A5002798653- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Blood Pressure and Hypertension Studies
- Statistical Methods and Inference
- Advanced Causal Inference Techniques
- Statistical Methods and Bayesian Inference
- Acute Myocardial Infarction Research
- Meta-analysis and systematic reviews
- Heart Failure Treatment and Management
- Optimal Experimental Design Methods
- Hormonal Regulation and Hypertension
- Advanced Statistical Methods and Models
- Cardiac Imaging and Diagnostics
- Cardiovascular Function and Risk Factors
- Atrial Fibrillation Management and Outcomes
- Lipoproteins and Cardiovascular Health
- Chronic Kidney Disease and Diabetes
- Heart Rate Variability and Autonomic Control
- Pharmaceutical Economics and Policy
- Diabetes Treatment and Management
- Cardiac electrophysiology and arrhythmias
- Antiplatelet Therapy and Cardiovascular Diseases
- Renin-Angiotensin System Studies
- Heart rate and cardiovascular health
- Cardiac Arrhythmias and Treatments
Seagen (United States)
2019
Lundbeck (United States)
2019
Amgen (United States)
2008-2017
Biostatistical Consulting (United States)
2015
Merck & Co., Inc., Rahway, NJ, USA (United States)
1996-2009
GTx (United States)
2007
American Society of Nephrology
2007
University Medical Center Groningen
2007
University of Groningen
2007
University of Michigan
2003-2006
Diabetic nephropathy is the leading cause of end-stage renal disease. Interruption renin-angiotensin system slows progression disease in patients with type 1 diabetes, but similar data are not available for 2, most common form diabetes. We assessed role angiotensin-II-receptor antagonist losartan 2 diabetes and nephropathy.A total 1513 were enrolled this randomized, double-blind study comparing (50 to 100 mg once daily) placebo, both taken addition conventional antihypertensive treatment...
Electrocardiographic left ventricular hypertrophy (LVH) is a strong predictor of cardiovascular (CV) morbidity and mortality. However, the predictive value changes in magnitude electrocardiographic LVH criteria during antihypertensive therapy remains unclear.To test hypothesis that lesser severity treatment associated with decreased CV mortality, independent blood pressure levels reduction modality.Double-blind, randomized, parallel-group study conducted 1995-2001 among 9193 men women...
HMG-CoA Reductase Inhibitors (statins) reduce cardiac event rates in patients with stable coronary heart disease. Withdrawal of chronic statin treatment during acute syndromes may impair vascular function independent lipid-lowering effects and thus increase rate. We investigated the statins on rate 1616 Platelet Receptor Inhibition Ischemic Syndrome Management (PRISM) study who had artery disease chest pain previous 24 hours. recorded death nonfatal myocardial infarction 30-day follow-up....
ContextDrug intervention in placebo-controlled trials has been beneficial isolated systolic hypertension.ObjectiveTo test the hypothesis that losartan improves outcome better than atenolol patients with hypertension and electrocardiographically documented left ventricular hypertrophy (ECG-LVH).DesignDouble-blind, randomized, parallel-group study conducted 1995-2001.Setting ParticipantsA total of 1326 men women aged 55 through 80 years (mean, 70 years) blood pressure 160 to 200 mm Hg...
Background There has been uncertainty about the risk of new-onset diabetes in hypertensive individuals treated with different blood pressure-decreasing drugs. Objectives To study this who were at developing mellitus Losartan Intervention For Endpoint reduction hypertension (LIFE) study. Methods In LIFE study, a double-masked, randomized, parallel-group design, 9193 patients (46% men) (mean age 67 years, average pressure 174/98 mmHg after placebo run-in) and electrocardiogram-documented left...
Background— Electrocardiographic left ventricular hypertrophy (LVH) predicts cardiovascular morbidity and mortality, regression of ECG LVH may predict improved prognosis in hypertensive patients. However, uncertainty persists as to how best regress LVH. Methods Results— Regression with losartan versus atenolol therapy was assessed 9193 patients by Sokolow-Lyon voltage or Cornell voltage-duration product criteria enrolled the Losartan Intervention For Endpoint Reduction Hypertension (LIFE)...
Noninferiority trials are intended to show that the effect of a new treatment is not worse than an active control by more specified margin. These have number inherent weaknesses superiority do not: no internal demonstration assay sensitivity, single conservative analysis approach, lack protection from bias blinding, and difficulty in specifying noninferiority may sometimes be necessary when placebo group can ethically included, but it should recognized results such as credible those trial.
