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https://www.readbyqxmd.com/read/29768954/comparison-of-ldl-c-reduction-using-different-evolocumab-doses-and-intervals-biological-insights-and-treatment-implications
#1
Scott M Wasserman, Marc S Sabatine, Michael J Koren, Robert P Giugliano, Jason C Legg, Maurice G Emery, Sameer Doshi, Thomas Liu, Ransi Somaratne, John P Gibbs
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduces low-density lipoprotein cholesterol (LDL-C) and the risk of cardiovascular events. OBJECTIVES: To compare LDL-C reduction using evolocumab 140 mg once every 2 weeks (Q2W) or 420 mg monthly (QM) versus lower doses (70 mg Q2W or 280 mg QM) or placebo. METHODS: Patients received evolocumab 70 or 140 mg Q2W, 280 or 420 mg QM, or placebo Q2W or QM in two 12-week phase 2 studies: one with and one without statins...
January 1, 2018: Journal of Cardiovascular Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29710336/association-of-fibroblast-growth-factor-23-with-recurrent-cardiovascular-events-in-patients-after-an-acute-coronary-syndrome-a-secondary-analysis-of-a-randomized-clinical-trial
#2
Brian A Bergmark, Jacob A Udell, David A Morrow, Christopher P Cannon, Dylan L Steen, Petr Jarolim, Andrzej Budaj, Christian Hamm, Jianping Guo, KyungAh Im, Julia F Kuder, Eugene Braunwald, Marc S Sabatine, Michelle L O'Donoghue
Importance: Elevated fibroblast growth factor 23 (FGF-23) concentrations are associated with myocardial fibrosis and renin-angiotensin system upregulation, potentially providing prognostic information distinct from standard cardiovascular (CV) biomarkers. Objective: To evaluate the association of FGF-23 with recurrent CV events in patients after an acute coronary syndrome (ACS). Design, Setting, and Participants: C-terminal FGF-23 was measured in plasma samples using an established enzyme-linked immunosorbent assay system for 4947 patients within 30 days of ACS (median, 14 days) and with 1 additional CV risk factor in the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) trial of the lipoprotein-associated phospholipase A2 inhibitor darapladib vs placebo performed from December 1, 2009, to April 24, 2014 (median follow-up, 2...
April 18, 2018: JAMA Cardiology
https://www.readbyqxmd.com/read/29626068/clinical-benefit-of-evolocumab-by-severity-and-extent-of-coronary-artery-disease-an-analysis-from-fourier
#3
Marc S Sabatine, Gaetano M De Ferrari, Robert P Giugliano, Kurt Huber, Basil S Lewis, Jorge Ferreira, Julia F Kuder, Sabina A Murphy, Stephen D Wiviott, Christopher E Kurtz, Narimon Honarpour, Anthony C Keech, Peter S Sever, Terje R Pedersen
Background -The FOURIER trial recently showed that the PCSK9 inhibitor evolocumab significantly reduced major vascular events in patients with stable atherosclerotic cardiovascular disease, including patients with prior MI. Within the broad group of patients with prior MI, we hypothesized that readily ascertainable features would identify subsets that derive greater clinical risk reduction with evolocumab. Methods -The 22,351 patients with a prior MI were characterized based on time from most recent MI, number of prior MIs, and presence of residual multivessel coronary artery disease (≥40% stenosis in ≥2 large vessels)...
April 6, 2018: Circulation
https://www.readbyqxmd.com/read/29530884/inflammatory-and-cholesterol-risk-in-the-fourier-trial-further-cardiovascular-outcomes-research-with-pcsk9-inhibition-in-patients-with-elevated-risk
#4
Erin A Bohula, Robert P Giugliano, Lawrence A Leiter, Subodh Verma, Jeong-Gun Park, Peter S Sever, Armando Lira Pineda, Narimon Honarpour, Huei Wang, Sabina A Murphy, Anthony Keech, Terje R Pedersen, Marc S Sabatine
BACKGROUND : In the FOURIER trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Patients With Elevated Risk), the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor evolocumab reduced low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk. It is not known whether the efficacy of evolocumab is modified by baseline inflammatory risk. We explored the efficacy of evolocumab stratified by baseline high-sensitivity C-reactive protein (hsCRP). We also assessed the importance of inflammatory and residual cholesterol risk across the range of on-treatment LDL-C concentrations...
March 12, 2018: Circulation
https://www.readbyqxmd.com/read/29525817/pharmacogenetics-and-the-promise-of-personalized-medicine
#5
Marc S Sabatine
No abstract text is available yet for this article.
