Publications by authors named "Leiter L"

Article Synopsis
  • - Atrial fibrillation (AF) is more common in patients with type 2 diabetes and is linked to worse health outcomes; a trial called Harmony Outcomes was conducted to study the effects of albiglutide, a GLP-1 receptor agonist, on cardiovascular events in these patients.
  • - The trial included nearly 9,500 participants over 1.6 years and found that those with a history of AF had a higher rate of major adverse cardiac events, but albiglutide treatment reduced these events regardless of AF history.
  • - Although both groups on albiglutide experienced fewer AF events than those receiving a placebo, the reduction wasn't statistically significant, indicating that albiglutide can lower cardiovascular risks without
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Background: In Canada, 2 guidelines provide guidance for the management of dyslipidemia. The Patients, Experience, Evidence, Research simplified lipid guidelines, intended for primary care practitioners, and the Canadian Cardiovascular Society guidelines, intended for all practitioners, are based on differing methodologies with distinct priorities and preferences. The disparate approaches may contribute to confusion among family practitioners and their co-managed patients, with the potential for compromised care, differing standards for training in the fundamentals of lipidology, and differing criteria that might be used in practice audits to evaluate quality of care.

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Background: Many clinical practice guidelines recommend dietary pulses for the prevention and management of cardiovascular disease and diabetes. The impact of extracted pulse proteins remains unclear. We therefore conducted a systematic review and meta-analysis of randomized controlled trials of the effect of extracted pulse proteins on therapeutic lipid targets.

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  • An error grid is a tool that helps compare glucose levels measured by devices to see if they are correct and to identify any risks.
  • Experts created a new error grid called the DTS Error Grid that works for both blood glucose monitors (BGMs) and continuous glucose monitors (CGMs), organizing accuracy into five risk zones.
  • The results showed that the DTS Error Grid provides a clearer picture of how accurate these devices are and includes a separate matrix to evaluate how well CGMs track glucose trends over time.
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  • SGLT2 inhibitors like sotagliflozin show promise in improving health status for heart failure patients, but effects of SGLT1/SGLT2 inhibition remain unclear.* -
  • In the SOLOIST-WHF trial, patients taking sotagliflozin after a heart failure episode experienced a significant improvement in their Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scores compared to those on placebo.* -
  • Overall, sotagliflozin not only reduced hospitalizations and cardiovascular deaths but also led to improved symptoms and quality of life within four months, benefiting patients regardless of their left ventricular ejection fraction.*
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Background: Dietary guidelines recommend a shift to plant-based diets. Fortified soymilk, a prototypical plant protein food used in the transition to plant-based diets, usually contains added sugars to match the sweetness of cow's milk and is classified as an ultra-processed food. Whether soymilk can replace minimally processed cow's milk without the adverse cardiometabolic effects attributed to added sugars and ultra-processed foods remains unclear.

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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.

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Elevated low-density lipoprotein cholesterol (LDL-C) is a major causal factor for atherosclerotic cardiovascular disease (ASCVD), the leading cause of mortality worldwide. Statins are the recommended first-line lipid-lowering therapy (LLT) for patients with primary hypercholesterolemia and established ASCVD, with LLT intensification recommended in the substantial proportion of patients who do not achieve levels below guideline-recommended LDL-C thresholds with statin treatment alone. The proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibody evolocumab has demonstrated significant LDL-C reductions of 60% in the clinical trial and open-label extension settings, with LDL-C reductions observed early post-evolocumab initiation and maintained long term, during up to 8.

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Article Synopsis
  • A clinical risk model was created to identify individuals at higher risk for developing new-onset diabetes, helping to target those who would benefit most from weight loss medication.
  • The study analyzed data from over 21,000 patients without type 2 diabetes, assessing 27 risk factors and ultimately identifying five key predictors linked to new-onset diabetes.
  • The model demonstrated strong accuracy and differentiation in predicting risk levels and showed varying degrees of benefit from weight-loss therapy based on an individual's risk status.
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Type 2 diabetes (T2D) and lower-extremity peripheral artery disease (PAD) are growing global health problems associated with considerable cardiovascular (CV) and limb-related morbidity and mortality, poor quality of life and high healthcare resource use and costs. Diabetes is a well-known risk factor for PAD, and the occurrence of PAD in people with T2D further increases the risk of long-term complications. As the available evidence is primarily focused on the overall PAD population, we undertook a systematic review to describe the burden of comorbid PAD in people with T2D.

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Article Synopsis
  • The spectrum of cardiorenal and metabolic diseases includes various disorders like obesity, type 2 diabetes, chronic kidney disease, and heart failure, often co-existing in the same patient due to shared physiological pathways.
  • Recent trials have shown that treatments can benefit multiple conditions simultaneously, highlighting a need for updated clinical guidance.
  • An international task force of specialists has created the DCRM 2.0 Practice Recommendations, which consist of 22 graphics to help clinicians manage these complex conditions effectively, aiming to enhance patient health and outcomes.
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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).

