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https://www.readbyqxmd.com/read/28224402/assessment-of-correlation-between-early-and-late-efficacy-endpoints-to-identify-potential-surrogacy-relationships-in-non-hodgkin-lymphoma-a-literature-based-meta-analysis-of-108-phase-ii-and-phase-iii-studies
#1
Rui Zhu, Dan Lu, Yu-Waye Chu, Akiko Chai, Michelle Green, Nancy Zhang, Jin Yan Jin
Correlations between early and late efficacy endpoints were assessed to identify potential surrogate endpoints for overall survival (OS) or progression-free survival (PFS) with clinical trial-level data in three non-Hodgkin lymphoma (NHL) subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). One hundred and eight phase II-III trials (129 trial arms) in DLBCL, FL, and MCL were identified and included in the database. Correlations between efficacy endpoints were analyzed using weighted linear regression and Pearson's coefficient of determination (R (2))...
February 21, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28217229/evaluation-of-the-characteristics-of-rotational-activation-at-high-dominant-frequency-and-complex-fractionated-atrial-electrogram-sites-during-atrial-fibrillation
#2
Koji Kumagai, Kentaro Minami, Daisuke Kutsuzawa, Shigeru Oshima
BACKGROUND: High-dominant frequency (DF) and continuous complex fractionated atrial electrogram (CFAE) sites as surrogates for localized sources maintaining atrial fibrillation (AF) are potential AF ablation targets. This study aimed to evaluate the characteristics of a rotational activation at high-DF and continuous CFAE sites in AF patients. METHODS: Thirty-two consecutive AF patients (5 paroxysmal and 27 non-paroxysmal) underwent ablation using the NavX system...
February 2017: Journal of Arrhythmia
https://www.readbyqxmd.com/read/28213367/antibiotic-prophylaxis-for-infective-endocarditis-a-systematic-review-and-meta-analysis
#3
Thomas J Cahill, James L Harrison, Paul Jewell, Igho Onakpoya, John B Chambers, Mark Dayer, Peter Lockhart, Nia Roberts, David Shanson, Martin Thornhill, Carl J Heneghan, Bernard D Prendergast
OBJECTIVE: The use of antibiotic prophylaxis (AP) for prevention of infective endocarditis (IE) is controversial. In recent years, guidelines to cardiologists and dentists have advised restriction of AP to high-risk groups (in Europe and the USA) or against its use at all (in the UK). The objective of this systematic review was to appraise the evidence for use of AP for prevention of bacteraemia or IE in patients undergoing dental procedures. METHODS: We conducted electronic searches in Medline, Embase, Cochrane Library and ISI Web of Science...
February 17, 2017: Heart: Official Journal of the British Cardiac Society
https://www.readbyqxmd.com/read/28205339/doing-it-hard-in-the-bush-aligning-what-gets-measured-with-what-matters
#4
Malcolm I McDonald, Kenny D Lawson
What gets measured gets managed. Funding of health services is substantially determined by operational activity and specific outcome indicators. In day-to-day clinical decision-making, surrogate markers, such as glycosylated haemoglobin and blood pressure, are commonly used to modify risks of 'hard' outcomes that include kidney failure, ischaemic cardiac events, stroke and all-cause mortality. In many settings, surrogates are all we have to go on. As a consequence, current health funding models heavily rely on surrogate-based key performance indicators [KPIs]...
