Search results for "surrogate"
showing 10 items of 145 documents
Imaging appearance of treated hepatocellular carcinoma
2013
Surgical resection and imaging guided treatments play a crucial role in the management of hepatocellular carcinoma (HCC). Although the primary end point of treatment of HCC is survival, radiological response could be a surrogate end point of survival, and has a key role in HCC decision-making process. However, radiological assessment of HCC treatment efficacy is often controversial. There are few doubts on the evaluation of surgical resection; in fact, all known tumor sites should be removed. However, an unenhancing partial linear peripheral halo, in most cases, surrounding a fluid collection reducing in size during follow-up is demonstrated in successfully resected tumor with bipolar radio…
Renal protection by antihypertensive drugs
1998
During the last few years there has been a renewed interest in blood-pressure (BP)-induced kidney damage, owing to a progressive increase in the incidence and prevalence of hypertension and vascular diseases as a cause of end-stage renal disease (ESRD). The need to prevent ESRD demands continued efforts so as to identify early those people with hypertension who are at risk and to provide them with effective antihypertensive therapy. This review analyses what is needed in terms of surrogate endpoints for monitoring kidney damage and what is known about the impact of antihypertensive treatments in reducing the BP burden on the kidney in non-diabetic subjects. Although glomerular filtration ra…
A Large-Scale Trial Testing the Intensità of CYTOreductive Therapy to prevent Cardiovascular Events in Patients with Polycythemia Vera (CYTO-PV trial…
2012
Abstract Abstract 4 Introduction Current treatment recommendations in polycythemia vera (PV) have emphasized to maintain the hematocrit (HCT) values <0.45 based on hemorrheological notions, results of a few small observational retrospective studies and consensus of experts. However, post-hoc analysis of two large randomized clinical trials (namely PVSG-1 and ECLAP) failed to show a different incidence of major thrombosis when HCT levels were kept in the range between 0.40 and 0.50. So far, no randomized clinical trial has provided evidence-based data assessing the usefulness of tight HCT control in reducing thrombosis. Thus, uncertainty of the optimal HCT target exists in clinical practi…
Procalcitonin for the diagnosis of invasive candidiasis: what is the evidence?
2017
Abstracts Procalcitonin is a widely used marker for the evaluation of infection and sepsis and to guide antibiotic therapy. During the last decade, several studies evaluated its role and diagnostic performance as a surrogate marker for the identification of Candida spp. in suspected invasive candidiasis. A low serum level and a favorable negative predictive value are the main findings for procalcitonin in this setting. The aim of this report is to provide an updated brief summary of the evidence supporting the use of PCT for the management of invasive candidiasis.
Measurement of exhaled nitric oxide: comparison of 3 different analyzers
2018
Exhaled nitric oxide (FeNO) is used as a surrogate marker to monitor airway inflammation. Aim of this study was to compare the new FeNO analyzer Vivatmo pro from Bosch (BV) with the Niox Vero from Circassia (CN) and the CLD from Ecomedics (EC). In 106 asthma patients (median age 54 years (range 20-87), 60 % female, median ACT of 16, 85 % on inhaled corticosteroids (mean 1300 μg BDP), 36 % on therapy with biologics) 2 FeNO measurements per patient and per device were performed using each analyzer in a random sequence according to the ATS / ERS guidelines. Additionally, the success rate to achieve a valid NO value was evaluated. 70 % of the patients had FeNO values In conclusion, for the rang…
Luspatercept Increases Hemoglobin and Reduces Transfusion Burden in Patients with Low-Intermediate Risk Myelodysplastic Syndromes (MDS): Long-Term Re…
2016
Abstract Background: Management of anemia is a common therapeutic challenge in patients with MDS. Luspatercept (ACE-536), a fusion protein containing modified activin receptor type IIB, is being developed for treatment of anemia in lower-risk MDS. Luspatercept binds GDF11 and other TGF-β superfamily ligands to promote late-stage erythroid differentiation and increase hemoglobin (Hgb) levels (Suragani R, Nat Med, 2014 and Attie K, Am J Hematol, 2014). Aims: This is an ongoing, phase 2, multicenter, open-label, long-term extension study to evaluate the effects of luspatercept in patients (pts) with low-intermediate risk MDS. Endpoints include long-term safety and tolerability, erythroid respo…
Pioneer: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Avapritinib in Patients with Indolent or Smoldering Systemic Mastocytosis w…
2019
Background: The gain-of function mutation KIT D816V plays a central role in the pathogenesis of systemic mastocytosis (SM). Among subtypes of SM, indolent SM (ISM) is the most frequent and is associated with normal/near-normal life expectancy; smoldering SM (SSM) is a subtype with a relatively higher burden of mast cells and may be associated with an increased risk of progression to advanced mastocytosis. However, both ISM and SSM patients may experience severe symptoms associated with mast cell mediator release, such as pruritus, diarrhea, anaphylaxis, and bone pain, which can be severely debilitating and have a profoundly negative impact on quality of life. Symptomatic treatments (eg, ant…
Recognition and characterization of small colonic neoplasia with high-definition colonoscopy using i-Scan is as precise as chromoendoscopy
2010
Abstract Background The EPKi system (Pentax, Japan) enables resolution above HDTV. Aim of the study was to test the efficacy of HD+ alone and with the new post-processing digital filter i-Scan or chromoendoscopy (Methylene blue 0.1%) in screening for colorectal cancer. We focused on lesions less than 5 mm as a surrogate marker for the optical possibilities of the EPKi system. Methods The last 30 cm of the colon in a screening population were inspected with HD+ alone, in combination with i-Scan (2:1 randomisation) and subsequently with chromoendoscopy. All lesions were characterized and targeted biopsies were performed. Results i-Scan augmented in 69 patients the identification of lesions fr…
Subclinical atherosclerosis: independent predictor of cardiovascular events in a 20-years follow up of patients with or without metabolic syndrome
2013
Purpose: To evaluate the influence of carotid atherosclerosis and metabolic syndrome (MetS) on the prediction of cardiovascular events during a 20-years follow-up. Methods: We studied a population of 529 asymptomatic patients, divided into 2 groups according to the results of the carotid ultrasound evaluation: one without atherosclerotic lesions (198 patients) and a second one with an increased carotid IMT or asymptomatic carotid plaque (331 patients). In each of these groups, we identified two subgroups of subjects with and without MetS. Cardiovascular endpoints were investigated in a 20-years follow-up: acute myocardial infarction, angina, transient ischemic attack, ischemic stroke, abdom…
Effects of empagliflozin on CA125 trajectory in patients with chronic congestive heart failure
2021
INTRODUCTION: We aimed to evaluate the trajectory of two surrogates of fluid overload -antigen carbohydrate 125 (CA125) and amino-terminal pro-brain natriuretic peptide (NT-proBNP)- after the addition of oral empagliflozin to usual care in a cohort of patients with chronic heart failure (CHF) and type 2 diabetes (T2D). METHODS AND RESULTS: From October 2015 to February 2019, 60 ambulatory patients with CHF and T2D were retrospectively included. The primary endpoint was to assess the longitudinal trajectory of plasma levels of CA125 and NT-proBNP after empagliflozin initiation. Changes in quantitative variables were evaluated using linear mixed regression. Median CA125 and NT-proBNP at basel…