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https://www.readbyqxmd.com/read/27625344/efficacy-and-safety-of-alirocumab-150%C3%A2-mg-every-4%C3%A2-weeks-in-patients-with-hypercholesterolemia-not-on-statin-therapy-the-odyssey-choice-ii-study
#1
Erik Stroes, John R Guyton, Norman Lepor, Fernando Civeira, Daniel Gaudet, Gerald F Watts, Marie T Baccara-Dinet, Guillaume Lecorps, Garen Manvelian, Michel Farnier
BACKGROUND: The PCSK9 antibody alirocumab (75 mg every 2 weeks; Q2W) as monotherapy reduced low-density lipoprotein-cholesterol (LDL-C) levels by 47%. Because the option of a monthly dosing regimen is convenient, ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin-associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet alone. METHODS AND RESULTS: Patients were randomly assigned to placebo, alirocumab 150 mg Q4W or 75 mg Q2W (calibrator arm), with dose adjustment to 150 mg Q2W at week (W) 12 if W8 predefined LDL-C target levels were not met...
September 13, 2016: Journal of the American Heart Association
https://www.readbyqxmd.com/read/27618825/efficacy-and-safety-of-alirocumab-in-patients-with-heterozygous-familial-hypercholesterolemia-and-ldl-c-of-160%C3%A2-mg-dl-or-higher
#2
Henry N Ginsberg, Daniel J Rader, Frederick J Raal, John R Guyton, Marie T Baccara-Dinet, Christelle Lorenzato, Robert Pordy, Erik Stroes
PURPOSE: Even with statins and other lipid-lowering therapy (LLT), many patients with heterozygous familial hypercholesterolemia (heFH) continue to have elevated low-density lipoprotein cholesterol (LDL-C) levels. ODYSSEY HIGH FH (NCT01617655) assessed the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 monoclonal antibody, versus placebo in patients with heFH and LDL-C ≥ 160 mg/dl despite maximally tolerated statin ± other LLT. METHODS: Patients were randomized to subcutaneous alirocumab 150 mg or placebo every 2 weeks (Q2W) for 78 weeks...
October 2016: Cardiovascular Drugs and Therapy
https://www.readbyqxmd.com/read/27578122/triglyceride-lowering-therapies-reduce-cardiovascular-disease-event-risk-in-subjects-with-hypertriglyceridemia
#3
Kevin C Maki, John R Guyton, Carl E Orringer, Ian Hamilton-Craig, Dominik D Alexander, Michael H Davidson
BACKGROUND: Cardiovascular outcomes trials of fibrates, niacin, or omega-3 fatty acids alone, or added to a statin, have not consistently demonstrated reduced risk, but larger, statistically significant clinical benefits have been reported in subgroups with elevated triglycerides (TG) and/or elevated TG plus low high-density lipoprotein cholesterol (HDL-C). OBJECTIVE: To perform a meta-analysis of the effects of therapies targeting TG and TG-rich lipoprotein cholesterol on cardiovascular disease event risk in subjects with elevated TG or elevated TG paired with low HDL-C...
July 2016: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/27578118/statin-intolerance-in-a-referral-lipid-clinic
#4
Wanda C Lakey, Nicole G Greyshock, Carly E Kelley, Mohammad A Siddiqui, Umar Ahmad, Yuliya V Lokhnygina, John R Guyton
BACKGROUND: Statins effectively prevent atherosclerotic cardiovascular disease, but rates of statin discontinuation after adverse events are high. OBJECTIVE: Describe the range and relative frequencies of adverse events potentially attributable to statins in lipid referral practice and assess statin rechallenge outcomes. METHODS: Retrospective cohort study of 642 patients with statin-associated adverse events evaluated in a referral lipid clinic between January 1, 2004 and January 27, 2011...
