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Cardiovascular outcome trials

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https://www.readbyqxmd.com/read/29049868/a-novel-home-based-intervention-for-child-and-adolescent-obesity-the-results-of-the-wh%C3%A4-nau-pakari-randomized-controlled-trial
#1
Yvonne C Anderson, Lisa E Wynter, Cameron C Grant, Tami L Cave, José G B Derraik, Wayne S Cutfield, Paul L Hofman
OBJECTIVE: To report 12-month outcomes from a multidisciplinary child obesity intervention program, targeting high-risk groups. METHODS: In this unblinded randomized controlled trial, participants (recruited January 2012-August 2014) were aged 5 to 16 years, resided in Taranaki, Aotearoa/New Zealand, and had BMI ≥ 98th percentile or BMI > 91st percentile with weight-related comorbidities. Randomization was by minimization (age and ethnicity), with participants assigned to an intense intervention group (home-based assessments at 6-month intervals and a 12-month multidisciplinary program with weekly group sessions) or to a minimal-intensity control group with home-based assessments and advice at each 6-month follow-up...
October 19, 2017: Obesity
https://www.readbyqxmd.com/read/29049540/feasibility-process-and-outcomes-of-cardiovascular-clinical-trial-data-sharing-a-reproduction-analysis-of-the-smart-af-trial
#2
Hawkins C Gay, Abigail S Baldridge, Mark D Huffman
Importance: Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise. Objective: To evaluate the feasibility, process, and outcomes of a reproduction analysis of the THERMOCOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial using shared clinical trial data. Design, Setting, and Participants: A reproduction analysis of the SMART-AF trial was performed using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed through the Yale Open Data Access Project using the SAS Clinical Trials Data Transparency platform...
October 18, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/29049526/incorporating-patient-and-caregiver-experiences-into-cardiovascular-clinical-trial-design
#3
Sean P Collins, Phillip D Levy, Jane L Holl, Javed Butler, Yosef Khan, Tiffany L Israel, Gregg C Fonarow, Jacqueline Alikhaani, Eric Sarno, Alison Cook, Clyde W Yancy
Patient centeredness is a concept that is increasingly being viewed as essential for clinical research. A core principle involves a comprehensive assessment and integration of patient and caregiver perspectives into trial design. Importantly, this involves more than just soliciting feedback. Patients and caregivers are now considered vital members of the study team, even serving as coinvestigators who may help to conceive, plan, and develop the study; continue to direct the day-to-day conduct of the study; and fully participate in the dissemination of the study results...
October 11, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/29049467/updated-cost-effectiveness-assessments-of-pcsk9-inhibitors-from-the-perspectives-of-the-health-system-and-private-payers-insights-derived-from-the-fourier-trial
#4
Alejandro Arrieta, Jonathan C Hong, Rohan Khera, Salim S Virani, Harlan M Krumholz, Khurram Nasir
Importance: Preliminary cost-effectiveness analyses of proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) were based on benefits estimated from reductions in low-density lipoprotein cholesterol that occurred in PCSK9i trials with variable results. The recent Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial provides better information about the effectiveness of the drug. Objective: To use the trial results to determine the cost-effectiveness of a PCSK9i and statin treatment strategy compared with a statin alone strategy...
October 18, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/29047392/correction-to-report-from-the-2nd-cardiovascular-outcome-trial-cvot-summit-of-the-diabetes-and-cardiovascular-disease-d-cvd-easd-study-group
#5
Oliver Schnell, Eberhard Standl, Doina Catrinoiu, Stefano Genovese, Nebojsa Lalic, Jan Skra, Paul Valensi, Dario Rahelic, Antonio Ceriello
Following publication of the original article [1], author Antonio Ceriello requested that a correction be published in relation to his affiliations. His correct affiliations have been updated in this erratum. This correction is very important for the correct assignment of funds to his Institutions.
October 18, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/29047342/effectiveness-and-patient-safety-of-platelet-aggregation-inhibitors-in-the-prevention-of-cardiovascular-disease-and-ischemic-stroke-in-older-adults-a-systematic-review
#6
REVIEW
Maren Meinshausen, Anja Rieckert, Anna Renom-Guiteras, Moritz Kröger, Christina Sommerauer, Ilkka Kunnamo, Yolanda V Martinez, Aneez Esmail, Andreas Sönnichsen
BACKGROUND: Platelet aggregation inhibitors (PAI) are among the most frequently prescribed drugs in older people, though evidence about risks and benefits of their use in older adults is scarce. The objectives of this systematic review are firstly to identify the risks and benefits of their use in the prevention and treatment of vascular events in older adults, and secondly to develop recommendations on discontinuing PAI in this population if risks outweigh benefits. METHODS: Staged systematic review consisting of three searches...
