Health Care Resource Utilization With Dronedarone Versus Sotalol Following Catheter Ablation in Adults With Atrial Fibrillation.

Background: Clinical trials support dronedarone use for atrial fibrillation (AF) following catheter ablation (CA); however, comparative data on health care resource utilization (HCRU) with other antiarrhythmic drugs are lacking.

Methods: Retrospective analysis of Merative MarketScan databases (January 01, 2012-March 31, 2020) comparatively assessed HCRU in US adults with AF who received dronedarone or sotalol post-CA. Patients with ≥ 12-months' pre-CA data were followed from post-CA index treatment to disenrollment, death, or study end.

Utility of life stage-specific chemical risk assessments based on New Approach Methodologies (NAMs).

The safety assessments for chemicals targeted for use or expected to be exposed to specific life stages, including infancy, childhood, pregnancy and lactation, and geriatrics, need to account for extrapolation of data from healthy adults to these populations to assess their human health risk. However, often adequate and relevant toxicity or pharmacokinetic (PK) data of chemicals in specific life stages are not available. For such chemicals, New Approach Methodologies (NAMs), such as physiologically based pharmacokinetic (PBPK) modeling, biologically based dose response (BBDR) modeling, in vitro to in vivo extrapolation (IVIVE), etc.

Evaluating the toxicokinetics of some metabolites of a C6 polyfluorinated compound, 6:2 fluorotelomer alcohol in pregnant and nonpregnant rats after oral exposure to the parent compound.

The 6:2 fluorotelomer alcohol (6:2 FTOH) is a common impurity in per- and polyfluoroalkyl substances (PFASs) used in many applications. Our previous toxicokinetic (TK) evaluation of 6:2 FTOH calculated times to steady state (tss) of one of its metabolites, 5:3 fluorotelomer carboxylic acid (5:3A), in the plasma and tissues of up to a year after oral exposure to rats. Our current work further elucidated the TK of 5:3A and other metabolites of 6:2 FTOH in pregnant and nonpregnant rats after repeated oral exposure and examined the role of renal transporters in the biopersistence of 5:3A.

Dronedarone Versus Sotalol in Antiarrhythmic Drug-Naive Veterans With Atrial Fibrillation.

Background: Sotalol and dronedarone are both used for maintenance of sinus rhythm for patients with atrial fibrillation. However, while sotalol requires initial monitoring for QT prolongation and proarrhythmia, dronedarone does not. These treatments can be used in comparable patients, but their safety and effectiveness have not been compared head to head.

Cluster analysis of kidney function decline among males with Fabry disease in a large United States electronic health records database.

Background: Fabry disease (FD) is an X-linked lysosomal storage disorder caused by deficient α-galactosidase A activity. The spectrum of disease includes phenotypes ranging from "classic" to "later-onset," with varying kidney disease progression. Identifying patterns of declining kidney function and involvement of other major organs in patients with FD is important to guide therapy decisions.