July 2016: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/27530446/morphine-promotes-colonization-of-anastomotic-tissues-with-collagenase-producing-enterococcus-faecalis-and-causes-leak
#5
Baddr A Shakhsheer, Luke A Versten, James N Luo, Jennifer R Defazio, Robin Klabbers, Scott Christley, Alexander Zaborin, Kristina L Guyton, Monika Krezalek, Daniel P Smith, Nadim J Ajami, Joseph F Petrosino, Irma D Fleming, Natalia Belogortseva, Olga Zaborina, John C Alverdy
BACKGROUND: Despite ever more powerful antibiotics, newer surgical techniques, and enhanced recovery programs, anastomotic leaks remain a clear and present danger to patients. Previous work from our laboratory suggests that anastomotic leakage may be caused by Enterococcus faecalis strains that express a high collagenase phenotype (i.e., collagenolytic). Yet the mechanisms by which the practice of surgery shifts or selects for collagenolytic phenotypes to colonize anastomotic tissues remain unknown...
October 2016: Journal of Gastrointestinal Surgery: Official Journal of the Society for Surgery of the Alimentary Tract
https://www.readbyqxmd.com/read/27412149/a-proposed-framework-for-the-systematic-review-and-integrated-assessment-syrina-of-endocrine-disrupting-chemicals
#6
Laura N Vandenberg, Marlene Ågerstrand, Anna Beronius, Claire Beausoleil, Åke Bergman, Lisa A Bero, Carl-Gustaf Bornehag, C Scott Boyer, Glinda S Cooper, Ian Cotgreave, David Gee, Philippe Grandjean, Kathryn Z Guyton, Ulla Hass, Jerrold J Heindel, Susan Jobling, Karen A Kidd, Andreas Kortenkamp, Malcolm R Macleod, Olwenn V Martin, Ulf Norinder, Martin Scheringer, Kristina A Thayer, Jorma Toppari, Paul Whaley, Tracey J Woodruff, Christina Rudén
BACKGROUND: The issue of endocrine disrupting chemicals (EDCs) is receiving wide attention from both the scientific and regulatory communities. Recent analyses of the EDC literature have been criticized for failing to use transparent and objective approaches to draw conclusions about the strength of evidence linking EDC exposures to adverse health or environmental outcomes. Systematic review methodologies are ideal for addressing this issue as they provide transparent and consistent approaches to study selection and evaluation...
2016: Environmental Health: a Global Access Science Source
https://www.readbyqxmd.com/read/27091369/the-next-generation-of-risk-assessment-multiyear-study-highlights-of-findings-applications-to-risk-assessment-and-future-directions
#7
Ila Cote, Melvin E Andersen, Gerald T Ankley, Stanley Barone, Linda S Birnbaum, Kim Boekelheide, Frederic Y Bois, Lyle D Burgoon, Weihsueh A Chiu, Douglas Crawford-Brown, Kevin M Crofton, Michael DeVito, Robert B Devlin, Stephen W Edwards, Kathryn Z Guyton, Dale Hattis, Richard S Judson, Derek Knight, Daniel Krewski, Jason Lambert, Elizabeth Anne Maull, Donna Mendrick, Gregory M Paoli, Chirag Jagdish Patel, Edward J Perkins, Gerald Poje, Christopher J Portier, Ivan Rusyn, Paul A Schulte, Anton Simeonov, Martyn T Smith, Kristina A Thayer, Russell S Thomas, Reuben Thomas, Raymond R Tice, John J Vandenberg, Daniel L Villeneuve, Scott Wesselkamper, Maurice Whelan, Christine Whittaker, Ronald White, Menghang Xia, Carole Yauk, Lauren Zeise, Jay Zhao, Robert S DeWoskin
BACKGROUND: The Next Generation (NexGen) of Risk Assessment effort is a multiyear collaboration among several organizations evaluating new, potentially more efficient molecular, computational and systems biology approaches to risk assessment. This paper summarizes our findings, suggests applications to risk assessment, and identifies strategic research directions. OBJECTIVE: Our specific objectives were to test whether advanced biological data and methods could better inform our understanding of public health risks posed by environmental exposures...