February 16, 2017: Australian Journal of Rural Health
https://www.readbyqxmd.com/read/28203068/ectopic-fat-accumulation-in-patients-with-copd-an-eclipse-substudy
#5
Mickaël Martin, Natalie Almeras, Jean-Pierre Després, Harvey O Coxson, George R Washko, Isabelle Vivodtzev, Emiel Fm Wouters, Erica Rutten, Michelle C Williams, John T Murchison, William MacNee, Don D Sin, François Maltais
BACKGROUND: Obesity is increasingly associated with COPD, but little is known about the prevalence of ectopic fat accumulation in COPD and whether this can possibly be associated with poor clinical outcomes and comorbidities. The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) substudy tested the hypothesis that COPD is associated with increased ectopic fat accumulation and that this would be associated with COPD-related outcomes and comorbidities...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28202439/variable-reliability-of-surrogate-measures-of-insulin-sensitivity-after-roux-en-y-gastric-bypass
#6
Kirstine N Bojsen-Moller, Carsten Dirksen, Maria S Svane, Nils B Jørgensen, Jens J Holst, Erik A Richter, Sten Madsbad
Roux-en-Y gastric bypass (RYGB) induces weight loss and improves insulin sensitivity when evaluated by the hyperinsulinemic-euglycemic clamp (HEC). Surrogate indices of insulin sensitivity calculated from insulin and glucose concentrations at fasting or after an oral glucose tolerance test (OGTT) are frequently used, but have not been validated after RYGB. Our aim was to evaluate whether surrogate indices reliably estimate changes in insulin sensitivity after RYGB. Four fasting (inverse-HOMA-IR, HOMA2-%S, QUICKI, revised-QUICKI) and three OGTT-derived surrogates (Matsuda, Gutt, OGIS) were compared with HEC-estimated peripheral insulin sensitivity (Rd or Rd/I, depending on how the index was originally validated) and the tracer-determined hepatic insulin sensitivity index (HISI) in patients with preoperative type 2 diabetes (n=10) and normal glucose tolerance (n=10) 1 week, 3 months and 1 year postoperatively...
February 15, 2017: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
https://www.readbyqxmd.com/read/28197738/vaccines-for-staphylococcus-aureus-and-target-populations
#7
Clarissa Pozzi, Reuben Olaniyi, Lassi Liljeroos, Ilaria Galgani, Rino Rappuoli, Fabio Bagnoli
Staphylococcus aureus is a leading pathogen in surgical site, intensive care unit, and skin infections, as well as healthcare-associated pneumonias. These infections are associated with an enormous burden of morbidity, mortality, and increase of hospital length of stay and patient cost. S. aureus is impressively fast in acquiring antibiotic resistance, and multidrug-resistant strains are a serious threat to human health. Due to resistance or insufficient effectiveness, antibiotics and bundle measures leave a tremendous unmet medical need worldwide...
February 15, 2017: Current Topics in Microbiology and Immunology
https://www.readbyqxmd.com/read/28191271/the-unchartered-frontier-preventive-cardiology-between-the-ages-of-15-and-35-years
#8
Holly Gooding, Heather M Johnson
It is well established that atherosclerosis, the pathological basis of cardiovascular disease (CVD), begins in childhood and progresses steadily between the ages of 15 to 35 years. These adolescent and young adult years are also marked by significant physiological, psychological, and sociodemographic changes that impact both CVD risk factor development and CVD prevention and treatment strategies. In this review, we highlight the importance of the primordial prevention of CVD risk factors before they ever occur and the primary prevention of CVD by treating CVD risk factors in this age group...
September 2016: Current Cardiovascular Risk Reports
https://www.readbyqxmd.com/read/28188257/validation-of-progression-free-survival-as-a-surrogate-endpoint-for-overall-survival-in-malignant-mesothelioma-analysis-of-cancer-and-leukemia-group-b-and-north-central-cancer-treatment-group-alliance-trials
#9
Xiaofei Wang, Xiaoyi Wang, Lydia Hodgson, Stephen L George, Daniel J Sargent, Nate R Foster, Apar Kishor Ganti, Thomas E Stinchcombe, Jeffrey Crawford, Robert Kratzke, Alex A Adjei, Hedy L Kindler, Everett E Vokes, Herbert Pang
PURPOSE: The aim of this study was to investigate whether progression-free survival (PFS) can be considered a surrogate endpoint for overall survival (OS) in malignant mesothelioma. MATERIALS AND METHODS: Individual data were collected from 15 Cancer and Leukemia Group B (615 patients) and 2 North Central Cancer Treatment Group (101 patients) phase II trials. The effects of 5 risk factors for OS and PFS, including age, histology, performance status (PS), white blood cell count, and European Organisation for Research and Treatment of Cancer (EORTC) risk score, were used in the analysis...
