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Cardiovascular outcome trials

Fausto Castagnetti, Francesco Di Raimondo, Antonio De Vivo, Antonio Spitaleri, Gabriele Gugliotta, Francesco Fabbiano, Isabella Capodanno, Donato Mannina, Marzia Salvucci, Agostino Antolino, Roberto Marasca, Maurizio Musso, Monica Crugnola, Stefana Impera, Elena Trabacchi, Caterina Musolino, Francesco Cavazzini, Giuseppe Mineo, Patrizia Tosi, Carmela Tomaselli, Michele Rizzo, Sergio Siragusa, Miriam Fogli, Riccardo Ragionieri, Alessandro Zironi, Simona Soverini, Giovanni Martinelli, Michele Cavo, Paolo Vigneri, Fabio Stagno, Gianantonio Rosti, Michele Baccarani
Chronic myeloid leukemia (CML) treatment is based on company-sponsored and academic trials testing different tyrosine kinase inhibitors (TKIs) as first-line therapy. These studies included patients selected according to many inclusion-exclusion criteria, particularly age and comorbidities, with specific treatment obligations. In daily clinical practice (real-life), inclusion-exclusion criteria do not exist and the treatment outcome does not only depend on the choice of first-line TKI, but also on second- and third-line TKIs...
October 22, 2016: American Journal of Hematology
Raimund Weitgasser, Michaela Ratzinger, Margit Hemetsberger, Peter Siostrzonek
For over 30 years, intensive research efforts investigated the role of LDL cholesterol in the pathogenesis of cardiovascular disease. In various settings, large statin trials showed an association between LDL cholesterol levels and cardiovascular event rates. This association is often referred to as the 'LDL cholesterol hypothesis'. More recent trials on agents with totally different modes of action confirmed this association and indicated a causal relationship between lower LDL cholesterol levels and improved cardiovascular outcomes...
October 21, 2016: Wiener Medizinische Wochenschrift
Jennifer C Cook, Richard H Tran, J Herbert Patterson, Jo E Rodgers
PURPOSE: The pharmacology, clinical efficacy, and safety profiles of evolving therapies for the management of chronic heart failure (HF) and acute decompensated heart failure (ADHF) are described. SUMMARY: HF confers a significant financial burden despite the widespread use of traditional guideline-directed medical therapies such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, β-blockers, and aldosterone receptor antagonists, and the rates of HF-related mortality and hospitalization have remained unacceptably high...
November 1, 2016: American Journal of Health-system Pharmacy: AJHP
Taulant Muka, Lauren C Blekkenhorst, Joshua R Lewis, Richar L Prince, Nicole S Erler, Albert Hofman, Oscar H Franco, Fernando Rivadeneira, Jessica C Kiefte-de Jong
OBJECTIVE: We aimed to study whether dietary fat composition (n-3 and n-6 polyunsaturated fatty acids ratio (PUFAs) and PUFAs and saturated fatty acids (SFAs) ratio) is associated with total body fat (TF) and body fat distribution and whether this association was modified by the presence of chronic disease in middle-aged and elderly women in two population-based cohorts in the Netherlands and Australia. METHODS: The study was performed in the Rotterdam Study (RS), a prospective cohort study among subjects aged 55 years and older (N = 1182 women) and the Calcium Intake Fracture Outcome Study (CAIFOS), a 5-year randomized controlled trial among women age 70+ (N = 891)...
September 28, 2016: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
Camilla T Damsgaard, Lotte Lauritzen, Hanne Hauger, Stine Vuholm, Marie N Teisen, Christian Ritz, Max Hansen, Janni Niclasen, Christian Mølgaard
BACKGROUND: Most children in Western populations do not meet recommendations for fish consumption. Oily fish is an important source of n-3 long-chain polyunsaturated fatty acids (LCPUFA), which reduce blood pressure and plasma triacylglycerol in adults and may affect cognitive development and behavior. However, to our knowledge, the potential effects of oily fish on cardiometabolic health, cognitive function, and behavior in children have not been investigated. The aim of the FiSK Junior study is to investigate the effects of oily fish consumption on cardiovascular risk markers, cognitive function, and behavior in healthy children...
October 21, 2016: Trials
Mahnaz Ashoorkhani, Ali Bozorgi, Reza Majdzadeh, Hamed Hosseini, Ali Yoonessi, Ali Ramezankhani, Hassan Eftekhar
BACKGROUND: Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment...
