Tracleer (bosentan) / J&J, Roche 
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  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Trial completion date, Trial initiation date, Trial primary completion date:  MoD: Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Apr 9, 2020   
    P3,  N=100, Not yet recruiting, 
    Mean total costs were higher with endothelin receptor antagonists than phosphodiesterase type-5 inhibitors in all patients ($91,328 versus $72,401, P = 0.0003) and in adherent patients ($88,867 versus $56,300, P < 0.0001), driven by higher drug costs. Trial completion date: Dec 2024 --> Dec 2025 | Initiation date: Apr 2020 --> Jul 2021 | Trial primary completion date: Dec 2024 --> Dec 2025
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Trial completion, Trial completion date, Surgery:  Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension (clinicaltrials.gov) -  Mar 30, 2020   
    P=N/A,  N=50, Completed, 
    In the SSc group, limb salvage rate tended to be higher than in the non-SSc group. Recruiting --> Completed | Trial completion date: Dec 2016 --> Mar 2020
  • ||||||||||  Review, Journal:  Endothelin Receptor Antagonists: Status Quo and Future Perspectives for Targeted Therapy. (Pubmed Central) -  Mar 23, 2020   
    Treatment with approved endothelin receptor antagonists (ERAs), such as bosentan, ambrisentan, or macitentan, slow down PAH progression and relieves symptoms...Furthermore, in the SONAR (Study Of Diabetic Nephropathy With Atrasentan) trial, the selective ERA atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease...Preclinical studies regarding heart failure, cancer, and fibrotic diseases have demonstrated promising effects, but clinical trials have not yet produced measurable results. Nevertheless, the potential benefits of ERAs may not be fully realized.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Enrollment open:  BOSRET: Safety of Bosentan in Type II Diabetic Patients (clinicaltrials.gov) -  Mar 17, 2020   
    P1,  N=22, Recruiting, 
    Completed --> Terminated; Slow patient recruitment after arrival of macitentan on the market Not yet recruiting --> Recruiting
  • ||||||||||  Delayed Diagnosis of Alveolar Capillary Dysplasia with Misalignment of the Pulmonary Vein in a Term Infant (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area J) -  Mar 15, 2020 - Abstract #ATS2020ATS_8362;    
    She was started on sildenafil, treprostinil, diuretics, and a five-day course of methylprednisolone (2 mg/kg/day)...During her third admission at sixteen months of age, she was intubated for acute respiratory failure and had refractory pulmonary hypertension despite iNO, iloprost, treprostinil, bosentan, and sildenafil...Broad phenotypic differences have been reported for other FOXF1 mutations. Given her mild presentation and relatively prolonged survival, this variant may be characterized by a less severe presentation but no less fatal outcome.
  • ||||||||||  Using Cardiopulmonary Exercise Testing to Evaluate the Effects of Target Medicine for Pulmonary Artery Hypertension (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area B) -  Mar 15, 2020 - Abstract #ATS2020ATS_5809;    
    After the treatment of target medicines (sildenafil for 22 patients, tadalafil for 6 patients, ambrisentan for one patient, bosentan for one patient, iloprost for one patient, combined target medication for 2 patients),peak VO2, peak VO2/kg, peak VO2/heart rate (HR), peak workload, peak PetCO2, 6MWD were improved significantly (P<0.001, P<0.001, P=0.002, P<0.001, P<0.001, P=0.008), and rest VE/VCO2, VE/VCO2 slope, lowest VE/VCO2, lowest VE/VO2, NT-proBNP were significantly decreased (P=0.018, P=0.041, P=0.003, P=0.019, P<0.001). CPET can objectively and quantitatively evaluate the effects of target medicine for pulmonary artery hypertension, and correlate with the traditional index.
  • ||||||||||  sildenafil / Generic mfg., Tracleer (bosentan) / J&J, Roche, tadalafil / Generic mfg.
