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https://www.readbyqxmd.com/read/28355422/how-we-evaluate-biomarker-studies
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
https://www.readbyqxmd.com/read/28196110/ethnic-variation-in-medical-and-lifestyle-risk-factors-for-b-cell-non-hodgkin-lymphoma-a-case-control-study-among-israelis-and-palestinians
#7
Geffen Kleinstern, Rania Abu Seir, Riki Perlman, Areej Khatib, Ziad Abdeen, Husein Elyan, Ronit Nirel, Gail Amir, Asad Ramlawi, Fouad Sabatin, Paolo Boffetta, Eldad J Dann, Meirav Kedmi, Martin Ellis, Arnon Nagler, Dina Ben Yehuda, Ora Paltiel
BACKGROUND: Risk factors for B-cell non-Hodgkin lymphoma (B-NHL) have not been assessed among Palestinian Arabs (PA) and Israeli Jews (IJ). METHODS: In a case-control study we investigated self-reported medical and lifestyle exposures, reporting odds ratios (ORs) and 95% confidence intervals [CIs], by ethnicity, for overall B-NHL and subtypes. RESULTS: We recruited 823 cases and 808 healthy controls. Among 307 PA/516 IJ B-NHL cases (mean age at diagnosis = 51 [±17] versus 60 [±15] years, respectively) subtype distributions differed, with diffuse large B-cell lymphoma (DLBCL) being prominent among PA (71%) compared to IJ (41%); follicular lymphoma (FL), was observed in 14% versus 28%, and marginal zone lymphoma, in 2% versus 14%, respectively...
2017: PloS One
https://www.readbyqxmd.com/read/28122070/association-between-circulating-baseline-proprotein-convertase-subtilisin-kexin-type-9-levels-and-efficacy-of-evolocumab
#8
Nihar R Desai, Robert P Giugliano, Scott M Wasserman, John P Gibbs, Thomas Liu, Rob Scott, Marc S Sabatine
Importance: Levels of proprotein convertase subtilisin kexin type 9 (PCSK9) vary markedly across the population and are influenced by genetic and nongenetic factors. Evolocumab is a fully human, monoclonal antibody against PCSK9 that reduces low-density lipoprotein cholesterol (LDL-C) levels by 55% to 75%. Whether the efficacy of evolocumab varies based on an individual's baseline PCSK9 level remains unknown. Objective: To characterize variability in PCSK9 levels and determine whether the LDL-C level reduction achieved with evolocumab differs based on PCSK9 levels...
May 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28118447/interventions-to-lower-low-density-lipoprotein-cholesterol-and-cardiovascular-risk-reply
#9
LETTER
Michael G Silverman, Kyungah Im, Marc S Sabatine
No abstract text is available yet for this article.
January 24, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28110294/proprotein-convertase-subtilisin-kexin-type-9-pcsk9-inhibitors-comparing-and-contrasting-guidance-across-the-atlantic
#10
EDITORIAL
Marc S Sabatine
No abstract text is available yet for this article.
January 21, 2017: European Heart Journal
https://www.readbyqxmd.com/read/27959767/variation-in-pcsk9-and-hmgcr-and-risk-of-cardiovascular-disease-and-diabetes
#11
Brian A Ference, Jennifer G Robinson, Robert D Brook, Alberico L Catapano, M John Chapman, David R Neff, Szilard Voros, Robert P Giugliano, George Davey Smith, Sergio Fazio, Marc S Sabatine
BACKGROUND: Pharmacologic inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) are being evaluated in clinical trials for the treatment of cardiovascular disease. The effect of lowering low-density lipoprotein (LDL) cholesterol levels by inhibiting PCSK9 on the risk of cardiovascular events or diabetes is unknown. METHODS: We used genetic scores consisting of independently inherited variants in the genes encoding PCSK9 and 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR; the target of statins) as instruments to randomly assign 112,772 participants from 14 studies, with 14,120 cardiovascular events and 10,635 cases of diabetes, to groups according to the number of LDL cholesterol-lowering alleles that they had inherited...