October 21, 2016: Trials
Fernando J Martinez, Jørgen Vestbo, Julie A Anderson, Robert D Brook, Bartolome R Celli, Nicholas J Cowans, Courtney Crim, Mark Dransfield, Sally Kilbride, Julie Yates, David E Newby, Dennis Niewoehner, Peter Ma Calverley
BACKGROUND: Inhaled corticosteroids have been shown to decrease exacerbations in COPD patients with moderate to severe COPD. Their effect in patients with milder airflow obstruction remains unclear. OBJECTIVE: This was an analysis of exacerbations in the Study to Understand Mortality and MorbidITy (SUMMIT) study. DESIGN: In a double-blind randomized controlled trial, once daily inhaled placebo, fluticasone furoate (FF, 100 μg), vilanterol (VI, 25 μg) or the combination (FF/VI) was administered...
October 21, 2016: American Journal of Respiratory and Critical Care Medicine
Anne M Murray, Fang-Chi Hsu, Jeff D Williamson, R Nick Bryan, Hertzel C Gerstein, Mark D Sullivan, Michael E Miller, Iris Leng, Laura L Lovato, Lenore J Launer
AIMS/HYPOTHESIS: The Memory in Diabetes (MIND) substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, a double 2x2 factorial parallel-group randomised clinical trial, tested whether intensive compared with standard management of hyperglycaemia, BP or lipid levels reduced cognitive decline and brain atrophy in 2977 people with type 2 diabetes. We describe the results of the observational extension study, ACCORDION MIND ( registration no. NCT00182910), which aimed to measure the long-term effects of the three ACCORD interventions on cognitive and brain structure outcomes approximately 4 years after the trial ended...
October 20, 2016: Diabetologia
Emily E Regier, Manu V Venkat, Kelly L Close
IN BRIEF Concerns raised about the cardiovascular safety of type 2 diabetes medications such as rosiglitazone prompted the U.S. Food and Drug Administration to issue draft guidance in 2008 that, in practice, has required large cardiovascular outcomes trials (CVOTs) for all new type 2 diabetes therapies. After more than 7 years and six completed and published trials to date, this is an opportune time to consider whether these studies, as currently designed and conducted, accurately assess the long-term benefit/risk profile of new therapies and whether they represent an optimal use of limited health care resources...
October 2016: Clinical Diabetes: a Publication of the American Diabetes Association
W Schuyler Jones, Matthew T Roe, Elliott M Antman, Mark J Pletcher, Robert A Harrington, Russell L Rothman, William J Oetgen, Sunil V Rao, Mitchell W Krucoff, Lesley H Curtis, Adrian F Hernandez, Frederick A Masoudi
Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements...
October 25, 2016: Journal of the American College of Cardiology
Jefferson Luis Vieira, Francisco Yuri Macedo, Alexandre Miguel Benjo, Guilherme V Guimarães, Johanna Paola Contreras, Edimar A Bocchi
INTRODUCTION: Ambient air pollution is associated with adverse cardiovascular events. This meta-analysis aimed to investigate the short-term association between air pollution and cardiovascular effects on healthy volunteers. METHODS: We searched databases to identify randomized trials with controlled human exposures to either of two models for studying ambient particulate matter: diesel-exhaust or concentrated ambient particles. Estimates of size effect were performed using standardized mean difference (SMD)...
October 20, 2016: Annals of Medicine
F A K Mazari, J A Khan, N Samuel, G Smith, D Carradice, P C McCollum, I C Chetter
BACKGROUND: The aim was to compare the long-term outcomes of percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA + SEP) in patients with intermittent claudication owing to femoropopliteal disease. METHODS: Patients recruited to an RCT comparing these treatments were invited for long-term follow-up from 2010 to 2011. Indicators of limb ischaemia were recorded (ankle : brachial pressure index (ABPI) and treadmill walking distances)...
October 20, 2016: British Journal of Surgery
Michael B Boffa
PURPOSE OF REVIEW: Elevated plasma concentrations of lipoprotein(a) (Lp(a)) are an independent and causal risk factor for cardiovascular diseases including coronary artery disease, ischemic stroke, and calcific aortic valve stenosis. This review summarizes the rationale for Lp(a) lowering and surveys relevant clinical trial data using a variety of agents capable of lowering Lp(a). RECENT FINDINGS: Contemporary guidelines and recommendations outline populations of patients who should be screened for elevated Lp(a) and who might benefit from Lp(a) lowering...
December 2016: Current Atherosclerosis Reports
Welma Stonehouse, Grant D Brinkworth, Campbell H Thompson, Mahinda Y Abeywardena
BACKGROUND AND AIMS: In vitro, ex vivo and animal studies suggest palm-based tocotrienols and carotenes enhance vascular function, but limited data in humans exists. The aim was to examine the effects of palm-tocotrienols (TRF- 80) and palm-carotene (CC-60) supplementation on vascular function and cardiovascular disease (CVD) risk factors in adults at increased risk of impaired vascular function. METHODS: Ninety men and women (18-70 yr, 20-45 kg/m(2)) with type 2 diabetes, impaired fasting glucose and/or elevated waist circumference were randomised to consume either TRF-80 (420 mg/day tocotrienol + 132 mg/day tocopherol), CC-60 (21 mg/day carotenes) or placebo (palm olein) supplements for 8 weeks...
