Abstract:
:Type 2 diabetes mellitus (T2DM) is a major independent risk factor for cardiovascular disease, and diabetic dyslipidemia is a major contributor to cardiovascular risk in these patients. Here we report the rationale and design of a phase 3, double-blind study specifically designed to evaluate the lipid-lowering efficacy of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab in patients with T2DM and hyperlipidemia or mixed dyslipidemia who are on background statin therapy. In the BERSON (evolocumaB Efficacy for LDL-C Reduction in subjectS with T2DM On background statiN) trial, patients with T2DM, a screening low-density lipoprotein cholesterol (LDL-C) level of ≥ 2.6 mmol/L (≥100 mg/dL) or ≥ 3.4 mmol/L (≥130 mg/dL), and with or without statin treatment at screening, respectively, were enrolled and started on atorvastatin 20 mg/day for a lipid stabilization period of at least 4 weeks. Then, patients were randomly assigned in a 2:2:1:1 ratio to receive atorvastatin 20 mg once daily plus either evolocumab 140 mg every 2 weeks (Q2W), evolocumab 420 mg every month (QM), placebo Q2W, or placebo QM. The co-primary outcome measures were the percentage change from baseline in LDL-C at week 12 and the percentage change from baseline in LDL-C at the mean of weeks 10 and 12. The BERSON trial has completed enrollment. The study completed in the first half of 2018, and will provide information on the efficacy and safety of evolocumab in patients with T2DM and dyslipidemia.
journal_name
Clin Cardioljournal_title
Clinical cardiologyauthors
Lorenzatti AJ,Eliaschewitz FG,Chen Y,Fialkow J,Lu J,Baass A,Monsalvo ML,Hsu HC,Somaratne R,Ge Jdoi
10.1002/clc.23018subject
Has Abstractpub_date
2018-09-01 00:00:00pages
1117-1122issue
9eissn
0160-9289issn
1932-8737journal_volume
41pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:In clinical cardiology, heart rate variability is a putative index of autonomic cardiovascular function. Signs of reduced vagal activity are not only associated with an enhanced risk of sudden cardiac death, but such impaired heart rate variability became a new predictor of sudden cardiac death and other mor...
journal_title:Clinical cardiology
pub_type: 临床试验,杂志文章
doi:10.1002/clc.4960200710
更新日期:1997-07-01 00:00:00
abstract::A 55-year-old Caucasian woman suddenly developed substernal chest pain at rest accompanied by pallor, diaphoresis, nausea, and vomiting. Physical examination was otherwise unremarkable. The resting ECG showed T-wave inversion in all anterior leads which returned to normal 24 h after the onset of the symptoms. The pain...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960100614
更新日期:1987-06-01 00:00:00
abstract::Rapid assessment of patients presenting with acute chest pain is essential, in order to distinguish between those who have a life-threatening condition, such as myocardial infarction or unstable angina, and the substantial proportion who do not have an acute coronary syndrome. It is thus of vital importance that relia...
journal_title:Clinical cardiology
pub_type: 杂志文章,评审
doi:10.1002/clc.4960231306
更新日期:2000-01-01 00:00:00
abstract::Within 3 h after the onset of symptoms of myocardial infarction, 64 patients were randomly assigned to receive either a 1-h intravenous infusion of 1,500,000 IU of streptokinase (SK) or a conventional therapy. Infarct size was estimated in CK gram equivalent (CKg) by measurement of CK-MB every 3 hours during a 48-h pe...
journal_title:Clinical cardiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1002/clc.4960100704
更新日期:1987-07-01 00:00:00
abstract:BACKGROUND:Contraction-excitation feedback, that is, electrophysiologic changes that are caused or preceded by mechanical changes of the myocardium, has been extensively studied in the ventricles. The role of contraction-excitation feedback in the atria, and more particularly in the genesis and maintenance of atrial fi...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960200514
更新日期:1997-05-01 00:00:00
abstract:BACKGROUND:The normal and dilated heart behaves as a single functional unit during preload reduction: volume unloading in the setting of diastolic ventricular interaction allows for increased left ventricular (LV) filling. HYPOTHESIS:We hypothesized that reduction of venous return induced by a physiologic stimulus (ti...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960260909
更新日期:2003-09-01 00:00:00
abstract::Therapy for acute myocardial infarction has advanced dramatically since the early 1980s with the use of early intravenous fibrinolytic therapy. Combining low-dose fibrinolysis and platelet lysis appears to provide an additional increase in infarct-related artery (IRA) patency, but the large-scale mortality reduction t...
