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This Viewpoint discusses the use of breast density notifications to inform women with dense breast tissue of the potential need for supplemental cancer screening, as well as the need to ensure that such notifications are clear and understandable to women of all language backgrounds, literacy levels, educational levels, and socioeconomic backgrounds.
Ha mostrato di rallentare la malattia, costerà 26.500 dollari all’anno a persona
The FDA granted its first approval for a gene therapy for hemophilia in late November.
Approvazione il 28 aprile, costerà 18 dollari a dose
This Viewpoint discusses the controversy surrounding the FDA’s efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway.
This Viewpoint provides recommendations for improvements to strengthen legal obligations and decrease ambiguity for the US Food and Drug Administration regarding their reliance on voluntary preapproval withdrawal pledges.
The FDA authorized a software medical device intended to help anesthetists and other health professionals identify important anatomical structures in ultrasound images before inserting needles to deliver regional anesthesia.
This cross-sectional study estimates all US Food and Drug Administration anticancer approvals in recent years and evaluates if an association exists between their cost and efficacy.
New England Journal of Medicine, Volume 387, Issue 20, November 2022.
Presidente Sis 118, su pandemia abbandonare conflittualità
Studio, più vantaggi per uomini (-28%) rispetto donne (-17%)
This cohort study used the Drugs@FDA database to identify new drugs approved by the US Food and Drug Administration (FDA) and assess fulfillment of postmarket commitments and requirements.
Circulation, Volume 146, Issue Suppl_1, Page A11701-A11701, November 8, 2022. Background:In January 2021, vericiguat was approved by US FDA to reduce the risk of cardiovascular death and HF hospitalization following a recent worsening HF event based on results of the VICTORIA trial. Limited data are available characterizing generalizability to US clinical practice.Methods:We studied patients hospitalized with HF with reduced ejection fraction (HFrEF)
Circulation, Volume 146, Issue Suppl_1, Page A11293-A11293, November 8, 2022. Introduction:Ivabradine has been shown to be associated with atrial fibrillation (AF) in a metanalysis of 11 studies, however, AF has not been routinely reported as an adverse event of ivabradine in clinical trials. The FDA Adverse Event Reporting System (FAERS) is a publicly available database of adverse events (AE) of various drugs. We analyzed the database for real-world AF reporting with Ivabradine.Methods:FAERS was searched for the adverse events reported for ivabradine. All AF cases were individually analyzed.Results:A total of 3550 AE reports of Ivabradine were reported to FAERS from April 2011 to August 2021 out of which 1117 were cardiac adverse events. A total of 78 cases of AF were reported, accounting for 2.1% of the total AE reports and 31% of cardiac AE reports. Sex was reported in 83% of total AF cases, of which 50% were male, and the other 50% were female. 79% of the AF cases were reported by health care professionals, and 21% by consumers. 51% of cases were reported from the United States, 10% from France, and 9% from Germany. In 51% of the cases, no concomitant drug was given with ivabradine, and in 49% a concomitant drug was given; 10% of those was Digoxin/Digitalis that has been associated with AF. When searched using OpenVigilFDA (a web-based user interface to the FAERS for extraction and analysis of adverse events reports), the reporting odds ratio (ROR) of Ivabradine for AF was 3.18 (95% CI: 2.46 – 4.10) and the proportional reporting ratio was 3.15. The comparison of RORs of ivabradine with the drugs traditionally known to cause AF is shown in the figure.Conclusions:Disproportionate reporting of AF with ivabradine indicates that AF is associated with Ivabradine use. Further studies are required to confirm this association
Circulation, Volume 146, Issue Suppl_1, Page A10611-A10611, November 8, 2022. Introduction:SARS-CoV-2 has undergone mutations, yielding clinically relevant variants such as Delta and Omicron. Early detection of virus and effective therapeutic treatment independent of variants help control virus spread.Hypothesis:We hypothesized that in the genome of SARS-CoV-2 two highly conserved viroporins Orf3a and E channels directly related to virus replication may be explored as a target for detection and inhibition of viral replication independent of variants using FDA-approved ion channel modulators.Methods:A combination of a fluorescence potassium ion assay with three channel modulators (4-aminopyridine, emodin-Orf3a channel blocker, gliclazide-E channel blocker) in a 96-well plate format was developed to detect SARS-CoV-2 Orf3a/E channel activity. We subtracted the fluorescence signals in the absence and presence of emodin/gliclazide to detect Orf3a and E channel activity. Two FDA-approved drugs, amantadine (an antiviral) and amitriptyline (an antidepressant) that are also ion channel blockers, were used to test whether they can inhibit Orf3a/E channel activity in isolated virus (UV inactivated) and in nasal swab samples from Covid-19 patients. Twenty-one (21) Delta and thirty (30) Omicron nasal swab samples were used. Variants were confirmed by PCR sequencing.Results:Orf3a and E form non-voltage-gated ion channels that are highly conserved in SARS-CoV-2 variants. In UV-inactivated SARS-CoV-2 Alpha, Beta, and Delta variants, significant channel activity of Orf3a/E was detected based on an increase in fluorescence induced by 4-aminopyridine, and this increase in fluorescence was inhibited by emodin and gliclazide (IC50= 0.42mM). Amantadine and amitriptyline can inhibit Delta virus with amitriptyline being a more potent inhibitor than amantadine. In swab samples of Delta variants, both amitriptyline and amantadine inhibited the channel activity of viral proteins with IC50values of 0.73mM and 1.11mM, respectively. In swab samples of Omicron variants, amitriptyline inhibited the channel activity with an IC50of 0.76mM.Conclusions:We developed an efficient method to screen FDA-approved ion channel modulators that can be repurposed to inhibit SARS-CoV-2 viral replication independent of variants.
Il 29/10 giornata mondiale, riconoscere sintomi è importante
