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AstraZeneca to current Part III CVOT DECLARE-TIMI 58 outcomes at AHA Scientific Classes

Posted in News on 2nd November 2018

AstraZeneca will current 20 abstracts together with a late-breaking oral presentation on the total outcomes from the Part III cardiovascular (CV) outcomes trial (CVOT) DECLARE (Dapagliflozin Impact on Cardiovascular Occasions)-TIMI 58, the broadest SGLT2 inhibitor CVOT performed thus far, in addition to new analysis from the Firm’s Cardiovascular, Renal & Metabolism (CVMD) remedy space on the American Coronary heart Affiliation (AHA) Scientific Classes, November 10-12, 2018, in Chicago, Illinois, USA.

New proof will construct on broad scientific analysis from AstraZeneca that goals to assist redefine the administration of CVMD illnesses and handle the necessity for a extra proactive and holistic method to affected person care. Displays will embody findings from a number of the largest trials in broad affected person populations with FARXIGA (dapagliflozin) in kind 2 diabetes (T2D), BRILINTA (ticagrelor) in sufferers with a historical past of coronary heart assault, and in hyperkalemia.

Danilo Verge, Vice President, Cardiovascular, Renal & Metabolism, International Medical Affairs, mentioned: “An estimated 20 million individuals every year die from cardiovascular, renal and metabolic illnesses, but shared threat elements are steadily not recognized or addressed holistically. Our knowledge at AHA replicate an built-in method to managing the wants of sufferers residing with kind 2 diabetes and threat of cardiovascular or renal illness, and people with a historical past of heart problems at acute and long-term threat of recurrence. We stand firmly behind our mission to offer new options earlier in illness administration to those sufferers in danger for a number of problems.”

DECLARE-TIMI 58: a landmark CVOT evaluating CV threat in sufferers with T2D

Scientific trial outcomes exhibiting the protection and efficacy of FARXIGA vs. placebo on main CV and secondary renal efficacy outcomes in adults with T2D who’ve a number of CV threat elements or established CV illness, can be introduced in a late-breaking oral presentation (Late Breaking Summary #19485). DECLARE-TIMI 58 evaluated the CV outcomes of FARXIGA vs. placebo over a interval of as much as 5 years, throughout 33 international locations and in additional than 17,000 adults with T2D with a number of CV threat elements or established CV illness.

In September 2018, AstraZeneca introduced that FARXIGA met its main security endpoint of non-inferiority for main antagonistic cardiovascular occasions (MACE) and achieved a statistically-significant discount within the composite endpoint of hospitalization for coronary heart failure (hHF) or CV dying, one of many two main efficacy endpoints. Moreover, fewer MACE occasions have been noticed with FARXIGA for the opposite main efficacy endpoint, nevertheless, this didn’t attain statistical significance. Scientific trial outcomes introduced at AHA Scientific Classes 2018 will embody extra particulars on the first CV security and efficacy, in addition to secondary renal efficacy outcomes from DECLARE-TIMI 58. FARXIGA just isn’t indicated to cut back the chance of CV occasions, hHF or renal outcomes.

Three new sub-analyses from the PEGASUS-TIMI 54 trial can even be introduced. The trial in contrast BRILINTA (90mg or 60mg twice day by day) plus aspirin vs. aspirin alone in 21,162 sufferers with prior (1 to three years) coronary heart assault. The sub-analyses consider:

  • Whether or not scientific traits predicting bleeding and ischemic threat determine subgroups of sufferers who could derive profit from long-term therapy with BRILINTA, with a decrease threat of main bleeding (Poster #Sa2100)
  • The results of long-term use of BRILINTA in sufferers who’ve had a coronary heart assault and who didn’t obtain a coronary stent vs. those that did obtain a coronary stent placement (Oral Presentation #102)
  • The usage of high-sensitivity cardiac troponin to determine sufferers who’re at a higher-risk of main CV occasions (Oral Presentation #100)

Knowledge can even be introduced on potential threat elements for repeated or persistent hyperkalemia (Poster # SuMDP65).



