Jacques-Eric Gottenberg, MD, PhD
Department of Rheumatology
National Reference Center for Systemic Autoimmune Diseases
Strasbourg University Hospital, Université de Strasbourg
Strasbourg, France
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There is no recommendation for the choice of the second biologic in patients with rheumatoid arthritis and insufficient response to a first anti-TNF, which is a common situation in our daily practice (approximately one third of patients treated with anti-TNF). We therefore conducted the first randomized trial to date to investigate the best strategy in such a setting.
Dr. Patricia Ducy[/caption]
Patricia Ducy, PhD
Associate Professor
Department of Pathology & Cell Biology
Columbia University
New York, NY 10032
MedicalResearch.com: What is the background for this study?
Response: In the past few years, several large clinical studies have reported an association between the use of selective serotonin reuptake inhibitors (SSRIs) and an increased risk of bone fractures. Yet, a few studies conducted on small cohorts using these drugs for a short time showed a decrease in bone resorption parameters and thus minor bone gain.
To understand this paradox and to define how the deleterious effect of SSRIs could be prevented we conducted a series of studies in mice treated with fluoxetine, the active molecule of the widely prescribed SSRI Prozac.
Dr. Heather Sheardown[/caption]
Heather Sheardown PhD PEng FCAE
Scientific Director 20/20 NSERC Ophthalmic Materials Network
Professor, Department of Chemical Engineering
Canada Research Chair in Ophthalmic Biomaterials
McMaster University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Putting drops in the eye is well accepted from the standpoint of practitioners but is problematic for many patients. Therefore, particularly in cases where multiple drops are required in a day such as is the case with certain infections for example or a lifetime of drops is required such as is the case with diseases like glaucoma, patient compliance is a real issue. In addition, as much as 95% of any drop instilled in the eye is lost within the first 5 minutes, meaning that drug concentrations within the drop need to be higher to ensure that the required dose gets into the patient’s eye.
Therefore there is a real need for a better alternative to traditional eyedrops is needed. We have developed a new method of formulating drugs for delivery as drops that adhere to the mucous layer of the tear film, allowing for smaller amounts of drug to be delivered over a prolonged period of time. This means that fewer drops with lower drug concentrations can be delivered. This is a micelle based system that allows for the formulation of more hydrophobic drugs. A mucoadhesive component associated with the micelle binds to the mucin layer of the tears, meaning that the residence time on the eye is similar to that of this layer - between 4 and 7 days. Drug is slowly released from the micelle, allowing for prolonged treatment.
Dr. Aaron Kesselheim[/caption]
Aaron S. Kesselheim, M.D., J.D., M.P.H.
Associate Professor of Medicine at Harvard Medical School
Director, Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women's Hospital
Boston MA 02120
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It has been previously reported that the number of new cardiovascular drugs approved by the U.S. Food and Drug Administration (FDA) has declined in recent years. So we sought to empirically assess trends in the development of new cardiovascular therapeutics.
Dr. Gouni Gerthold[/caption]
Prof. Dr. Ioana Gouni-Berthold MD
Center for Endocrinology, Diabetes and Preventive Medicine (ZEDP)
University of Cologne
Cologne, Germany
MedicalResearch.com: What is the background for this study?
Response: In Europe, up to half of the population aged between 35 and 64 has hypercholesterolemia (high levels of low-density lipoprotein cholesterol [LDL-C]), putting them at risk of heart disease. Despite increased treatment rates in recent years, many patients still do not receive adequate therapy, and heart disease remains the biggest cause of death in the USA and most European countries.
Two drugs, alirocumab and evolocumab, have recently been approved for lowering LDL-C in patients with hypercholesterolaemia as an ‘add-on’ therapy to other lipid-lowering medication, or for use alone in patients unable to tolerate statins. These drugs have a unique mode of action– they inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that binds to LDL receptors and targets them for degradation. In the absence of PCSK9, the LDL receptor recycling is restored and the receptors are able to remove LDL from the blood.
Both alirocumab and evolocumab have been tested in numerous patient populations in phase 3 trials; albeit evolocumab has an additional indication of homozygous familial hypercholesterolemia. We therefore felt that there was a need to collate the available data to assess the efficacy and safety of each agent. We chose reduction in LDL-C as our outcome of interest, because this was the primary endpoint of the pivotal clinical trials.
