Search results for "Randomized"
showing 10 items of 2323 documents
Zofenopril and Ramipril in Combination with Acetyl Salicylic Acid in Postmyocardial Infarction Patients with Left Ventricular Systolic Dysfunction: A…
2016
Summary Objective In the SMILE-4 study, zofenopril + acetyl salicylic acid (ASA) was more effective than ramipril + ASA on 1-year prevention of major cardiovascular events (MACE) in patients with acute myocardial infarction complicated by left ventricular dysfunction. In this retrospective analysis, we evaluated drug efficacy in subgroups of patients, according to a history of diabetes mellitus. Methods The primary study endpoint was 1-year combined occurrence of death or hospitalization for cardiovascular causes. Diabetes was defined according to medical history (previous known diagnosis). Results A total of 562 of 693 (81.0%) patients were classified as nondiabetics and 131 (18.9%) as dia…
Early Treatment With Zofenopril and Ramipril in Combination With Acetyl Salicylic Acid in Patients With Left Ventricular Systolic Dysfunction After A…
2017
Abstract: The SMILE-4 study showed that in patients with left ventricular dysfunction (LVD) after acute myocardial infarction, early treatment with zofenopril plus acetyl salicylic acid is associated with an improved 1-year survival, free from death or hospitalization for cardiovascular (CV) causes, as compared to ramipril plus acetyl salicylic acid. We now report CV outcomes during a 5-year follow-up of the patients of the SMILE-4 study. Three hundred eighty-six of the 518 patients completing the study (51.2%) could be tracked after the study end and 265 could be included in the analysis. During the 5.5 (±2.1) years of follow-up, the primary endpoint occurred in 27.8% of patients originall…
Comparison between zofenopril and ramipril in combination with acetylsalicylic acid in patients with left ventricular systolic dysfunction after acut…
2012
Background: Angiotensin-converting enzyme inhibitors (ACEIs) are largely employed for treating patients with left ventricular dysfunction (LVD), but their efficacy may be negatively affected by concomitant administration of acetylsalicylic acid (ASA), with some difference among the different compounds. Hypothesis: The interaction between ASA and the two ACEIs zofenopril and ramipril may result in a different impact on survival of cardiac patients, due to differences in the pharmacological properties of the two ACEIs. Methods: This phase IIIb, randomized, double-blind, parallel-group, multicenter, European study compared the safety and efficacy of zofenopril (60 mg/day) and ramipril (10 mg/d…
5-Year Experience of In-Hospital Outcomes After Percutaneous Left Atrial Appendage Closure in Germany
2019
The aim of this study was to evaluate 5-year in-hospital trends and safety outcomes of left atrial appendage (LAA) closure in the German nationwide inpatient sample.The safety and efficacy of percutaneous LAA closure have been demonstrated in randomized trials and prospective cohort studies, but results from large samples are missing.Data on patient characteristics and in-hospital safety outcomes for all percutaneous LAA closures performed in Germany between 2011 and 2015 were analyzed. Overall, 15,895 inpatients were included.The annual number of LAA occlusions increased from 1,347 in 2011 to 4,932 in 2015 (β = 1.00; 95% confidence interval [CI]: 0.95 to 1.01; p 0.001), with a nonsignifica…
Beta‐blockers withdrawal in patients with heart failure with preserved ejection fraction and chronotropic incompetence: Effect on functional capacity…
2020
Abstract Background The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence (ChI) has emerged as a crucial pathophysiological mechanism. Beta‐blockers, drugs with negative chronotropic effects, are commonly used in HFpEF, although current evidence does not support its routine use in these patients. Hypothesis We postulate beta‐blockers may have deleterious effects in HFpEF and ChI. This work aims to evaluate the short‐term effect of beta‐blockers withdrawal on functional capacity assessed by the maximal oxygen uptake (peakVO2) in patients with HFpEF and ChI. Methods This is a prospective, crossover, randomized (1…
Blue-light imaging compared with high-definition white light for real-time histology prediction of colorectal polyps less than 1 centimeter: a prospe…
2019
Blue-light imaging (BLI) is a new chromoendoscopy technique, potentially useful for differentiating neoplastic from nonneoplastic lesions. The present study was aimed at comparing BLI with high-definition white light (HDWL) in the real-time histology prediction of colon polyps 10 mm.Consecutive outpatients undergoing colonoscopy with the ELUXEO 7000 endoscopy platform and 760 series video colonoscopes (Fujifilm Co, Tokyo, Japan) who had at least 1 polyp 10 mm were randomized to BLI or HDWL for polyp characterization. The accuracy of high-confidence real-time histology prediction (adenoma vs not adenoma) by either BLI or HDWL for polyps 10 mm (primary end-point) and diminutive (≤5 mm) polyps…
Effects of long-acting bronchodilators in COPD patients according to COPD severity and ICS use
2013
SummaryBackgroundIndacaterol is a once-daily, long-acting β2-agonist bronchodilator that improves dyspnoea and health status in patients with moderate-to-severe COPD. While its bronchodilator effects have been shown to be maintained in different patient subgroups, effects on clinical outcomes in certain subgroups are not yet defined.MethodsPost-hoc analysis of pooled clinical study data to investigate efficacy and safety of indacaterol compared with placebo and other long-acting bronchodilators (formoterol, salmeterol, open-label tiotropium) in patient subgroups defined by COPD severity (GOLD stage II or III; n = 4082) and ICS use at baseline (no/yes; n = 4088). Efficacy outcomes were troug…
Effects of a Classroom Training Program for Promoting Health Literacy Among IT Managers in the Workplace: A Randomized Controlled Trial.
2018
Objective IT managers have received limited attention in health literacy research, although they are subject to special professional demands. The aim of this study was to evaluate a training program designed to promote health literacy among managers. Methods A randomized controlled trial with a sample of 171 industry managers from one IT company was conducted. Effects of classroom training on health literacy, psychological well-being, self-rated health, and cortisol awakening response were investigated using pre- (t0), post- (t1), and follow-up (t2) surveys. Results The intervention effects (time and group) were not significant for the primary outcome of health literacy. At the second measu…
Health-related quality of life in individuals with metabolic syndrome: A cross-sectional study
2020
Abstract Introduction and objectives Metabolic syndrome (MetS) is a combination of various cardiovascular risk factors with a major impact on morbidity and premature mortality. However, the impact of MetS on self-reported health-related quality of life (HRQoL) is unknown. This study evaluated the HRQoL in a Spanish adult population aged 55 years and older with MetS. Method A cross-sectional analysis was performed with baseline data from the PREDIMED-Plus multicentre randomized trial. The participants were 6430 men and women aged 55–75 years with overweight/obesity (body mass index ≥27 and ≤40 kg/m2) and MetS. The SF-36 questionnaire was used as a tool to measure HRQoL. Scores were calculate…
Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately …
2017
Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50â75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2â3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and…