    Novel Intronic TBX4 Mutation Associated with Lung Disease, Pulmonary Arterial Hypertension and Skeletal Abnormalities with Variable Penetrance in a Single Family (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area A) -  Mar 15, 2020 - Abstract #ATS2020ATS_5728;    
    He was treated with inhaled nitric-oxide and later transitioned to sildenafil...Over the subsequent 2 years, his lung disease progressed; most recent follow-up (at age 5) was notable for a 4L oxygen requirement and moderate-severe pulmonary arterial hypertension requiring tadalafil and bosentan...Paternal DNA shows the same variant. Neither the patient’s mother nor older sister carried the TBX4 variant; both were healthy and did not have skeletal or respiratory findings.Our study characterizes a novel intronic variant in TBX4 associated with pulmonary hypertension, a lung development disorder, and limb abnormalities in a single family with variable penetrance.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Journal:  Efficient reconstitution of hepatic microvasculature by endothelin receptor antagonism in liver sinusoidal endothelial cells. (Pubmed Central) -  Mar 14, 2020   
    As molecular targets for improving transplanted cell engraftment and proliferation will be highly significant, this study determined whether ET receptor antagonism by the drug bosentan could overcome cell losses due to cell transplantation-induced cytotoxicity...Therefore, ETA/B antagonism in donor cells will advance vascular reconstitution. Extensive experience with ETA/B antagonists will facilitate translation in people.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Review, Journal:  Current Pharmacological Approach to ARDS: The Place of Bosentan. (Pubmed Central) -  Mar 13, 2020   
    There is currently no pharmacological agent with proven efficacy in this syndrome, and many drugs are being studied for this purpose. One of these is the endothelin receptor antagonist bosentan.
  • ||||||||||  ambrisentan / Generic mfg., Opsumit (macitentan) / Nippon Shinyaku, J&J, Tracleer (bosentan) / J&J, Roche
    [VIRTUAL] COSTS OF TREATMENTS OF PULMONARY HYPERTENSION IN POOR POPULATION OF COLOMBIA. () -  Mar 8, 2020 - Abstract #ISPOR2020ISPOR_1137;    
    With these data and with a prevalence of 52 cases per 1.000.000 habitants, we could say that the annual economic burden of PAH treatment would be about $5,505,328. These findings create awareness and provide valuable information for the development of strategies aimed at controlling costs and avoiding financial risks associated to it.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Trial completion, Phase classification, Enrollment change, FDG PET:  Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-FDG and 82Rb PET/CT on PAH and CTEPH (clinicaltrials.gov) -  Mar 3, 2020   
    P=N/A,  N=2, Completed, 
    It is to be hoped that centralised procurement at the regional level would bring further savings. Recruiting --> Completed | Phase classification: P1/2 --> PN/A | N=40 --> 2
  • ||||||||||  mycophenolate mofetil / Generic mfg., Tracleer (bosentan) / J&J, Roche
    [VIRTUAL] DRAMATIC SCLERODERMA DEBUT WITH MALIGNANT HYPERTENSION AND RENAL CRISIS (Poster Area) -  Feb 21, 2020 - Abstract #SSWC2020SSWC_548;    
    As approach for SRC-related malignant hypertension is principally different from other hypertension emergencies, proper diagnosis is crucial. Awareness of SRC is essential in cases of unexplained malignant hypertension; involvement of rheumatologists and nephrologists in such cases may change diagnostic and treatment paradigm with positive impact on patient outcome.
  • ||||||||||  cyclophosphamide intravenous / Generic mfg.
    [VIRTUAL] MALIGNANCY IN A SINGLE CENTER COHORT OF SYSTEMIC SCLEROSIS PATIENTS (Poster Area) -  Feb 21, 2020 - Abstract #SSWC2020SSWC_546;    
    SSc-Ca patients had high mortality rate and mostly dead from cancer. Solid tumors were not associated with SRC; other SSc complications were reported similarly in SSc-Ca and SSc-CF patients.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo
    [VIRTUAL] REFRACTORY DIGITAL ULCERS WITH NECROSIS IN PATIENT WITH OVERLAP SYNDROME – EFFECT OF HYPERBARIC OXYGEN TREATMENT (Poster Area) -  Feb 21, 2020 - Abstract #SSWC2020SSWC_535;    
    The initial immunosuppressive treatment with methotrexate, hydroxychloroquine and low dose prednisolone was changed over the years to rituximab and later to mycophenolate...Longtime antibiotics, local wound treatment and addition of sildenafil, bosentan, acetyl salicylic acid and iloprost did not achieve stabilizing of ulcer progression... This case illustrates the difficulty in treating refractory systemic sclerosis related ulcers and the possible rescue therapy that hyperbaric oxygen therapy can achieve in selected cases.