Dr. F. Leland McClure[/caption]
F. Leland McClure III, MSci, PhD, F-ABFT
Medical science liaison director
Quest Diagnostics
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Many physicians associate Quest Diagnostics with their lab service needs because of our leadership in laboratory testing. But Quest is more than a lab, which is why we refer to ourselves as a diagnostic information services provider. This means that we help providers, health plans and even patients use the insights we derive from our lab testing data to deliver better care, quality and outcomes, both for the patient and the managed population.
Our 2016 Quest Diagnostics Health Trends(TM) Prescription Drug Monitoring Report is an example of how we provide important health insights from Quest's laboratory data. Prescription drug misuse is a major epidemic in the United States. Laboratory testing can help identify if a patient is using or misusing prescribed medications. For instance, lab tests can show evidence of additional medications and other drugs in a patient’s urine specimen, suggesting potentially dangerous drug combinations. Earlier this year, the CDC issued guidelines that call for laboratory testing for patients prescribed certain medications, such as opioids, that carry a risk of abuse.
Quest's prescription drug monitoring services help the physician identify if a patient is taking or not taking up to about four dozen drugs, such as oxycodone, Adderall XR® and Percocet®. For the Quest analysis, we analyzed more than 3 million de-identified lab test results.
In this report, we found that 54 percent of patients’ results tested in 2015 showed evidence of drug misuse, slightly above the 53 percent misuse rate in 2014. That is certainly unacceptably high, but it’s a significant decline from the high of 63 percent we observed in 2011.
We also found that an increasing proportion of patients who misuse medications combine their prescription medication with non-prescribed drugs. Among patients with inconsistent test results, forty-five percent of these patients showed evidence of one or more other drug(s) in addition to their prescribed drug regimen. That’s much higher than our findings of 35 percent in 2014 and 2013, 33 percent in 2012, and 32 percent in 2011.
Finally, we were alarmed by the data showing the connection between heroin and benzodiazepines misuse. Our data showed one in three heroin users combine their drug use with benzodiazepines, the vast majority of which were unprescribed. This is an extremely dangerous practice given that benzodiazepines can have strong respiratory depressant effects when combined with other substances. Drug combinations, but particularly of heroin with benzodiazepines, can be potentially very dangerous, leading to coma and even death in some cases.
Dr. Jeffrey Munson[/caption]
Jeffrey Munson, MD, MSCE
Assistant Professor
The Dartmouth Institute for Health Policy & Clinical Practice
Assistant Professor, Department of Medicine
Geisel School of Medicine at Dartmouth
MedicalResearch.com: What is the background for this study?
Response: Fragility fractures due to osteoporosis are a common and costly event among older Americans. Patients who experience one fragility fracture are at increased risk to have a second fracture. Our group is interested in exploring ways in which the risk of a second fracture could be reduced.
In this paper, we studied prescription drug use both before and after fracture. We know many prescription drugs have been shown to increase the risk of fracture, but we don’t know whether doctors try to reduce the use of these drugs after a fracture has occurred. Our study was designed to answer this question.
Dr. Evie Stergiakouli[/caption]
Dr Evie Stergiakouli
Lecturer in Genetic Epidemiology and Statistical Genetics
MRC Integrative Epidemiology Unit
University of Bristol
Bristol UK
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Acetaminophen is considered safe to use during pregnancy. However, research suggests that acetaminophen use in pregnancy is associated with abnormal neurodevelopment. It is possible that this association might be confounded by unmeasured behavioural factors linked to acetaminophen use. We compared acetaminophen use during pregnancy to postnatal acetaminophen use and partner's acetaminophen use. Only acetaminophen use during pregnancy has the potential to cause behavioural problems in the offspring. Any associations with postnatal acetaminophen use and partner's acetaminophen use would be due to confounding. Behavioural problems in the offspring were only associated with acetaminophen use during pregnancy.
Dr. Dirk Huebner[/caption]
Dirk Huebner, MD
Senior Medical Director
Oncology Therapeutic Area Unit
Takeda Pharmaceutical Company
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. Cutaneous T-cell lymphoma, also known as CTCL, is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis.
