The Safety Profile of COVID-19 Convalescent Plasma.

Despite concerns about potential side effects, based both on historical experience with plasma products and more recent concerns about contemporary use of plasma, COVID-19 convalescent plasma has been shown to be a very safe product. Research early in the COVID-19 pandemic documented-among the very large population of convalescent plasma recipients in the US Convalescent Plasma Study component of the FDA-authorized Expanded Access Program-that the overall risk profile was no different than that seen for fresh frozen plasma, a product used routinely in medical practice. The safety of CCP was further demonstrated using real-world evidence, pragmatic trials, and formal randomized trials.

Lipoprotein (a): Underrecognized Risk with a Promising Future.

Lipoprotein a (Lp(a)) is a lipid biomarker that binds cholesterol and bears independent cardiovascular risk. Strategies to lower the level of Lp(a) and mitigate such risk are important both for primary and secondary prevention. Currently there are no approved therapies targeting Lp(a) directly.

Estimates of actual and potential lives saved in the United States from the use of COVID-19 convalescent plasma.

In the Spring of 2020, the United States of America (USA) deployed COVID-19 convalescent plasma (CCP) to treat hospitalized patients. Over 500,000 patients were treated with CCP during the first year of the pandemic. In this study, we estimated the number of actual inpatient lives saved by CCP treatment in the United States of America based on CCP weekly use, weekly national mortality data, and CCP mortality reduction data from meta-analyses of randomized controlled trials and real-world data.

PRELIMINARY IMPACT OF SUPPORTIVE HOUSING ON HOSPITAL UTILIZATION FOR INDIVIDUALS EXPERIENCING HOMELESSNESS.

Housing instability has been shown to negatively impact physical and mental health, with a corresponding increase in health care utilization. In 2019, through a Maryland Medicaid 1115 Health Choice Waiver, 10 Baltimore city hospitals joined with the city of Baltimore and the local nonprofit Health Care for the Homeless to support an innovative program that provides permanent housing and wraparound services to individuals at risk of homelessness. Here, we describe the inception of the program and its subsequent expansion with the investment of the city hospitals.

Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease: A Pooled Analysis of the ORION-10 and ORION-11 Randomized Trials.

Objective: To evaluate the efficacy, safety, and tolerability of inclisiran in participants with atherosclerotic cardiovascular disease (ASCVD) from ORION-10 and ORION-11 stratified by key patient characteristics.

Patients And Methods: Participants were randomized 1:1 to receive 300 mg inclisiran sodium (284 mg inclisiran) or placebo on days 1, 90, 270, and 450, alongside background lipid-lowering therapy. This pooled, post hoc analysis stratified participants with ASCVD by sex, age, race, kidney function, body mass index, and glycemic status.

Social support moderates association between area deprivation index and changes in physical health among adults in the Baltimore Study of Black Aging (BSBA).

Despite the association of neighborhood quality with poorer adult health, limited research has explored the association between neighborhood disadvantage, e.g. Area Deprivation Index (ADI), and older Black adults' health, prospectively.

Inclisiran in individuals with diabetes or obesity: Post hoc pooled analyses of the ORION-9, ORION-10 and ORION-11 Phase 3 randomized trials.

Aims: To conduct a pooled analysis of Phase 3 trials investigating the efficacy and safety of inclisiran across glycaemic and body mass index (BMI) strata.

Materials And Methods: Participants were randomized 1:1 to receive 300 mg inclisiran sodium or placebo twice yearly, after initial and 3-month doses up to 18 months, with background oral lipid-lowering therapy. Analyses were stratified by glycaemic status (normoglycaemia, prediabetes, and diabetes) or BMI (<25, ≥25 to <30, ≥30 to <35, and ≥35 kg/m).

Neighborhood disadvantage is associated with working memory and hippocampal volumes among older adults.

It is not well understood how neighborhood disadvantage is associated with specific domains of cognitive function and underlying brain health within older adults. Thus, the objective was to examine associations between neighborhood disadvantage, brain health, and cognitive performance, and examine whether associations were more pronounced among women. The study included 136 older adults who underwent cognitive testing and MRI.

Estimating potential cardiovascular health benefits of improved population level control of LDL cholesterol through a twice-yearly siRNA-based approach: A simulation study of a health-system level intervention.

Background And Aims: Inclisiran, an siRNA therapy, consistently reduces low-density lipoprotein cholesterol (LDL-C) with twice-yearly dosing. Potential cardiovascular benefits of implementing inclisiran at a population level, added to statins, were evaluated through simulation.

