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Will unpredictable side effects dim the promise of new Alzheimer ’s drugs?
A sea change is underway in the treatment of Alzheimer’s disease, where for the first time a drug that targets the disease’s pathology and clearly slows cognitive decline has hit the U.S. market. A related therapy will likely be approved in the coming months. As many neurologists, patients, and brain scientists celebrate, they’re also nervously eyeing complications from treatment: brain swelling and bleeding, which in clinical trials affected up to about one-third of patients and ranged from asymptomatic to fatal. The side effect—amyloid-related imaging abnormalities, or ARIA—remains mysterious. “We don’...
Source: Science of Aging Knowledge Environment - August 2, 2023 Category: Geriatrics Source Type: research

Reply: Association between triple therapy and major adverse cardiovascular events in COPD patients
We thank P. Almagro and P. Martinez-Camblor for their interest in our work and for their salient comments. While we agree that there is no universally accepted definition of major adverse cardiovascular event (MACE), the US Food and Drug Administration (FDA) and the European Medicines Agency include nonfatal myocardial infarction and stroke as well as cardiovascular (CV) mortality in their MACE definition [1]. Importantly, this definition includes both haemorrhagic and ischaemic stroke [1–4]. In our study, we followed this classical "three-point" definition of MACE (including haemorrhagic strokes). While this definit...
Source: European Respiratory Journal - March 2, 2023 Category: Respiratory Medicine Authors: Yang, M.-J., Guo, S.-L., Sin, D. D. Tags: Correspondence Source Type: research

MRI for all: Cheap portable scanners aim to revolutionize medical imaging
.news-article__hero--featured .parallax__element{ object-position: 47% 50%; -o-object-position: 47% 50%; } The patient, a man in his 70s with a shock of silver hair, lies in the neuro intensive care unit (neuro ICU) at Yale New Haven Hospital. Looking at him, you’d never know that a few days earlier a tumor was removed from his pituitary gland. The operation didn’t leave a mark because, as is standard, surgeons reached the tumor through his nose. He chats cheerfully with a pair of research associates who have come to check his progress with a new and potentially revolutionary device they are testing. The cylind...
Source: Science of Aging Knowledge Environment - February 23, 2023 Category: Geriatrics Source Type: research

As some hail new antibody treatment for Alzheimer ’s, safety and benefit questions persist
In a packed San Francisco conference room with a celebratory atmosphere, upbeat company representatives and scientists yesterday presented detailed clinical trial data on the first Alzheimer’s treatment shown to clearly, albeit modestly, slow the disease’s normal cognitive decline. The antibody therapy has buoyed a field marked by decades of failures. Now, it appears to be on the cusp of being greenlit by the U.S. Food and Drug Administration (FDA). Yet other researchers warn of potential risks, including brain swelling and brain hemorrhages that were linked to the recently disclosed deaths of two trial participants wh...
Source: Science of Aging Knowledge Environment - December 1, 2022 Category: Geriatrics Source Type: research

Trial of a prehospital intervention with traditional Chinese medicine for acute stroke (TRACE): Protocol for a mixed-methods research study
Discussion: The results of the TRACE study will provide preliminary evidence for the relationship between XNJI used within 24 h of onset and the presence of END on the third day after stroke onset; it will aid in improving the current knowledge regarding the early use of XNJI for stroke first aid.Clinical Trial Registration:clinicaltrials.gov, identifier NCT04275349
Source: Frontiers in Pharmacology - August 29, 2022 Category: Drugs & Pharmacology Source Type: research

Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions
RARITAN, N.J., April 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs. Data from the two analyses demonstrate the role that the XARELTO® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and ...
Source: Johnson and Johnson - April 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Off-label reduced-dose apixaban does not reduce hemorrhagic risk in Taiwanese patients with nonvalvular atrial fibrillation: A retrospective, observational study
East Asians are reportedly at high risk of anticoagulant-related bleeding; therefore, some physicians prefer to prescribe low-dose direct oral anticoagulants (DOACs). Little is known about the therapeutic effectiveness and safety of off-label reduced-dose apixaban in East Asians with nonvalvular atrial fibrillation (AF). We aimed to investigate the effectiveness and safety of off-label reduced-dose apixaban in Taiwanese patients with nonvalvular AF. This retrospective cohort study enrolled 1073 patients with nonvalvular AF who took apixaban between July 2014 and October 2018 from 4 medical centers in southern Taiwan. Th...
Source: Medicine - June 11, 2021 Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research