ADCETRIS® (brentuximab vedotin) is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL. The Phase 3 ALCANZA trial compared the use of single-agent ADCETRIS to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy.
The study met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4). The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm.
Dr. Jenny Shen[/caption]
Jenny Shen, MD, MS
Assistant Professor of Medicine
David Geffen School of Medicine at UCLA
Los Angeles Biomedical Institute at Harbor-UCLA Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: With cardiovascular disease being the No. 1 cause of death in end-stage kidney disease patients on peritoneal dialysis, we examined two classes of medications commonly prescribed to prevent cardiovascular events in these patients and found no significant difference in outcomes.
The two classes of medications, angiotensin-converting enzyme inhibitors (ACEI) and angiotensin-II receptor blockers (ARB), have slightly different mechanisms and could theoretically have differing outcomes. Previous studies had suggested that ACEI may lead to a kinin-mediated increase in insulin sensitivity not seen with ARB. This could potentially lower the cardiovascular risk in patients on peritoneal dialysis because they are exposed to high glucose loads in their dialysate that may lead to insulin resistance and its associated cardiovascular risk.
Using a national database, the U.S. Renal Data System, we surveyed records for all patients enrolled in Medicare Part D who initiated maintenance peritoneal dialysis from 2007 to 2011. Of those, we found 1,892 patients using either drug class. Surveying their medical records, we found no difference in cardiovascular events or deaths between the users for each class of medication.
Dr. Koeberle[/caption]
PD Dr. Andreas Koeberle
Lehrstuhl für Pharmazeutische/Medizinische Chemie Institut für Pharmazie Biologisch-Pharmazeutische Fakultät
Friedrich-Schiller-Universität
Jena Philosophenweg Jena
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Natural products from plants used in traditional medicine are valuable sources for identifying novel strategies as well as lead structures for drug development. The diterpenoids carnosol and carnosic acids from Salvia spp. (sage) represent such candidate compounds. They exert prominent anti-inflammatory activities though their molecular mechanisms are incompletely understood, which hampers their pharmacological use.
Our study investigated the potential of carnosol and carnosic acid in inflammatory pain and addressed the cellular consequences and the molecular interactions with key targets. We demonstrate that the two diterpenoids have anti-inflammatory and anti-nociceptive effects in established mouse models of inflammation, and describe 5-lipoxygenase and microsomal prostaglandin E2 synthase-1, two key enzymes of inflammation, as primary targets. Moreover, we characterized the functional consequences of enzyme inhibition in a cellular context and investigated structural aspects of ligand/target interactions.
Dr. Andersen[/caption]
Stig Ejdrup Andersen MD, PhD
Clinical Pharmacology Unit
Zealand University Hospital
Roskilde Denmark
MedicalResearch.com: What is the background for this study?
Response: For decades, we have used sulphonylurea derivates in the medical treatment of type 2 diabetes. Although several newer drugs have become available, adding an SU is still a recommended and acceptable strategy when metformin monotherapy fails. The SUs are among the cheapest glucose lowering drugs on the marked but the risk of hypoglycaemia make clinicians prefer a newer oral drug such as a DPP-IV inhibitor or a SGLT-2 inhibitor to ansulphonylurea because even mild hypoglycaemia may affect the patients’ quality of life negatively.
Several meta-analyses have examined the effectiveness and safety of noninsulin antidiabetic drug, all of which have considered the SUs a homogenous drug class. Pharmacologically, however, the SU agents are quite different. In 2004, a randomized controlled trial by Shernthaner et al. indicated that in comparison with glimepiride, gliclazide MR is equally effective and is associated with fewer hypoglycaemic episodes. Still, head-to-head comparisons of the SU-agents as add-on to metformin are few. In the absence of robust designed comparative trials, we decided to compare the relative risk of hypoglycaemia among the newer SU-agents in a network meta-analysis.
