Risultati per: FDA approva un nuovo trattamento per l’emicrania

The US Food and Drug Administration (FDA) recently approved a new treatment for schizophrenia that relies on a novel mechanism of action. Oral xanomeline and trospium chloride, marketed as Cobenfy, is the first antipsychotic drug authorized to treat the disease via cholinergic receptors instead of dopamine receptors, which has historically been the therapeutic pathway.

The US Food and Drug Administration (FDA) recently approved the nasal spray influenza vaccine FluMist for at-home administration beginning in 2025, making it the first flu vaccine that won’t need to be administered by a clinician.

Circulation, Volume 150, Issue Suppl_1, Page A4147077-A4147077, November 12, 2024. Background:Tricuspid regurgitation (TR) worsens heart failure symptoms and perpetuates right ventricular failure (RVF). Given the limited efficacy of medicines and high risk of surgical mortality, percutaneous therapeutic options are gaining importance. The TRILUMINATE study reported an 86% reduction in TR severity and 4% mortality rate using Triclip G4 tricuspid transcatheter edge-to-edge repair (T-TEER) system with improvement in health status. Triclip subsequently gained FDA approval for TR on April 2, 2024.Objective:To evaluate reported device and patient related adverse events during early experience with Triclip system for T-TEER.Methods:The events reported for Triclip since it gained FDA approval were extracted from the FDA MAUDE database. Previously published reports, duplicates and events before FDA approval were excluded. Grades of TR at baseline and after T-TEER associated with single leaflet device attachment (SLDA) were compared using Wilcoxon rank sum test.Results:After excluding 14 reports, 45 were included, dating from 04/02/24 to 05/31/24. Of these, 31 (67.4%) featured patient complications, with SLDA being the most frequent (n=24, 53%).(Figure-1) Cause of SLDA was reported in 8 reports.(Figure-2) SLDA led to regression of TR to pre-procedure levels in 10 patients and Polymorphic VT in one patient. Other patient issues included damage to leaflets (n=7, 15.6%) which necessitated surgery in one case and prompted consideration of the same in another. There were 4 reports of clip entrapment in the chordae. Device-related issues included 3 cases of leaks in the steerable guide catheter affecting its ability to hold the column, knotting on the lock line, difficulties with positioning the second clip above the valve, clip reopening beyond the expected 5°, clip opening while locked but staying closed post-deployment, delays in clip delivery, and challengers in guiding catheter positioning. No acute deaths were reported in the MAUDE database within 2 months of device approval.Conclusion:Our research findings summarize the reported adverse events during the early period following FDA approval of Triclip G4 T-TEER system. This provides valuable insights into common failure modes and complications, offering guidance on their optimal utilization. Multiple adverse events can be noted soon after approval of the Triclip, underscoring the importance of good initial training and proctoring.

Circulation, Volume 150, Issue Suppl_1, Page A4125667-A4125667, November 12, 2024. Background:Renal denervation (RDN) has been shown in randomized trials to improve blood pressure compared with a sham procedure. Currently, there are two FDA-approved RDN devices in the United States (US). While nearly half of the US population has hypertension (HTN), the number of patients who may benefit from RDN therapy remains uncertain. In this study, we used a nationally representative dataset to approximate the proportion of patients with HTN who may be eligible for consideration of RDN based on selective criteria.Methods:All adult patients with HTN who participated in the National Health and Nutrition Examination Survey (NHANES) between the years 2009-2020 were identified. We characterized the proportion of these participants that met eligibility criteria based on 1) the FDA indication, 2) the SCAI 2023 RDN position statement, and 3) enrollment criteria from the RDN on-medication randomized trials. National estimates were obtained utilizing survey weighting from the NHANES multistage probability survey design.Results:In total, we identified 16,677 patients with HTN in the US, representing a weighted total of 113,786,149 patients (Table). Using the FDA indication, 31.6% (95% CI, 30.7%-32.6%) of patients meet eligibility criteria for RDN, corresponding to 35,988,870 US adults. By the SCAI 2023 position statement selection criteria, 21.5% (95% CI, 20.7%-22.3%) of patients are eligible for consideration of RDN. Based on enrollment criteria from the RDN on-medication randomized trials, 2.05% (95% CI, 1.81%-2.33%) of US adults meet eligibility for consideration of RDN (Figure).Conclusions:Our findings indicate that nearly one third of US adults with HTN are eligible for consideration of RDN based on the FDA indication; however, a smaller proportion of patients would be eligible based upon society recommendations and randomized trial inclusion criteria. Future studies are needed to further inform which patients will best benefit from this intervention.

