Madrigal Announces US Availability of Resmetirom (Rezdiffra), First Patients Treated for NASH
Resmetirom to treat NASH with F2-F3 fibrosis, the only approved therapy, is available through Madrigal's specialty pharmacy network, the company said.
Novel Web Tool Determines Consumer Eligibility for OTC Statin, With High Clinician Concordance
The web app showed more than 90% concordance with clinical assessment of eligibility for low dose rosuvastatin; study yields 35.5% reduction in LDL-C.
Pfizer: MONeT Study Topline Data Positive for Abrysvo in Adults Aged 18 to 59 Years at High Risk for RSV-LRTD
Pfizer plans to submit the phase 3 MONeT data to regulatory bodies in support of an expanded label for Abrysvo to include adults aged 18 to 59, the company said.
Semaglutide 2.4 mg Improves Functional Status, Body Weight in Adults with HFpEF, Obesity, T2D
ACC.24: Results of STEP HFpEF DM showed significant improvement in quality of life measures among adults with obesity-related HFpEF and type 2 diabetes.
Zilebesiran Reduces SBP by Up to 14 mm Hg on Background SOC in Uncontrolled Hypertension: KARDIA-2
ACC.24: Zilebesiran led to clinically and statistically significant reductions in SBP on top of either a diuretic, CCB, or ARB; SQ dosing is every 3-6 months.
Secondary CVD Prevention Requires Much More than "Usual Care," Says Michael Koren, MD,
ACC.24: Individuals with ASCVD not at target LDL-C on maximum statin therapy need immediate intervention and one that works, said V-INITIATE primary investigator.
The Inclisiran Impact on PCSK9: A Primary Care Primer
ACC.24: Michael Koren, MD, highlights how the nonstatin lipid-lowering medication's mechanism of action against PCSK9 differs from others in the category.
Michael J Koren, MD, Reviews Success of "Inclisiran First" Strategy and Implications for Clinical Practice
ACC.24: The primary investigator of the VICTORION-INITIATE study explains why new strategies are needed to accelerate LDL-C lowering in high-risk individuals.
"Inclisiran First" Strategy Leads to 60% Reduction in LDL-C vs 7% for Usual Care: VICTORION-INITIATE Findings
ACC. 24: A structured, systematic approach to lipid-lowering therapy in secondary prevention is needed to ensure targets are met and met swiftly, said researchers.
Optimal Cardioprotective BMI for Adults with Type 2 Diabetes Could Vary by Age, New Study Suggests
In a population cohort of adults with T2D, a BMI above "normal" range appeared more likely to protect against CV death in those older than age 65 years than those younger.
Older, Mentally Altered Adults at Greatest Risk for Inappropriate Diagnosis of CAP
More than 1 in 10 older adults were misdiagnosed with community-acquired pneumonia and nearly all were treated with a full course of antibiotics, a new study found.
Nontraditional Risk Factors More Likely to Cause Stroke in Young Adults, Study Finds
Migraine was the most important nontraditional risk factor linked to stroke in adults aged 18 to 34 years and should be considered in evaluation for an event.
ARS Pharma Submits Response to FDA Complete Response Letter for neffy (epinephrine nasal spray)
Positive findings from a repeat dosing study of neffy under nasal allergen challenge conditions will support a potential PDUFA date of October 2, 2024, the company said.
New Follow-Up Measure After Stool-Based CRC Test Could Improve Colonoscopy Rates, Outcomes
The quality performance measure is viable and reliable and could help improve early CRC detection rates via timely colonoscopy following abnormal stool-based test.
Atogepant Found More Effective for Migraine Prevention vs Rimegepant in New Analysis
Atogepant was associated with fewer monthly migraine days, fewer acute medication use days, and greater QoL compared with rimegepant after 12 weeks.
Obesity Care Needs More Cardiology Support, Suggest 2 New Studies
ACC.2024: Two abstracts presented during the ACC Scientific Sessions indicate cardiologists are very hesitant to prescribe medical therapy for obesity.
CAC Progression in Postmenopausal Women Found Double that of Men in New Research
ACC.24: Loss of estrogen's cardioprotective effect could account for the 2-fold greater increase in CAC score seen among postmenopausal women compared with men.
Vaccination of Older Adults Against RSV Could Reduce Symptomatic Cases by 1 Million per Year: Modeling Study
The study looked at the impact over 3 years but found that most of the averted burden, including more than 8000 fewer deaths, occur in the first year after vaccination.
Eisai Files sBLA for Lecanemab-irmb Maintenance Dosing, Reports Delay on SC Formulation
The sBLA for once-monthly maintenance IV dosing of lecanemab is complete but a rolling application for a weekly subQ option has been set back, said Eisai.
Icosapent Ethyl Reduces MACE Across Range of Baseline Lp(a): REDUCE-IT Analysis
ACC.24: Icosapent ethyl was associated with reduced rate of MACE at all baseline levels of Lp(a) in participants with elevated TG and at high risk for CVD.
FDA Issues Warning Letters to 6 Companies Marketing Misbranded OTC Topical Analgesics
Specifically, the topical analgesics, available over the counter, may contain higher than labeled concentrations of lidocaine, according to the agency.
Moderna Next-Gen mRNA COVID-19 Vaccine Meets Primary Endpoints in NextCOVE Phase 3 Trial
The mRNA bivalent vaccine candidate produced a "more robust" immune response vs Spikevax and particularly in adults over the age of 65 years, said Moderna.
Viking Therapeutics Oral Antiobesity Agent Returns Positive Results in Small Study
The once daily tablet, VK2375, is headed to a phase 2 trial later this year and is an oral version of Viking's investigational injectable GLP-1/GIP mimetic currently in phase 2.
Steven Nissen, MD, Discusses Historic Bempedoic Acid Labeling for CV Risk Reduction
CLEAR Outcomes PI Steven Nissen, MD, links findings from the pivotal trial with labeling updates that make bempedoic acid the only nonstatin agent approved to reduce CV risk.
Sotagliflozin Impact on Stroke, MI to Be Explored in 4 Posters at ACC.24
The novel SGLT-2/SGLT-1 inhibitor reduced risk of stroke, MI, and demonstrates significant antiplatelet activity in post-hoc analyses of SCORED phase 3 trial.
Remotely Delivered Lipid Lowering Program Results in Sustained Target LDL-C Levels in High-Risk Population
ACC.2024: In a cohort of people at high risk of ASCVD, three-quarters achieved target LDL-C levels at 6 months and 12 months while using a remote algorithm-directed program.
Concomitant SSRI and DOAC Use Increases Risk of Major Bleeding, Including ICH: New Findings
Overall, a 33% increased risk of major bleeding was seen, with risk highest during the first 30 days of concomitant use and persistent, but lower, after 6 months.
FDA Approves Fixed-Dose Macitentan/Tadalafil Tablets (Opsynvi) For Pulmonary Arterial Hypertension
For the first time, 2 drugs recommended as first line treatment for PAH are combined in a single oral once-daily therapy, which could reduced burden of care.
FDA Expands Bempedoic Acid Label to Include Primary, Secondary CV Risk Reduction, With or Without Statins
Bempedoic acid is now the only non-statin therapy indicated for primary CVD prevention, with potential to expand treatment access to millions, said Esperion Therapeutics.
Medicare Will Cover AOM Semaglutide for Cardiovascular Risk Reduction: A First
CMS says Medicare Part D plans will cover semaglutide for individuals with overweight/obesity who have preexisting CVD, a first after 40 years of legal prohibition.