Posted in: Drug Trial Information | Medical Situation Information

Tags: Acute Kidney Harm, Angioedema, Aspirin, AstraZeneca, Autoimmunity, Biopharmaceutical, Bladder, Bladder Most cancers, Bleeding, Blood, Breastfeeding, Most cancers, Cardiovascular Illness, Ldl cholesterol, Scientific Trial, Clopidogrel, Creatinine, Diabetes, Diabetes Mellitus, Diabetic Ketoacidosis, Dialysis, Eating regimen, Medication, Dyspnea, Erythema, Train, Fever, Gangrene, Glucose, Coronary heart, Coronary heart Assault, Coronary heart Failure, Hyperkalemia, Hypersensitivity, Hypoglycemia, Hypotension, Insulin, Kidney, Life Expectancy, Lipoprotein, Metabolism, Mortality, Neuroscience, Oncology, Ache, Pancreas, Peptic Ulcer, Placebo, Being pregnant, Pyelonephritis, Renal illness, Analysis, Respiratory, Statin, Stent, Stroke, Surgical procedure, Thrombosis, Troponin, Sort 1 Diabetes, Sort 2 Diabetes, Ulcer

Epidiolex Now Obtainable to Deal with Seizures Related With LGS, Dravet Syndrome

Posted in News on 2nd November 2018

November 01, 2018

Epidiolex is supplied as a 100mg/mL strawberry-flavored oral solution

Epidiolex is supplied as a 100mg/mL strawberry-flavored oral solution

Epidiolex (cannabidiol oral solution) has been made available by GW Pharmaceuticals for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients ≥2 years old.

The Food and Drug Administration (FDA) approved the treatment in June 2018, making it the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, as well as the first treatment indicated for patients with Dravet syndrome. The approval of Epidiolex was based on data from 3 randomized, double-blind, placebo-controlled trials involving patients with either LGS or Dravet syndrome. In September 2018, Epidiolex was rescheduled from a Schedule I substance to a Schedule V, the lowest restriction classification.

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Epidiolex is supplied as a 100mg/mL strawberry-flavored oral solution. The product is packaged with a calibrated measuring device and is recommended to measure and deliver the prescribed dose. Any unused portion of the medication should be discarded after 12 weeks of first opening the bottle.

Prior to starting treatment, patient serum transaminases (ALT and AST) and total bilirubin levels should be obtained because of the risk of hepatocellular injury. Food may affect levels of Epidiolex, therefore patients should be advised to take the drug consistently either in the fasted or fed state.

GW Pharmaceuticals has also launched the Epidiolex Engage support program to help patients and clinicians navigate the steps to obtaining Epidiolex; the program also provides education and resources to patients and caregivers.

“We are delighted to announce that Epidiolex is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals. “We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”

For more information visit epidiolexhcp.com.

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Examine highlights accuracy of DecisionDx-Melanoma prognostic take a look at in sufferers with Stage II-IIIA melanoma

Posted in News on 1st November 2018

Fortress Biosciences, Inc., the pores and skin most cancers diagnostics firm offering molecular diagnostics to enhance most cancers administration choices, in the present day introduced the presentation of information highlighting how the accuracy of the DecisionDx®-Melanoma gene expression profile (GEP) take a look at in sufferers with Stage II and IIIA melanoma can enhance adjuvant scientific trial design on the 2018 Society for Melanoma Analysis Worldwide Congress held in Manchester, England from October 24-27.

The research titled, “Implications of a 31-gene expression profile take a look at for cutaneous melanoma on AJCC-based danger evaluation and adjuvant remedy trial design,” was introduced as a poster on the assembly.

Examine Background

  • The adjuvant therapy setting for melanoma has skilled vital advances lately. Whereas therapies present clear advantages for a subset of melanoma sufferers, additionally they will be related to vital adversarial results. Correct evaluation of particular person affected person danger is more and more vital to information therapy choices, particularly for these with no proof of illness.
  • The evaluation targeted on using the DecisionDx-Melanoma take a look at to tell which Stage II and IIIA melanoma sufferers are at excessive danger of recurrence and may benefit from adjuvant remedy. Adjuvant remedy trials are being thought-about or underway for Stage II and Stage IIIA sufferers, however recurrence charges on this inhabitants make trials on this inhabitants difficult.
  • The research assessed whether or not the DecisionDx-Melanoma take a look at might have a job in affected person choice for future adjuvant remedy scientific trials, and evaluated the potential price financial savings related to affected person enrollment based mostly on danger evaluation.

