Journal articleEur Heart J · June 23, 2026
BACKGROUND AND AIMS: Aficamten is a next-in-class, oral selective cardiac myosin inhibitor that ameliorates hypercontractility in hypertrophic cardiomyopathy (HCM). This study assessed the safety and efficacy of extended aficamten treatment in symptomatic ...
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Journal articleJACC Heart Fail · February 2026
BACKGROUND: Disopyramide, used in obstructive hypertrophic cardiomyopathy (oHCM) for its negative inotropic properties mediated by its reduction in cytosolic calcium, has been recommended for decades as an option to relieve resistant obstruction. Aficamten ...
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Journal articleCirc Heart Fail · February 2026
BACKGROUND: Hypertrophic cardiomyopathy (HCM) is an important cause of morbidity and mortality in children, but treatment options are limited. Aficamten, a next-in-class cardiac myosin inhibitor, directly targets the hypercontractility underlying HCM. Afic ...
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Journal articleAm Heart J · January 2026
BACKGROUND: Prior to 2025, Medicare Part D included a coverage gap during which beneficiaries were responsible for substantially higher portions of medication costs. The impact of this on oral anticoagulant (OAC) prescription fills and subsequent stroke in ...
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Journal articleJACC Heart Fail · August 2025
BACKGROUND: Long-term safety and efficacy data for aficamten in symptomatic obstructive hypertrophic cardiomyopathy are needed. OBJECTIVES: This study aims to evaluate 48-week experience from the ongoing FOREST-HCM (A Follow-Up, Open-Label, Research Evalua ...
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Journal articleJ Am Coll Cardiol · November 5, 2024
BACKGROUND: Standard-of-care (SoC) medications for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) are recommended as first-line therapy despite the lack of evidence from controlled clinical trials and well known off-target side effects. OB ...
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Journal articleEur J Heart Fail · September 2024
AIMS: The aim of this study was to report safety and efficacy of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM) over 36 weeks in the ongoing FOREST-HCM trial. METHODS AND RESULTS: Patients were started on aficamten 5 mg daily ...
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Journal articleCPT Pharmacometrics Syst Pharmacol · June 2022
Obesity is an increasingly alarming public health threat, with nearly 20% of children classified as obese in the United States today. Children with obesity are commonly prescribed the opioids fentanyl and methadone, and accurate dosing is critical to reduc ...
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Journal articleCirculation · October 19, 2021
BACKGROUND: The relative cardiovascular safety of gonadotropin-releasing hormone (GnRH) antagonists compared with GnRH agonists in men with prostate cancer and known atherosclerotic cardiovascular disease remains controversial. METHODS: In this internation ...
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Journal articleJ Clin Pharmacol · March 2021
Hydrochlorothiazide (HCTZ) is a thiazide diuretic used in adults and children for the treatment of hypertension and edema. The pharmacokinetic (PK) properties of HCTZ in children are not well characterized, particularly among children with obesity who freq ...
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Journal articleN Engl J Med · January 14, 2021
BACKGROUND: The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS: We randomly assigne ...
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Journal articleClin Transl Sci · November 2020
Metoclopramide is commonly used for gastroesophageal reflux. The aims of the present study were to develop a pediatric population pharmacokinetic (PopPK) model, which was applied to simulate the metoclopramide exposure following dosing used in clinical pra ...
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Journal articleCurrent Treatment Options in Cardiovascular Medicine · November 1, 2020
Purpose of review: Low molecular weight heparin (LMWH) has been the standard of care for patients with cancer-associated thrombosis (CAT) for over 10 years; however, its adoption has been limited. The appearance of direct acting oral anticoagulants (DOACs) ...
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Journal articleJ Cardiovasc Transl Res · June 2020
Androgen deprivation therapy (ADT) has been the cornerstone of prostate cancer treatment. ADT delays cancer progression, alleviates cancer-related symptoms, and is associated with survival gains. Despite these established benefits, the extended duration of ...
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Journal articleJ Clin Pharmacol · May 2020
Differences in fentanyl pharmacokinetics (PK) between obese and nonobese adults have previously been reported; however, the impact of childhood obesity on fentanyl PK is relatively unknown. We developed a population pharmacokinetic (PopPK) model using oppo ...
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Journal articleTrials · April 9, 2020
BACKGROUND: The primary goal of phase 2 and 3 clinical trials is to evaluate the safety and effectiveness of therapeutic interventions, and efficient and reproducible ascertainment of important clinical events, either as clinical outcome events (COEs) or a ...