  • ||||||||||  sildenafil / Generic mfg., Tracleer (bosentan) / J&J, Roche
    [VIRTUAL] TREATMENT EFFECTS ON OUTCOME IN SYSTEMIC SCLEROSIS PATIENTS WITH MILDLY ELEVATED PULMONARY PRESSURE (Poster Area) -  Feb 21, 2020 - Abstract #SSWC2020SSWC_260;    
    SSc patients with mildly elevated mPAP on PAH treatment had a trend to increased survival despite a greater reduction in 6MWD than treatment naïve patients. The number of treated patients was low and larger trials are needed to assess the potential benefit of an earlier introduction of PAH specific medication.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Enrollment closed, Trial completion date:  FUTURE 3 Ext: FUTURE 3 Study Extension (clinicaltrials.gov) -  Feb 18, 2020   
    P3,  N=58, Active, not recruiting, 
    The number of treated patients was low and larger trials are needed to assess the potential benefit of an earlier introduction of PAH specific medication. Completed --> Active, not recruiting | Trial completion date: Aug 2014 --> May 2020
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Clinical, Journal:  Bosentan Therapy in a Patient with Failed Fontan Procedure: A Case Report. (Pubmed Central) -  Jan 16, 2020   
    After 3 months of bosentan therapy, the MPAP was 12 mmHg and the PVRI was 4.1 woods/m2. We observed that bosentan reduces the PVRI and complications such as pleural effusion and ascites after a failed Fontan procedure.
  • ||||||||||  tezosentan (ACT-050089) / Roche, Tracleer (bosentan) / J&J, Roche
    Clinical, PK/PD data, Journal:  Target-Mediated Population Pharmacokinetic Modeling of Endothelin Receptor Antagonists. (Pubmed Central) -  Jan 16, 2020   
    We observed that bosentan reduces the PVRI and complications such as pleural effusion and ascites after a failed Fontan procedure. The developed TMDD PK models are a next step towards understanding the complex PK of ERAs and further support the hypothesis that TMDD is a class effect of ERAs.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche
    Preclinical, Journal:  Novel propyl karaya gum nanogels for bosentan: In vitro and in vivo drug delivery performance. (Pubmed Central) -  Jan 15, 2020   
    Pre-clinical testing of the mucoadhesive nanogel formulations exhibited that the system could monitor the anti-hypertensive activity for a prolonged period. Overall, this propyl KG micellar nanogel system had a great potential and splendid outlook to serve as novel oral controlled release carriers for poorly soluble drugs with outstanding pharmacodynamics.
  • ||||||||||  Precision care for alveolar capillary dysplasia (Carmel Mission Inn – Carmelo Ballroom) -  Jan 4, 2020 - Abstract #WSMRF2020WSMRF_205;    
    Conclusions This case describes a patient with ACD who has survived for more than 4 years with medical therapy. His acute response to nicardipine and his long-term response to amlodipine suggests that AVT can be used to guide precision care, even in a patient with right heart failure.
  • ||||||||||  ambrisentan / Generic mfg., Opsumit (macitentan) / Nippon Shinyaku, J&J, Tracleer (bosentan) / J&J, Roche
    Preclinical, Journal:  Role of endothelin-1 clearance in the haemodynamic responses to endothelin-1 in the pulmonary and hindquarter vasculature of anaesthetised rats. (Pubmed Central) -  Dec 23, 2019   
    Similarly, macitentan (30 mg/kg) or ambrisentan (10 mg/kg) caused significant block of responses to endothelin-1...Our work confirms the role of ET receptors in the pulmonary vasculature that decrease the circulating levels of endothelin-1. This has important consequences in selecting an appropriate ET and ET dual receptor antagonist to effectively block endothelin-1-mediated pulmonary vasoconstriction.
  • ||||||||||  Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  PTN_POPS: Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (clinicaltrials.gov) -  Dec 12, 2019   
    P=N/A,  N=3520, Completed, 
    In the absence of myocardial ischemia, PAH treatment may be the best option in cases like this. Recruiting --> Completed | N=10000 --> 3520 | Trial completion date: Feb 2020 --> Nov 2019 | Trial primary completion date: Feb 2020 --> Nov 2019