March 11, 2018: JAMA Cardiology
https://www.readbyqxmd.com/read/29406853/ticagrelor-for-secondary-prevention-of-atherothrombotic-events-in-patients-with-multivessel-coronary-disease
#6
Sameer Bansilal, Marc P Bonaca, Jan H Cornel, Robert F Storey, Deepak L Bhatt, Ph Gabriel Steg, Kyungah Im, Sabina A Murphy, Dominick J Angiolillo, Robert G Kiss, Alexander N Parkhomenko, Jose Lopez-Sendon, Daniel Isaza, Assen Goudev, Frederic Kontny, Peter Held, Eva C Jensen, Eugene Braunwald, Marc S Sabatine, A J Oude Ophuis
BACKGROUND: Patients with prior myocardial infarction (MI) and multivessel coronary disease (MVD) are at high risk for recurrent coronary events. OBJECTIVES: The authors investigated the efficacy and safety of ticagrelor versus placebo in patients with MVD in the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction 54) trial. METHODS: Patients with a history of MI 1 to 3 years before inclusion in the PEGASUS-TIMI 54 trial were stratified in a pre-specified analysis based on the presence of MVD...
February 6, 2018: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/29332981/the-unique-and-interactive-effects-of-parent-and-school-bonds-on-adolescent-delinquency
#7
Elaina Sabatine, Melissa Lippold, Kirsten Kainz
Parent and school bonds are protective against delinquency. This study used longitudinal data and multilevel Poisson regression models (MLM) to examine unique and interactive associations of parent and school bonds on youth delinquency in a sample of rural adolescents ( n = 945; 84% White). We investigated whether youth sex or transitioning to a new middle school moderated the linkages between parent and school bonds and later delinquency. Results indicated reduced delinquency was associated with positive parent and school relationships...
November 2017: Journal of Applied Developmental Psychology
https://www.readbyqxmd.com/read/29327884/cognitive-function-in-a-randomized-trial-of-evolocumab
#8
Robert P Giugliano, Marc S Sabatine, Brian R Ott
No abstract text is available yet for this article.
November 16, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29322605/declare-timi-58-participants-baseline-characteristics
#9
Itamar Raz, Ofri Mosenzon, Marc P Bonaca, Avivit Cahn, Eri T Kato, Michael G Silverman, Deepak L Bhatt, Lawrence A Leiter, Darren K McGuire, John P H Wilding, Ingrid A M Gause-Nilsson, Anna M Langkilde, Peter A Johansson, Marc S Sabatine, Stephen D Wiviott
AIM: To describe the baseline characteristics of participants randomized in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE-TIMI 58) trial, the pivotal study conducted to assess cardiovascular (CV) outcomes with dapagliflozin. METHODS: The DECLARE-TIMI 58 trial will analyse 17 160 patients with type 2 diabetes randomized to treatment with dapagliflozin (10 mg/d) or matching placebo. We analysed their baseline characteristics. RESULTS: The participants' mean ± SD age was 63...
January 11, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29133605/low-density-lipoprotein-cholesterol-lowering-with-evolocumab-and-outcomes-in-patients-with-peripheral-artery-disease-insights-from-the-fourier-trial-further-cardiovascular-outcomes-research-with-pcsk9-inhibition-in-subjects-with-elevated-risk
#10
Marc P Bonaca, Patrice Nault, Robert P Giugliano, Anthony C Keech, Armando Lira Pineda, Estella Kanevsky, Julia Kuder, Sabina A Murphy, J Wouter Jukema, Basil S Lewis, Lale Tokgozoglu, Ransi Somaratne, Peter S Sever, Terje R Pedersen, Marc S Sabatine
BACKGROUND: The PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor evolocumab reduced low-density lipoprotein cholesterol and cardiovascular events in the FOURIER trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). We investigated the efficacy and safety of evolocumab in patients with peripheral artery disease (PAD) as well as the effect on major adverse limb events. METHODS: FOURIER was a randomized trial of evolocumab versus placebo in 27 564 patients with atherosclerotic disease on statin therapy followed for a median of 2...
January 23, 2018: Circulation
https://www.readbyqxmd.com/read/29117276/clinical-efficacy-and-safety-of-evolocumab-in-high-risk-patients-receiving-a-statin-secondary-analysis-of-patients-with-low-ldl-cholesterol-levels-and-in-those-already-receiving-a-maximal-potency-statin-in-a-randomized-clinical-trial
#11
Robert P Giugliano, Anthony Keech, Sabina A Murphy, Kurt Huber, S Lale Tokgozoglu, Basil S Lewis, Jorge Ferreira, Armando Lira Pineda, Ransi Somaratne, Peter S Sever, Terje R Pedersen, Marc S Sabatine
Importance: Current guidelines for atherosclerotic cardiovascular disease focus on high-intensity statins and targeting or using a threshold low-density lipoprotein cholesterol (LDL-C) level of less than 70 mg/dL for the highest-risk patients. Whether further reduction of LDL-C beyond these boundaries would be beneficial is unknown. Objective: To compare outcomes of evolocumab vs placebo in patients with stable atherosclerotic cardiovascular disease and a baseline LDL-C of less than 70 mg/dL and in those receiving background treatment with a maximal-potency statin...