Glorimar Ortiz[/caption]
Glorimar Ortiz, MS
Senior Researcher/Statistician
NRI-National Association of State Mental Health Program Directors Research Institute
Falls Church, VA 22042
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Despite the lack of empirical evidence that antipsychotic polypharmacy produces greater outcomes to antipsychotic monotherapy, and that several clinical guidelines recommend against it, patients with a diagnosis of schizophrenia continue to being discharged on polypharmacy. Over the past few years, attempts have been made to lower the rate of antipsychotic polypharmacy throughout the country. Most of the existing literature on this topic are based on Medicaid claims data which exclude data for patients discharged from state psychiatric inpatient hospitals. Our study is very important because it is the first time that data on the use of antipsychotic medications are analyzed using a large sample of discharges from state psychiatric inpatient hospitals. These hospitals now have the opportunity to benchmark their antipsychotic medication use rate with national rates more accurately, and therefore, develop and implement performance improvement activities that are more precise. The study found that 12% of all discharges were prescribed two or more antipsychotic medications. Of those patients discharged on at least one antipsychotic medication, 18% were prescribed two or more antipsychotics. The study also found that patients with a schizophrenia diagnosis and an inpatient hospital stay of 3 months or longer are more likely of being discharged on polypharmacy, and that the main reason for this was to reduce patient’s symptoms. Antipsychotic polypharmacy affects nearly 10,000 patients with schizophrenia annually in state psychiatric inpatient hospitals.
Dr. Mark Pimentel[/caption]
Mark Pimentel, MD
Associate Professor, Medicine
Director, GI Motility Program
Director, GI Motility Laboratory
Cedars-Sinai
IBS-C Clinical Advisory Board (Chair) at Synthetic Biologics
Los Angeles, CA
MedicalResearch.com: What is the background for this study?
Dr. Pimentel: The SYN-010 program is based on research from my group at Cedars-Sinai Medical Center, and other researchers and collaborators worldwide, investigating the role of intestinal methane production in functional gastrointestinal disorders. Low levels of intestinal methane are a ubiquitous by-product of normal intestinal microbial digestion; however, elevated intestinal methane levels are correlated with decreased intestinal motility and increased symptom severity in patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
Methane in humans is produced almost exclusively by the intestinal microorganism Methanobrevibacter smithii (M. smithii). Highest levels of M. smithii are found in the colon; however, overgrowth of M. smithii into the small intestine has also been observed. Previous work from my laboratory demonstrated that methane production by M. smithii in stool samples from IBS-C patients is inhibited by the lactone form of lovastatin. Lovastatin lactone does not appear to eradicate microbial species in the intestine, which should reduce the risk of intestinal dysbiosis and/or the development of microbial resistance.
SYN-010 is a proprietary, modified-release, oral formulation of lovastatin lactone, designed to protect lovastatin lactone from the stomach and release the active ingredient in two different locations of the intestinal tract where the M. smithii reside. SYN-010 exerts its therapeutic effect at the level of the intestinal microbiome and does not require absorption into the systemic circulation or conversion of the active ingredient (lovastatin lactone) to the cholesterol lowering β-hydroxyacid form.
Dr. Suetonia Palmer[/caption]
MedicalResearch.com Interview with:
Principal investigator A/Prof Suetonia Palmer PhD
University of Otago, New Zealand
[caption id="attachment_26202" align="alignleft" width="142"]
Dr. Giovanni Strippoli[/caption]
Senior investigator
Prof. Giovanni Strippoli
MD, PhD, MPH, MM
University of Sydney, Australia and Diaverum, Sweden
MedicalResearch.com: What is the background for this study?
Response: Network meta-analysis is a new technique that allows us to evaluate ALL medical therapies for a specific clinical problem. We wondered whether any of the usual drugs used to treat glucose levels in people with diabetes were safest or most effective.
Dr. M. N. V. Ravi Kumar[/caption]
M. N. V. Ravi Kumar PhD
Professor of Pharmaceutical Sciences
Texas A&M Rangel College of Pharmacy
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The use of ligands for receptor-mediated drug delivery offers potential for improving both the safety and efficacy of pharmaceuticals. Research to date, however, has yet to overcome some of the significant challenges of targeted drug delivery, one of which is competitive affinity with endogenous ligands. This competition for the receptor binding site can impair both natural cell processes and uptake of the drug complex across the cell wall.
