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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
#1
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...
November 13, 2017: 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
#2
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...
November 8, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/29050564/a-missense-variant-in-plec-increases-risk%C3%A2-of-atrial-fibrillation
#3
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
#4
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...
September 14, 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
#5
Pierre Deharo, Gregory Ducrocq, Christoph Bode, Marc Cohen, Thomas Cuisset, Shamir Mehta, Charles V Pollack, Stephen D Wiviott, Yedid Elbez, Marc Sabatine, P Gabriel Steg
Background -In patients with non ST-elevation myocardial infarction (NSTEMI) and Global Registry of Acute Coronary Events (GRACE) score >140, coronary angiography (CAG) is recommended by European and American guidelines within 24h. We sought to study the association of a "very early" (i.e. ≤12h), early (12-24h) and delayed (>24h) CAG in NSTEMI with GRACE score >140 with ischemic outcomes. Methods -The Treatment of Acute coronary syndrome with Otamixaban (TAO) trial randomized patients with NSTEMI and CAG scheduled within 72h to heparin plus eptifibatide versus otamixaban...
September 11, 2017: Circulation
https://www.readbyqxmd.com/read/28882235/efficacy-and-safety-of-ticagrelor-over%C3%A2-time-in-patients-with-prior-mi-in%C3%A2-pegasus-timi-54
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/28768310/low-density-lipoprotein-cholesterol-treatment-in-the-proprotein-convertase-subtilisin-kexin-type-9-inhibitor-era-getting-back-on-target
#12
Marc S Sabatine, Robert P Giugliano
No abstract text is available yet for this article.
September 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28750695/cost-effectiveness-of-long-term%C3%A2-ticagrelor-in-patients-with-prior-myocardial-infarction-results-from-the-pegasus-timi-54-trial
#13
RANDOMIZED CONTROLLED TRIAL
Elizabeth A Magnuson, Haiyan Li, Kaijun Wang, Katherine Vilain, Ali Shafiq, Marc P Bonaca, Deepak L Bhatt, Marc Cohen, Philippe Gabriel Steg, Robert F Storey, Eugene Braunwald, Marc S Sabatine, David J Cohen
BACKGROUND: In patients with a myocardial infarction (MI) 1 to 3 years earlier, treatment with ticagrelor + low-dose aspirin (ASA) reduces the risk of cardiovascular (CV) death, MI, or stroke compared with low-dose aspirin alone, but at an increased risk of major bleeding. OBJECTIVES: The authors evaluated cost-effectiveness of ticagrelor + low-dose ASA in patients with prior MI within the prior 3 years. METHODS: The authors performed a prospective economic substudy alongside 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, which randomized 21,162 patients to ASA alone, ticagrelor 60 mg twice daily + low-dose ASA, or ticagrelor 90 mg twice daily + low-dose ASA...
August 1, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28736647/an-elderly-man-with-remote-history-of-metastatic-melanoma-now-with-localized-pancreas-cancer-and-new-liver-masses
#14
Neil Vasan, Maria Ignez Braghiroli, Alexander N Shoushtari, Richard Kinh Gian Do, Marcia Edelweiss, Ali Shamseddine, Walid Faraj, Deborah Mukherji, Ali Haydar, Ashwaq Olayan, Fouad Sabatin, Rita Assi, Imane El Dika, Leonard B Saltz, Ghassan K Abou-Alfa, Eileen M O'Reilly
No abstract text is available yet for this article.
June 2017: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28355422/how-we-evaluate-biomarker-studies
#15
Mintu P Turakhia, Marc S Sabatine
No abstract text is available yet for this article.
May 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28335837/potent-p2y12-inhibitors-in-men%C3%A2-versus%C3%A2-women-a%C3%A2-collaborative%C3%A2-meta-analysis%C3%A2-of%C3%A2-randomized%C3%A2-trials
#16
COMPARATIVE STUDY
Emily S Lau, Eugene Braunwald, Sabina A Murphy, Stephen D Wiviott, Marc P Bonaca, Steen Husted, Stefan K James, Lars Wallentin, Peter Clemmensen, Matthew T Roe, E Magnus Ohman, Robert A Harrington, Jessica L Mega, Deepak L Bhatt, Marc S Sabatine, Michelle L O'Donoghue
BACKGROUND: Sex-specific differences in response to antiplatelet therapies have been described. Whether women and men derive comparable benefit from intensification of antiplatelet therapy remains uncertain. OBJECTIVES: The study investigated the efficacy and safety of the potent P2Y12 inhibitors in patients with coronary artery disease. METHODS: A collaborative sex-specific meta-analysis was conducted of phase III or IV randomized trials of potent P2Y12 inhibitors, including prasugrel, ticagrelor, and intravenous cangrelor...