December 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/29050564/a-missense-variant-in-plec-increases-risk-of-atrial-fibrillation
#12
Rosa B Thorolfsdottir, Gardar Sveinbjornsson, Patrick Sulem, Anna Helgadottir, Solveig Gretarsdottir, Stefania Benonisdottir, Audur Magnusdottir, Olafur B Davidsson, Sridharan Rajamani, Dan M Roden, Dawood Darbar, Terje R Pedersen, Marc S Sabatine, Ingileif Jonsdottir, David O Arnar, Unnur Thorsteinsdottir, Daniel F Gudbjartsson, Hilma Holm, Kari Stefansson
BACKGROUND: Genome-wide association studies (GWAS) have yielded variants at >30 loci that associate with atrial fibrillation (AF), including rare coding mutations in the sarcomere genes MYH6 and MYL4. OBJECTIVES: The aim of this study was to search for novel AF associations and in doing so gain insights into the mechanisms whereby variants affect AF risk, using electrocardiogram (ECG) measurements. METHODS: The authors performed a GWAS of 14,255 AF cases and 374,939 controls, using whole-genome sequence data from the Icelandic population, and tested novel signals in 2,002 non-Icelandic cases and 12,324 controls...
October 24, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28927706/cardiovascular-safety-and-efficacy-of-the-pcsk9-inhibitor-evolocumab-in-patients-with-and-without-diabetes-and-the-effect-of-evolocumab-on-glycaemia-and-risk-of-new-onset-diabetes-a-prespecified-analysis-of-the-fourier-randomised-controlled-trial
#13
Marc S Sabatine, Lawrence A Leiter, Stephen D Wiviott, Robert P Giugliano, Prakash Deedwania, Gaetano M De Ferrari, Sabina A Murphy, Julia F Kuder, Ioanna Gouni-Berthold, Basil S Lewis, Yehuda Handelsman, Armando Lira Pineda, Narimon Honarpour, Anthony C Keech, Peter S Sever, Terje R Pedersen
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduced LDL cholesterol and cardiovascular events in the FOURIER trial. In this prespecified analysis of FOURIER, we investigated the efficacy and safety of evolocumab by diabetes status and the effect of evolocumab on glycaemia and risk of developing diabetes. METHODS: FOURIER was a randomised trial of evolocumab (140 mg every 2 weeks or 420 mg once per month) versus placebo in 27 564 patients with atherosclerotic disease who were on statin therapy, followed up for a median of 2·2 years...
December 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28893843/timing-of-angiography-and-outcomes-in-high-risk-patients-with-non-st-segment-elevation-myocardial-infarction-managed-invasively-insights-from-the-tao-trial-treatment-of-acute-coronary-syndrome-with-otamixaban
#14
RANDOMIZED CONTROLLED TRIAL
Pierre Deharo, Gregory Ducrocq, Christoph Bode, Marc Cohen, Thomas Cuisset, Shamir R Mehta, Charles Pollack, Stephen D Wiviott, Yedid Elbez, Marc S Sabatine, Philippe Gabriel Steg
BACKGROUND: In patients with non-ST-segment-elevation myocardial infarction (NSTEMI) and GRACE (Global Registry of Acute Coronary Events) score >140, coronary angiography (CAG) is recommended by European and American guidelines within 24 hours. We sought to study the association of very early (ie, ≤12 hours), early (12-24 hours), and delayed (>24 hours) CAG in patients with NSTEMI with GRACE score >140 with ischemic outcomes. METHODS: The TAO trial (Treatment of Acute Coronary Syndrome With Otamixaban) randomized patients with NSTEMI and CAG scheduled within 72 hours to heparin plus eptifibatide versus otamixaban...