journal_title:Clinical cardiology
pub_type: 杂志文章,评审
doi:10.1002/clc.4960221605
更新日期:1999-08-01 00:00:00
abstract::We investigated 26 patients admitted to our catheterization laboratory with a diagnosis of acute myocardial infarction. In each case acute revascularization was unsuccessful, but the diagnosis was confirmed by angiography. In 11 patients with an uncomplicated course of acute myocardial infarction magnetic resonance im...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960091102
更新日期:1986-11-01 00:00:00
abstract::Thrombolytic therapy for prosthetic heart valve thrombosis has recently been receiving increased attention and is now frequently used an alternative to high-risk surgery. A case is presented describing a novel thrombolytic therapy regimen with emphasis on the role of transesophageal echocardiography in diagnosis and m...
journal_title:Clinical cardiology
pub_type: 杂志文章,评审
doi:10.1002/clc.4960181117
更新日期:1995-11-01 00:00:00
abstract:BACKGROUND:Inflammation is a key factor in the development of atherosclerotic disease and acute coronary syndromes (ACS). The P2Y(12) receptor antagonists ticagrelor (AZD6140) and clopidogrel may have anti-inflammatory effects. The objective of this analysis from the Dose Confirmation Study Assessing Anti-Platelet Effe...
journal_title:Clinical cardiology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1002/clc.20732
更新日期:2010-04-01 00:00:00
abstract:BACKGROUND:Overt hypothyroidism has been found to be associated with cardiovascular disease. Moreover, subclinical hypothyroidism is a strong indicator of risk for aortic atherosclerosis and myocardial infarction. HYPOTHESIS:We hypothesized that variation of thyroid function within the normal range may influence the p...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960261205
更新日期:2003-12-01 00:00:00
abstract::The pacemaker syndrome refers to symptoms and signs in the pacemaker patient caused by inadequate timing of atrial and ventricular contractions. The lack of normal atrioventricular synchrony may result in decreased cardiac output and venous "cannon A waves." A sudden increase in atrial pressure at the onset of asynchr...
journal_title:Clinical cardiology
pub_type: 杂志文章,评审
doi:10.1002/clc.4960140410
更新日期:1991-04-01 00:00:00
abstract::Lipoprotein(a) [Lp(a)] is independently associated with atherosclerotic cardiovascular disease and calcific aortic valve stenosis. Elevated Lp(a) affects approximately one in five individuals and meaningfully contributes to the residual cardiovascular risk in individuals with otherwise well-controlled risk factors. Wi...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.23456
更新日期:2020-11-01 00:00:00
abstract:BACKGROUND:The most recent published guidelines regarding management of patients surviving an acute myocardial infarction (AMI) advocate the administration of aspirin (ASA), beta blockers (BB), and angiotensin-converting enzyme inhibitors (ACEi) and discourages the use of calcium-channel blockers (CCB). Previous data c...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960240204
更新日期:2001-02-01 00:00:00
abstract:BACKGROUND:Massive evidence supports that increase of lipids bring more risk of atherosclerosis. However, it is not clear if lipids measured a long time ago bear more risk than the current measurement. HYPOTHESIS:Lipids measured currently is more associated with carotid atherosclerosis than lipids measured long time a...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.22015
更新日期:2012-08-01 00:00:00
abstract::The occurrence and influence of coronary collateral circulation and obstruction of the supplying coronary arteries on left ventricular contractility, prevalence of myocardial infarction, and bicycle exercise ergometer test were studied in a random sample of 286 patients with angiographically documented coronary artery...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960140206
更新日期:1991-02-01 00:00:00
abstract:BACKGROUND:Recently, electrocardiogram (ECG) criteria have been proposed for the diagnosis of acute myocardial infarction (AMI) in the presence of left bundle-branch block (LBBB). However, clinical experience indicates that such ECG changes indicative of AMI are occasionally noted in clinically stable patients with LBB...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960241004
更新日期:2001-10-01 00:00:00
abstract::The purpose of this study was to evaluate the antihypertensive effect of a new calcium antagonist, clentiazem, on inpatients or outpatients with essential hypertension. After blood pressure was stable and greater than 160/95 mmHg with placebo for at least a 2-week observation period, oral clentiazem was administered o...