Tenecteplase for Acute Ischemic Stroke Treatment
Semin Neurol DOI: 10.1055/s-0040-1722722The introduction of thrombolytic therapy in the 1990s has transformed acute ischemic stroke treatment. Thus far, intravenous recombinant tissue plasminogen activator (rt-PA) also known as alteplase is the only thrombolytic proven to be efficacious and approved by the United States Food and Drug Administration. But the thrombolytic agent tenecteplase (TNK) is emerging as a potential replacement for rt-PA. TNK has greater fibrin specificity, slower clearance, and higher resistance to plasminogen activator inhibitor-1 than rt-PA. Hence, TNK has the potential to provide superior lysis wi...
Source: Seminars in Neurology - January 20, 2021 Category: Neurology Authors: Baird, Alison E. Jackson, Richard Jin, Weijun Tags: Review Article Source Type: research

The streptokinase therapy complications and its associated risk factors in patients with acute ...
Acute myocardial infarction (AMI) is one of the main leading causes of mortality and morbidity. Despite the progress in the treatment of AMI, streptokinase is still being used in many countries. Because of the critical condition of patients with AMI and complications of streptokinase therapy, this study was performed to evaluate the pattern of adverse drug reaction (ADRs) induced by streptokinase and its associated risk factors in patients with acute ST elevation MI. A prospective cross-sectional study in a 14-month period was done at the university affiliated referral cardiovascular center. The Naranjo probability scale a...
Source: Iranian Journal of Pharmaceutical Research - February 28, 2018 Category: Drugs & Pharmacology Source Type: research

All bleeding stops — but does idarucizumab (Praxbind) make it stop faster?
3.5 out of 5 stars Persistent life-threatening hemorrhage after administration of idarucizumab. Alhashem HM et al. Am J Emerg Med 2016 June 30 [Epub ahead of print] Reference Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for stroke and embolism prophylaxis in patients with non-valve-related atrial fibrillation. When it was first released in 2008, a major disincentive to widespread use was the lack of a reliable reversal agent to treat major bleeds, or to administer before necessary invasive procedures. In October 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind), a monoclonal ant...
Source: The Poison Review - July 27, 2016 Category: Toxicology Authors: Leon Gussow Tags: Medical anticoagulant hemorrhage idarucizumab pradaxa praxbind reversal agent Source Type: news

Thrombolysis-Related Hemorrhage
Intravenous tissue plasminogen activator (tPA) improves outcomes when administered within 4.5 hours of symptom onset of ischemic stroke. Symptomatic intracranial hemorrhage (sICH) is the most feared complication after administration of intravenous tPA. The percentage of patients with a good functional outcome after sICH (as defined by the Safe Implementation of Thrombolysis in Stroke-Monitoring Study) following administration of tPA has been shown to be less than 7%, and mortality rates can be greater than 50%. Almost 2 decades after approval of intravenous tPA by the US Food and Drug Administration, our ability to prevent...
Source: JAMA Neurology - October 26, 2015 Category: Neurology Source Type: research

Cardiovascular safety of albiglutide in the Harmony programme: a meta-analysis
Publication date: Available online 11 August 2015 Source:The Lancet Diabetes & Endocrinology Author(s): Miles Fisher, Mark C Petrie, Philip D Ambery, Jill Donaldson, John J V McMurray, June Ye Background Albiglutide is a glucagon-like peptide-1 receptor agonist, a new class of drugs used to treat type 2 diabetes. We did a prospective meta-analysis of the cardiovascular safety of albiglutide as stipulated by the US Food and Drug Administration recommendations for the assessment of new treatments for diabetes. Methods We did a meta-analysis of eight phase 3 trials and one phase 2b trial in which patients wer...
Source: The Lancet Diabetes and Endocrinology - August 12, 2015 Category: Endocrinology Source Type: research

The Efficacy of Rivaroxaban in Patients With Atrial Fibrillation
Atrial fibrillation (AF), the most common form of cardiac arrhythmia, is a major risk factor for cardioembolic stroke. Dose-adjusted warfarin has been the gold standard for stroke prophylaxis in moderate- to high-risk patients with AF. However, the use of warfarin therapy is greatly limited by its narrow therapeutic window, numerous dietary restrictions, and drug–drug interactions, and an increased risk of hemorrhage. As a result, great emphasis has been placed on developing a new anticoagulant agent with fewer risks and limitations. Current data suggest that the oral direct factor Xa inhibitor rivaroxaban is a safe and ...
Source: American Journal of Therapeutics - September 1, 2014 Category: Drugs & Pharmacology Tags: Therapeutic Review Source Type: research

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