December 1, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27751237/2016-acc-aha-guideline-focused-update-on-duration-of-dual-antiplatelet-therapy-in-patients-with-coronary-artery-disease-a-report-of-the-american-college-of-cardiology-american-heart-association-task-force-on-clinical-practice-guidelines
#12
Glenn N Levine, Eric R Bates, John A Bittl, Ralph G Brindis, Stephan D Fihn, Lee A Fleisher, Christopher B Granger, Richard A Lange, Michael J Mack, Laura Mauri, Roxana Mehran, Debabrata Mukherjee, L Kristin Newby, Patrick T O'Gara, Marc S Sabatine, Peter K Smith, Sidney C Smith, Jonathan L Halperin, Glenn N Levine, Sana M Al-Khatib, Kim K Birtcher, Biykem Bozkurt, Ralph G Brindis, Joaquin E Cigarroa, Lesley H Curtis, Lee A Fleisher, Federico Gentile, Samuel Gidding, Mark A Hlatky, John S Ikonomidis, José A Joglar, Susan J Pressler, Duminda N Wijeysundera
No abstract text is available yet for this article.
November 2016: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/27673306/association-between-lowering-ldl-c-and-cardiovascular-risk-reduction-among-different-therapeutic-interventions-a-systematic-review-and-meta-analysis
#13
REVIEW
Michael G Silverman, Brian A Ference, Kyungah Im, Stephen D Wiviott, Robert P Giugliano, Scott M Grundy, Eugene Braunwald, Marc S Sabatine
IMPORTANCE: The comparative clinical benefit of nonstatin therapies that reduce low-density lipoprotein cholesterol (LDL-C) remains uncertain. OBJECTIVE: To evaluate the association between lowering LDL-C and relative cardiovascular risk reduction across different statin and nonstatin therapies. DATA SOURCES AND STUDY SELECTION: The MEDLINE and EMBASE databases were searched (1966-July 2016). The key inclusion criteria were that the study was a randomized clinical trial and the reported clinical outcomes included myocardial infarction (MI)...
September 27, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27576775/prevention-of-stroke-with-ticagrelor-in-patients-with-prior-myocardial-infarction-insights-from-pegasus-timi-54-prevention-of-cardiovascular-events-in-patients-with-prior-heart-attack-using-ticagrelor-compared-to-placebo-on-a-background-of-aspirin-thrombolysis
#14
RANDOMIZED CONTROLLED TRIAL
Marc P Bonaca, Shinya Goto, Deepak L Bhatt, P Gabriel Steg, Robert F Storey, Marc Cohen, Erica Goodrich, Laura Mauri, Ton Oude Ophuis, Mikhail Ruda, Jindřich Špinar, Ki-Bae Seung, Dayi Hu, Anthony J Dalby, Eva Jensen, Peter Held, David A Morrow, Eugene Braunwald, Marc S Sabatine
BACKGROUND: In the PEGASUS-TIMI 54 trial (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), ticagrelor reduced the risk of major adverse cardiovascular events when added to low-dose aspirin in stable patients with prior myocardial infarction, resulting in the approval of ticagrelor 60 mg twice daily for long-term secondary prevention. We investigated the incidence of stroke, outcomes after stroke, and the efficacy of ticagrelor focusing on the approved 60 mg twice daily dose for reducing stroke in this population...
September 20, 2016: Circulation
https://www.readbyqxmd.com/read/27548077/antiplatelet-therapy-for-long-term-secondary-prevention-after-myocardial-infarction
#15
Marc P Bonaca, Marc S Sabatine
No abstract text is available yet for this article.
September 1, 2016: JAMA Cardiology
https://www.readbyqxmd.com/read/27532444/editorial-on-pegasus-timi-54
#16
EDITORIAL
Giulia Magnani, Marc P Bonaca, Marc S Sabatine
No abstract text is available yet for this article.
