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Condition: Stroke
Management: Food and Drug Administration (FDA)

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Total 621 results found since Jan 2013.

Modeling the public health impact of voxelotor in the management of sickle cell disease in France
The objective of this study was to estimate the impact of voxelotor on the burden of SCD in France using a modeling approach, accounting for its anticipated adoption and diffusion over the next 5 years. We designed a sequential multi-cohort model to project and compare the cumulative incidence of SCD complications over a 20-year time horizon in a world with and without voxelotor. A distribution of patients was simulated across various levels of Hb response based on the phase 3 HO PE trial results, and relative risk reduction was adjusted using published meta-analysis results that projected risk reduction due to a 1 g/dL in...
Source: PLoS One - September 13, 2023 Category: Biomedical Science Authors: Fr édéric Galacteros Source Type: research

Cardiovascular comorbidities in atopic dermatitis: Potential implications for the use of Janus kinase inhibitors
To the Editor: The Food and Drug Administration recently approved the use of 2 oral Janus kinase (JAK) inhibitors —abrocitinib and upadacitinib—for patients with moderate-to-severe atopic dermatitis (AD) not adequately controlled with systemic therapies, including biologics, or when the use of such treatments is inadvisable.1,2 In September 2021, the Food and Drug Administration issued a boxed warning for a ll JAK inhibitors regarding the increased risk of serious infections, heart attack, stroke, cancer, blood clots, and death.
Source: Journal of the American Academy of Dermatology - August 19, 2023 Category: Dermatology Authors: J. Mark Jackson, Amanda Althoff, Lawrence Rasouliyan, Stacey Long, Carla L. Zema Tags: Research letter Source Type: research

Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week
J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055.ABSTRACTAmong statin-treated patients, inflammation assessed by means of high-sensitivity C-reactive protein (hsCRP) is a more powerful determinant of cardiovascular death and all-cause mortality than low-density-lipoprotein cholesterol (LDL-C). Several therapies that target residual inflammatory risk significantly reduce vascular event rates. For coronary artery disease patients already taking guideline-directed medical care, including statins, low-dose colchicine (0.5 mg/d orally) has been shown to safely lower major adverse cardiovascular even...
Source: Atherosclerosis - August 9, 2023 Category: Cardiology Authors: Kyle Nelson Valentin Fuster Paul M Ridker Source Type: research

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

Testosterone Treatments Aren ’ t Linked to Heart Risks When Patients Are Carefully Monitored, Study Finds
Advertisements for treatments for “low T,” or low testosterone levels in middle-aged and older men, have led to spikes in demand. But the safety and legitimacy of those testosterone therapies hasn’t been clear. In a new study published in the New England Journal of Medicine and presented at the Endocrine Society’s annual meeting, researchers provide the most conclusive evidence yet that testosterone treatments appear to be safe for the heart and are not associated with an increased risk of certain heart-related events. In the study, led by researchers at the Cleveland Clinic, more than 5,200 men age...
Source: TIME: Health - June 16, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthscienceclimate heart health Source Type: news

Can ‘toxic’ bilirubin treat a variety of illnesses?
Generations of medical and biology students have been instilled with a dim view of bilirubin. Spawned when the body trashes old red blood cells, the molecule is harmful refuse and a sign of illness. High blood levels cause jaundice, which turns the eyes and skin yellow and can signal liver trouble. Newborns can’t process the compound, and although high levels normally subside, a persistent surplus can cause brain damage. Yet later this year up to 40 healthy Australian volunteers may begin receiving infusions of the supposedly good-for-nothing molecule. They will be participating in a phase 1 safety trial, sponsored ...
Source: ScienceNOW - June 8, 2023 Category: Science Source Type: news

Plain language summary of results from ORION-10 and ORION-11: Two studies to learn how well inclisiran works in people with high cholesterol
Future Cardiol. 2023 Jun 6. doi: 10.2217/fca-2022-0133. Online ahead of print.ABSTRACTWHAT IS THIS PLAIN LANGUAGE SUMMARY ABOUT?: This is a summary of the article describing the results of the ORION-10 and ORION-11 studies, which was published in the New England Journal of Medicine in April 2020. The studies included adult participants with atherosclerotic cardiovascular disease (ASCVD). ASCVD happens when the blood vessels that carry blood from the heart to other areas of the body are blocked by fatty build-up (plaque) causing a heart attack, stroke, or other problems. High levels of low-density lipoprotein cholesterol (L...
Source: Atherosclerosis - June 7, 2023 Category: Cardiology Authors: Kausik K Ray R Scott Wright Source Type: research

Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
RARITAN, NJ, May 25, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical...
Source: Johnson and Johnson - May 25, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Transcatheter Left Atrial Appendage Closure
Methodist Debakey Cardiovasc J. 2023 May 16;19(3):67-77. doi: 10.14797/mdcvj.1215. eCollection 2023.ABSTRACTAtrial fibrillation is the most common arrhythmia worldwide, placing a large population at risk for potentially disabling ischemic strokes, yet an estimated 50% of eligible patients cannot tolerate or are contraindicated to receive oral anticoagulation. Within the last 15 years, transcatheter options for left atrial appendage closure (LAAC) have provided a valuable alternative to chronic oral anticoagulation for reducing risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. With newer...
Source: Methodist DeBakey Cardiovascular Journal - May 22, 2023 Category: Cardiology Authors: Gordon X Wong Gagan D Singh Source Type: research