Examine Particulars and Key Findings

  • The DecisionDx-Melanoma take a look at was beforehand validated in a cohort of 690 sufferers from 18 facilities to precisely predict 5-year danger of recurrence for sufferers with melanoma (Class 1A lowest danger; Class 2B highest danger).
  • This evaluation included a subset of 173 sufferers who had Stage II or IIIA melanoma (restaged utilizing American Joint Committee on Most cancers [AJCC] eightth version).
  • Sufferers within the Stage II-IIIA cohort who had a Class 1A DecisionDx-Melanoma take a look at end result had a 5-year melanoma-specific survival (MSS) price of 100%, just like the danger of sufferers with Stage 1A melanoma. Stage II-IIIA sufferers who had a Class 2B end result had an MSS of 85%, just like a Stage IIIB danger.
  • Equally, 5-year recurrence-free survival for sufferers within the Stage II-IIIA cohort who had a Class 2B DecisionDx-Melanoma take a look at end result was 39% and distant metastasis-free survival was 54%, considerably decrease than these for sufferers with a Class 1A end result.
  • Examine outcomes confirmed that utilizing the DecisionDx-Melanoma take a look at to pick sufferers for a scientific trial, pattern measurement may very well be decreased by 36% with an total discount in trial prices if enrollment targeted on sufferers with a excessive danger of recurrence as decided by a DecisionDx-Melanoma Class 2B end result.

“Optimization of adjuvant scientific trial enrollment for melanoma is more and more vital given the adversarial results which can be related to present focused and immune checkpoint therapies,” mentioned Sancy Leachman M.D., Ph.D., Professor and chair, Division of Dermatology and Director, Melanoma Analysis Program, Oregon Well being & Science College. “These information help utility of the DecisionDx-Melanoma take a look at to establish Stage II-IIIA sufferers who’re at larger danger for recurrence and metastasis and are due to this fact acceptable candidates for adjuvant remedy consideration in a scientific trial.”


Posted in: Drug Trial Information | Medical Situation Information

Tags: Adjuvant Remedy, Most cancers, Carcinoma, Cell, Medical Trial, Dermatology, Diagnostics, Gene, Gene Expression, Genes, Laboratory, Lymph Node, Melanoma, Metastasis, Molecular Diagnostics, pH, Analysis, Pores and skin, Pores and skin Most cancers, Tumor

Extreme Acute Respiratory Misery Syndrome Following HCTZ Administration

Posted in News on 1st November 2018

October 31, 2018

Although most cases resolve with supportive care, severe cases may require intubation and vv-ECMO

Although most cases resolve with supportive care, severe cases may require intubation and vv-ECMO

A recent report published in The Journal of Emergency Medicine describes the case of a male patient who experienced hydrochlorothiazide (HCTZ)-induced pulmonary edema that was complicated by acute respiratory distress syndrome (ARDS) and discusses the approach that was taken for his treatment.

The patient, who was in his 50s, had a past medical history significant for hypertension, which was managed with HCTZ. The study authors reported that the patient began to feel unwell and experienced difficulty breathing 30 minutes after administration of HCTZ. After developing ARDS and progressive hypoxemia in the emergency department of a referring hospital, he was transferred to the study authors’ institution for evaluation of refractory hypoxemia. During his transfer of care, the patient’s pulses could not be palpated, therefore chest compressions and intravenous epinephrine were initiated. Chest compressions were discontinued once his pulses were palpated again.

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After performing a physical examination and various laboratory tests, vasopressors were initiated. “Although the patient was persistently hypotensive and requiring high-dose vasopressors, we thought that this was most likely due to profound hypoxemia and acidemia causing global myocardial depression and vasoplegia rather than a primary cardiogenic shock,” the study authors explained.

The patient was therefore cannulated for venovenous extracorporeal membrane oxygenation (vv-ECMO) in the emergency department. “Packed red blood cells were infused empirically when the patient was placed on the ECMO circuit and within 15 min of ECMO cannulation, persistent pulse oximetry readings above 88% were achieved,” the study authors reported.

The patient’s ARDS resolved after several days of ECMO, at which point, he was decannulated and extubated. The allergy and medical teams later obtained an extensive patient history, which revealed that the patient had likely experienced 2 previous episodes of HCTZ-induced pulmonary edema.

“One of the most commonly prescribed antihypertensives, HCTZ is associated with rare cases of pulmonary edema, which typically develop within minutes to hours of the initial dose of the medication,” the study authors stated. They added, “Although most cases resolve with supportive care, severe cases may require intubation and even vv-ECMO.”