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Journal articleJACC CardioOncol · March 2020
OBJECTIVES: This study will compare the incidence of major adverse cardiovascular events (MACEs) with androgen deprivation therapy (ADT) among men with advanced prostate cancer who are being treated with a gonadotropin-releasing hormone (GnRH) antagonist v ...
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Journal articleUrol Oncol · February 2020
Prostate cancer (PCa) is the most common cancer among men. Advances in early detection and successful treatments have improved cancer-specific survival. With prolonged survival, PCa patients now suffer from the effects of aging and are at increasing risk f ...
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Journal articleJ Clin Pharmacol · December 2019
Milrinone is a type 3 phosphodiesterase inhibitor used to improve cardiac output in critically ill infants and children. Milrinone is primarily excreted unchanged in the urine, raising concerns for toxic accumulation in the setting of renal dysfunction of ...
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Journal articleJACC CardioOncol · December 2019
The discipline of cardio-oncology has expanded at a remarkable pace. Recent developments and challenges to clinicians who practice cardio-oncology were presented at the Global Cardio-Oncology Summit on October 3 to 4, 2019, in São Paulo, Brazil. Here, we p ...
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Journal articleAntimicrob Agents Chemother · September 9, 2019
Doxycycline is a tetracycline-class antimicrobial labeled by the United States (U.S.) Food and Drug Administration for children >8 years of age for many common childhood infections. Doxycycline is not labeled for children ≤8 years of age, due to the associ ...
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Journal articleCurr Treat Options Cardiovasc Med · June 15, 2019
PURPOSE OF REVIEW: This paper will focus on novel breast cancer therapies used in clinical practice today, as well as review our understanding of standard therapies and their potential impact on cardiovascular health. RECENT FINDINGS: Established and novel ...
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Journal articleEur Heart J Qual Care Clin Outcomes · April 1, 2019
AIMS: The management of anticoagulation therapy in patients with atrial fibrillation (AF) and cancer is challenging due to increased thrombotic and bleeding risks. We sought to determine the safety and efficacy of rivaroxaban in patients with AF and a hist ...
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Journal articleCirculation · February 12, 2019
BACKGROUND: Modern cardiometabolic clinical trials often include cardiovascular death as a component of a composite primary outcome, requiring central adjudication by a clinical events committee to classify cause of death. However, sometimes the cause of d ...
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Journal articleFront Cardiovasc Med · 2019
Patients with cancer face a high short-term risk of arterial thromboembolism. One of the most fatal manifestations of arterial thromboembolism is myocardial infarction (MI), and patients with cancer face a 3-fold greater risk of MI than patients without ca ...
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Journal articleJ Am Heart Assoc · December 18, 2018
Background Vorapaxar, a protease-activated receptor-1 antagonist, is approved for secondary prevention of cardiovascular events but is associated with increased intracranial hemorrhage. Methods and Results TRACER (Thrombin Receptor Antagonist for Clinical ...
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Journal articleLancet · October 27, 2018
BACKGROUND: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine t ...
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Journal articleJ Clin Pharmacol · August 2018
Ketamine is an N-methyl D-aspartate receptor antagonist used off-label to facilitate dissociative anesthesia in children undergoing invasive procedures. Available for both intravenous and intramuscular administration, ketamine is commonly used when vascula ...
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Journal articleJ Pharmacokinet Pharmacodyn · June 2018
Amiodarone is a first-line antiarrhythmic for life-threatening ventricular fibrillation or ventricular tachycardia in children, yet little is known about its pharmacokinetics (PK) in this population. We developed a population PK (PopPK) model using samples ...
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Journal articleTher Drug Monit · February 2018
BACKGROUND: Dried blood spot (DBS) is a practical sampling strategy for pharmacokinetic studies in neonates. The utility of DBS to determine the population pharmacokinetics (pop-PK) of ampicillin, as well as accuracy versus plasma samples, was evaluated. M ...
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Journal articleAntimicrob Agents Chemother · January 2018
Trimethoprim (TMP)-sulfamethoxazole (SMX) is used to treat various types of infections, including community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) and Pneumocystis jirovecii infections in children. Pharmacokinetic (PK) data for infa ...
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Journal articleMinerva Endocrinol · September 2017
INTRODUCTION: The aim of this review is to discuss the consequences of potential pharmacokinetic interactions between proton pump inhibitors (PPIs) and antiplatelet therapy on cardiovascular (CV) outcomes and provide guidance on the management of concomita ...