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Article Synopsis
  • The study aimed to evaluate the long-term effectiveness and safety of inclisiran, a medication used for lowering LDL cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or related conditions.
  • ORION-8, the study in question, involved 3274 patients who received inclisiran twice yearly and monitored their LDL-C levels and any adverse effects over a period of up to 6.8 years.
  • The results indicated that 78.4% of the patients achieved their LDL-C goals, with a significant average reduction in LDL-C levels and few mild side effects reported, suggesting inclisiran is both effective and well-tolerated for long-term use.
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This review synthesized the evidence from randomized controlled trials comparing the effect of meal replacements (MRs) as part of a weight loss intervention with conventional food-based weight loss diets on cardiometabolic risk in individuals with pre-diabetes and features of metabolic syndrome. MEDLINE, EMBASE, and Cochrane Library were searched through January 16, 2024. Data were pooled using the generic inverse variance method and expressed as mean difference [95% confidence intervals].

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Article Synopsis
  • Ticagrelor, when added to aspirin, was found to reduce major adverse cardiovascular events (MACE) but also increased the risk of bleeding in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease.
  • In a study involving 19,220 patients over a median of 3 years, those with peripheral artery disease (PAD) who received the placebo had significantly higher risks of both MACE and limb events compared to those on ticagrelor.
  • While ticagrelor demonstrated a reducing effect on limb events such as revascularization and acute limb ischemia, the overall bleeding risk also increased; further studies are necessary to explore the balance of benefits and risks in various patient groups.
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Article Synopsis
  • - REDUCE-IT trial showed icosapent ethyl (IPE) decreased major cardiovascular events by 25%, but the exact reasons for its benefits were unclear, leading to the IPE-PREVENTION CardioLink-14 trial to explore its effect on vascular regenerative (VR) cell content in individuals with high triglycerides.
  • - In the study, 70 individuals on statins were given either IPE (4 g/day) or usual care; results showed IPE increased the frequency of ALDHSSC CD133 progenitor cells and reduced oxidative stress in progenitor cells, even as overall ALDHSSC cell frequency decreased.
  • - The findings suggest that IPE not only impacts VR cell content but may also
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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.

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Aim: To analyse the effects of albiglutide, a glucagon-like peptide 1 receptor agonist, on cardiovascular outcomes in older adults aged ≥65 years with type 2 diabetes and cardiovascular disease who participated in the Harmony Outcomes trial (NCT02465515).

Materials And Methods: We conducted a post hoc analysis of the primary endpoint of the Harmony Outcomes trial-time to first occurrence of a major adverse cardiovascular event-in subgroups of participants aged <65 and ≥65 years and <75 and ≥75 years at baseline. Hazard ratios and 95% confidence intervals (CIs) were generated using Cox proportional hazards regression.

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Introduction: The 2021 Canadian Cardiovascular Society (CCS) guidelines recommend intensive low-density lipoprotein cholesterol (LDL-C) reduction for patients with atherosclerotic cardiovascular disease (ASCVD). For patients above LDL-C threshold on maximally tolerated statins, adding ezetimibe and/or a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) is recommended. This population-based, real-world study examined cardiovascular (CV) events in patients with ASCVD who are on statins and above current guideline threshold LDL-C levels.

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Aims: Large outcome trials have demonstrated cardiovascular benefits of selected glucagon-like peptide-1 (GLP-1) receptor agonists. We examined coronary disease outcomes in the Harmony Outcomes trial of the GLP-1 receptor agonist albiglutide.

Methods And Results: Harmony Outcomes was an event-driven, multicenter, double-blind, and placebo-controlled trial involving 9463 patients >40 years of age with type-2 diabetes and established atherosclerotic cardiovascular disease.

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Background: The reduction of low-density lipoprotein cholesterol (LDL-C) with evolocumab, a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9i), reduces the risk of major adverse cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD) with a prior MI, prior stroke, or symptomatic peripheral artery disease, with no offsetting safety concerns. The effect of evolocumab on CV outcomes in lower risk patients without a history of MI or stroke has not been explored.

Study Design: VESALIUS-CV is a randomized, double-blind, placebo-controlled, global clinical trial designed to evaluate the effect of evolocumab on the risk of major cardiovascular events in patients at high cardiovascular risk but without a prior ischemic event.

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Article Synopsis
  • N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels are lower in obese patients, and its relationship with heart failure risk related to BMI is not fully understood.
  • Analysis of data from three clinical trials with overweight and obese patients showed a significant inverse relationship between NT-proBNP levels and BMI, with higher BMI correlating to increased risk of hospitalization for heart failure (HHF).
  • Treatment with dapagliflozin reduced HHF risk across BMI categories, notably showing greater risk reduction for patients with higher BMI and elevated NT-proBNP levels.
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