two fenofibrate choline formulations in healthy subjects under fed and fasted condition. (Pubmed Central) - Aug 7, 2019
The method was successfully established for the quantitative analysis of FF and GLY in their combined pharmaceutical inhaler capsules to validate the therapeutic efficiency of the combined drugs in quality control labs. The reference and the test formulations of 135 mg choline fenofibrate show comparable pharmacokinetic profiles of fenofibric acid under both fed and fasted conditions and are considered bioequivalent..
- |||||||||| glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Anoro Ellipta (umeclidinium + vilanterol) / Innoviva, GSK
Journal: Inhaled Triple Therapy in Severe Chronic Obstructive Pulmonary Disease (COPD) (Pubmed Central) - Aug 3, 2019
Beclometasone/formoterol/glycolpyrronium and fluticasonfuroate/umeclidinium/vilanterol are the first triple combination therapies approved in a fixed-dose inhaler for COPD patients. The domains of triple fixed-dose formulations are COPD patients in groups C and D.
- |||||||||| Journal: Improving Diabetic Retinopathy Outcomes: FIELD Fenofibrate. (Pubmed Central) - Aug 2, 2019
It discusses data from FIELD and other trials to support the use of fenofibrate as a secondary preventive therapy for diabetic retinopathy. These data contrast with the lack of retinal benefit shown in major cardiovascular outcome trials of other blood pressure lowering and glucose lowering agents such as empagliflozin, liraglutide, perindopril + indapamide, and ramipril.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Preclinical, Journal: Terminalia Sericea aqueous leaf extract protects growing wistar rats against fructose-induced fatty liver disease. (Pubmed Central) - Aug 1, 2019
...Methods Thirty 21-day old male Wistar rat pups were randomly allocated to five treatments: group I - plain gelatine cubes (PGC) + plain tap water (PW), group II - 12% FS + PGC, group III - gelatine cubes containing fenofibrate (Feno) at a dose of 100 mg/kg body + FS, group IV - gelatine cubes containing the low dose (100 mg/kg body mass per day) of the T. sericea extract (TsL) + FS, group V - gelatine cubes containing the high dose (400 mg/kg body mass per day) of the T. sericea extract (TsH) + FS...The T. sericea extracts at 400 mg/kg per day suppressed the fructose-induced liver lipid accumulation and macrovesicular steatosis similarly to 100 mg/kg per day of Feno. Conclusions These findings suggest that the aqueous T. sericea leaf extract at 400 mg/kg per day could potentially protect against fructose-induced lipid accumulation as well as macrovesicular steatosis.
- |||||||||| glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis
Clinical, Journal: Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. (Pubmed Central) - Aug 1, 2019
P3
In patients with symptomatic COPD, FEV <50%, and an exacerbation history, extrafine BDP/FF/G delayed disease deterioration compared with BDP/FF, tiotropium, and IND/GLY. The studies are registered in ClinicalTrials.gov: TRILOGY, NCT01917331; TRINITY, NCT01911364; TRIBUTE, NCT02579850.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Activation and Expression of Peroxisome Proliferator-Activated Receptor Alpha Are Associated with Tumorigenesis in Colorectal Carcinoma. (Pubmed Central) - Jul 31, 2019
...In the present study, we found that fenofibrate, a PPAR-α agonist, significantly inhibited cell proliferation and induced apoptosis in colorectal carcinoma cells...The correlation between the expression of nuclear PPAR-α and clinicopathological factors was evaluated in human colorectal carcinoma tissues, and the nuclear expression of PPAR-α was significantly higher in well-to-moderately differentiated adenocarcinoma than in mucinous adenocarcinoma (P<0.05). These findings indicate that activation of PPAR-α may be involved in anticancer effects in colorectal carcinomas, and nuclear expression of PPAR-α may be a therapeutic target for colorectal adenocarcinoma treatment.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Do changes in DNA methylation mediate or interact with SNP variation? A pharmacoepigenetic analysis. (Pubmed Central) - Jul 26, 2019
These findings indicate that activation of PPAR-α may be involved in anticancer effects in colorectal carcinomas, and nuclear expression of PPAR-α may be a therapeutic target for colorectal adenocarcinoma treatment. These results suggest that there is stronger evidence for interaction between genotype and methylation on change in triglycerides than for methylation mediating the effect of genotype.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Investigation of parent-of-origin effects induced by fenofibrate treatment on triglycerides levels. (Pubmed Central) - Jul 26, 2019
We performed POO effect association analyses of SNPs with TGs, as well as association analyses of SNPs with DNA methylation probes. These analyses, which were followed by a causal inference test, established that the paternal effect at the SNP rs301621 is induced by treatment and is not mediated by methylation level at cg10206250.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Incorporating methylation genome information improves prediction accuracy for drug treatment responses. (Pubmed Central) - Jul 26, 2019
These analyses, which were followed by a causal inference test, established that the paternal effect at the SNP rs301621 is induced by treatment and is not mediated by methylation level at cg10206250. Compared to using SNP data only, adding methylation data in prediction models slightly improved the error rate; further prediction error reduction is achieved by a combination of genome, methylation genome, and environmental factors.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Comparison of novel and existing methods for detecting differentially methylated regions. (Pubmed Central) - Jul 26, 2019
Cluster analysis and mixed models may need some predimension reduction based on existing literature, data filtering, and supplementary statistical methods, and gene-set enrichment analysis requires biological insight. Our novel method detected the same DMR identified by two existing methods and detected two additional DMRs not identified by any of the existing methods we compared.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Epigenetics, heritability and longitudinal analysis. (Pubmed Central) - Jul 26, 2019