October 16, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/29046987/blood-pressure-parameters-and-their-associations-with-death-in-patients-with-chronic-kidney-disease
#7
REVIEW
Samaya Qureshi, Robert Lorch, Sankar D Navaneethan
PURPOSE OF REVIEW: Optimal blood pressure (BP) parameters among patients with chronic kidney disease (CKD) have been a matter of debate. This review critically evaluates recent literature to better define the associations of BP parameters and death among individuals with non-dialysis-dependent CKD. RECENT FINDINGS: Observational studies report a "U- or J-shaped" association between BP and all-cause mortality in CKD and caution-intensive BP lowering in the elderly...
October 18, 2017: Current Hypertension Reports
https://www.readbyqxmd.com/read/29046921/pioglitazone-reduces-cold-induced-brown-fat-glucose-uptake-despite-induction-of-browning-in-cultured-human-adipocytes-a-randomised-controlled-trial-in-humans
#8
Rebecca K C Loh, Melissa F Formosa, Nina Eikelis, David A Bertovic, Mitchell J Anderson, Shane A Barwood, Shane Nanayakkara, Neale D Cohen, Andre La Gerche, Anne T Reutens, Kenneth S Yap, Thomas W Barber, Gavin W Lambert, Martin H Cherk, Stephen J Duffy, Bronwyn A Kingwell, Andrew L Carey
AIMS/HYPOTHESIS: Increasing brown adipose tissue (BAT) activity is a possible therapeutic strategy to increase energy expenditure and glucose and lipid clearance to ameliorate obesity and associated comorbidities. The thiazolidinedione (TZD) class of glucose-lowering drugs increase BAT browning in preclinical experimental models but whether these actions extend to humans in vivo is unknown. The aim of this study was to determine the effect of pioglitazone treatment on adipocyte browning and adaptive thermogenesis in humans...
October 18, 2017: Diabetologia
https://www.readbyqxmd.com/read/29045334/blood-pressure-parameters-and-morbid-and-mortal-outcomes-in-nondialysis-dependent-chronic-kidney-disease
#9
Carl P Walther, Aravind Chandra, Sankar D Navaneethan
PURPOSE OF REVIEW: Observational and interventional studies provide conflicting evidence regarding optimal blood pressure (BP) control in persons with chronic kidney disease (CKD). Recent publications provide additional information to inform therapeutic decision-making. RECENT FINDINGS: Targeting SBP to less than 120 mmHg, versus less than 140 mmHg, decreased cardiovascular events and all-cause mortality in persons with nondiabetic CKD. A meta-analysis of trials testing blood pressure management among nondialysis-dependent CKD patients (15 924 total patients) found more intensive therapies generally reduced mortality in all subgroups...
October 16, 2017: Current Opinion in Nephrology and Hypertension
https://www.readbyqxmd.com/read/29045253/gut-microbial-diversity-in-hiv-infection-post-combined-antiretroviral-therapy-a-key-target-for-prevention-of-cardiovascular-disease
#10
Mohamed El-Far, Cécile L Tremblay
PURPOSE OF REVIEW: Although the HIV-infected population is living longer and getting older under current treatment regimens, significant challenges arise for health management as the infection is associated with various premature aging phenotypes, particularly increased incidence of cardiovascular diseases (CVDs). Here we review the current understanding of HIV-related gut dysbiosis in association with CVD and advances in clinical trials aiming to restore gut microbial diversity. RECENT FINDING: Identification of a unique signature for gut dysbiosis in HIV infection between different cohorts remains challenging...
October 17, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/29044915/pre-discharge-and-early-post-discharge-troponin-elevation-among-patients-hospitalized-for-heart-failure-with-reduced-ejection-fraction-findings-from-the-astronaut-trial
#11
Stephen J Greene, Javed Butler, Gregg C Fonarow, Haris P Subacius, Andrew P Ambrosy, Muthiah Vaduganathan, Marco Triggiani, Scott D Solomon, Eldrin F Lewis, Aldo P Maggioni, Michael Böhm, Ovidiu Chioncel, Savina Nodari, Michele Senni, Faiez Zannad, Mihai Gheorghiade
AIMS: Troponin levels are commonly elevated among patients hospitalized for heart failure (HF), but the prevalence and prognostic significance of early post-discharge troponin elevation are unclear. This study sought to describe the frequency and prognostic value of pre-discharge and post-discharge troponin elevation, including persistent troponin elevation from the inpatient to outpatient settings. METHODS AND RESULTS: The ASTRONAUT trial (NCT00894387; http://www...