April 19, 2016: Environmental Health Perspectives
https://www.readbyqxmd.com/read/27036394/effects-of-extended-release-niacin-added-to-simvastatin-ezetimibe-on-glucose-and-insulin-values-in-aim-high
#8
Ronald B Goldberg, Vera A Bittner, Richard L Dunbar, Jerome L Fleg, George Grunberger, John R Guyton, Lawrence A Leiter, Ruth McBride, Jennifer G Robinson, Debra L Simmons, Carol Wysham, Ping Xu, William E Boden
BACKGROUND: Niacin is an antidyslipidemic agent that may cause blood sugar elevation in patients with diabetes, but its effects on glucose and insulin values in nondiabetic statin-treated subjects with cardiovascular disease and at high risk for diabetes are less well known. METHODS: This was a prespecified, intent-to-treat analysis of the Atherothrombosis Intervention in Metabolic syndrome with low high-density lipoprotein/high triglycerides: Impact on Global Health outcomes trial which randomized 3,414 participants at 92 centers in the US and Canada to extended-release niacin (ERN) plus simvastatin/ezetimibe (ERN) or simvastatin/ezetimibe plus placebo (Placebo)...
July 2016: American Journal of Medicine
https://www.readbyqxmd.com/read/26687696/efficacy-and-safety-of-alirocumab-vs-ezetimibe-in-statin-intolerant-patients-with-a-statin-rechallenge-arm-the-odyssey-alternative-randomized-trial
#9
Patrick M Moriarty, Paul D Thompson, Christopher P Cannon, John R Guyton, Jean Bergeron, Franklin J Zieve, Eric Bruckert, Terry A Jacobson, Stephen L Kopecky, Marie T Baccara-Dinet, Yunling Du, Robert Pordy, Daniel A Gipe
BACKGROUND: Statin intolerance limits many patients from achieving optimal low-density lipoprotein cholesterol (LDL-C) concentrations. Current options for such patients include using a lower but tolerated dose of a statin and adding or switching to ezetimibe or other non-statin therapies. METHODS: ODYSSEY ALTERNATIVE (NCT01709513) compared alirocumab with ezetimibe in patients at moderate to high cardiovascular risk with statin intolerance (unable to tolerate ≥2 statins, including one at the lowest approved starting dose) due to muscle symptoms...
November 2015: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/26600562/key-characteristics-of-carcinogens-as-a-basis-for-organizing-data-on-mechanisms-of-carcinogenesis
#10
Martyn T Smith, Kathryn Z Guyton, Catherine F Gibbons, Jason M Fritz, Christopher J Portier, Ivan Rusyn, David M DeMarini, Jane C Caldwell, Robert J Kavlock, Paul F Lambert, Stephen S Hecht, John R Bucher, Bernard W Stewart, Robert A Baan, Vincent J Cogliano, Kurt Straif
BACKGROUND: A recent review by the International Agency for Research on Cancer (IARC) updated the assessments of the > 100 agents classified as Group 1, carcinogenic to humans (IARC Monographs Volume 100, parts A-F). This exercise was complicated by the absence of a broadly accepted, systematic method for evaluating mechanistic data to support conclusions regarding human hazard from exposure to carcinogens. OBJECTIVES AND METHODS: IARC therefore convened two workshops in which an international Working Group of experts identified 10 key characteristics, one or more of which are commonly exhibited by established human carcinogens...
June 2016: Environmental Health Perspectives
https://www.readbyqxmd.com/read/26490017/2015-acc-aha-scai-focused-update-on-primary-percutaneous-coronary-intervention-for-patients-with-st-elevation-myocardial-infarction-an-update-of-the-2011-accf-aha-scai-guideline-for-percutaneous-coronary-intervention-and-the-2013-accf-aha-guideline-for-the
#11
Glenn N Levine, Eric R Bates, James C Blankenship, Steven R Bailey, John A Bittl, Bojan Cercek, Charles E Chambers, Stephen G Ellis, Robert A Guyton, Steven M Hollenberg, Umesh N Khot, Richard A Lange, Laura Mauri, Roxana Mehran, Issam D Moussa, Debabrata Mukherjee, Henry H Ting, Patrick T O'Gara, Frederick G Kushner, Deborah D Ascheim, Ralph G Brindis, Donald E Casey, Mina K Chung, James A de Lemos, Deborah B Diercks, James C Fang, Barry A Franklin, Christopher B Granger, Harlan M Krumholz, Jane A Linderbaum, David A Morrow, L Kristin Newby, Joseph P Ornato, Narith Ou, Martha J Radford, Jacqueline E Tamis-Holland, Carl L Tommaso, Cynthia M Tracy, Y Joseph Woo, David X Zhao
No abstract text is available yet for this article.