October 14, 2016: Atherosclerosis
IJsbrand T Klip, Adriaan A Voors, Dorine W Swinkels, Stephan J L Bakker, Jenny E Kootstra-Ros, Carolyn S Lam, Pim van der Harst, Dirk J van Veldhuisen, Peter van der Meer
AIMS: Heart failure (HF) is a common manifestation of patients with primary and secondary causes of iron overload, whereas in patients with established HF iron deficiency impairs outcome. Whether iron stores, either depleted or in overload, amplify the risk for new-onset HF among healthy individuals is unknown. The present study aimed to assess whether markers of iron status or the iron-regulatory hormone hepcidin are associated with new-onset HF or cardiovascular (CV) events in the general population...
October 19, 2016: European Journal of Heart Failure
T Thomsen, M Aadahl, N Beyer, M L Hetland, K Løppenthin, J Midtgaard, R Christensen, B A Esbensen
BACKGROUND: Patients with rheumatoid arthritis (RA) spend a high proportion of their waking time in sedentary behaviour (SB) and have an increased risk of cardiovascular disease. Reduction of SB and increase in light intensity physical activity has been suggested as a means of improvement of health in patients with mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in sedentary populations. To evaluate descriptively the feasibility of recruitment, randomisation, outcome assessments, retention and the acceptability of an individually tailored, theory-based behavioural intervention targeting reduction in daily sitting time in patients with RA...
October 18, 2016: BMC Musculoskeletal Disorders
Valentina Carubelli, Gad Cotter, Beth Davison, Jemal Gishe, Stefanie Senger, Ivano Bonadei, Elio Gorga, Valentina Lazzarini, Carlo Lombardi, Marco Metra
BACKGROUND: In-hospital worsening heart failure (WHF) is predictive of worse post-discharge outcomes and has been recently used as an endpoint in clinical trials in acute heart failure (AHF). METHODS: We described the clinical and prognostic significance of WHF in consecutive patients hospitalized for AHF at our institute. WHF was defined as worsening signs and symptoms of HF requiring treatment intensification. We compared WHF events by day 7 (early WHF) with WHF occurring at any time during admission...
October 5, 2016: International Journal of Cardiology
Reecha Sofat, Jackie A Cooper, Meena Kumari, Juan P Casas, Jacqueline P Mitchell, Jayshree Acharya, Simon Thom, Alun D Hughes, Steve E Humphries, Aroon D Hingorani
BACKGROUND: The association of APOE genotype with circulating apolipoprotein E (ApoE) concentration and cardiovascular disease (CVD) risk is well established. However, the relationship of circulating ApoE concentration and CVD has received little attention. METHODS AND FINDINGS: To address this, we measured circulating ApoE concentration in 9,587 individuals (with 1,413 CVD events) from three studies with incident CVD events: two population-based studies, the English Longitudinal Study of Ageing (ELSA) and the men-only Northwick Park Heart Study II (NPHSII), and a nested sub-study of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT)...
October 2016: PLoS Medicine
Michel Farnier
PURPOSE OF REVIEW: After the approval of alirocumab and evolocumab, the first two monoclonal antibodies (mAbs) targeting proprotein convertase subtilisin kexin type 9 (PCSK9), this review provides an update on recent PCSK9 inhibitors data and describes recommendations for the use before the results of the ongoing cardiovascular endpoint trials. RECENT FINDINGS: New studies and complementary analysis of phase III trials have consistently shown that alirocumab and evolocumab are highly effective in reducing LDL-cholesterol and to some extent lipoprotein (a)...
October 17, 2016: Current Opinion in Lipidology
Neil Poulter, Aisha Anjum, Mary Cross, Emanuela Falaschetti, Christos Savopoulos, Ilias Kanellos, Matyas Szigeti, Simon Thom, Apostolos Hatzitolios
OBJECTIVE: Some data suggest that nocturnal rather than daytime dosing of antihypertensive agents may have beneficial effects on consequent cardiovascular outcomes. This trial was designed to evaluate whether ABPM levels differ by timing of drug dosing, as a possible explanation for these observations. DESIGN AND METHOD: 103 male or female patients aged 18-80 years with "controlled" hypertension (≤150/≤90 mmHg) for at least three months on stable therapy of ≥1 antihypertensive agent were recruited from two centres; London and Thessaloniki...
September 2016: Journal of Hypertension
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