October 17, 2017: European Journal of Heart Failure
https://www.readbyqxmd.com/read/29044764/estimated-glomerular-filtration-rate-and-the-risk-benefit-profile-of-intensive-blood-pressure-control-among-non-diabetic-patients-a-post-hoc-analysis-of-a-randomized-clinical-trial
#12
Yoshitsugu Obi, Kamyar Kalantar-Zadeh, Ayumi Shintani, Csaba P Kovesdy, Takayuki Hamano
BACKGROUND: The Systolic Blood Pressure Intervention Trial (SPRINT; ClinicalTrials. gov, NCT01206062) reported reduced cardiovascular events by intensive blood pressure (BP) control among hypertensive patients without diabetes. However, the risk-benefit profile of intensive BP control may differ across estimated glomerular filtration rate (eGFR) levels. METHODS: This is a post-hoc analysis of the SPRINT. Non-diabetic hypertensive adults (n=9,361) with eGFR >20 mL/min/1...
October 16, 2017: Journal of Internal Medicine
https://www.readbyqxmd.com/read/29044394/prediction-of-cardiovascular-risk-in-patients-with-familial-hypercholesterolaemia
#13
Guillermo Villa, Bruce Wong, Lucie Kutikova, Kausik K Ray, Pedro Mata, Eric Bruckert
Aims: Patients with familial hypercholesterolaemia (FH) have an elevated cardiovascular (CV) risk. The objective of this analysis was to adjust CV risk equations derived in non-FH populations with hyperlipidaemia to predict CV risk in FH patients, and then to use these adjusted CV risk equations in a decision analytic model in order to predict lifetime CV risk in FH patients. Methods and results: A literature search of publications reporting CV risk in FH patients identified the publication with the most credible estimate of CV risk increase...
October 1, 2017: European Heart Journal. Quality of Care & Clinical Outcomes
https://www.readbyqxmd.com/read/29042392/renal-and-cardiovascular-effects-of-sodium-glucose-cotransporter-2-sglt2-inhibition-in-combination-with-loop-diuretics-in-diabetic-patients-with-chronic-heart-failure-recede-chf-protocol-for-a-randomised-controlled-double-blind-cross-over-trial
#14
Natalie A Mordi, Ify R Mordi, Jagdeep S Singh, Fatima Baig, Anna-Maria Choy, Rory J McCrimmon, Allan D Struthers, Chim C Lang
INTRODUCTION: Type 2 diabetes (T2D) and heart failure (HF) are a frequent combination, where treatment options remain limited. There has been increasing interest around the sodium-glucose cotransporter 2 (SGLT2) inhibitors and their use in patients with HF. Data on the effect of SGLT2 inhibitor use with diuretics are limited. We hypothesise that SGLT2 inhibition may augment the effects of loop diuretics and the benefits of SGLT2 inhibitors may extend beyond those of their metabolic (glycaemic parameters and weight loss) and haemodynamic parameters...
October 16, 2017: BMJ Open
https://www.readbyqxmd.com/read/29040716/dietary-carbohydrates-components-of-energy-balance-and-associated-health-outcomes
#15
Harry A Smith, Javier T Gonzalez, Dylan Thompson, James A Betts
The role of dietary carbohydrates in the development of obesity and associated metabolic dysfunction has recently been questioned. Within the last decade, the Scientific Advisory Committee on Nutrition carried out a comprehensive evaluation of the role of dietary carbohydrates in human health. The current review aims to complement and extend this report by providing specific consideration of the effects of the component parts of energy balance, their interactions, and their culmination on energy storage and health...
