Dr. Stein[/caption]
Evan A Stein MD PhD FACC
COO/CSO
LIB Therapeutics
Cincinnati. OH USA 45227
MedicalResearch.com: What is the background for this study?
Response: Cardiovascular disease (CVD) remains the main cause of morbidity and mortality worldwide and is increasing in rapidly industrializing countries and is projected to cause more than >20 million deaths annually over the next 15 years. Low-density lipoprotein cholesterol (LDL-C) is well established as a major, easily modifiable, risk factor for CVD. Reductions with statins and, more recently, PCSK9 inhibitors, all agents which directly or indirectly upregulate the LDL receptor and enhance LDL-C clearance, have demonstrated CVD event reductions in cardiovascular outcome trials. Extensive data from these trials, provide a rough estimate that every 40 mg/dL reduction in LDL-C will reduce the risk of major CV cardiovascular events by 22% to 24%. Furthermore, trials with PCSK9 inhibitors added to statins which achieve substantial additional LDL-C reduction show and CVD event reduction remains linear to very low LDL-C levels without signals of adverse events.
Based on this body of evidence, recent revisions to national and international guidelines, now advocate for greater LDL-C reductions and lower LDL-C treatment goals, for patients not achieving these goals on statins alone. The current consensus target goal for LDL-C in patients with CVD, or who are at very-high risk for of CVD, is now less than <55 mg/dL, and <70 mg/dL for those at high risk.
This global trial of over 900 patients with CVD, or at very or high risk for CVD, on maximally tolerated statins assessed the 52-week efficacy and safety of monthly lerodalcibep.
Dr. Hussain[/caption]
Dr Monira Hussain
Senior Research Fellow &
ECF Clinical Research Australian Fellow
Public Health and Preventive Medicine
Monash University
Melbourne VIC
MedicalResearch.com: What is the background for this study?
Response: 25% of males and 44% of females aged 60 years or over experience minimal trauma fractures. Minimal trauma fractures are a clinical outcome of osteoporosis and may occur following little or no trauma i.e. fractures following a fall from standing height or less. Minimal trauma fractures are silent, people may not notice that they are at high risk of the disease until a bone is broken.
I was aware of previous studies reporting that high-density lipoprotein cholesterol (HDL-C) was elevated in patients with osteoporosis. Two animal studies showing that HDL-C reduces bone mineral density by reducing osteoblast number and function provide a plausible explanation for why high HDL-C may increase the risk of fractures.
Our study, the ASPirin in Reducing Events in the Elderly (ASPREE), and the ASPREE fracture substudy provide unique data that could determine whether these findings might apply to fracture risk in healthy older adults. The study collected data including HDL-C levels and fractures from more than 16,000 community-dwelling older adults. These participants were followed-up for a median of 4 years.
Dr. Ribeiro[/caption]
Fernando Ribeiro PhD
School of Health Sciences
Institute of Biomedicine - iBiMED
University of Aveiro
Aveiro, Portugal
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Resistant hypertension is a puzzling problem without a clear solution. The available treatment options to lower blood pressure, namely medication and renal denervation, have had limited success, making nonpharmacological strategies good candidates to optimize the treatment of this condition.
Exercise training is consistently recommended as adjuvant therapy for patients with hypertension, yet, it is with a great delay that the efficacy of exercise training is being tested in patients with resistant hypertension.
Having that in mind, the EnRicH trial was designed to address whether the benefits of an exercise intervention with proven results in hypertensive individuals are extended to patients with resistant hypertension, a clinical population with low responsiveness to drug therapy. Exercise training was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure compared with control (usual care).
Dr. Margaret Ryan[/caption]
Margaret Ryan MD MPH
Medical Director of Defense Health Agency Immunization
Healthcare Division
Pacific Region Office, San Diego CA
Clinical Professor at the University of California San Diego
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Military clinicians, especially those in the Defense Health Agency Immunization Healthcare Division, first became aware of a few cases of myocarditis following COVID-19 vaccination in early Feb 2021. These cases included young men who presented with chest pain a few days after 2nd dose of mRNA (Pfizer or Moderna) vaccine. As more young people became eligible for 2nd doses of vaccine, more cases were identified. By late April, the military had identified 23 cases of myocarditis, with remarkably similar presentations, after COVID-19 vaccination. This case series is described in the current issue of JAMA Cardiology.
Dr. Lee[/caption]
Michelle Lee, MD, PharmD
Fellow-in-training, Health Services Research & Development
Michael E. DeBakey VA Medical Center, Houston, TX
[caption id="attachment_57209" align="alignleft" width="128"]
Dr. Virani[/caption]
Senior & Corresponding Author
Salim S. Virani, MD, PhD, FACC, FAHA, FASPC
Professor, Section of Cardiovascular Research
Director, Cardiology Fellowship Training Program
Baylor College of Medicine
Staff Cardiologist, Michael E. DeBakey Veterans Affairs Medical Center
Co-Director, VA Advanced Fellowship in Health Services Research & Development Michael E. DeBakey VA Medical Center, Houston, TX
Investigator, Health Policy, Quality and Informatics Program
Michael E. DeBakey Veterans Affairs Medical Center HSR&D Center of Innovation
Houston, TX
MedicalResearch.com: What is the background for this study?
