- Heart Failure Treatment and Management
- Cardiovascular Function and Risk Factors
- Cardiac pacing and defibrillation studies
- Potassium and Related Disorders
- Cardiac electrophysiology and arrhythmias
- Pharmacogenetics and Drug Metabolism
- Blood Pressure and Hypertension Studies
- Hormonal Regulation and Hypertension
- Medication Adherence and Compliance
- Pharmacological Effects and Toxicity Studies
- Cardiovascular Syncope and Autonomic Disorders
- Receptor Mechanisms and Signaling
- Cardiac Imaging and Diagnostics
- Biosimilars and Bioanalytical Methods
- Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Viral Infections and Immunology Research
- Atrial Fibrillation Management and Outcomes
- Air Quality and Health Impacts
- Neuropeptides and Animal Physiology
- Cardiac Ischemia and Reperfusion
- Electroconvulsive Therapy Studies
- Diabetes Treatment and Management
- Opioid Use Disorder Treatment
- Poisoning and overdose treatments
- Firm Innovation and Growth
Novartis (United States)
2019-2025
Tris Pharma (United States)
2024-2025
Duke University Hospital
2024
Clinical Research Institute
2024
Novartis (Germany)
2024
Massachusetts General Hospital
2021-2022
Texas A&M University
2021
University of North Carolina at Chapel Hill
1996-2001
IQVIA (United States)
1998-2001
University of North Carolina Health Care
1999
In patients with heart failure and reduced ejection fraction (HFrEF), treatment sacubitril-valsartan reduces N-terminal pro-b-type natriuretic peptide (NT-proBNP) concentrations. The effect of on cardiac remodeling is uncertain.To determine whether NT-proBNP changes in HFrEF treated correlate measures volume function.Prospective, 12-month, single-group, open-label study enrolled 78 outpatient sites the United States. Sacubitril-valsartan was initiated dose adjusted. Enrollment commenced...
U.S. guidelines recommend consideration of sacubitril/valsartan in chronic heart failure (HF) and mildly reduced or preserved ejection fraction (EF). Whether initiation is safe effective EF >40% after a worsening (WHF) event unknown. PARAGLIDE-HF (Prospective comparison ARNI with ARB Given following stabiLization In DEcompensated HFpEF) assessed vs valsartan recent WHF event. double-blind, randomized controlled trial patients enrolled within 30 days The primary endpoint was time-averaged...
Abstract Aims The PARAGLIDE-HF trial demonstrated reductions in natriuretic peptides with sacubitril/valsartan compared valsartan patients heart failure (HF) mildly reduced or preserved ejection fraction who had a recent worsening HF event, but was not adequately powered to examine clinical outcomes. PARAGON-HF included subset of PARAGLIDE-HF-like were recently hospitalized for HF. Participant-level data from and pooled better estimate the efficacy safety reducing cardiovascular renal events...
The efficacy and safety of sacubitril/valsartan in patients hospitalized with heart failure (HF) across the spectrum left ventricular ejection fraction (EF) has not been described. Data from randomized trials HF EF ≤40% (PIONEER-HF [Comparison Sacubitril/Valsartan Versus Enalapril on Effect NT-proBNP Patients Stabilized From an Acute Heart Failure Episode] trial) >40% (PARAGLIDE-HF [Prospective comparison ARNI ARB Given following stabiLization In DEcompensated HFpEF] recent worsening (WHF)...
Abstract Aims Whether prior treatment with angiotensin‐converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) modifies efficacy and safety of sacubitril/valsartan (Sac/Val) in patients heart failure (HF) ejection fraction (EF) >40% is unclear, thus Sac/Val according to ACEi/ARB status at baseline was assessed. Methods results This a pre‐specified analysis Prospective comparison ARNI ARB Given following stabiLization In DEcompensated HFpEF (PARAGLIDE‐HF), double‐blind,...
The PARAGON-HF trial studied the effect of sacubitril/valsartan (Sac/Val) compared with valsartan (Val) on clinical outcomes in patients chronic heart failure preserved ejection fraction (HFpEF) or mildly reduced EF (HFmrEF). Further data are needed regarding use Sac/Val these groups and recent worsening (WHF) events key populations not broadly represented trial, including those de novo HF, severely obese Black patients.The PARAGLIDE-HF is a multicenter, double-blind, randomized, controlled...