Four conclusions from this GAW20 working group are: (a) QC measures are an important consideration for EWAS studies that are investigating multiple time points or repeated measurements; (b) application of heritability estimates between time points for individual CpG sites is a useful QC measure for DNA methylation studies; (c) drug intervention demonstrated strong epigenome-wide DNA methylation patterns across the 2 time points; and (d) new statistical methods are required to account for the environmental contributions of DNA methylation across time. These contributions demonstrate numerous opportunities exist for the analysis of longitudinal data in future epigenetic studies.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Causal modeling in a multi-omic setting: insights from GAW20. (Pubmed Central) - Jul 26, 2019
These contributions demonstrate numerous opportunities exist for the analysis of longitudinal data in future epigenetic studies. The GAW20 contributions illustrate the diversity of possible approaches to causal inference in the multi-omic context, highlighting the promises and assumptions of each method and the benefits of integrating both across methods and across omics layers for the most robust and comprehensive insights into disease processes.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Association analyses of repeated measures on triglyceride and high-density lipoprotein levels: insights from GAW20. (Pubmed Central) - Jul 26, 2019
The GAW20 contributions illustrate the diversity of possible approaches to causal inference in the multi-omic context, highlighting the promises and assumptions of each method and the benefits of integrating both across methods and across omics layers for the most robust and comprehensive insights into disease processes. Although it is difficult to identify a common message emanating from the different contributions because of the diversity in the issues addressed, the unifying theme of the contributions lie in the search for novel analytic strategies to circumvent the limitations of existing methodologies to detect genetic association.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Detecting responses to treatment with fenofibrate in pedigrees. (Pubmed Central) - Jul 26, 2019
Although it is difficult to identify a common message emanating from the different contributions because of the diversity in the issues addressed, the unifying theme of the contributions lie in the search for novel analytic strategies to circumvent the limitations of existing methodologies to detect genetic association. Results indicate that (a) CpG ML are responsive to Fb; (b) CpG ML should be included in models predicting the TG level responses to Fb;.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi, Parmodia (pemafibrate) / Kowa
Journal: Efficacy and safety of pemafibrate (K-877), a selective peroxisome proliferator-activated receptor α modulator, in patients with dyslipidemia: Results from a 24-week, randomized, double blind, active-controlled, phase 3 trial. (Pubmed Central) - Jul 24, 2019
Such an approach improves efficiency of precipitation inhibitor selection, whilst also improving the likelihood that the most optimal formulation will be realized. Pemafibrate was superior to fenofibrate in terms of serum TG-lowering effect and hepatic and renal safety.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: 5-(4-Hydroxyphenyl)-3H-1,2-dithiole-3-thione-based fibrates as potential hypolipidemic and hepatoprotective agents. (Pubmed Central) - Jul 24, 2019
...Preliminary screening of all the synthesized compounds was done by using an acute model (Triton WR-1339 model), in which compound 6 shown more significant antidyslipidemic activity than fenofibrate (FF)...Moreover, compound 6 displayed hepatoprotective effect, a significant amelioration in hepatic indices (AST and ALT) toxicity was observed and the histological examination showed that compound 6 inhibited the development of hepatic lipid accumulation and ameliorated the damage in hepatic tissue compared to model mice. Additional effects such as the potent antioxidant and anti-inflammatory action confirmed and reinforced the efficacy of compound 6 as a new agent of dual-effect hypolipidemic and hepatoprotective activities.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Fenofibrate Nanocrystal Composite Microparticles for Intestine-Specific Oral Drug Delivery System. (Pubmed Central) - Jul 19, 2019
This phenomenon was confirmed by a real-time in situ UV-imaging system known as the surface dissolution imager (SDI), which was used to monitor drug release events by measuring the color intensity and concentration gradient formation. All these results proved that our NCSM approach is an innovative idea in oral drug delivery systems, as it resolves significant challenges in the intestine-specific release of hydrophobic drugs while avoiding fast dissolution or burst release.
- |||||||||| Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi, Tirosint (levothyroxine) / IBSA Institute Biochemical SA
Journal: Mast Cell Activation Syndrome. (Pubmed Central) - Jul 11, 2019
Although her "rash" had initially responded to fexofenadine, it soon became refractory to treatment. Her family history was significant only for thyroid disease.
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Clinical, Journal: Lipoprotein Glomerulopathy in a Hispanic Female: A Case Report and Literature Review. (Pubmed Central) - Jul 10, 2019
...After stabilizing her blood pressure, the patient was started on fenofibrate to treat her high cholesterol and improve her renal function...However, after one year of treatment, her renal function started to decline and the patient was referred to a transplant center for further management. To the best of our knowledge, this the first reported incidence of LPG in a Hispanic female.
- |||||||||| micronized fenofibrate / Generic mfg., fenofibrate / Generic mfg.
Biomarker, Trial primary completion date: Fenofibrate in Type 2 Diabetes (clinicaltrials.gov) - Jul 8, 2019
P4, N=40, Recruiting,
To the best of our knowledge, this the first reported incidence of LPG in a Hispanic female. Trial primary completion date: Jun 2019 --> Oct 2019
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi
Journal: Fenofibrate and Dyslipidemia: Still a Place in Therapy? (Pubmed Central) - Jul 6, 2019
However, recent observations indicate that fenofibrate treatment may provide a reliable complementary support against residual cardiovascular risk. We therefore summarize current evidence on fenofibrate, seeking to provide an updated interpretation of recent studies in the field.
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