March 15, 2016: Circulation
https://www.readbyqxmd.com/read/26287278/evaluation-of-baseline-corrected-qt-interval-and-azithromycin-prescriptions-in-an-academic-medical-center
#12
Rachael A Lee, Allison Guyton, Danielle Kunz, Gary R Cutter, Craig J Hoesley
BACKGROUND: Azithromycin is used in the inpatient setting for a variety of conditions. In 2013, the US Food and Drug Administration released a warning regarding risk for corrected QT (QTc) prolongation and subsequent arrhythmias. Knowledge of inpatient prescribing patterns of QTc prolonging medications with respect to patient risk factors for adverse cardiovascular events can help recognize safe use in light of these new warnings. OBJECTIVE: To assess inpatient prescribing patterns, risk factors for QTc prolongation, and relationship between drug-drug interactions and cardiac monitoring in patients receiving azithromycin...
January 2016: Journal of Hospital Medicine: An Official Publication of the Society of Hospital Medicine
https://www.readbyqxmd.com/read/26238287/appropriate-patient-selection-or-health-care-rationing-lessons-from-surgical-aortic-valve-replacement-in-the-placement-of-aortic-transcatheter-valves-i-trial
#13
RANDOMIZED CONTROLLED TRIAL
Wilson Y Szeto, Lars G Svensson, Jeevanantham Rajeswaran, John Ehrlinger, Rakesh M Suri, Craig R Smith, Michael Mack, D Craig Miller, Patrick M McCarthy, Joseph E Bavaria, Lawrence H Cohn, Paul J Corso, Robert A Guyton, Vinod H Thourani, Bruce W Lytle, Mathew R Williams, John G Webb, Samir Kapadia, E Murat Tuzcu, David J Cohen, Hartzell V Schaff, Martin B Leon, Eugene H Blackstone
OBJECTIVES: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement. METHODS: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6...
September 2015: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/26110167/antiretroviral-effects-on-host-lipoproteins-are-associated-with-changes-in-hepatitis-c-virus-hcv-rna-levels-in-human-immunodeficiency-virus-hcv-coinfected-individuals
#14
Susanna Naggie, Keyur Patel, Lan-Yan Yang, Shein-Chung Chow, Victoria Johnson, John R Guyton, Andrew J Muir, Mark Sulkowski, Charles Hicks
We evaluated the impact of antiretroviral-induced dyslipidemia on hepatitis C virus (HCV) biogenesis in human immunodeficiency virus (HIV)/HCV coinfected patients. This study used serum samples from antiretroviral-naive HIV/HCV patients initiating their first regimen as part of AIDS Clinical Trials Group study protocols (A5142, A5202). Initiation of antiretrovirals increased most lipoproteins and apolipoproteins. In the multivariable model, changes in apolipoproteins were associated with changes in log10 HCV RNA from baseline to week-24 of therapy...
April 2015: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/25933731/effect-of-surgical-atrial-fibrillation-ablation-at-the-time-of-cardiac-surgery-on-risk-of-postoperative-pacemaker-implantation
#15
COMPARATIVE STUDY
Mikhael F El-Chami, José Nilo G Binongo, Mathew Levy, Faisal M Merchant, Michael Halkos, Vinod Thourani, Omar Lattouf, Robert Guyton, John Puskas, Angel R Leon
The aim of this study was to retrospectively investigate whether performing surgical atrial fibrillation (AF) ablation in conjunction with cardiac surgery (CS) increases the risk for postoperative permanent pacemaker (PPM) requirement. The 30-day risk for PPM requirement was analyzed in consecutive patients who underwent CS from January 2007 to August 27, 2013. Patients were divided into 3 groups: (1) those who underwent AF ablation concomitant with CS (AF ABL), (2) patients with any history of AF who underwent surgery who did not undergo ablation (AF NO ABL), and (3) those with no histories of AF who underwent surgery (NO AF)...