November 14, 2017: Circulation
https://www.readbyqxmd.com/read/28882235/efficacy-and-safety-of-ticagrelor-over-time-in-patients-with-prior-mi-in-pegasus-timi-54
#15
RANDOMIZED CONTROLLED TRIAL
Marc P Bonaca, Robert F Storey, Pierre Theroux, P Gabriel Steg, Deepak L Bhatt, Marc C Cohen, KyungAh Im, Sabina A Murphy, Giulia Magnani, Ton Oude Ophuis, Mikhail Rudah, Alexander Parkhomenko, Daniel Isaza, Gabriel Kamensky, Assen Goudev, Gilles Montalescot, Eva C Jensen, Per Johanson, Eugene Braunwald, Marc S Sabatine
BACKGROUND: Ticagrelor reduces ischemic risk in patients with prior myocardial infarction (MI). It remains unclear whether ischemic risk and the benefits of prolonged P2Y12 inhibition in this population remain consistent over time. OBJECTIVES: The study sought to investigate the pattern of ischemic risk over time and whether the efficacy and safety of ticagrelor were similar early and late after randomization. METHODS: The PEGASUS-TIMI (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction) 54 trial randomized patients with prior MI (median 1...
September 12, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28859947/clinical-efficacy-and-safety-of-achieving-very-low-ldl-cholesterol-concentrations-with-the-pcsk9-inhibitor-evolocumab-a-prespecified-secondary-analysis-of-the-fourier-trial
#16
Robert P Giugliano, Terje R Pedersen, Jeong-Gun Park, Gaetano M De Ferrari, Zbigniew A Gaciong, Richard Ceska, Kalman Toth, Ioanna Gouni-Berthold, Jose Lopez-Miranda, François Schiele, François Mach, Brian R Ott, Estella Kanevsky, Armando Lira Pineda, Ransi Somaratne, Scott M Wasserman, Anthony C Keech, Peter S Sever, Marc S Sabatine
BACKGROUND: LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). METHODS: In this prespecified secondary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up...
October 28, 2017: Lancet
https://www.readbyqxmd.com/read/28846118/association-of-genetic-variants-related-to-cetp-inhibitors-and-statins-with-lipoprotein-levels-and-cardiovascular-risk
#17
COMPARATIVE STUDY
Brian A Ference, John J P Kastelein, Henry N Ginsberg, M John Chapman, Stephen J Nicholls, Kausik K Ray, Chris J Packard, Ulrich Laufs, Robert D Brook, Clare Oliver-Williams, Adam S Butterworth, John Danesh, George Davey Smith, Alberico L Catapano, Marc S Sabatine
Importance: Some cholesteryl ester transfer protein (CETP) inhibitors lower low-density lipoprotein cholesterol (LDL-C) levels without reducing cardiovascular events, suggesting that the clinical benefit of lowering LDL-C may depend on how LDL-C is lowered. Objective: To estimate the association between changes in levels of LDL-C (and other lipoproteins) and the risk of cardiovascular events related to variants in the CETP gene, both alone and in combination with variants in the 3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) gene...
September 12, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28832867/cost-effectiveness-of-evolocumab-therapy-for-reducing-cardiovascular-events-in-patients-with-atherosclerotic-cardiovascular-disease
#18
Gregg C Fonarow, Anthony C Keech, Terje R Pedersen, Robert P Giugliano, Peter S Sever, Peter Lindgren, Ben van Hout, Guillermo Villa, Yi Qian, Ransi Somaratne, Marc S Sabatine
Importance: The proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab has been demonstrated to reduce the composite of myocardial infarction, stroke, or cardiovascular death in patients with established atherosclerotic cardiovascular disease. To our knowledge, long-term cost-effectiveness of this therapy has not been evaluated using clinical trial efficacy data. Objective: To evaluate the cost-effectiveness of evolocumab in patients with atherosclerotic cardiovascular disease when added to standard background therapy...
October 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28813546/pcsk9-inhibitors-statins-low-density-lipoprotein-cholesterol-mevalonate-pathway-and-toxicity-reply
#19
Michael J Koren, Marc S Sabatine
No abstract text is available yet for this article.
October 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28813214/cognitive-function-in-a-randomized-trial-of-evolocumab
#20
RANDOMIZED CONTROLLED TRIAL
Robert P Giugliano, François Mach, Kenton Zavitz, Christopher Kurtz, Kyungah Im, Estella Kanevsky, Jingjing Schneider, Huei Wang, Anthony Keech, Terje R Pedersen, Marc S Sabatine, Peter S Sever, Jennifer G Robinson, Narimon Honarpour, Scott M Wasserman, Brian R Ott
Background Findings from clinical trials of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have led to concern that these drugs or the low levels of low-density lipoprotein (LDL) cholesterol that result from their use are associated with cognitive deficits. Methods In a subgroup of patients from a randomized, placebo-controlled trial of evolocumab added to statin therapy, we prospectively assessed cognitive function using the Cambridge Neuropsychological Test Automated Battery. The primary end point was the score on the spatial working memory strategy index of executive function (scores range from 4 to 28, with lower scores indicating a more efficient use of strategy and planning)...
August 17, 2017: New England Journal of Medicine
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