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JOURNAL ARTICLE
Jean-Claude Tardif, Ewa Karwatowska-Prokopczuk, Eric St Amour, Christie M Ballantyne, Michael D Shapiro, Patrick M Moriarty, Seth J Baum, Eunju Hurh, Victoria J Bartlett, Joyce Kingsbury, Amparo L Figueroa, Veronica J Alexander, Joseph Tami, Joseph L Witztum, Richard S Geary, Louis St L O'Dea, Sotirios Tsimikas, Daniel Gaudet
AIMS: Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated antisense oligonucleotide targeted to hepatic APOC3 mRNA to inhibit apolipoprotein C-III (apoC-III) production, in lowering triglyceride levels in patients at high risk for or with established cardiovascular disease. METHODS AND RESULTS: A randomized, double-blind, placebo-controlled, dose-ranging study was conducted in 114 patients with fasting serum triglycerides 200-500 mg/dL (2...
January 13, 2022: European Heart Journal
#22
JOURNAL ARTICLE
Harold E Bays, Seth J Baum, Eliot A Brinton, Jorge Plutzky, Jeffrey C Hanselman, Rujun Teng, Christie M Ballantyne
OBJECTIVE: Statins are sometimes associated with worsened glycemic control. Patients with type 2 diabetes mellitus (T2DM) may require non-statin therapies to achieve low-density lipoprotein cholesterol (LDL-C) lowering goals. This study evaluated the efficacy and safety of bempedoic acid 180 mg plus ezetimibe 10 mg fixed-dose combination (BA + EZE FDC) in patients with T2DM and hypercholesterolemia who were not receiving background statins or other lipid-lowering therapy. METHODS: Patients with T2DM and elevated LDL-C levels were enrolled into this phase 2, double-blind study (NCT03531905)...
December 2021: American journal of preventive cardiology
#23
JOURNAL ARTICLE
Stephen A Harrison, Seth J Baum, Nadege T Gunn, Ziad H Younes, Anita Kohli, Rashmee Patil, Margaret J Koziel, Harinder Chera, Jeff Zhao, Manu V Chakravarthy
INTRODUCTION: AXA1125 and AXA1957 are novel, orally administered endogenous metabolic modulator compositions, specifically designed to simultaneously support multiple metabolic and fibroinflammatory pathways associated with nonalcoholic fatty liver disease (NAFLD). This study assessed safety, tolerability, and biologic activity of AXA1125 and AXA1957 in NAFLD. METHODS: In this multicenter, 16-week, placebo-controlled, single-blind, randomized clinical study in subjects with NAFLD stratified by type 2 diabetes, AXA1125 24 g, AXA1957 13...
August 12, 2021: American Journal of Gastroenterology
#24
JOURNAL ARTICLE
Seth J Baum, Pallavi B Rane, Sasikiran Nunna, Mohdhar Habib, Kiran Philip, Kainan Sun, Xin Wang, Rolin L Wade
OBJECTIVE: We assessed national- and state-level geographic variations among patients with a history of ≥1 major atherosclerotic cardiovascular disease (ASCVD) event in: (1) the proportion of patients with retrospectively identified 2018 American College of Cardiology/American Heart Association guideline very high-risk (VHR) ASCVD criteria; (2) utilization of guideline-directed lipid-lowering therapy (LLT); and (3) the proportion of patients with persistent low-density lipoprotein cholesterol (LDL-C) elevations despite statin and/or ezetimibe use...
June 2021: American journal of preventive cardiology
#25
JOURNAL ARTICLE
Moon Young Kim, Deepali Sen, Ronald R Drummond, Matthew C Brandenburg, Kathryn Lp Biesanz, Alfred Hj Kim, Seth A Eisen, Carolyn M Baum, Erin R Foster
OBJECTIVES: This study aimed to investigate the distribution of cognitive function in people with systemic lupus erythematosus (SLE) by objective and self-report measures and associations between cognition and participation among people with SLE. METHODS: Fifty-five volunteers with SLE (age: 39.7 ± 12.7yrs, female: 92.7%) completed the Montreal Cognitive Assessment (MoCA) to measure cognitive ability objectively, the Cognitive Symptom Inventory (CSI) and PROMIS Cognitive Function 8a (CF) to assess self-reported everyday cognition, and PROMIS-43 Profile to assess self-reported ability to participate in social roles and activities (participation) and other disease-associated symptoms (e...
