Risultati per: La FDA approva il sistema di riabilitazione dell’ictus

New England Journal of Medicine, Ahead of Print.

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This study examines the frequency of drug patent invalidations based on inequitable conduct.

We are entering a new era of computerized clinical decision support (CDS) tools. Companies are increasingly using artificial intelligence and/or machine learning (AI/ML) to develop new CDS devices, which are defined by the US Food and Drug Administration (FDA) as software used in disease prevention, diagnosis, or treatment. Recognizing the potential implications for clinical practice, the 21st Century Cures Act enjoined the FDA to regulate these new devices.

This case series study examines the clinical evidence cited for US Food and Drug Administration–approved clinical decision support devices for use in the critical care setting.

The US Food and Drug Administration (FDA) agreed to review an application to allow eligible adult patients to self-administer FluMist, AstraZeneca’s nasal spray flu vaccine that uses a live, weakened version of the virus to prompt an immune response. Under the application, caregivers would also be able to administer the vaccine to people aged 2 to 49 years who are not immunocompromised.

A new committee focused on digital health technologies, including artificial intelligence, machine learning, and virtual reality, will advise the US Food and Drug Administration (FDA) on the risks, benefits, and clinical outcomes linked with these tools, the agency announced.

Si chiama Ixchiq ed è prodotto dall’europea Valneva. Il virus, trasmesso dalle zanzare, è diffuso soprattutto nelle regioni tropicali e subtropicali

Circulation, Volume 148, Issue Suppl_1, Page A13319-A13319, November 6, 2023. Introduction:BAROSTIM NEO® is a Baroreflex activation therapy (BAT) system which has been approved recently by FDA for patients with refractory heart failure. Post market experience of BAT related complications and performance issues have not been reported.Objective:To analyze the post-approval device failures and patient related adverse events (AE) associated with Barostim NEO® system using Manufacturer and User Facility Device Experience (MAUDE) database.Methods:A MAUDE database search was conducted on December 7, 2022, for reports received between Jan 1, 2019, to November 30, 2022. Manual search of the MAUDE database conducted using the term “Barostim” in the brand name section. The AE were adjudicated to various categories based on the review of the event description for each medical device report (MDR).Results:A total of 22 events were reported which included MDRs reported by physicians or manufacturer or both. Device related malfunction was reported in 45.5% (n=10) whereas patient related AE reported in 77.3% (n=17) cases. Of total device related AE, material split, cut or torn was most commonly reported problem (32%, n=7), followed by high impedance (13.6%, n=3) and low impedance (9.1%, n=2). Of the patient related AE, 32% (n=7) were related to clinical or subclinical infection, 18.2% (n=4) hematoma, 13.6% (n=3) heart failure or myocardial injury, 9.1% (n=2) stroke/CVA, 9.1% and 9.1% (n=2) twiddler’s syndrome. No carotid artery or jugular injury and procedure related death reported in the study period. The report is limited by the lack of information on the total number of BAT devices implanted across the country.Conclusions:This study provides a wide range of device malfunction and patient related post-approval adverse events for Barostim device which have not been reported in any clinical trial/study before. The reported complications seem to be in line with other cardiac implantable electronic devices and no BAT specific complications were noted.

Circulation, Volume 148, Issue Suppl_1, Page A18569-A18569, November 6, 2023. Introduction:Despite robust evidence for, and Food and Drug Administration (FDA) approval of sodium-glucose cotransporter-2 inhibitors (SGLT2i) for heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF), use of this therapy is suboptimal.Hypothesis:We aimed to determine 1) prescribing context (inpatient/outpatient) and prescriber type of SGLT2i; 2) patient and provider level predictors of SGLT2i prescription in the year following FDA approval.Methods:All patients in a diverse, multi-state (Ohio and Florida), multi practice/hospital integrated system who had least 1 ambulatory encounter for HF and documented EF >40% were included. Data come from the electronic health record. We compared patients who were prescribed SGLT2i in the year post FDA approval 2/24/22-2/24/23 against those who were not using multivariable logistic regression to assess independent predictors of SGLT2i prescription.Results:20,255 patients with HFpEF/HFmrEF were included in the study. Mean age 73±9 yrs, female (49.8%), Black (17.4%), DM2 (34%), AFib (43%), CKD (35%), baseline medications: BB (52.4%), ACEi/ARB (41%), MRA (19.7%), ARNI (6.5%), SGLT2i (3.2%). There were 1118 (5.6%) patients were newly prescribed SGLT2i in the study period. SGLT2i were most commonly initiated by cardiology 54.2%, general medicine 25.3% and endocrinology 8.5%. Of prescriptions, 82.9% were outpatient, 17.1% inpatient. Independent patient level predictors of SGLT2i prescription were DM2 2.82 (2.09-3.82), p

