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Total 209 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
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
FDA Approves New Menopause Drug for Hot Flashes
WASHINGTON — U.S. health regulators on Friday approved a new type of drug for women dealing with uncomfortable hot flashes caused by menopause.
The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills.
Astellas’ drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide “an additional safe and effective treatment option for women,” in a statement.
More than 80% of women experience hot flashes during menopause,...
Source: TIME: Health - May 15, 2023 Category: Consumer Health News Authors: Matthew Perrone/AP Tags: Uncategorized Drugs healthscienceclimate wire Source Type: news
Straight from the heart: Mysterious lipids may predict cardiac problems better than cholesterol
Stephanie Blendermann, 65, had good reason to worry about heart disease. Three of her sisters died in their 40s or early 50s from heart attacks, and her father needed surgery to bypass clogged arteries. She also suffered from an autoimmune disorder that results in chronic inflammation and boosts the odds of developing cardiovascular illnesses. “I have an interesting medical chart,” says Blendermann, a real estate agent in Prior Lake, Minnesota.
Yet Blendermann’s routine lab results weren’t alarming. At checkups, her low-density lipoprotein (LDL), or “bad,” cholesterol hovered around the 100 milligrams-per-...
Source: Science of Aging Knowledge Environment - March 16, 2023 Category: Geriatrics Source Type: research
New VOYAGER PAD Analysis Confirms Consistent Benefit of XARELTO ® (rivaroxaban) Plus Aspirin Following Lower Extremity Revascularization (LER)
TITUSVILLE, NJ, March 5, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD. Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of ...
Source: Johnson and Johnson - March 5, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Here ’s an Alternative to Statins for Lowering Cholesterol
Statins have revolutionized heart disease by lowering cholesterol effectively—by up to 50% or more. But anywhere from 7% to 29% of people who take them may be more susceptible to its side effects, which include weakening of muscles and pain, and decide they can’t tolerate them. In a recent study published in JAMA Network Open, for example, researchers at Brigham and Women’s Hospital reported that more than 20% of patients seen at the hospital from 2000 to 2018 who were recommended to take statins refused to take them, and those who refused took three times as long to lower their LDL cholesterol to target ...
Source: TIME: Health - March 4, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthscienceclimate heart health Source Type: news
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
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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
FDA Experts Vote to Make All COVID-19 Vaccines and Boosters Bivalent
In a unanimous decision, all 21 voting members of the U.S. Food and Drug Administration’s (FDA) vaccine committee recommended that the U.S. start using the same COVID-19 virus strain in all of the COVID-19 vaccines, including primary and booster doses.
That means the bivalent booster dose, which targets both the original SARS-CoV-2 strain and the Omicron BA.4/5 strains, would soon become the only type used for all primary shots and boosters.
The decision reflects a turning point in the pandemic. Until now, vaccine makers have tried to keep up with constantly evolving variants, but they’ve always been a few step...
Source: TIME: Health - January 27, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news
FDA Approves Lecanemab, a New Alzheimer ’s Drug
On Jan. 6, the U.S. Food and Drug Administration (FDA) approved a new drug to treat Alzheimer’s disease in its early stages.
Lecanemab, which will be available under the name Leqembi, can slow the cognitive decline associated with Alzheimer’s disease by 27%, according to data submitted to the FDA by the drug’s developers, Eisai and Biogen. It’s only the second medication to show any improvement in neurodegeneration, a key criterion in the FDA’s consideration for approval.
“For a long time, this is what we have been looking for,” says Dr. Sam Gandy, professor of neurology and psychi...
Source: TIME: Health - January 6, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized Drugs healthscienceclimate Source Type: news
Scientists tie third clinical trial death to experimental Alzheimer ’s drug
As enthusiasm mounts for a new experimental antibody that appears to slow cognitive decline in some Alzheimer’s patients, a third death linked to the drug during its clinical testing may amplify concerns about its safety.
Science
has obtained medical records showing a 79-year-old Florida woman participating in an ongoing trial of the antibody died in mid-September after experiencing extensive brain swelling and bleeding, as well as seizures. Multiple neuroscientists who reviewed the records at
Science
’s request believe her death was likely caused by the antibody, lecanemab.
“The brain swelling and t...
Source: ScienceNOW - December 21, 2022 Category: Science Source Type: news