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Journal articleEur Heart J Qual Care Clin Outcomes · July 1, 2017
AIMS: The presence of cancer can complicate treatment choices for patients with atrial fibrillation (AF) increasing both the risk of thrombotic and bleeding events. METHODS AND RESULTS: Using data from Outcomes Registry for Better Informed Treatment of Atr ...
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Journal articleTher Drug Monit · February 2017
BACKGROUND: Drugs that exhibit close margins between therapeutic and toxic blood concentrations are considered to have a narrow therapeutic index (NTI). The Food and Drug Administration has proposed that NTI drugs should have more stringent bioequivalence ...
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Journal articleTher Drug Monit · December 2016
BACKGROUND: Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic ...
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Journal articleTher Drug Monit · October 2016
BACKGROUND: Sirolimus, an immunosuppressive agent used in renal transplantation, can prevent allograft rejection. Identification of the therapeutic index (the ratio of minimum toxic concentration to minimum therapeutic concentration) for immunosuppresants ...
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Journal articleAm Heart J · April 2016
BACKGROUND: Adverse event collection in randomized clinical trials establishes drug safety. Although costly and regulated, it is rarely studied. METHODS: Adverse event data from 4 clinical trials (APPRAISE-2, PLATO, TRACER, TRILOGY ACS) comprising 48,118 p ...
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Journal articleJ Clin Pharmacol · March 2016
Hydroxyurea (HU) is a crucial therapy for children with sickle cell anemia, but its off-label use is a barrier to widespread acceptance. We found HU exposure is not significantly altered by liquid vs capsule formulation, and weight-based dosing schemes pro ...
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Journal articleClin Neuropharmacol · 2016
OBJECTIVES: Our study aimed to determine whether data obtained from the medical literature can be used to estimate the therapeutic index of 5 antiepileptic drugs (AEDs): carbamazepine, lamotrigine, phenobarbital, phenytoin, and valproate. METHODS: We perfo ...
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Journal articleJ Am Heart Assoc · October 29, 2015
BACKGROUND: Observational studies evaluating the possible interaction between proton pump inhibitors (PPIs) and clopidogrel have shown mixed results. We conducted a systematic review comparing the safety of individual PPIs in patients with coronary artery ...
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Journal articleCirc Cardiovasc Qual Outcomes · July 2015
BACKGROUND: Adequate representation by sex in trials allows generalizability of results. We examined representation of women in clinical trials during a 17-year period in which inclusion criteria were broadened and federal mandates for representativeness w ...
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Journal articleTher Innov Regul Sci · July 2015
Detection of off-target cardiovascular (CV) effects remains a significant challenge to drug development. Documentation of CV events in non-CV trials is often inadequate to interpret imbalances between treatment arms, which may lead to concerns about potent ...
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Journal articleCirc Cardiovasc Qual Outcomes · January 2015
BACKGROUND: Discordant results have been reported on the effects of concomitant use of proton pump inhibitors (PPIs) and dual antiplatelet therapy (DAPT) for cardiovascular outcomes. We conducted a systematic review comparing the effectiveness and safety o ...
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Journal articleBioanalysis · 2015
BACKGROUND: Trimethoprim-sulfamethoxazole (TMP-SMX) is an antimicrobial drug combination commonly prescribed in children and adults. The study objectives were to validate and apply an HPLC-MS/MS method to quantify TMP-SMX in dried plasma spots (DPS) and dr ...
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Journal articleDrug Des Devel Ther · 2015
Each year, despite optimal use of recommended acute and secondary prevention therapies, 4%-5% of patients with acute coronary syndrome (ACS) experience relapse of ACS or other cardiovascular events including stroke, heart failure, or sudden cardiac death a ...
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Journal articleJ Thromb Thrombolysis · October 2014
Currently, there is a lack of consensus among guidelines for the postdischarge treatment of patients presenting with acute coronary syndrome (ACS) who have a long-term indication for anticoagulation. We conducted a systematic review comparing the safety an ...
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Journal articleClin Pharmacol Ther · October 2014
Clindamycin is commonly prescribed to treat children with skin and skin-structure infections (including those caused by community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA)), yet little is known about its pharmacokinetics (PK) across pe ...