June 2021: Lupus
#26
JOURNAL ARTICLE
Siva H Yedlapati, Safi U Khan, Swapna Talluri, Ahmed N Lone, Muhammad Zia Khan, Muhammad Shahzeb Khan, Ann M Navar, Martha Gulati, Heather Johnson, Seth Baum, Erin D Michos
Background Influenza infection causes considerable morbidity and mortality in patients with cardiovascular disease. We assessed the effects of the influenza vaccine on mortality and cardiovascular outcomes in patients with cardiovascular disease. Methods and Results We searched PubMed, Embase, and the Cochrane Library through January 2020 for randomized controlled trials and observational studies assessing the effects of influenza vaccine on mortality and cardiovascular outcomes in patients with cardiovascular disease...
March 16, 2021: Journal of the American Heart Association
#27
RANDOMIZED CONTROLLED TRIAL
Robert S Rosenson, Lesley J Burgess, Christoph F Ebenbichler, Seth J Baum, Erik S G Stroes, Shazia Ali, Nagwa Khilla, Robert Hamlin, Robert Pordy, Yuping Dong, Vladimir Son, Daniel Gaudet
BACKGROUND: Patients with refractory hypercholesterolemia, who have high low-density lipoprotein (LDL) cholesterol levels despite treatment with lipid-lowering therapies at maximum tolerated doses, have an increased risk of atherosclerosis. In such patients, the efficacy and safety of subcutaneous and intravenous evinacumab, a fully human monoclonal antibody against angiopoietin-like 3, are not known. METHODS: In this double-blind, placebo-controlled, phase 2 trial, we enrolled patients with or without heterozygous familial hypercholesterolemia who had refractory hypercholesterolemia, with a screening LDL cholesterol level of 70 mg per deciliter or higher with atherosclerosis or of 100 mg per deciliter or higher without atherosclerosis...
December 10, 2020: New England Journal of Medicine
#28
JOURNAL ARTICLE
William E Boden, Seth Baum, Peter P Toth, Sergio Fazio, Deepak L Bhatt
Hypertriglyceridemia is associated with increased cardiovascular disease (CVD) risk. The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated that the purified, stable ethyl ester of eicosapentaenoic acid, icosapent ethyl (IPE), added to statins reduced CVD events by 25% (p < 0.001), leading to an expanded indication in the USA. IPE is now approved as an adjunct to maximally tolerated statins to reduce CVD event risk in adults with triglyceride (TG) levels ≥150 mg/dl and either established CVD or diabetes mellitus plus ≥2 additional CVD risk factors...
September 22, 2020: Future Cardiology
#29
RANDOMIZED CONTROLLED TRIAL
Daniel Gaudet, Ewa Karwatowska-Prokopczuk, Seth J Baum, Eunju Hurh, Joyce Kingsbury, Victoria J Bartlett, Amparo L Figueroa, Philip Piscitelli, Walter Singleton, Joseph L Witztum, Richard S Geary, Sotirios Tsimikas, Louis St L O'Dea
AIMS: Loss-of-function mutations in ANGPTL3 are associated with beneficial effects on lipid and glucose metabolism and reduced risk of coronary artery disease. Vupanorsen (AKCEA-ANGPTL3-L Rx ) is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits angiopoietin-like 3 (ANGPTL3) protein synthesis. METHODS AND RESULTS: This was a double-blind, placebo-controlled, dose-ranging, Phase 2 study. Patients (N =105) with fasting triglycerides >150 mg/dL (>1...
October 21, 2020: European Heart Journal
#30
JOURNAL ARTICLE
Amit Khera, Seth J Baum, Ty J Gluckman, Martha Gulati, Seth S Martin, Erin D Michos, Ann Marie Navar, Pam R Taub, Peter P Toth, Salim S Virani, Nathan D Wong, Michael D Shapiro
The coronavirus disease 2019 (COVID-19) pandemic has consumed our healthcare system, with immediate resource focus on the management of high numbers of critically ill patients. Those that fare poorly with COVID-19 infection more commonly have cardiovascular disease (CVD), hypertension and diabetes. There are also several other conditions that raise concern for the welfare of patients with and at high risk for CVD during this pandemic. Traditional ambulatory care is disrupted and many patients are delaying or deferring necessary care, including preventive care...