Sacubitril/valsartan (S/V) treatment is associated with reverse cardiac remodeling and reductions in biomarkers reflecting ventricular wall stress myocardial injury, such as NT-proBNP (N-terminal pro-B-type natriuretic peptide), hs-cTnT (high-sensitivity troponin T), soluble suppressor of tumorigenicity 2 (sST2). How longitudinal changes these analyzed collectively are patients heart failure reduced ejection fraction treated S/V uncertain.In a prospective study fraction, this prespecified...
Background Losartan is metabolized by CYP2C9 and CYP3A4 to an active metabolite, E3174, which has greater antihypertensive activity than the parent compound. Coadministered drugs that inhibit or induce metabolic processes may therefore alter pharmacokinetics pharmacologic response of losartan E3174. Objective Methods Ten healthy volunteers were studied assess effects inhibition nonspecific P450 enzyme induction on Subjects completed three 1-week phases separated 6 days: 50 mg every morning,...
Serum digoxin concentrations (SDCs) are frequently sampled before completion of drug distribution. If elevated, these may be misinterpreted, potentially leading to a misdiagnosis toxicity.To determine the frequency elevated SDCs (>2.6 nmol/L [>2.0 ng/mL]) obtained at appropriate postdosing intervals and evaluate clinically defined toxicity in patients with SDCs.The medical records adult assayed 5 general hospitals North Carolina during 3-month period (May 1 through July 31, 1996) were...
Background Efficacy and tolerability of sacubitril/valsartan (Sac/Val) is not well characterized in heart failure (HF) with ejection fraction >40% initiated in‐hospital. Thus, this prespecified PARAGLIDE‐HF (Prospective Comparison ARNI With ARB Given Following Stabilization In Decompensated HFpEF) analysis assessed the effects Sac/Val versus valsartan (Val) by location initiation HF recent worsening HF. Methods Results This double‐blind, randomized controlled trial patients in‐hospital...
Gender‐based differences in cytochrome P450 (CYP) activity may occur due to endogenous hormonal fluctuations with the menstrual cycle, which are altered by oral contraceptives. This study assessed average and within‐subject variability CYP3A4 CYP2D6 men, women taking Triphasil®, regularly menstruating not receiving Thirty‐three healthy volunteers participated this 28‐day pilot (12 Triphasil®) (OCs), 11 on exogenous progesterone or estrogen (no OCs), 10 men. activities were phenotyped...
Treatment of heart failure with reduced ejection fraction (EF) may improve patient-reported health outcomes.The purpose this study was to determine timing and magnitude change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 scores following initiation sacubitril/valsartan interaction amino-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations.From a single-arm, open-label patients initiated on sacubitril/valsartan, KCCQ-23 NT-proBNP were obtained at baseline follow-up...
Decompensated heart failure (HF) can be categorized as de novo or worsening of chronic HF. In PARAGLIDE-HF (Prospective comparison ARNI with ARB Given following stabiLization DEcompensated HFpEF), among patients an ejection fraction >40% that stabilized after HF, sacubitril/valsartan led to a significantly greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and was associated clinical benefit compared valsartan.
The objective of this study was to examine the pharmacokinetic and pharmacodynamic consequences concomitant administration fluoxetine carvedilol in heart failure patients. Fluoxetine (20 mg) or matching placebo administered a randomized, double‐blind, two‐period crossover 10 patients previously identified as extensive metabolizers CYP2D6 substrates. Patients were maintained on dose 25 50 mg bid given fluoxetine/placebo for minimum 28 days. Plasma collected over 12‐hour dosing interval,...
Losartan is an angiotensin II receptor antagonist that metabolized by CYP2C9 and CYP3A4 to a more potent antihypertensive metabolite, E3174. Interaction studies with inhibitors of have not demonstrated significant changes in the pharmacokinetics losartan or The authors assessed steady‐state E3174 when administered alone concomitantly fluvastatin, specific inhibitor. A prospective, open‐label, crossover study was conducted 12 healthy volunteers combination fluvastatin. baseline phase 7 days...
To describe the elimination of diltiazem and desacetyldiltiazem in an overdose situation.An 18-year-old woman ingested controlled delivery 14.94 g a suicide attempt. After arriving at hospital unresponsive hypotensive, her condition progressed to complete heart block, cardiogenic shock, asystole, acute renal failure. Supportive care consisted vasopressors, intravenous calcium, glucagon, charcoal hemoperfusion, temporary transvenous pacing, intraaortic balloon pump. 12 days hospital, patient...