March 28, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28304224/evolocumab-and-clinical-outcomes-in-patients-with-cardiovascular-disease
#17
RANDOMIZED CONTROLLED TRIAL
Marc S Sabatine, Robert P Giugliano, Anthony C Keech, Narimon Honarpour, Stephen D Wiviott, Sabina A Murphy, Julia F Kuder, Huei Wang, Thomas Liu, Scott M Wasserman, Peter S Sever, Terje R Pedersen
BACKGROUND: Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy...
May 4, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28300867/consistent-platelet-inhibition-with-ticagrelor-60-mg-twice-daily-following-myocardial-infarction-regardless-of-diabetes-status
#18
Mark R Thomas, Dominick J Angiolillo, Marc P Bonaca, Ramzi A Ajjan, Heather M Judge, Fabiana Rollini, Francesco Franchi, Arif J Ahsan, Deepak L Bhatt, Julia F Kuder, Philippe Gabriel Steg, Marc Cohen, Rangasamy Muthusamy, Marc S Sabatine, Robert F Storey
Diabetes increases cardiovascular risk and reduces pharmacodynamic response to some oral antiplatelet drugs. This study aimed to determine whether ticagrelor 60 mg twice daily (bid) provided potent and consistent platelet inhibition in patients with vs without diabetes in the PEGASUS-TIMI 54 platelet function substudy. Out of 180 patients studied, 58 patients were randomised to and had received at least four weeks of ticagrelor 60 mg bid, with 20 (34 %) having diabetes, 58 patients received ticagrelor 90 mg bid, with 12 (21 %) having diabetes, and 64 patients received placebo, with 18 (28 %) having diabetes...
March 16, 2017: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/28291870/long-term-low-density-lipoprotein-cholesterol-lowering-efficacy-persistence-and-safety-of-evolocumab-in-treatment-of-hypercholesterolemia-results-up-to-4-years-from-the-open-label-osler-1-extension-study
#19
Michael J Koren, Marc S Sabatine, Robert P Giugliano, Gisle Langslet, Stephen D Wiviott, Helina Kassahun, Andrea Ruzza, Yuhui Ma, Ransi Somaratne, Frederick J Raal
Importance: The Open-Label Study of Long-term Evaluation Against LDL-C (OSLER-1) evaluated the durability of long-term efficacy and safety during long-term therapy with evolocumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9). Objective: To determine whether LDL-C level reductions with evolocumab persist across different populations. Secondary objectives included assessment of adverse events, antidrug antibodies, and factors contributing to treatment discontinuation...
June 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28207168/design-and-rationale-of-the-ebbinghaus-trial-a-phase-3-double-blind-placebo-controlled-multicenter-study-to-assess-the-effect-of-evolocumab-on-cognitive-function-in-patients-with-clinically-evident-cardiovascular-disease-and-receiving-statin-background-lipid
#20
RANDOMIZED CONTROLLED TRIAL
Robert P Giugliano, Francois Mach, Kenton Zavitz, Christopher Kurtz, Jingjing Schneider, Huei Wang, Anthony Keech, Terje R Pedersen, Marc S Sabatine, Peter S Sever, Narimon Honarpour, Scott M Wasserman, Brian R Ott
Some observational studies raised concern that statins may cause memory impairment, leading to a US Food and Drug Administration warning. Similar questions were raised regarding proprotein convertase subtilisin/kexin-type 9 inhibitors (PCSK9i) and neurocognitive function. No prospectively designed study has evaluated the relationship between long-term PCSK9i use and cognition changes. Patients with prior cardiovascular disease treated with maximally tolerated statin enrolled in FOURIER (the randomized, double-blind, placebo-controlled cardiovascular outcome study of the PCSK9i evolocumab) could participate in this prospective assessment of cognitive function (EBBINGHAUS)...
February 2017: Clinical Cardiology
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