October 2015: European Heart Journal. Cardiovascular Pharmacotherapy
https://www.readbyqxmd.com/read/27444932/aptamer-based-proteomic-profiling-reveals-novel-candidate-biomarkers-and-pathways-in-cardiovascular-disease
#17
Debby Ngo, Sumita Sinha, Dongxiao Shen, Eric W Kuhn, Michelle J Keyes, Xu Shi, Mark D Benson, John F O'Sullivan, Hasmik Keshishian, Laurie A Farrell, Michael A Fifer, Ramachandran S Vasan, Marc S Sabatine, Martin G Larson, Steven A Carr, Thomas J Wang, Robert E Gerszten
BACKGROUND: Single-stranded DNA aptamers are oligonucleotides of ≈50 base pairs in length selected for their ability to bind proteins with high specificity and affinity. Emerging DNA aptamer-based technologies may address limitations of existing proteomic techniques, including low sample throughput, which have hindered proteomic analyses of large cohorts. METHODS: To identify early biomarkers of myocardial injury, we applied an aptamer-based proteomic platform that measures 1129 proteins to a clinically relevant perturbational model of planned myocardial infarction (PMI), patients undergoing septal ablation for hypertrophic cardiomyopathy...
July 26, 2016: Circulation
https://www.readbyqxmd.com/read/27440003/atherothrombotic-risk-stratification-and-the-efficacy-and-safety-of-vorapaxar-in-patients-with-stable-ischemic-heart-disease-and-previous-myocardial-infarction
#18
RANDOMIZED CONTROLLED TRIAL
Erin A Bohula, Marc P Bonaca, Eugene Braunwald, Philip E Aylward, Ramon Corbalan, Gaetano M De Ferrari, Ping He, Basil S Lewis, Piera A Merlini, Sabina A Murphy, Marc S Sabatine, Benjamin M Scirica, David A Morrow
BACKGROUND: Patients with stable ischemic heart disease and previous myocardial infarction (MI) vary in their risk for recurrent cardiovascular events. Atherothrombotic risk assessment may be useful to identify high-risk patients who have the greatest potential to benefit from more intensive secondary preventive therapy such as treatment with vorapaxar. METHODS: We identified independent clinical indicators of atherothrombotic risk among 8598 stable, placebo-treated patients with a previous MI followed up for 2...
July 26, 2016: Circulation
https://www.readbyqxmd.com/read/27438319/long-term-tolerability-of-ticagrelor-for-the-secondary-prevention-of-major-adverse-cardiovascular-events-a-secondary-analysis-of-the-pegasus-timi-54-trial
#19
Marc P Bonaca, Deepak L Bhatt, Ton Oude Ophuis, P Gabriel Steg, Robert Storey, Marc Cohen, Julia Kuder, Kyungah Im, Giulia Magnani, Andrzej Budaj, Pierre Theroux, Christian Hamm, Jindrich Špinar, Robert G Kiss, Anthony J Dalby, Felix A Medina, Frederic Kontny, Philip E Aylward, Eva C Jensen, Peter Held, Eugene Braunwald, Marc S Sabatine
IMPORTANCE: In the PEGASUS-TIMI 54 trial, treatment with ticagrelor reduced the incidence of cardiovascular death, myocardial infarction, or stroke by 15% to 16% among stable patients compared with placebo. However, more patients prematurely discontinued treatment with ticagrelor than with placebo. OBJECTIVE: To investigate the reasons and timing of discontinuation of treatment with ticagrelor among stable patients prior myocardial infarction. DESIGN, SETTING, AND PARTICIPANTS: In the PEGASUS-TIMI 54 trial, 21 162 stable outpatients with prior myocardial infarction were randomly assigned to 90 mg of ticagrelor twice daily, 60 mg of ticagrelor twice daily, or placebo, with all of the patients receiving a low dose of aspirin...
July 1, 2016: JAMA Cardiology
https://www.readbyqxmd.com/read/27438098/the-prospects-for-cardiovascular-proteomics-a-glass-approaching-half-full
#20
Mark D Benson, Marc S Sabatine, Robert E Gerszten
No abstract text is available yet for this article.
June 1, 2016: JAMA Cardiology
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