Circulation, Volume 148, Issue Suppl_1, Page A18533-A18533, November 6, 2023. Introduction:Nivolumab and Ipilimumab are human monoclonal antibodies that target cell surface PD1 and anti-CTLA-4 receptors respectively. Nivolumab and ipilimumab combination is used for metastatic small cell lung carcinoma, advanced renal cell carcinoma and metastatic melanoma. The pre-approval CHECKMATE trials have underestimated the occurrence of cardiovascular adverse events (AEs). In contradiction, post-marketing studies have demonstrated a higher incidence of cardiac AEs, particularly myocarditis.Therefore, it is important to establish a post-marketing safety profile of these medications.Methods:We investigated the cardiovascular AEs of nivolumab and ipilimumab using U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Healthcare professionals (HCPs) reported 79.73% and 80.92% of AEs until March 2023 for nivolumab and ipilimumab respectively. We conducted further subgroup analysis of cardiovascular AEs in male, females as well as in three age groups: 18-64, 65-85 and >85 years.Results:Amongst the cardiovascular AEs reported by HCPs, myocarditis was reported in 905 (1.55 %) in nivolumab vs 445 (1.72%) in ipilimumab group. There were higher reports of other cardiovascular AEs including heart failure (1.15% vs 0.74%), pericarditis/pericardial effusion (1.19% vs 0.6% ), myocardial infarction (0.18% vs 0.71%), cardiomyopathy (0.36% vs 0.29%), cardiac arrest (0.41% vs 0.53%) and cardiac death (0.01% vs 0.02%) in nivolumab vs ipilimumab. On sub-group analysis, we observed higher incidence of myocarditis in females (1.54% vs 1.6%) males (1.73% vs. 1.84%) and in patient with age 18-65 years (1.17% vs 1.15%) in both nivolumab vs ipilimumab group as compared to previous studies.Conclusions:The reported events of myocarditis were significantly higher in FAERS reporting as compared to the CHECKMATE trials (

Circulation, Volume 148, Issue Suppl_1, Page A16736-A16736, November 6, 2023. Introduction:One-year mortality risk for a pulmonary arterial hypertension (PAH) patient is the most substantial. Accordingly, the initial risk stratification should be the most accurate to ensure appropriate aggressiveness of the primary treatment choices. According to PAH guidelines, the European 3-strata system is recommended at baseline for risk assessment. However, the US REVEAL2.0 and REVEAL Lite risk scores also provide high performances. Yet, comparison of risk assessment performances at baseline in the same dataset of patients is still missing.Hypothesis:REVEAL 2.0 provide higher discrimination performances than the European 3-strata system at baseline. We aim to compare the discrimination power at baseline of the currently available tools.Methods:Treatment naïve PAH patients from 6 PAH trials were provided by the FDA and harmonized (AMBITION n=500, ARIES n=126, PATENT n=221, PHIRST n=77, GRIPHON n=231, and SERAPHIN n=270). Kaplan-Meier and log-rank tests were performed for each of the following tools: noninvasive FRENCH method (FR), European 3-strata system (E3), COMPERA2.0 4-strata (CO), REVEAL2.0 (RE), and REVEAL Lite (RL). Their C-indices were compared. A total of 100 bootstrap samples were obtained from the original data providing a robust method for comparing across the different tools.Results:Among the 1,425 patients, 78% were female, 54% NYHA 3-4 with a median age of 51(38, 64) yo, 6-min walking distance of 365(295, 418)m, mPAP of 49(38, 59) mmHg, PVR 9.3(6.2, 13.5) WU. At baseline, the C-index for FR, CO, E3, RL, and RE were 0.64, 0.67, 0.68, 0.69, 0.73, respectively. Out of the 100 bootstrap samples, 99% led to a better C-index for RE compared to E3, with a statistically significant paired t-test (p

New England Journal of Medicine, Ahead of Print.

This Viewpoint discusses the US Food and Drug Administration’s Project Optimus, which focuses on new oncology drug dose optimization and examines concerns about the accelerated postmarketing approval of adjusted dosing of oncologic drugs.

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