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Journal articleLancet · September 27, 2014
BACKGROUND: p38 MAPK inhibition has potential myocardial protective effects. We assessed losmapimod, a potent oral p38 MAPK inhibitor, in patients with non-ST-segment elevation myocardial infarction (NSTEMI) in a double-blind, randomised, placebo-controlle ...
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Journal articleAntimicrob Agents Chemother · June 2014
Although ampicillin is the most commonly used drug in neonates, developmental pharmacokinetic (PK) data to guide dosing are lacking. Ampicillin is primarily renally eliminated, and developmental changes are expected to influence PK. We conducted an open-la ...
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Journal articleCurrent Cardiovascular Risk Reports · January 1, 2014
Cardiovascular disease (CVD) is the leading cause of mortality in women. Differences in pathophysiology, diagnosis, and treatment of women with cardiovascular disease compared with men have become a major focus during the past decades. Guideline of CVD pre ...
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Journal articleProgress in Pediatric Cardiology · January 1, 2014
The long-term survival and overall prognosis of patients affected by malignancies has dramatically improved in the last several decades, primarily as a result of improvements in early detection of certain cancers and to advances of pharmacological cancer t ...
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Journal articleAm Heart J · November 2012
The p38 mitogen-activated protein kinase (MAPK) is a nexus point in inflammation, sensing, and stimulating cytokine production and driving cell migration and death. In acute coronary syndromes, p38MAPK inhibition could stabilize ruptured atherosclerotic pl ...
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Journal articleN Engl J Med · October 4, 2012
BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, ...
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Journal articleCirc Cardiovasc Qual Outcomes · November 1, 2011
BACKGROUND: The 2007 update of the ACC/AHA guidelines for STEMI patients recommended addition of clopidogrel to aspirin regardless of reperfusion strategy, with a bolus dose in patients <75 years of age. METHODS AND RESULTS: We evaluated use and dose of ea ...
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Journal articleAm Heart J · November 2011
BACKGROUND: Dose adjustment of renally excreted antithrombotic drugs is recommended for patients with reduced renal function. We examined the influence of dose modification on bleeding and efficacy. METHODS: Based on initial study drug infusion rate, Early ...
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Journal articleJAMA · May 11, 2011
CONTEXT: Acute ST-segment elevation myocardial infarction (STEMI) is a leading cause of morbidity and mortality. In experimental models of MI, erythropoietin reduces infarct size and improves left ventricular (LV) function. OBJECTIVE: To evaluate the safet ...
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Journal articleAm Heart J · May 2011
BACKGROUND: Patient adherence to medications is crucial for reducing risks following acute coronary syndrome (ACS). We assessed the degree to which medication beliefs were associated with patient adherence to β-blockers, angiotensin-converting enzyme inhib ...
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Journal articleVasc Health Risk Manag · 2011
Coronary heart disease is the major cause of morbidity and mortality throughout the world, and is responsible for approximately one of every six deaths in the US. Angina pectoris is a clinical syndrome characterized by discomfort, typically in the chest, n ...
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Journal articleAm Heart J · December 2010
BACKGROUND: Current American College of Cardiology/American Heart Association guidelines recommend initiation or intensification of statin therapy to achieve low-density lipoprotein cholesterol (LDL-C) goals after an acute coronary syndrome (ACS), yet litt ...
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Journal articleAm Heart J · November 2010
BACKGROUND: Acute myocardial infarction (MI) remains a leading cause of death despite advances in pharmacologic and percutaneous therapies. Animal models of ischemia/reperfusion have demonstrated that single-dose erythropoietin may reduce infarct size, dec ...
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Journal articleAm Heart J · May 2010
BACKGROUND: Prompt reperfusion for patients with ST-segment elevation myocardial infarction (STEMI) is a class I guideline recommendation and has been shown to reduce mortality. However, many STEMI patients in contemporary practice still do not receive any ...
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Journal articleCirculation · April 20, 2010
BACKGROUND: Factor Xa and factor IIa (thrombin) play roles in thrombotic complications after percutaneous coronary intervention. M118 is a novel low-molecular-weight heparin that has been rationally designed to capture the desired attributes of unfractiona ...
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Journal articleAm Heart J · April 2010
BACKGROUND: Beliefs such as self-reported low necessity for medications and high concerns about medications are associated with nonadherence. Changes in these beliefs during long-term care have not previously been studied and were evaluated for purposes of ...