July 1, 2015: American Journal of Cardiology
https://www.readbyqxmd.com/read/25659486/prediction-of-the-impact-of-venoarterial-extracorporeal-membrane-oxygenation-on-hemodynamics
#16
Kazuo Sakamoto, Keita Saku, Takuya Kishi, Takamori Kakino, Atsushi Tanaka, Takafumi Sakamoto, Tomomi Ide, Kenji Sunagawa
Although venoarterial extracorporeal membrane oxygenation (ECMO) was developed to rescue patients with cardiogenic shock, the impact of ECMO on hemodynamics is often unpredictable and can lead to hemodynamic collapse. In this study, we developed a framework in which we incorporated ECMO into the extended Guyton's model of circulatory equilibrium and predicted hemodynamic changes in response to ECMO. We first determined the cardiac output (CO) curves of left and right heart (to generate the integrated CO curve) without ECMO in eight normal and seven dogs with left ventricular dysfunction...
April 15, 2015: American Journal of Physiology. Heart and Circulatory Physiology
https://www.readbyqxmd.com/read/25499937/efficacy-and-safety-of-alirocumab-a-monoclonal-antibody-to-pcsk9-in-statin-intolerant-patients-design-and-rationale-of-odyssey-alternative-a-randomized-phase-3-trial
#17
RANDOMIZED CONTROLLED TRIAL
Patrick M Moriarty, Terry A Jacobson, Eric Bruckert, Paul D Thompson, John R Guyton, Marie T Baccara-Dinet, Daniel Gipe
BACKGROUND: Statin intolerance has been a major limitation in the use of statins, especially at higher doses. New effective treatments are needed for lowering low-density lipoprotein cholesterol (LDL-C) in patients who cannot tolerate daily statin doses. OBJECTIVE: ODYSSEY ALTERNATIVE (NCT01709513) evaluates efficacy and safety of alirocumab, a fully human proprotein convertase subtilisin/kexin type 9 monoclonal antibody, in patients with well-documented statin intolerance and moderate to very high cardiovascular risk...
November 2014: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/25273784/a-geophysical-shock-and-air-blast-simulator-at-the-national-ignition-facility
#18
K B Fournier, C G Brown, M J May, S Compton, O R Walton, N Shingleton, J O Kane, G Holtmeier, H Loey, P B Mirkarimi, W H Dunlop, R L Guyton, E Huffman
The energy partitioning energy coupling experiments at the National Ignition Facility (NIF) have been designed to measure simultaneously the coupling of energy from a laser-driven target into both ground shock and air blast overpressure to nearby media. The source target for the experiment is positioned at a known height above the ground-surface simulant and is heated by four beams from the NIF. The resulting target energy density and specific energy are equal to those of a low-yield nuclear device. The ground-shock stress waves and atmospheric overpressure waveforms that result in our test system are hydrodynamically scaled analogs of full-scale seismic and air blast phenomena...
September 2014: Review of Scientific Instruments
https://www.readbyqxmd.com/read/25151468/examining-hemodialysis-reliable-outflow-catheter-performance-and-cost-in-hemodialysis-access
#19
Daniel J Torrent, Mandy R Maness, Swapnil D Kachare, Jill N Zink, Carl E Haisch, Robert C Harland, Claire Morgan, Rodney L Guyton, Avery G Colomb, David W Barham, Eric C Katz, Michael C Stoner
BACKGROUND: The Hemodialysis Reliable Outflow (HeRO) vascular access device is a hybrid polytetrafluoroethylene graft-stent construct designed to address central venous occlusive disease. Although initial experience has demonstrated excellent mid-term patency rates, subsequent studies have led to external validity questions. The purpose of this study was to examine a single center experience with this vascular access device in challenging access cases with associated costs. METHODS: A retrospective study representing the authors' cumulative HeRO vascular access device experience was undertaken...
November 2014: Journal of Surgical Research
https://www.readbyqxmd.com/read/25060521/obesity-cholesterol-metabolism-and-breast-cancer-pathogenesis
#20
Donald P McDonnell, Sunghee Park, Matthew T Goulet, Jeff Jasper, Suzanne E Wardell, Ching-Yi Chang, John D Norris, John R Guyton, Erik R Nelson
Obesity and altered lipid metabolism are risk factors for breast cancer in pre- and post-menopausal women. These pathologic relationships have been attributed in part to the impact of cholesterol on the biophysical properties of cell membranes and to the influence of these changes on signaling events initiated at the membrane. However, more recent studies have indicated that the oxysterol 27-hydroxycholesterol (27HC), and not cholesterol per se, may be the primary biochemical link between lipid metabolism and cancer...
September 15, 2014: Cancer Research
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