Response: Atherosclerotic cardiovascular disease (ASCVD), defined as ischemic heart disease (IHD), ischemic cerebrovascular disease (ICVD), or peripheral arterial disease (PAD), is the leading cause of death globally. Particularly in young ASCVD patients, secondary prevention with antiplatelet therapy and statins are extremely important in reducing disease burden.
Dr. Vigen[/caption]
Rebecca Vigen, MD, MSCS
Assistant Professor of Internal Medicine
UT Southwestern
MedicalResearch.com: What is the background for this study?
Response: Emergency department overcrowding is an urgent health priority and chest pain is a common reason for emergency department visits. We developed a new protocol that uses high sensitivity cardiac troponin testing with a risk assessment tool that guides decisions on discharge and stress testing for patients presenting with chest pain. The protocol allows us to rule out heart attacks more quickly than the protocols utilizing an older troponin assay.
Dr. Fanaroll[/caption]
Alexander C. Fanaroff, MD, MHS
Assistant Professor of Medicine, Division of Cardiovascular Medicine
University of Pennsylvania
MedicalResearch.com: What is the background for this study?
Response: This is a secondary analysis of the ARTEMIS, a cluster randomized trial of copayment assistance for P2Y12 inhibitors in patients that had myocardial infarction. One of the primary endpoints of ARTEMIS was persistence with P2Y12 inhibitors: Did the patient continue to take a P2Y12 inhibitor over the entire 1 year following MI? In ARTEMIS, we captured persistence data in two ways, patient report and pharmacy fill records. What we did in this study was to look at the agreement between persistence as measured by these two methods.
Dr. Vaccarino[/caption]
Viola Vaccarino, MD, PhD
Wilton Looney Professor and Chair in Cardiovascular Research
Dept. of Epidemiology, Rollins School of Public Health
Professor, Dept. of Medicine, School of Medicine
Emory University
MedicalResearch.com: What is the background for this study?
Response: Psychological stress has been linked to increased risk for cardiovascular disease. The mechanisms have not been clear. One hypothesis has been that chronic or repeated exposure to psychological stress can cause a phenomenon of “wear-and-tear” of the vascular system due to activation of the neuroendocrine stress systems, eventually leading to accelerated plaque formation and adverse cardiovascular events. However, this has never been demonstrated in humans.
In some individuals, psychological stress can induce a transitory impairment of the endothelium, a phenomenon known as endothelial dysfunction. A healthy endothelium is essential in blood flow regulation and in maintaining cardiovascular health.
Dr. Sepehrvand[/caption]
Nariman Sepehrvand, MD
Research Associate & PhD Candidate
Canadian VIGOUR Centre, and Department of Medicine,
University of Alberta, Edmonton, Canada
Medical Research: Can you tell us a little bit about the background of this study?
Dr. Sepehrvand: As you know the traditional randomized clinical trials (RCT) have been criticized from time to time for the lack of generalizability, high costs and lengthy processes. Pragmatic trials with the primary goal of informing patients, clinicians, healthcare administrators and policy-makers about the effectiveness of biomedical and behavioral interventions have the potential to address those shortcomings by enrolling a population representative of the populations in which the intervention will be eventually applied to and by streamlining and simplifying the trial-related procedures. We knew about the challenges that trialists encounter in the design and implementation of pragmatic trials, so we were wondering how pragmatic or explanatory are cardiovascular (CV) RCTs and if there has been any change over time!
Dr. Kronenberg[/caption]
MedicalResearch.com Interview with:
Florian Kronenberg, MD
Division of Genetic Epidemiology
Department of Medical Genetics, Molecular and Clinical Pharmacology
Medical University of Innsbruck, Innsbruck, Austria
MedicalResearch.com: What is the background for this study?
Response: Lp(a) is one of the most prevalent lipoprotein risk factors for cardiovascular disease. Roughly 20% of the general Caucasian population have concentrations above 50 mg/dL and the 10% with the highest concentrations have a 2 to 3-fold increased risk for myocardial infarction.
There is strong evidence from genetic studies that high Lp(a) concentrations are causally related to cardiovascular outcomes. Until recently there was no drug available which lowers Lp(a) without any effects on other lipoproteins. This has recently changed by the development of drugs that block the production of Lp(a) in an impressive way. These drugs have to be studied in randomized controlled trials whether they not only lower Lp(a) concentrations but also cardiovascular outcomes. For the planning of such studies it is crucial to estimate the amount of Lp(a) lowering required to show a clinical benefit.