Jansson PS, Leisten DC, Sarkisian TM, Wilcox SR, Lee J. Recurrent Hydrochlorothiazide-Induced Acute Respiratory Distress Syndrome Treated With Extracorporeal Membrane Oxygenation. The Journal of Emergency Medicine. 2018 DOI: doi.org/10.1016/j.jemermed.2018.09.019.

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New Metropolis of Hope CAR T cell trial focuses on HER2-positive breast most cancers sufferers with mind metastases

Posted in News on 31st October 2018

Ladies with HER2-positive breast most cancers that has unfold to the mind want extra remedy choices, and Metropolis of Hope and Mustang Bio Inc. are assembly that problem. A brand new Metropolis of Hope chimeric antigen receptor (CAR) T cell trial – the primary to deal with HER2-positive breast most cancers sufferers with mind metastases – is now enrolling potential members.

The section 1 trial can be performed in an outpatient setting and also will be the primary to make use of intraventricular supply of CAR T cells on to the brains of those sufferers. It should check the protection and effectiveness of the CAR T cell remedy for sufferers who’ve tried different kinds of remedy which can be not efficient. HER2 refers to a cancer-causing protein known as human epidermal progress issue receptor-2, which is discovered on the cell floor of breast most cancers cells, in addition to some lung, colon and different most cancers cells, and a few melanoma cells. About 20 % of breast most cancers sufferers are HER2-positive, based on the American Most cancers Society.

“For a lady who already has breast most cancers, studying mind tumor has developed generally is a horrifying prognosis as a result of there are few remedy choices obtainable. CAR T cell remedy could also be one other software in our struggle towards this devastating illness,” stated Jana Portnow, M.D., Metropolis of Hope affiliate medical professor within the Division of Medical Oncology & Therapeutics Analysis and affiliate director of the Mind Tumor Program. Portnow and Saul Priceman, Ph.D., assistant analysis professor in Metropolis of Hope’s T cell immunotherapy program, who performed preclinical analysis that led to the trial’s growth, are main the CAR T cell trial.

“Our hope is that the HER2-specific CAR T cell remedy will goal and kill HER2-positive most cancers cells, and safely and successfully deal with mind metastases in these sufferers,” Priceman added.

CAR T cell remedy is a kind of cell-based immunotherapy during which a affected person’s personal T cells are reprogrammed to actively hunt down and destroy cancerous cells. For this trial, the affected person’s T cells can be remoted from the blood and genetically engineered to precise a CAR that permits these immune cells to focus on and eradicate HER2-positive most cancers cells.

Metropolis of Hope, a acknowledged chief in CAR T cell therapies, has handled greater than 200 sufferers since its CAR T program began within the late 1990s. The establishment continues to have one of the complete CAR T cell medical analysis applications on the planet – it presently has 16 ongoing CAR T medical trials, together with a trial that opened lately for sufferers with main glioblastoma that expresses the HER2 protein. The establishment plans to open a trial within the coming months for sufferers with bone metastatic prostate most cancers.

Mustang Bio Inc., an organization centered on the event of novel immunotherapies primarily based on proprietary CAR T know-how and gene therapies for uncommon illnesses, licensed the HER2 know-how from Metropolis of Hope in 2017.

The HER2 trial meets a vital want – it’s estimated that almost half of all ladies with HER2-positive breast most cancers will ultimately develop mind metastases. The present commonplace of look after treating mind metastases makes use of HER2-targeted medicine and/or radiation.

“Focused brokers do not at all times work due to the blood-brain barrier, a semipermeable membrane that always prevents quick access of doubtless efficient therapeutic medicine to the tumors,” Portnow stated. “Likewise, radiation has its limitations in durably controlling illness. These sufferers are in determined want of secure and more practical therapies.”

Metropolis of Hope researchers had been the primary to make use of intraventricular supply of CAR T cells in sufferers with glioblastoma, one of many deadliest kinds of mind tumors. They discovered that injecting engineered CAR T cells domestically right into a affected person’s mind, or regionally by infusion within the ventricular system, has the potential to eradicate mind tumors.

“As a result of such a CAR T cell supply was discovered to be secure, Metropolis of Hope will now additionally use this route of administration for sufferers on this trial,” Priceman added.



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