Tafolecimab in Chinese Patients With Hypercholesterolemia (CREDIT-4): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial.

Background: Tafolecimab is a novel fully human proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody, developed for the treatment of hypercholesterolemia.

Objectives: The purpose of this study was to assess the efficacy and safety of tafolecimab in Chinese patients at high or very high cardiovascular risk with hypercholesterolemia.

Methods: Patients with diagnoses of heterozygous familial hypercholesterolemia (HeFH) by the Simon Broome criteria or at high or very high cardiovascular risk with nonfamilial hypercholesterolemia, with screening low-density lipoprotein cholesterol (LDL-C) level ≥1.

Association between basal septal hypertrophy and left ventricular geometry in a community population.

Background: Left ventricular (LV) geometry is closely associated with cardiovascular disease; however, few studies have evaluated the relationship between basal septal hypertrophy (BSH) and LV geometry. In this study, we examined the relationship between BSH and LV geometry in a Beijing community population.

Methods: The clinical and echocardiographic data of 1032 participants from a community in Beijing were analyzed.

Reduced left atrial contractile strain with speckle tracking analysis predicts abnormal plasma NTproBNP in an asymptomatic community population.

Background: The left atrium (LA) is closely related to left ventricular diastolic function. Two-dimensional speckle tracking strain and strain rate (SR) imaging has been applied in the study of LA function. We intended to explore the relationship between global LA deformation parameters and plasma NTproBNP levels in asymptomatic community residents with normal ejection fraction and normal LA volume.

A Potential Long-Acting LDL-Cholesterol-Lowering PCSK9 Monoclonal Antibody: Randomized, Placebo-Controlled Phase 1 Studies.

The aim of the studies was to evaluate the safety, tolerability, and efficacy of tafolecimab, a novel proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody, in Chinese healthy volunteers and patients with hypercholesterolemia. Fifty-eight healthy volunteers (phase 1a) were randomized to receive a single dose of 25, 75, 150, 300, 450, or 600 mg tafolecimab subcutaneously, 75 or 450 mg intravenously, or placebo. Sixty patients with hypercholesterolemia (phase 1b) were randomized to receive 75 or 140 mg tafolecimab every 2 weeks, 300 or 420 mg every 4 weeks, or 450 or 600 mg every 6 weeks subcutaneously or placebo for 12 weeks.

Efficacy and safety of hybutimibe in combination with atorvastatin for treatment of hypercholesteremia among patients with atherosclerotic cardiovascular disease risk equivalent: A multicenter, randomized, double-blinded phase III study.

Background: To evaluate the safety and efficacy of hybutimibe plus atorvastatin for lipid control in hypercholesterolemia patients with atherosclerotic cardiovascular disease risk equivalent.

Methods: In this double-blind phase III study, we 1:1 randomly assigned 255 hypercholesterolemia patients with atherosclerotic cardiovascular disease to receive hybutimibe plus atorvastatin or placebo plus atorvastatin. The primary endpoint was the rate of change of plasma low-density lipoprotein-cholesterol (LDL-C) level at 12 weeks from baseline.

Left atrial phasic function remodeling during its enlargement: a two-dimensional speckle-tracking echocardiography study.

Background: Left atrial (LA) size is often used as a surrogate marker of LA function in clinical practice, with larger atrial thought to represent a "dysfunctioning" atrium, since there is no accepted 'gold' standard to evaluate LA function. The exact relationship between LA size and phasic function, and whether LA dysfunction occur before LA enlargement (LAE) may be of clinical interest while have not been fully studied. Two-dimensional speckle-tracking echocardiography (2D STE) was showed a promising method in measuring LA physical deformation.

Treatment of Chinese Patients with Hypertriglyceridemia with a Pharmaceutical-Grade Preparation of Highly Purified Omega-3 Polyunsaturated Fatty Acid Ethyl Esters: Main Results of a Randomized, Double-Blind, Controlled Trial.

