Search results for "endpoint"

A comparison of semiparametric approaches to evaluate composite endpoints in heart failure trials

2021

In heart failure trials efficacy is usually proven by a composite endpoint including cardiovascular death (CVD) and recurrent heart failure hospitalisations (HFH), evaluated with time-to-first-event analysis based on a Cox model. As a considerable fraction of events is ignored that way, recurrent event[for full text, please go to the a.m. URL]

Obinutuzumab (GA101) in Combination with Pixantrone for the Treatment of Patients with Relapsed Aggressive B-Cell Lymphoma:Â a Phase II Trial (GOAL)

2018

Abstract Background: A substantial proportion of patients fail first line treatment of diffuse large B-cell lymphoma. Currently available salvage therapies are often ineffective and cannot be tolerated, especially for elderly patients. Thus, probably less than 25% of patients achieve a long lasting remission. Regimens like gemcitabine/oxaliplatin, or bendamustin, both in combination with rituximab are available for elderly or after failure of HDT, however induce only short lived responses. Obinutuzumab (GA101) is a type II anti-CD20 antibody, with preclinical evidence of superiority over rituximab in xenograft models of MCL and DLBCL. Recently a large phase III trial failed to show a benefi…

Coronary chronic total occlusions and mortality in patients with ventricular tachyarrhythmias.

2020

Aims This study sought to assess the prognostic impact of coronary chronic total occlusions (CTO) in patients presenting with ventricular tachyarrhythmias on admission. Methods and results A large retrospective registry was used, including all consecutive patients presenting with ventricular tachyarrhythmias on admission and undergoing coronary angiography from 2002 to 2016. Patients with a CTO were compared with all other patients (non-CTO) for prognostic outcomes. Statistics comprised Kaplan-Meier and Cox regression analyses. Within a total of 1,461 consecutive patients included with ventricular tachyarrhythmias on admission, a CTO was present in 20%. At midterm follow-up of 18 months, th…

Clinical outcomes of patients with diabetes mellitus treated with Absorb bioresorbable vascular scaffolds: a subanalysis of the European Multicentre …

2017

Background Data on the clinical performance of bioresorbable scaffolds in patients with diabetes mellitus (DM) are still limited. The present study reported 1-year clinical outcomes associated with the use of everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS; Abbott Vascular, Santa Clara, CA) in DM patients. Methods and Results This was a subanalysis from the GHOST-EU (Gauging coronary Healing with biOresorbable Scaffolding plaTforms in Europe) multicenter retrospective registry including patients treated with Absorb BVS between November 2011 and September 2014. In this study, a comparative analysis stratified according to DM was performed. The primary endpoint was target lesi…

Efficacy of coronary revascularization in patients with acute chest pain managed in a chest pain unit.

2009

To investigate the safety of discharge of patients deemed at low risk of cardiac events after evaluation in a chest pain unit and to determine the prognostic effect of revascularization of patients deemed at high risk.The study population consisted of 1088 patients presenting at the emergency department from January 15, 2001, to September 1, 2006, with chest pain but without ischemia on electrocardiography or troponin elevation. Patients were managed by a chest pain unit protocol that included early exercise testing. Three groups of patients were distinguished: (1) those discharged after exercise testing (424 [39%]); (2) those in whom unstable angina was ruled out after in-hospital evaluati…

Effect of aspirin on renal disease progression in patients with type 2 diabetes: A multicenter, double-blind, placebo-controlled, randomized trial. T…

2017

Background Type 2 diabetes mellitus (T2DM) is one of the most common causes of chronic kidney disease and kidney failure. It has been estimated that the annual decline of estimated glomerular filtration rate (eGFR) among patients with T2DM is approximately 2.0-2.5 mL min−1 y−1. Cyclooxygenase-dependent eicosanoids, such as 11-dehydro-thromboxane (Tx)B2, are increased in T2DM patients and are potentially involved in the regulation of renal blood flow. Animal models showed that cyclooxygenase inhibitors, such as aspirin, are associated with improvements in renal plasma flow and eGFR values. Hypothesis The primary end point of the LEDA trial is to evaluate the 1-year decline of eGFR in T2DM pa…

Plasma Torquetenovirus (TTV) DNA load as a surrogate marker of reconstitution of CMV-specific immunity in the allogeneic stem cell transplantation se…

2016

P0200KEEP ON (KEEPING RAAS INHIBITION TREATMENT WITH OPTIMAL POTASSIUM CONTROL). DESIGN OF A CLINICAL TRIAL OF USING SODIUM ZIRCONIUM CYCLOSILICATE F…

2020

Abstract Background and Aims Hyperkalemia (HK) is a potentially life-threatening condition, in patients with chronic kidney disease (CKD) and congestive heart failure (CHF). The majority of patients affected with CKD or CHF, must be treated with inhibitors of renin angiotensin aldosterone system (RAASi) and mineralocorticoid receptor antagonists (MRAs). However, the treatments previously mentioned, increase the risk of HK episodes, which is the main cause of RAASi and MRAs downtitration or discontinuation, representing an undesirable clinical scenario, given that the patients are at high risk of be deprived of their nephroprotective effect and cardio-renal benefits The aim of the study is: …

Results of the TOP Study: Prospectively Randomized Multicenter Trial of an Ex Vivo Tacrolimus Rinse Before Transplantation in EDC Livers

2016

Background. Organ shortage results in the transplantation of extended donor criteria (EDC) livers which is associated with increased ischemia-reperfusion injury (IRI). Experimental studies indicate that an organ rinse with the calcineurin inhibitor tacrolimus before implantation protects against IRI. The tacrolimus organ perfusion study was initiated to examine the effects of ex vivo tacrolimus perfusion on IRI in transplantation of EDC livers. Methods. A prospective randomized multicenter trial comparing ex vivo perfusion of marginal liver grafts (>= 2 EDC according to Eurotransplant manual) with tacrolimus (20 ng/mL) or histidine-tryptophane-ketoglutarate solution (control) was carried ou…

New Lipid Modulating Drugs: The Role of Microsomal Transport Protein Inhibitors

2011

Microsomal triglyceride transfer protein (MTP) is involved in the synthesis of very low density lipoprotein in the liver. Its deficiency results in abetalipoproteinemia. MTP inhibitors target the assembly and secretion of apolipoprotein B-containing lipoproteins. These agents may potentially play a role, alone or in combination, in the treatment of hypercholesterolemia or hypertriglyceridemia. Clinical applications of MTP inhibitors initially focused primarily on high-dose monotherapy in order to produce substantial reductions in LDL-cholesterol levels but these proved to induce significant hepatic steatosis and transaminase elevations. However, likely orphan indications for MTP inhibitors,…