This article presents a unique, non-competitive active transport strategy for crossing the intestinal barrier. Gambogic acid (GA), as a ligand, was coupled with a polymer called poly(lactic-co--glycolic acid) (PLGA) that in turn can encapsulate drugs forming nanosystems to bind to transferrin receptors within the intestinal wall, which facilitated active gut barrier crossing. The study results show peak plasma concentrations of Cyclosporine A (CsA) in orally dosed rodents at 6 hours with the GA-ladened nanosystems vs 24 hours without GA. Additionally, brain concentrations of CsA are twice as high dosing with PLGA-GA NS compared with PLGA-NS (without GA).
Ms. Leigh Purvis[/caption]
Leigh Purvis, MPA
Director of Health Services Research
AARP Public Policy Institute
Editors’ note: In conjunction with the AARP’s new investigative piece, 'Supplement Pills That Promise Too Much', Leigh Purvis, Director of the AARP Health Services Research program discussed the issue of the proliferation of supplements, often with labels that make extraordinary health benefit claims.
MedicalResearch.com: How many Americans use nutritional supplements? How big is the business of supplements?
Response: Supplements are very popular in the United States. This is particularly true for older adults. A recent study found that the proportion of older adults using supplements increased from 52 percent in 2005 to 64 percent in 2011, and the share using multiple supplements grew by nearly 50 percent.
According to the National Institutes of Health, American spent an estimated $36.7 billion on dietary supplements in 2014.
MedicalResearch.com Interview with: [caption id="attachment_25811" align="alignleft" width="200"] Dr. Mostafa Borahay[/caption] Mostafa Borahay, MD, PhD, FACOG Assistant Professor Department of Obstetrics and Gynecology Galveston, TX MedicalResearch.com: What is the background for this study? What are the main findings? Response: Uterine fibroids are the commonest tumors of the female reproductive system. More than 50% of women are estimated to...
Dr. Wai Liu[/caption]
Dr Wai Liu
Senior Research Fellow
St George's University of London
London
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Naltrexone is a drug commonly used to wean addicts off alcohol and heroin, but clinical evidence has shown that when the drug is used at lower doses, patients would exhibit alter immunity. The symptoms that patients with a number of autoimmune diseases and those associated with chronic pain would ease significantly. Additionally, a number of reports showed patients with some forms of cancer would experience therapeutic benefit. Interestingly, the doses of the drug was crucial, and the non-conventional effects of naltrexone was only achieved at doses that were lower that what was conventionally used. We set about to understand why a drug could have such different effects when used at differing doses. Our results show that the genetic profile of the drug is subtly different at the two different doses, which helped us identify novel ways in which the drug could be used to induce an anticancer effect.
Dr. Kieran Breen[/caption]
Dr Kieran Breen PhD
Director of Research, Brain Tumour Research
University of Portsmouth, UK
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There is evidence that aspirin (acetyl salicylic acid) can be toxic to brain tumour cells. However, its existing preparations cannot readily enter the brain because the drug is a suspension rather than being completely soluble. Furthermore, there can be significant side effects associated with the existing form of the drug including gastric bleeding. The object of this research was to develop a new formulation of aspirin which is truly soluble. When combined with two other compounds, the drug enters the brain and can therefore target the tumour cells. This study also showed that aspirin can kill tumour cells without causing any damage to the normal nerve cells.
Dr. Gregory Marcus[/caption]
Dr. Gregory M. Marcus MD
Gregory M Marcus, MD, MAS, FACC, FAHA, FHRS
Director of Clinical Research
Division of Cardiology
Endowed Professor of Atrial Fibrillation Research
University of California, San Francisco
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Conduction system disease, or blockages in the electrically system (as opposed to blockages in the blood vessels, of which most are well-aware), is a common condition responsible for both heart failure in many patients as well as the need for pacemaker implantation. Although treatments for the disease are available, there are no known means to prevent it. This is important as the primary treatment, a pacemaker, can itself cause problems (including procedural complications, a long-term risk of infection with repeated battery changes, and even a greater risk of heart failure). In addition, predictors of what types of individuals are at risk for developing conduction disease has largely remained unknown.
