Dapagliflozin Gets Breakthrough Therapy Status for CKD Indication
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
Cardiology
AHA Issues Statement on Drug-Induced Arrhythmias
The objective of the statement was to review and discuss medications that may cause or exacerbate arrhythmias.
Risk of Cardiac Events With Azithromycin, Amoxicillin Compared
The aim of the study was to use real-world data to compare the risk of cardiac events in new users of azithromycin vs amoxicillin.
Confirmatory Testing No Longer Needed for 23andMe’s CYP2C19 Report
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report.
Gadavist Imaging Bulk Package Approved for Multi-Patient Dosing
Gadavist® Imaging Bulk Package is supplied as 604.72mg/mL of gadobutrol in 30mL and 65mL multidose containers.
Empagliflozin Heart Failure Study Meets Primary End Point
The double-blind EMPEROR-Reduced trial enrolled 3730 adults with HFrEF, with and without diabetes.
FDA to Review Furosemide Formulation Delivered Via On-Body Infusor
Furoscix is an investigational, proprietary, pH-neutral formulation of furosemide designed for subcutaneous administration via a wearable, pre-programmed on-body drug delivery system for outpatient self-administration.
Trial Investigating Dapagliflozin in CKD Meets All End Points
The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
Mavacamten Gets Breakthrough Therapy Status for Obstructive Hypertrophic Cardiomyopathy
The designation is supported by results from the phase 3 EXPLORER-HCM trial that evaluated mavacamten in 251 adult patients with symptomatic, obstructive HCM.
GI Bleeding Rates With P2Y12 Platelet Inhibitors Compared
Ticagrelor and prasugrel, the newer generation of P2Y12-inhibiting antiplatelet agents, were found to be associated with fewer gastrointestinal bleeding events the first year after percutaneous coronary intervention compared with clopidogrel.