Aims We evaluated the TIMI Risk Score for Unstable Angina and Non-ST Elevation Myocardial Infarction predicting clinical outcomes efficacy of tirofiban in non-ST elevation acute coronary syndromes.
The present study describes the effects of tirofiban, a nonpeptide platelet glycoprotein (GP) IIb/IIIa receptor blocker, on characteristics culprit lesions in patients with unstable angina (UA) or non-Q-wave myocardial infarction (NQWMI).Of 1915 enrolled PRISM-PLUS, 1491 had readable film obtained median 65 hours after randomization. A core laboratory examined for intracoronary thrombus burden (primary end point) and TIMI flow grade distribution severity obstruction underlying coronary...
In clinical endpoint trials, the association between a baseline covariate and risk of an is often measured by hazard ratio as calculated Cox regression model, illustrated Kaplan-Meier curves comparing cohorts defined levels covariate. The model easily extended to case time-varying covariates; however, there no clear approach for similarly extending standard estimator. Various ad hoc procedures that have been used in medical literature are seriously flawed. This article discusses estimator...
Diabetic nephropathy is the most important cause of ESRD. The aim this study was to develop a risk score from predictors for ESRD, with and without death, in Reduction Endpoints NIDDM Angiotensin II Antagonist Losartan (RENAAL) compare ability ESRD its components predict developed coefficients independent factors multivariate analysis baseline variables equals (1.96 x log [urinary albumin:creatinine ratio]) - (0.78 serum albumin [g/dl]) + (1.28 creatinine [mg/dl]) (0.11 hemoglobin [g/dl])....
The present study aimed to determine the frequency and impact on clinical outcome of atrial fibrillation (AF) in patients with acute myocardial infarction (AMI) left ventricular dysfunction.In OPTIMAAL trial, 5477 AMI signs dysfunction were included. At baseline, 655 (12%) had AF, 345 (7.2%) developed new-onset AF during follow-up (2.7 +/- 0.9 years). Older patients, history angina worse Killip class more frequently (P < 0.001). Patients at baseline increased risk relative those without for...
Ideally, a clinical trial should be able to demonstrate not only statistically significant improvement in the primary efficacy endpoint, but also that magnitude of effect is clinically relevant. One proposed approach address this question responder analysis, which continuous measure dichotomized into "responders" and "non-responders." In paper we discuss various weaknesses with approach, including potentially large cost statistical efficiency, as well its failure achieve main goal. We...
Abstract The term ‘futility’ is used to refer the inability of a clinical trial achieve its objectives. In particular, stopping when interim results suggest that it unlikely statistical significance can save resources could be on more promising research. There are various approaches have been proposed assess futility, including stochastic curtailment, predictive power, probability, and group sequential methods. this paper, we describe contrast these approaches, discuss several issues...
The ECG strain pattern of lateral ST depression and T-wave inversion is a marker for left ventricular hypertrophy (LVH) adverse prognosis in population studies. However, whether an independent predictor cardiovascular (CV) morbidity mortality the setting aggressive antihypertensive therapy unclear. ECGs were examined at study baseline 8854 hypertensive patients with LVH who treated blinded manner atenolol- or losartan-based regimens. Strain was defined by presence downsloping convex segment...
OBJECTIVE—Our current aims were to investigate whether 1) baseline urinary albumin-to-creatinine ratio (UACR) predicted cardiovascular outcomes, 2) changes in UACR differed between treatments, 3) benefits of losartan related its influence on UACR, and 4) reduction albuminuria reduced events. RESEARCH DESIGN AND METHODS—In 1,063 patients with diabetes, hypertension, left ventricular hypertrophy, was measured for a mean 4.7 years. The primary composite end point included death, myocardial...
The Losartan Intervention For Endpoint reduction in hypertension (LIFE) study showed that treatment with the angiotensin II type-1 receptor antagonist losartan reduces overall stroke risk compared conventional therapy beta-blocker atenolol. We conducted secondary analyses LIFE to determine extent which cerebrovascular benefits of apply different clinical subgroups and subtypes assess dependence these on baseline time-varying covariates. Among 9193 hypertensive patients electrocardiographic...
Background — The role of glycoprotein IIb/IIIa receptor antagonists for the treatment patients with acute coronary syndrome and renal insufficiency remains undefined. Methods Results Patients from Platelet Receptor Inhibition in Ischemic Syndrome Management Limited by Unstable Signs Symptoms (PRISM-PLUS) trial were stratified creatinine clearance (CrCl) assessed respect to assignment tirofiban/heparin versus heparin alone risk adverse outcomes bleeding. severe (defined as a serum ≥2.5 mg/dL)...