February 10, 2017: Oncologist
https://www.readbyqxmd.com/read/28176907/a-randomized-trial-of-once-daily-fluticasone-furoate-vilanterol-or-vilanterol-versus-placebo-to-determine-effects-on-arterial-stiffness-in-copd
#10
Surya P Bhatt, Mark T Dransfield, John R Cockcroft, Jie Wang-Jairaj, Dawn A Midwinter, David B Rubin, Catherine A Scott-Wilson, Courtney Crim
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is associated with increased cardiovascular morbidity and mortality. Elevated arterial stiffness, measured by aortic pulse wave velocity (aPWV), is a cardiovascular risk surrogate and is potentially modifiable by inhaled corticosteroid/long-acting beta2-agonist combinations in patients with COPD. MATERIALS AND METHODS: The effects of once-daily inhaled fluticasone furoate/vilanterol (FF/VI) 100/25 µg, VI 25 µg, versus placebo on arterial stiffness in patients with COPD and baseline aPWV ≥11...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28168513/drop-out-from-cardiovascular-magnetic-resonance-in-a-randomized-controlled-trial-of-st-elevation-myocardial-infarction-does-not-cause-selection-bias-on-endpoints
#11
Peter Nørkjær Laursen, L Holmvang, H Kelbæk, N Vejlstrup, T Engstrøm, J Lønborg
BACKGROUND: The extent of selection bias due to drop-out in clinical trials of ST-elevation myocardial infarction (STEMI) using cardiovascular magnetic resonance (CMR) as surrogate endpoints is unknown. We sought to interrogate the characteristics and prognosis of patients who dropped out before acute CMR assessment compared to CMR-participants in a previously published double-blinded, placebo-controlled all-comer trial with CMR outcome as the primary endpoint. METHODS: Baseline characteristics and composite endpoint of all-cause mortality, heart failure and re-infarction after 30 days and 5 years of follow-up were assessed and compared between CMR-drop-outs and CMR-participants using the trial screening log and the Eastern Danish Heart Registry...
February 6, 2017: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
https://www.readbyqxmd.com/read/28146212/impact-of-high-risk-for-obstructive-sleep-apnea-on-survival-after-acute-coronary-syndrome-insights-from-the-erico-registry
#12
Flavia C Maia, Alessandra C Goulart, Luciano F Drager, Henrique L Staniak, Itamar de Souza Santos, Paulo Andrade Lotufo, Isabela M Bensenor
BACKGROUND: Obstructive sleep apnea (OSA) is a very often clinical condition that can be associated with high mortality risk, particularly in coronary heart disease (CHD). The diagnosis of OSA is not always accessible via the gold-standard method polysomnography. OBJECTIVE: To evaluate long-term influence of the high risk for OSA on fatal and non-fatal outcomes after acute coronary syndrome (ACS) in the Acute Coronary Syndrome Registry Strategy (ERICO) Study using the Berlin questionnaire as a surrogate...
January 2017: Arquivos Brasileiros de Cardiologia
https://www.readbyqxmd.com/read/28143688/sleep-apnea-state-of-the-art
#13
REVIEW
Martin R Cowie
Many patient with, or at risk of, cardiovascular disease have sleep disordered breathing (SDB), which can be either obstructive (with intermittent collapse of the upper airway) or central (episodic loss of respiratory drive). SDB is associated with sleep disturbance, hypoxemia, hemodynamic changes, and sympathetic activation. Such patients have a worse prognosis than those without SDB. Mask-based therapies of positive airway pressure targeted at SDB can improve measures of sleep quality and partially normalize the sleep and respiratory physiology, but recent randomized trials of cardiovascular outcomes in SDB have either been neutral (obstructive sleep apnea) or suggested the possibility of harm, likely from increased sudden death, in central sleep apnea...
December 20, 2016: Trends in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28123303/vtd-melphalan-is-well-tolerated-and-results-in-very-high-rates-of-stringent-cr-and-mrd-negative-status-in-multiple-myeloma
#14
Kalyan Nadiminti, Kamal Kant Singh Abbi, Sarah L Mott, Lindsay Dozeman, Annick Tricot, Allyson Schultz, Sonya Behrends, Fenghuang Zhan, Guido Tricot
The addition of cytotoxic drugs to high-dose melphalan as a preparative regimen for autologous stem cell transplantation in multiple myeloma has not resulted in superior activity. Although novel agents have significantly improved outcome in multiple myeloma, their role in preparative regimens remains largely unknown. We have evaluated the toxicity and efficacy of combining bortezomib, thalidomide, and dexamethasone with high-dose melphalan. An institutional review board-approved retrospective analysis was performed on 100 consecutive patients receiving 153 transplants; 53 had tandem transplants; 64 patients received early transplants; and 36 had salvage transplantation...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28121543/to-first-do-no-harm-you-must-start-with-good-evidence
#15
(no author information available yet)
The intrepid young oncologist's criticism of cancer screening and surrogate endpoints has stirred up controversy. Prasad thinks that providers should offer medical therapies that do more good than harm. "I mean things that matter to people, which is living longer, living better."