March 2020: American journal of preventive cardiology
#31
JOURNAL ARTICLE
Johanna Hansen, Alina Baum, Kristen E Pascal, Vincenzo Russo, Stephanie Giordano, Elzbieta Wloga, Benjamin O Fulton, Ying Yan, Katrina Koon, Krunal Patel, Kyung Min Chung, Aynur Hermann, Erica Ullman, Jonathan Cruz, Ashique Rafique, Tammy Huang, Jeanette Fairhurst, Christen Libertiny, Marine Malbec, Wen-Yi Lee, Richard Welsh, Glen Farr, Seth Pennington, Dipali Deshpande, Jemmie Cheng, Anke Watty, Pascal Bouffard, Robert Babb, Natasha Levenkova, Calvin Chen, Bojie Zhang, Annabel Romero Hernandez, Kei Saotome, Yi Zhou, Matthew Franklin, Sumathi Sivapalasingam, David Chien Lye, Stuart Weston, James Logue, Robert Haupt, Matthew Frieman, Gang Chen, William Olson, Andrew J Murphy, Neil Stahl, George D Yancopoulos, Christos A Kyratsous
Neutralizing antibodies have become an important tool in treating infectious diseases. Recently, two separate approaches yielded successful antibody treatments for Ebola-one from genetically humanized mice and the other from a human survivor. Here, we describe parallel efforts using both humanized mice and convalescent patients to generate antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, which yielded a large collection of fully human antibodies that were characterized for binding, neutralization, and three-dimensional structure...
August 21, 2020: Science
#32
JOURNAL ARTICLE
Eric J Formeister, Rachel Baum, P Daniel Knott, Rahul Seth, Patrick Ha, William Ryan, Ivan El-Sayed, Jonathan George, Andrew Larson, Karolina Plonowska, Chase Heaton
OBJECTIVES/HYPOTHESIS: Machine learning (ML) is a type of artificial intelligence wherein a computer learns patterns and associations between variables to correctly predict outcomes. The objectives of this study were to 1) use a ML platform to identify factors important in predicting surgical complications in patients undergoing head and neck free tissue transfer, and 2) compare ML outputs to traditionally employed logistic regression models. STUDY DESIGN: Retrospective cohort study...
December 2020: Laryngoscope
#33
RANDOMIZED CONTROLLED TRIAL
Sotirios Tsimikas, Ewa Karwatowska-Prokopczuk, Ioanna Gouni-Berthold, Jean-Claude Tardif, Seth J Baum, Elizabeth Steinhagen-Thiessen, Michael D Shapiro, Erik S Stroes, Patrick M Moriarty, Børge G Nordestgaard, Shuting Xia, Jonathan Guerriero, Nicholas J Viney, Louis O'Dea, Joseph L Witztum
BACKGROUND: Lipoprotein(a) levels are genetically determined and, when elevated, are a risk factor for cardiovascular disease and aortic stenosis. There are no approved pharmacologic therapies to lower lipoprotein(a) levels. METHODS: We conducted a randomized, double-blind, placebo-controlled, dose-ranging trial involving 286 patients with established cardiovascular disease and screening lipoprotein(a) levels of at least 60 mg per deciliter (150 nmol per liter)...
January 16, 2020: New England Journal of Medicine
#34
JOURNAL ARTICLE
Seth J Baum, Tiziana Sampietro, Dev Datta, Patrick M Moriarty, Beat Knusel, Jingjing Schneider, Ransi Somaratne, Christopher Kurtz, Bernd Hohenstein
BACKGROUND: Lipoprotein apheresis (LA) can effectively lower lipoproteins but is an invasive procedure. OBJECTIVE: The objective of this study was to evaluate whether evolocumab can reduce LA requirement in patients undergoing chronic LA. METHODS: Patients on regular weekly or every-2-week LA and moderate- to high-intensity statin (if tolerated) with pre-LA low-density lipoprotein cholesterol (LDL-C) levels ≥2.6 mmol/L (100 mg/dL) to ≤4...