Based on the fact that the majority of conduction disease is due to fibrosis, or scarring, of the conduction system, we sought to test the hypothesis that a common drug for high blood pressure with anti-fibrotic properties, Lisinopril, might reduce the risk of new conduction system disease. We took advantage of the fact that more than 20,000 patients with hypertension were randomized to three common high blood pressure drugs that work via different mechanisms in the ALLHAT trial: Lisinopril, amlodipine, and chlorthalidone. We found that participants randomly assigned to Lisinopril were statistically significantly less likely to develop conduction disease. In addition, our analyses revealed several risk factors for the development of conduction disease: older age, male sex, diabetes, smoking, a thicker heart, and white race (compared to black race).
Dr. Amanda Paschke[/caption]
Amanda Paschke, MD
Director, Infectious Disease Clinical Research
Merck Research Laboratories
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Relebactam is an investigational beta-lactamase inhibitor being developed as a fixed-dose combination with imipenem/cilastatin, which is a broad-spectrum antibiotic in the carbapenem class. In preclinical studies, this combination demonstrated antibacterial activity against a broad range of multidrug-resistant Gram-negative pathogens, including those producing extended-spectrum beta-lactamases such as Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae and AmpC-producing Pseudomonas aeruginosa. Many of the most concerning infections caused by “superbugs” are caused by Gram-negative bacteria. These bacteria have evolved to be resistant to commonly used antibacterials, and even to antibacterials used as “last resort” treatment, which is why finding ways to treat them has become urgent. The addition of relebactam to imipenem is designed to restore activity of imipenem against certain imipenem-resistant strains of Gram-negative bacteria known to cause serious infections among people who often have other underlying medical conditions, which complicates treatment.
This was a Phase 2, multicenter, randomized, double-blind, non-inferiority study. The study looked at the use of relebactam plus imipenem versus imipenem alone for the treatment of adult patients with complicated urinary tract infections. The primary endpoint for the trial was microbiological response at the completion of IV study therapy. The study met its primary endpoint, demonstrating that the combination of relebactam with imipenem was as at least as effective as imipenem alone for the treatment of complicated urinary tract infections. The trial also demonstrated that the combination of relebactam plus imipenem is well-tolerated, with a safety profile similar to that of imipenem alone in this patient.
Dr. Thomas Gaziano[/caption]
Thomas Andrew Gaziano, MD, MSc
Department of Cardiology
Assistant Professor
Harvard Medical School
MedicalResearch.com: What is the background for this study?
Response: Heart failure (HF) is the leading cause of admissions to hospitals in the United States and the associated costs run between $24-47 billion annually. Targeting neurohormonal pathways that aggravate the disease has the potential to reduce admissions. Enalapril, an angiotensin converting enzyme-inhibitor (ACEI), is more commonly prescribed to treat HF than Sacubitril/Valsartan, an angiotensin-receptor/neprilysin inhibitor (ARNI). The latter was shown to reduce cardiovascular death and hospitalizations due to heart failure in a multi-country, randomized clinical (PARADIGM-HF), compared to Enalapril. In order to assess the cost-effectiveness of Sacubitril/Valsartan, compared to Enalapril, in the United States, we created a model population with population characteristics equivalent to the population in the PARADIGM-HF trial. Using a 2-state Markov model we simulated HF death and hospitalizations for patients with a left ventricular ejection fraction (LVEF) of 40% or less.
Dr. Gregg Fonarow[/caption]
Gregg C. Fonarow, MD, FACC, FAHA
Eliot Corday Professor of Cardiovascular Medicine and Science
Director, Ahmanson-UCLA Cardiomyopathy Center
Co-Chief of Clinical Cardiology, UCLA Division of Cardiology
Co-Director, UCLA Preventative Cardiology Program
David Geffen School of Medicine at UCLA
Los Angeles, CA, 90095-1679
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Fonarow: Angiotensin receptor neprilysin inhibitors (ARNI) have been demonstrated to reduce mortality in patients with heart failure with reduced ejection fraction. However, to date, the population level impact of optimal implementation of this therapy in the United States has not been evaluated.
This new analysis estimates that as many 28,484 deaths in heart failure with reduced ejection fraction patients annually could be prevented or postponed with optimal use of angiotensin receptor neprilysin inhibitors (with sensitivity analyses demonstrating a range of 18,230 to 41,017).