journal_title:Clinical cardiology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1002/clc.4960140112
更新日期:1991-01-01 00:00:00
abstract:BACKGROUND:The finding of aortic regurgitation at a classical examination is a diastolic murmur. HYPOTHESIS:Aortic regurgitation is more likely to be associated with a systolic than with a diastolic murmur during routine screening by a noncardiologist physician. METHODS:In all, 243 asymptomatic patients (mean age 42 ...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960270905
更新日期:2004-09-01 00:00:00
abstract:BACKGROUND:Following successful cavotricuspid isthmus (CTI) ablation during typical atrial flutter (AFL), anticoagulation therapy is usually withdrawn. However, potential subsequent atrial fibrillation (AF) in these patients may increase embolic risk in the long term. Embolic rates in this setting have not been clearly...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.22538
更新日期:2016-06-01 00:00:00
abstract::It has been debated whether dilated cardiomyopathy seen in patients with acquired immune deficiency syndrome is caused by the virus itself or by the combination of other factors such as presence of opportunistic pathogens and/or severe immunosuppression. This paper describes the first reported case of a patient with h...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960200815
更新日期:1997-08-01 00:00:00
abstract::A patient with vasospastic angina who developed myocardial ischemia following ethanol ingestion but not after exercise was described. Myocardial ischemia was evidenced by electrocardiograms (ECGs) and thallium-201 scintigrams. The blood acetaldehyde level after ethanol ingestion was abnormally high. The time course an...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960160514
更新日期:1993-05-01 00:00:00
abstract::In this report, a rare case of tricuspid stenosis uncomplicated by other valve lesions is presented, with clinical, hemodynamic, echocardiographic, and angiographic studies. The patient was markedly incapacitated, mostly as a result of a restricted cardiac output. Tricuspid commissurotomy was performed, with a stenoti...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960060406
更新日期:1983-04-01 00:00:00
abstract::After reviewing these published studies, I think one can conclude that in the patient population with chronic and/or paroxysmal atrial fibrillation, warfarin is beneficial and the benefits outweigh the risks. However, it is important to point out that patients at high risk for embolic disease, for example, dilated car...
journal_title:Clinical cardiology
pub_type: 社论
doi:10.1002/clc.4960160703
更新日期:1993-07-01 00:00:00
abstract::ACC/AHA guidelines assign a class I indication for use of myocardial perfusion imaging (MPI) for the evaluation of chest pain in patients with acute coronary syndromes and a nondiagnostic ECG. However, MPI is not a widely used modality for the evaluation of patients who present to the ER with chest pain and an interme...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.20549
更新日期:2010-02-01 00:00:00
abstract:BACKGROUND:Disruption of the atherosclerotic plaque is a common feature of both acute coronary syndromes and balloon dilatation of coronary artery stenoses. HYPOTHESIS:The study was undertaken to evaluate whether the known association of cholesterol levels and acute coronary syndromes also exists for the occurrence of...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4950260708
更新日期:2003-07-01 00:00:00
abstract::Cardiovascular diseases (CVDs) pose a major burden in Africa, but data on temporal trends in disease burden are lacking. We assessed trends in CVD admissions and outcomes in central Ghana using a retrospective analysis of data from January 2004 to December 2015 among patients admitted to the medical wards of a tertiar...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.22753
更新日期:2017-10-01 00:00:00
abstract:BACKGROUND:Acute coronary syndromes (ACS) are characterized by activation of systemic and local inflammatory mediators. The interrelation between these soluble inflammatory markers and their association with markers of myocardial necrosis have not been extensively studied. HYPOTHESIS:The study was undertaken to evalua...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960280405
更新日期:2005-04-01 00:00:00
abstract::This study was conducted to determine the long-term effects of percutaneous transluminal coronary angioplasty (PTCA) on the incidence of myocardial infarction, survival, and relief of symptoms. A total of 124 patients were included in the study and were followed for 16 to 25 months. The success rate of PTCA was 91.2% ...
journal_title:Clinical cardiology
pub_type: 杂志文章
doi:10.1002/clc.4960120805
更新日期:1989-08-01 00:00:00
abstract:BACKGROUND:The optimal strategy for treating late presenters of ST-elevation myocardial infarction (STEMI) remains uncertain. HYPOTHESIS:percutaneous coronary intervention (PCI) has a favorable effect on left ventricular (LV) remodeling and clinical outcomes in late presenters of STEMI. METHODS:Patients with STEMI wh...
journal_title:Clinical cardiology
pub_type: 杂志文章,多中心研究
doi:10.1002/clc.22356
更新日期:2015-02-01 00:00:00