Circulation, Volume 150, Issue Suppl_1, Page A4142327-A4142327, November 12, 2024. Background:Apixaban and rivaroxaban are common agents used for anticoagulation to treat and prevent blood clots and to prevent stroke in people with atrial fibrillation.Research question:As anticoagulants, there is a risk of bleeding occurring. The question is, which of these two medications has a higher risk of bleeding from various organ systems.Goals:Using the FAERS database to calculate the reporting odds ratio (ROR) for the risk of ocular, cerebral, gastrointestinal, rectal, and renal hemorrhage in addition to epistaxis and hemoptysis of these medications.Methods:We manually extracted data from the FAERS database owned by the FDA on hemorrhagic events related to Apixaban and Rivaroxaban from January 2012 to March 2024. We calculated the reported odds ratio for both drugs to compare their respective hemorrhagic outcomes.Results:The total AE reported for apixaban and rivaroxaban from 2012 to March 2024 was 87490 and 88026, respectively. Rivaroxaban has an increased risk for cerebral (ROR 1.73, 95% CI 1.60 to 1.86), gastrointestinal (ROR 5.91, 95% CI 5.61 to 6.22), rectal (ROR 4.64, 95% CI 4.21 to 5.12), renal (ROR 3.83, 95% CI 2.87 to 5.11), epistaxis (ROR 2.06, 95% CI 1.93 to 2.20) and hemoptysis (ROR 3.20, 95% CI 2.80 to 3.66) compared to apixaban with a significant p-value. There was no statistical significance in reported cases of ocular hemorrhage in apixaban versus rivaroxaban.Conclusion:Apixaban and rivaroxaban are common medications used in the treatment of people with atrial fibrillation to reduce the risk of clots and stroke. The FAERs database compared the risk of ocular, cerebral, gastrointestinal, rectal, and renal hemorrhage and epistaxis and hemoptysis of these medications. There was no statistical significance in reported cases of ocular hemorrhage in apixaban versus rivaroxaban. Rivaroxaban overall has a significantly higher risk of bleeding in multiple organ systems, especially cerebral, gastrointestinal, rectal, and renal hemorrhage, as well as epistaxis and hemoptysis. Apixaban would be a better option for people at risk for or with a history of these complications.

Circulation, Volume 150, Issue Suppl_1, Page A4142273-A4142273, November 12, 2024. Background:GLP-1 Receptor Agonists have become widely used for treating Diabetes Mellitus Type 2 and weight loss in patients across the United States. However, new data reports increasing cases of pancreatitis, acute kidney injury, increased Hba1c, and thyroid malignancy.Research question:Like many medications, GLP-1 receptor antagonists have a risk of side effects. The question is which medication, Semaglutide or Tirzepatide, has the highest risk of developing the above mentioned side effects.Goals:Using the FAERS database to calculate the reporting odds ratio (ROR) for the risk of pancreatitis, acute kidney injury, increased HgA1c, and thyroid malignancy.Methods:The FDA’s FAERS system gathers information on adverse events and medication errors. The data shows that both Semaglutide and Tirzepatide have been linked to pancreatitis, acute kidney injury, elevation in HbA1c, and various types of thyroid malignancies. For consistent analysis, this data covers the period from 2022 to 2024 for both drugs.Results:January 2022- March 2024 data showed that Semaglutide and Tirzepatide had 11584 AE and 29453 AE, respectively. Semaglutide had a higher risk of developing pancreatitis, elevation of HbA1c, and thyroid malignancy compared to Tirzepatide (ROR 2.62, 95% CI 2.21-3.10) (ROR 1.72, 95% CI 1.38 to 2.15), (ROR 4.32, 95%CI 2.66 to 7.01) respectively. However, Semaglutide had 72% fewer reported cases of AKI than Semaglutide (ROR 0.28, 95% CI= 0.20 to 0.37).Conclusion:Lately, the popularity of GLP-1 Agonists is soaring mainly due to their role in facilitating weight loss and providing additional cardiovascular benefits. To the best of our knowledge, this is the first study comparing the likelihood of these four AEs with Semaglutideand Tirzepatide, using the FAERS Database. Being the newer agent, Tirzepatide is significantly less strongly associated with three AEs than AKI. Additional studies are needed to investigate further the epidemiology and pathophysiology of AKI with Tirzepatide use. In the meantime, Tirzepatide should be the drug of choice in patients who are at high risk for pancreatitis, thyroid cancer, and poorly controlled DM. Semaglutide might be considered in chronic kidney disease patients.

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The US Food and Drug Administration (FDA) recently issued its final rule to raise the minimum age for buying tobacco products from 18 to 21 years old. These products include cigarettes as well as smokeless tobacco.

The US Food and Drug Administration (FDA) expanded approval of an automated insulin delivery system to include its use for people with type 2 diabetes aged 18 years or older. The software, marketed as the Insulet SmartAdjust, works with an automated insulin pump and a glucose sensor to adjust insulin delivery every 5 minutes. The FDA previously authorized it for those with type 1 diabetes aged 2 years or older.

To more closely target SARS-CoV-2 variants currently circulating in the US, the US Food and Drug Administration (FDA) authorized an updated formula of the messenger RNA (mRNA) COVID-19 vaccine, the agency announced in mid-August.