Methods: For each participant in the ORION-10 and ORION-11 trials comparing inclisiran with placebo, baseline 10-year cardiovascular risk was estimated using the SMART equation.

Safety and Tolerability of Inclisiran for Treatment of Hypercholesterolemia in 7 Clinical Trials.

Background: Inclisiran is a small interfering RNA agent to lower low-density lipoprotein cholesterol.

Objectives: The purpose of this study was to provide reliable evidence to date on the long-term safety profile of inclisiran.

Methods: This post hoc analysis comprised patients treated with 300 mg inclisiran sodium or placebo in the completed (ORION-1, -3, -5, -9, -10, and -11) and ongoing (ORION-8) trials.

Inclisiran in patients with prior myocardial infarction: A post hoc pooled analysis of the ORION-10 and ORION-11 Phase 3 randomised trials.

Background And Aims: Among patients with prior myocardial infarction (MI), the risk of future ischaemic cardiovascular events is increased, and intensive lipid-lowering therapy (LLT) is indicated to achieve guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals. Here, the efficacy and safety of inclisiran, a small interfering ribonucleic acid, were evaluated in patients with or without prior MI from the pooled ORION-10 and ORION-11 Phase 3 trials.

Methods: Patients (n = 2636) were randomised 1:1 to receive 284 mg inclisiran (300 mg inclisiran sodium) or placebo on Day 1, Day 90, and 6-monthly thereafter over 18 months, along with background oral LLT, including statins.

Rates Among Hospitalized Patients With COVID-19 Treated With Convalescent Plasma: A Systematic Review and Meta-Analysis.

Objective: To examine the association of COVID-19 convalescent plasma transfusion with mortality and the differences between subgroups in hospitalized patients with COVID-19.

Patients And Methods: On October 26, 2022, a systematic search was performed for clinical studies of COVID-19 convalescent plasma in the literature from January 1, 2020, to October 26, 2022. Randomized clinical trials and matched cohort studies investigating COVID-19 convalescent plasma transfusion compared with standard of care treatment or placebo among hospitalized patients with confirmed COVID-19 were included.

Plain language summary of results from ORION-10 and ORION-11: two studies to learn how well inclisiran works in people with high cholesterol.

What Is This Plain Language Summary About?: This is a summary of the article describing the results of the ORION-10 and ORION-11 studies, which was published in the in April 2020. The studies included adult participants with atherosclerotic cardiovascular disease (ASCVD). ASCVD happens when the blood vessels that carry blood from the heart to other areas of the body are blocked by fatty build-up (plaque) causing a heart attack, stroke, or other problems.

Efficacy and safety of inclisiran in patients with cerebrovascular disease: ORION-9, ORION-10, and ORION-11.

Patients with cerebrovascular disease (CeVD) have been shown to benefit from lipid-lowering therapies, but guideline-recommended levels of low-density lipoprotein cholesterol (LDL-C) are often not attained with statin treatment alone. The ORION-9, ORION-10, and ORION-11 trials evaluated the efficacy and safety of inclisiran in 3660 primary and secondary prevention patients with hyperlipidemia despite maximum tolerated statin treatment. This pooled analysis comprised 202 randomized patients from those trials with established CeVD who had received either 284 mg inclisiran (equivalent to 300 mg inclisiran sodium,  = 110) or placebo ( = 92) on Days 1, 90, and 6-monthly thereafter up to Day 540.

Efficacy and Safety of Inclisiran in Patients with Polyvascular Disease: Pooled, Post Hoc Analysis of the ORION-9, ORION-10, and ORION-11 Phase 3 Randomized Controlled Trials.

Purpose: Patients with polyvascular disease (PVD) are at very high cardiovascular risk and require intensive lipid-lowering therapy. This analysis describes the lipid-lowering efficacy and safety of inclisiran versus placebo in patients with and without PVD.

Methods: In this post hoc analysis of the ORION-9, ORION-10, and ORION-11 trials, patients were randomized 1:1 to receive 284 mg inclisiran (300 mg inclisiran sodium) or placebo on day 1, day 90, and 6-monthly thereafter.

Chordal Preservation Mitral Valve Replacement for Delayed MitraClip Failure.

Mitral valve replacement may be indicated in delayed MitraClip (Abbott) failure. Although it would be best to preserve the chordal apparatus during surgical mitral valve replacement, this has not been reported for delayed MitraClip failure, probably because there is almost always impressive inflammation around the MitraClip, which has likely precluded previous attempts at chordal preservation. A successful surgical chordal preservation mitral valve replacement in delayed MitraClip failure is reported here.