Search results for "Place"

Effects of canagliflozin on serum potassium in people with diabetes and chronic kidney disease: the CREDENCE trial

2021

Abstract Aims  Hyperkalaemia is a common complication of type 2 diabetes mellitus (T2DM) and limits the optimal use of agents that block the renin–angiotensin–aldosterone system, particularly in patients with chronic kidney disease (CKD). In patients with CKD, sodium‒glucose cotransporter 2 (SGLT2) inhibitors provide cardiorenal protection, but whether they affect the risk of hyperkalaemia remains uncertain. Methods and results  The CREDENCE trial randomized 4401 participants with T2DM and CKD to the SGLT2 inhibitor canagliflozin or matching placebo. In this post hoc analysis using an intention-to-treat approach, we assessed the effect of canagliflozin on a composite outcome of time to eith…

Simulation of left ventricular outflow tract (LVOT) obstruction in transcatheter mitral valve-in-ring replacement.

2020

Left ventricular outflow tract (LVOT) obstruction is a feared complication of transcatheter mitral valve replacement (TMVR). This procedure leads to an elongation of LVOT in the left ventricle (namely, the neoLVOT), ultimately portending hemodynamic impairment and death. This study sought to understand the biomechanical implications of LVOT obstruction in two patients who underwent TMVR as an "off-label" application of the Edwards SAPIEN 3 (S3) Ultra transcatheter heart valve (THV). A computational framework of TMVR was developed to assess the neoLVOT area and quantify the sub-aortic flow structure. We observed that the annuloplasty ring serves as the key anchor zone of S3 Ultra THV. A good…

Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without typ…

2020

Abstract Aims The EMPERIAL (Effect of EMPagliflozin on ExeRcise ability and HF symptoms In patients with chronic heArt faiLure) trials evaluated the effects of empagliflozin on exercise ability and patient-reported outcomes in heart failure (HF) with reduced and preserved ejection fraction (EF), with and without type 2 diabetes (T2D), reporting, for the first time, the effects of sodium-glucose co-transporter-2 inhibition in HF with preserved EF (HFpEF). Methods and results HF patients with reduced EF (HFrEF) (≤40%, N = 312, EMPERIAL-Reduced) or preserved EF (>40%, N = 315, EMPERIAL-Preserved), with and without T2D, were randomized to empagliflozin 10 mg or placebo for 12 weeks. The …

Genistein in the Metabolic Syndrome: Results of a Randomized Clinical Trial

2013

Context: This study was performed to evaluate the effects of genistein on metabolic and cardiovascular risk factors in Caucasian postmenopausal subjects with metabolic syndrome (MetS). Objective: Our objective was to assess the effects of genistein on surrogate endpoints associated with diabetes and cardiovascular disease. Design and Setting: This was a randomized, double-blind, placebo-controlled trial at 3 university medical centers in Italy. Patients: Patients included 120 postmenopausal women with MetS according to modified Third Report of the National Cholesterol Education Program (NCEP), Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Tre…

Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency

2003

Summary objective Little is known of the usefulness of GH secretagogues (GHSs) in GH-deficient (GHD) adults. The objective of this study was to determine the number of responders to treatment with NN703 in GHD adults. design A multicentre, randomized, double-blind, and placebo-controlled study. patients Ninety-seven GHD adults were included. measurements The GH response before and after 1 week of oral treatment with NN703 (n = 83) or placebo (n = 14) was determined. The first and last dose of NN703 was 3 mg/kg, whereas the dose of NN703 was 1·5 mg/kg/day during the 6 days between the first and last doses. Furthermore, all 97 patients received 1 µg/kg GH-releasing hormone (GHRH) 3 weeks afte…

Granulocyte–Macrophage Colony-Stimulating Factor in the Therapy of Adults with De Novo Acute Myeloblastic Leukemia: An Update of a Double-Blind Rando…

1997

We investigated whether granulocytemacrophage colony-stimulating factor (GMCSF) given concomitantly with chemotherapy (CT) improves the outcome of adults with de novo acute myeloblastic leukemia (AML) by increasing the efficacy of CT and reducing infections. CT included cytarabine (ara-C) daunorubicin, and etoposide (DAV) for induction and early consolidation therapy and one cycle with high-dose (patients aged ≤50 years) or intermediate-dose ara-C (patients aged >50 years) /daunorubicin for late consolidation therapy. Eighty patients were randomized after DAV 1 to receive either GM-CSF (Escherichia coli, 250 µg/m2 per day, s.c.) or placebo starting 48 h prior to DAV II and the subsequent co…

Multicentre randomized placebo-controlled trial of ursodeoxycholic acid with or without colchicine in symptomatic primary biliary cirrhosis

2000

Aim: To establish the efficacy of combination therapy with ursodeoxycholic acid (UDCA) and colchicine in patients with symptomatic primary biliary cirrhosis (PBC), defined by the presence of liver cirrhosis, pruritus or bilirubin exceeding 2 mg/mL. Methods: A total of 90 patients were randomly assigned to ursodeoxycholic acid 500 mg/daily plus placebo (UDCA group, n=44), or ursodeoxycholic acid at the same dosage plus colchicine, 1 mg/daily (UDCA/C group, n=46). The two groups were comparable for age, sex, stage of disease, severity of pruritus, bilirubin, and Mayo score. All patients underwent clinical, ultrasonographic, and biochemical examinations at entry and then every 6 months up to 3…

Atherosclerosis, degenerative aortic stenosis and statins

2009

Aortic stenosis is the most common valvular heart disease among adult subjects in western countries The current treatment for aortic stenosis is aortic valve replacement. The possibility of a medical treatment that can slow the progression of aortic stenosis is very fascinating and statins have been tested to reduce the progression of degenerative aortic stenosis (DAS). The rationale for statin treatment in DAS has a deep pathophysiological substrate, in fact inflammation and lipid infiltration constitute the same histopathological pattern of both aortic stenosis and atherosclerosis and these two conditions have the same risk factors. Whether retrospective studies have shown some efficacy o…

The necessity of placebo application in psychotropic drug trials.

1990

Prospective Comparison on Cardiac Iron and Liver Iron by MR In Thalassemia Major Patients Treated with Combination Deferipron–Desferrioxamine Versus …

2010

Abstract Abstract 5164 Introduction: Using T2* MR a randomised placebo controlled study from Sardinia demonstrated combination therapy with deferiprone and desferrioxamine (DFP+DFO) significantly more effective than DFO in improving myocardial iron. One non-randomised study from Sardinia and one observational study from Greece seem to confirm for DFP+DFO therapy the most rapid clearance of cardiac iron. No data are available in literature about prospective comparisons on cardiac iron and function and liver iron in TM patients treated with DFP+DFO versus DFP and DFO in monotherapy. The aim of this multi-centre study was to assess prospectively in a large clinical setting the efficacy of the …