Long-term treatment with inclisiran was found to be well  tolerated in a diverse population, without new safety signals, supporting the safety of inclisiran in patients with dyslipidemia, according to a study published in JACC.

R. Scott Wright, MD, FACC, et al., conducted a post hoc analysis of participants in both completed and ongoing ORION trials, including 3,576 patients treated with 300 mg inclisiran sodium for up to six years and 1,968 patients treated with placebo for up to 1.5 years. The majority of participants were diagnosed with atherosclerotic cardiovascular disease (ASCVD) and were taking a statin. The authors analyzed exposure-adjusted incidence rates and Kaplan-Meier estimates of the cumulative incidence of reported treatment-emergent adverse events, abnormal laboratory measurements and incidence of antidrug antibodies.

Results showed that treatment-emergent adverse events that were serious or led to discontinuation – hepatic, muscle and kidney events, incident diabetes, elevations of creatine kinase or creatinine accrued – were comparable for up to 1.5 years, with similar trends continuing for inclisiran beyond the period with available placebo data. Fewer major cardiovascular events were reported as treatment-emergent adverse events in the inclisiran group during this period.

In addition, treatment-induced antidrug antibodies were uncommon with inclisiran (4.6%), with few of these cases persistent (1.4%). This complication was not associated with greater incidence of serious treatment-emergent adverse events or drug discontinuation.

In an accompanying editorial comment, Christie M. Ballantyne, MD, FACC, Abdul Mannan Khan Minhas, MD, and Carl E. Orringer, MD, FACC, write, "Inclisiran is a promising new therapy with the advantages of less-frequent dosing, robust LDL-C reduction, good tolerability, and a favorable safety profile. Large ASCVD outcomes trials will help us to better determine whether this agent will safely and effectively reduce ASCVD risk."

Wright RS, Koenig W, Landmesser U, et al. J Am Coll Cardiol 2023;82:2251-61.

Cardiac imaging technologies are increasing rapidly and are becoming increasingly important in helping the growing congenital heart disease (CHD) population who are being treated with more complex surgical and catheter-based procedures, according to a JACC Scientific Statement published in JACC.

Advanced practice providers (APPs) are a vital group in the  multidisciplinary care needed to manage the complex and evolving populations in the cardiac intensive care unit (CICU) and could be leveraged to improve patient care, according to an article published in JACC.

Stress and depression are common among women at the time of myocardial infarction (MI) and for two months after, and women with MI  and obstructive coronary artery disease (MI-CAD) may have higher stress levels than those with MI with nonobstructive coronary arteries (MINOCA), according to a study published in JACC.

A diagnosis of atrial fibrillation (AFib) was associated with an increased risk of mild cognitive impairment (MCI) and progression to dementia, according to a study published in JACC: Advances.

The integrated application of novel multimodality imaging techniques may improve diagnostic precision for the screening and monitoring of disease activity for patients with systemic inflammatory diseases (SIDs), according to a JACC Scientific Statement published in JACC.