October 5, 2017: Nutrition Reviews
https://www.readbyqxmd.com/read/29040687/mortality-risk-in-patients-on-hemodiafiltration-versus-hemodialysis-a-real-world-comparison-from-the-dopps
#16
Francesco Locatelli, Angelo Karaboyas, Ronald L Pisoni, Bruce M Robinson, Joan Fort, Raymond Vanholder, Hugh C Rayner, Werner Kleophas, Stefan H Jacobson, Christian Combe, Friedrich K Port, Francesca Tentori
Background: With its convective component, hemodiafiltration (HDF) provides better middle molecule clearance compared with hemodialysis (HD) and is postulated to improve survival. A previous analysis of Dialysis Outcomes and Practice Patterns Study (DOPPS) data in 1998-2001 found lower mortality rates for high replacement fluid volume HDF versus HD. Randomized controlled trials have not shown uniform survival advantage for HDF; in secondary (non-randomized) analyses, better outcomes were observed in patients receiving the highest convection volumes...
October 11, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/29040525/beta-blockers-for-heart-failure-with-reduced-mid-range-and-preserved-ejection-fraction-an-individual-patient-level-analysis-of-double-blind-randomized-trials
#17
John G F Cleland, Karina V Bunting, Marcus D Flather, Douglas G Altman, Jane Holmes, Andrew J S Coats, Luis Manzano, John J V McMurray, Frank Ruschitzka, Dirk J van Veldhuisen, Thomas G von Lueder, Michael Böhm, Bert Andersson, John Kjekshus, Milton Packer, Alan S Rigby, Giuseppe Rosano, Hans Wedel, Åke Hjalmarson, John Wikstrand, Dipak Kotecha
Aims: Recent guidelines recommend that patients with heart failure and left ventricular ejection fraction (LVEF) 40-49% should be managed similar to LVEF ≥ 50%. We investigated the effect of beta-blockers according to LVEF in double-blind, randomized, placebo-controlled trials. Methods and results: Individual patient data meta-analysis of 11 trials, stratified by baseline LVEF and heart rhythm (Clinicaltrials.gov: NCT0083244; PROSPERO: CRD42014010012). Primary outcomes were all-cause mortality and cardiovascular death over 1...
October 10, 2017: European Heart Journal
https://www.readbyqxmd.com/read/29040268/benefit-and-harm-of-intensive-blood-pressure-treatment-derivation-and-validation-of-risk-models-using-data-from-the-sprint-and-accord-trials
#18
Sanjay Basu, Jeremy B Sussman, Joseph Rigdon, Lauren Steimle, Brian T Denton, Rodney A Hayward
BACKGROUND: Intensive blood pressure (BP) treatment can avert cardiovascular disease (CVD) events but can cause some serious adverse events. We sought to develop and validate risk models for predicting absolute risk difference (increased risk or decreased risk) for CVD events and serious adverse events from intensive BP therapy. A secondary aim was to test if the statistical method of elastic net regularization would improve the estimation of risk models for predicting absolute risk difference, as compared to a traditional backwards variable selection approach...
October 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29039146/estrogen-based-hormone-therapy-in-women-with-primary-ovarian-insufficiency-a-systematic-review
#19
Nydia Burgos, Dahima Cintron, Paula Latortue-Albino, Valentina Serrano, Rene Rodriguez Gutierrez, Stephanie Faubion, Gabriela Spencer-Bonilla, Patricia J Erwin, Mohammad Hassan Murad
PURPOSE: Sex hormones play a role in bone density, cardiovascular health, and wellbeing throughout reproductive lifespan. Women with primary ovarian insufficiency (POI) have lower estrogen levels requiring hormone therapy (HT) to manage symptoms and to protect against adverse long-term health outcomes. Yet, the effectiveness of HT in preventing adverse outcomes has not been systematically assessed. We summarize the evidence regarding effects of HT on bone and cardiovascular health in women with POI...
October 16, 2017: Endocrine
https://www.readbyqxmd.com/read/29038906/pcsk9-mutations-in-familial-hypercholesterolemia-from-a-groundbreaking-discovery-to-anti-pcsk9-therapies
#20
REVIEW
Petra El Khoury, Sandy Elbitar, Youmna Ghaleb, Yara Abou Khalil, Mathilde Varret, Catherine Boileau, Marianne Abifadel
PURPOSE OF REVIEW: In 2003, Abifadel et al. (Nat. Genet. 34:154-156, 2003) identified PCSK9, encoding proprotein convertase subtilisin/kexin type 9, as the third causal gene for autosomal dominant hypercholesterolemia. This review focuses on the main steps from this major breakthrough in familial hypercholesterolemia (FH) to the latest clinical trials with the anti-PCSK9 antibodies. RECENT FINDINGS: The year 2015 was remarkable in cardiovascular disease through the field of cholesterol...
October 17, 2017: Current Atherosclerosis Reports
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