October 2016: Managed Care
https://www.readbyqxmd.com/read/28120314/evaluating-periodontal-treatment-to-prevent-cardiovascular-disease-challenges-and-possible-solutions
#16
REVIEW
Anwar T Merchant, Salim S Virani
PURPOSE OF REVIEW: Periodontal disease is correlated with cardiovascular disease (CVD) in observational studies, but a causal connection has not been established. The empirical evidence linking periodontal disease and CVD consists of a large body of observational and mechanistic studies, but a limited number of clinical trials evaluating the effects of periodontal treatment on surrogate CVD endpoints. RECENT FINDINGS: No randomized controlled trial has been conducted to evaluate the effect of periodontal treatment on CVD risk...
January 2017: Current Atherosclerosis Reports
https://www.readbyqxmd.com/read/28116974/clinical-evidence-supporting-us-food-and-drug-administration-approval-of-otolaryngologic-prescription-drug-indications-2005-2014
#17
Vinay K Rathi, Bo Wang, Joseph S Ross, Nicholas S Downing, Aaron S Kesselheim, Stacey T Gray
Objective The US Food and Drug Administration (FDA) approves indications for prescription drugs based on premarket pivotal clinical studies designed to demonstrate safety and efficacy. We characterized the pivotal studies supporting FDA approval of otolaryngologic prescription drug indications. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects Recently approved (2005-2014) prescription drug indications for conditions treated by otolaryngologists or their multidisciplinary teams...
January 1, 2017: Otolaryngology—Head and Neck Surgery
https://www.readbyqxmd.com/read/28116919/morning-blood-pressure-surge-and-arterial-stiffness-in-newly-diagnosed-hypertensive-patients
#18
Ali Kıvrak, Süleyman Özbiçer, Gülhan Yüksel Kalkan, Mustafa Gür
OBJECTIVE: We aimed to investigate the relationship between the morning blood pressure (BP) surge and arterial stiffness in patients with newly diagnosed hypertension. SUBJECTS AND METHODS: Three hundred and twenty four (mean age 51.7 ± 11.4 years) patients who had newly diagnosed hypertension with 24 h ambulatory BP monitoring were enrolled. Parameters of arterial stiffness, pulse wave velocity and augmentation index (Aix) were measured by applanation tonometry and aortic distensibility was calculated by echocardiography...
January 24, 2017: Blood Pressure
https://www.readbyqxmd.com/read/28114139/uric-acid-vascular-stiffness-and-chronic-kidney-disease-is-there-a-link
#19
Juan C Ramirez-Sandoval, L Gabriela Sanchez-Lozada, Magdalena Madero
Controversy exists with regard to the causal role of hyperuricemia in chronic kidney disease. Vascular stiffness may be the link that explains the relation between hyperuricemia and kidney disease. Hyperuricemia is associated with a number of effects on the vascular endothelium and vascular smooth muscle cells, including an increase in oxidative stress, production of vasoconstrictors, and changes on the structural properties of the large artery wall. Observational evidence in large epidemiological cross-sectional studies suggests that there is an independent association between uric acid and arterial stiffness...
January 24, 2017: Blood Purification
https://www.readbyqxmd.com/read/28108738/spect-and-pet-radiopharmaceuticals-for-molecular-imaging-of-apoptosis-from-bench-to-clinic
#20
Xiaobo Wang, Han Feng, Shichao Zhao, Junling Xu, Xinyu Wu, Jing Cui, Ying Zhang, Yuhua Qin, Zhiguo Liu, Tang Gao, Yongju Gao, Wenbin Zeng
Owing to the central role of apoptosis in many human diseases and the wide-spread application of apoptosis-based therapeutics, molecular imaging of apoptosis in clinical practice is of great interest for clinicians, and holds great promises. Based on the well-defined biochemical changes for apoptosis, a rich assortment of probes and approaches have been developed for molecular imaging of apoptosis with various imaging modalities. Among these imaging techniques, nuclear imaging (including single photon emission computed tomography and positron emission tomography) remains the premier clinical method owing to their high specificity and sensitivity...
January 18, 2017: Oncotarget
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