October 11, 2019: Journal of Clinical Lipidology
#35
RANDOMIZED CONTROLLED TRIAL
Stephen A Harrison, Mustafa R Bashir, Cynthia D Guy, Rong Zhou, Cynthia A Moylan, Juan P Frias, Naim Alkhouri, Meena B Bansal, Seth Baum, Brent A Neuschwander-Tetri, Rebecca Taub, Sam E Moussa
BACKGROUND: Non-alcoholic steatohepatitis (NASH) is characterised by hepatic steatosis, inflammation, hepatocellular injury, and progressive liver fibrosis. Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and reducing lipotoxicity. We aimed to assess the safety and efficacy of resmetirom in patients with NASH. METHODS: MGL-3196-05 was a 36-week randomised, double-blind, placebo-controlled study at 25 centres in the USA...
November 30, 2019: Lancet
#36
RANDOMIZED CONTROLLED TRIAL
Anne C Goldberg, Lawrence A Leiter, Erik S G Stroes, Seth J Baum, Jeffrey C Hanselman, LeAnne T Bloedon, Narendra D Lalwani, Pragna M Patel, Xin Zhao, P Barton Duell
IMPORTANCE: Additional treatment options are needed for patients who do not achieve sufficient reduction in low-density lipoprotein cholesterol (LDL-C) level with available lipid-lowering therapies. OBJECTIVE: To assess the efficacy of bempedoic acid vs placebo in patients at high cardiovascular risk receiving maximally tolerated lipid-lowering therapy. DESIGN, SETTING, AND PARTICIPANTS: Phase 3, randomized, double-blind, placebo-controlled clinical trial conducted at 91 clinical sites in North America and Europe from November 2016 to September 2018, with a final date of follow-up of September 22, 2018...
November 12, 2019: JAMA
#37
REVIEW
Michael D Shapiro, David J Maron, Pamela B Morris, Mikhail Kosiborod, Pratik B Sandesara, Salim S Virani, Amit Khera, Christie M Ballantyne, Seth J Baum, Laurence S Sperling, Deepak L Bhatt, Sergio Fazio
Although significant progress has been made to reduce the global burden of cardiovascular disease, efforts have focused primarily on treatment of manifest disease rather than on prevention of events. An enormous opportunity exists to transition focus from intervention to providing equal attention to prevention of cardiovascular disease. The nascent specialty of "preventive cardiology" is emerging from the background of long-established services such as lipid, diabetes, hypertension, and general cardiology clinics...
October 15, 2019: Journal of the American College of Cardiology
#38
COMPARATIVE STUDY
Kelly D Myers, Niloofar Farboodi, Mkaya Mwamburi, William Howard, David Staszak, Samuel Gidding, Seth J Baum, Katherine Wilemon, Daniel J Rader
BACKGROUND: Atherosclerotic cardiovascular disease remains a major cause of death and disability, especially for high-risk familial hypercholesterolemia individuals. PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitors) reduce low-density lipoprotein cholesterol levels and cardiovascular event rates. However, PCSK9i prescriptions are rejected at high rates by payers, and use is often delayed or eventually abandoned as a treatment option. We tested the hypothesis that acute coronary syndromes, coronary interventions, stroke, and cardiac arrest are more prevalent in patients with rejected or abandoned PCSK9i prescriptions than for those with paid PCSK9i prescriptions...
August 2019: Circulation. Cardiovascular Quality and Outcomes
#39
REVIEW
Seth J Baum, Kenneth P Scholz
Patients with established atherosclerotic cardiovascular (CV) disease remain at increased risk of major adverse cardiovascular events even during optimal lipid-lowering therapy. Recent studies using the methods of Mendelian randomization, as well as analyses of data from large statin trials, have concluded that elevated triglyceride (TG) levels contribute to that increased risk. Omega-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish and shellfish (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) reduce TG levels when added to the diet in sufficient amounts, and they have favorable effects on several other markers of CV risk...
September 2019: Clinical Cardiology
#40
JOURNAL ARTICLE
Seth D Baum
To prevent catastrophic asteroid-Earth collisions, it has been proposed to use nuclear explosives to deflect away earthbound asteroids. However, this policy of nuclear deflection could inadvertently increase the risk of nuclear war and other violent conflict. This article conducts risk-risk tradeoff analysis to assess whether nuclear deflection results in a net increase or decrease in risk. Assuming nonnuclear deflection options are also used, nuclear deflection may only be needed for the largest and most imminent asteroid collisions...
June 6, 2019: Risk Analysis: An Official Publication of the Society for Risk Analysis
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