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Journal articleCirc Cardiovasc Qual Outcomes · March 2010
BACKGROUND: The 2007 American Heart Association guidelines for cardiovascular disease prevention in women drew heavily on results from randomized clinical trials; however, representation of women in trials of cardiovascular disease prevention has not been ...
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Journal articleAm Heart J · November 2009
BACKGROUND: Currently recommended anticoagulant agents used in the setting of percutaneous coronary intervention (PCI) inhibit, with varying degrees of intensity, 2 critical targets (factor Xa and/or IIa) of the coagulation cascade, yet they carry signific ...
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Journal articleJ Am Geriatr Soc · November 2009
OBJECTIVES: To describe the persistent use of evidence-based cardiovascular medications (EBCMs) 3 months after discharge from an acute coronary syndrome (ACS) event and patient-reported reasons for nonpersistence across age groups. DESIGN: Medication Appli ...
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Journal articleAm Heart J · November 2009
BACKGROUND: Although adequate representation of specific subgroups (eg, women and the elderly) in randomized controlled trials (RCTs) has been under intense scrutiny, there are few data on representation by race. METHODS: Using all RCTs cited by the 2007 A ...
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Journal articleAm J Cardiol · July 15, 2009
Use of evidence-based medicine (EBM) improves outcomes after acute coronary syndromes (ACS), yet patients often discontinue prescribed therapies after discharge. Although such discontinuation is well documented, patients' reasons for medication discontinua ...
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Journal articleArch Intern Med · August 11, 2008
BACKGROUND: Patient medical records are important means of communication among health care providers. Limited evaluation has been performed of the quality of the medical records or its association with health care processes or outcomes. METHODS: We perform ...
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Journal articleAm Heart J · August 2008
BACKGROUND: Unfractionated heparin (UFH) is a mainstay of treatment for patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS), but the practice of weight-adjusted bolus and infusion dosing has not been carefully evaluated. METHODS: Usi ...
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Journal articleCurr Opin Cardiol · July 2008
PURPOSE OF REVIEW: Chronic kidney disease is becoming common among patients with acute coronary syndromes and is associated with substantial cardiovascular morbidity and mortality. Often, patients with chronic kidney disease are excluded from clinical tria ...
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Journal articleCirculation · June 3, 2008
BACKGROUND: Whether selective factor IXa inhibition produces an appropriate anticoagulant effect when combined with platelet-directed therapy in patients with stable coronary artery disease is unknown. REG1 consists of RB006 (drug), an injectable RNA aptam ...
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Journal articleJ Am Coll Cardiol · March 11, 2008
OBJECTIVES: Our purpose was to compare formulae for estimating glomerular filtration rate (GFR) in non-ST-segment elevation acute coronary syndromes (NSTE ACS) patients. BACKGROUND: Assessment of GFR is important for antithrombotic dose adjustment in NSTE ...
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Journal articleClin Cardiol · March 2008
BACKGROUND: The prognostic value of cardiac troponins (cTn) in patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) and chronic kidney disease (CKD) is debated. HYPOTHESIS: We tested the performance of cTnI and cTnT for risk stratific ...
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Journal articleExpert Rev Cardiovasc Ther · January 2008
Ranolazine is a piperazine derivative believed to reduce anginal symptoms by preventing ischemia-mediated sodium and calcium overload in myocardial cells through inhibition of the late sodium current (late INa). Three small studies demonstrated the antiang ...
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Journal articleCirculation · December 5, 2006
BACKGROUND: Selectivity, titratability, rapidity of onset, and active reversibility are desirable pharmacological properties of anticoagulant therapy administered for acute indications and collectively represent an attractive platform to maximize patient s ...
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Journal articleJ Clin Periodontol · February 2005
OBJECTIVES: A relationship between poor oral health and coronary heart disease (CHD) and systemic inflammatory and haemostatic factors has been recently documented in an Italian population. The present study was performed to assess whether intensive dental ...
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Journal articleJ Clin Periodontol · January 2004
OBJECTIVES: To assess the relationship between poor oral health and coronary heart disease (CHD) and systemic inflammatory and haemostatic factors in an Italian population. MATERIAL AND METHODS: The study population consisted of 63 males aged 40-65 years w ...
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Journal articlePathophysiol Haemost Thromb · 2002
Among patients with ST elevation-acute coronary syndrome (ACS) novel thrombolytic agents can be given as a bolus (reteplase, tenecteplase) and their delivery is easier and may shorten the time to treatment, providing the ideal tool in the pre-hospital sett ...
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