Introduction: The lipid-modifying potential of omega-3 polyunsaturated fatty acids in Chinese patients is under-researched. We conducted a multicenter, randomized, placebo-controlled, double-blind, parallel-group study of twice-daily treatment with OMACOR (OM3EE), a prescription-only formulation of highly purified ethyl esters of omega-3 polyunsaturated fatty acids in Chinese adult patients (≥18 years) who had elevated baseline fasting serum triglycerides (TG).

Methods: Patients were stratified according to the severity of their hypertriglyceridemia (severe HTG, with baseline TG ≥500 and <1000 mg/dL or moderate HTG, with baseline TG >200 and <500 mg/dL) or use of statins.

Association of epicardial fat thickness with left ventricular diastolic function parameters in a community population.

Background: We examined the relationship between epicardial fat thickness (EFT) measured by echocardiography and left ventricular diastolic function parameters in a Beijing community population.

Methods: We included 1004 participants in this study. Echocardiographic parameters including E and A peak velocity, the early diastolic velocities (e') of the septal and lateral mitral annulus using tissue doppler imaging, E/e', and EFT were measured.

Relation between Blood Pressure Variability within a Single Visit and Stroke.

Blood pressure variability (BPV) has been identified as an important risk factor for cardiovascular events. The white coat effect (WCE), which is measured as the first systolic blood pressure (SBP) measurement minus the mean of the second and third measurements, is a BPV indicator within a single visit. In total, 2,972 participants who had three measurements of BP within a single visit were included.

Association between inter-arm difference in SBP and central blood pressure in a Beijing community cohort.

Objective: The inter-arm SBP difference (IASBPD) can serve as a predictor of cardiovascular disease (CVD). In this study, we aimed to determine the relationship between IASBPD and central blood pressure (CBP).

Methods: The study cohort comprised of 7842 eligible individuals.

Efficacy and Safety of PCSK9 Monoclonal Antibodies in Patients at High Cardiovascular Risk: An Updated Systematic Review and Meta-Analysis of 32 Randomized Controlled Trials.

Introduction: Proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies are powerful lipid-lowering drugs which have been shown to improve clinical endpoints in patients with hypercholesterolemia. However, it is not clear how effective PCSK9 monoclonal antibodies are for patients at high cardiovascular risk. Also, whether the effectiveness of PCSK9 monoclonal antibodies varies between different drug types, dosages, race, and indications for PCSK9 monoclonal antibodies remains unclear.

The association between carotid intima-media thickness and new-onset hypertension in a Chinese community-based population.

Background: Hypertension and arterial vasculopathy may be mutual causes and effects. It is unknown whether carotid intima-media thickness (cIMT) is reliably predictive of the presence of newly developed hypertension in the Chinese population. This study evaluated the impacts of cIMT on new-onset hypertension in a community-based population without hypertension at baseline in China.

The relationship between carotid intima-media thickness and carotid plaque: a cohort study in China.

Both carotid intima-media thickness (cIMT) and carotid plaque (CP) quantified by B-mode ultrasound have been proposed as surrogate imaging biomarkers of subclinical atherosclerosis, while the relationship between cIMT and CP, whether cIMT evaluation in a given patient might allow for predicting the development of a carotid plaque, is still discussed controversially. We investigated the cross-sectional relationship between cIMT and CP, and the predictive value of cIMT for incident CP formation in 1078 subjects with mean age of 52 ± 5 years in a community based atherosclerosis cohort in Beijing. Participants underwent ultrasonography of bilateral carotid arteries and received vascular risk factor assessment at baseline and after a mean of 2.

Noninvasive central systolic blood pressure, not peripheral systolic blood pressure, independently predicts the progression of carotid intima-media thickness in a Chinese community-based population.

This study aimed to investigate the predictive values of central systolic blood pressure (cSBP) and peripheral systolic blood pressure (pSBP) for the progression of carotid intima-media thickness (cIMT). A total of 953 Chinese participants from an atherosclerosis cohort with complete information, including baseline cSBP, questionnaire information, biochemical examination, baseline, and follow-up carotid ultrasonography quantitative data, were included in this study. A multilinear regression model, adjusted for possible covariates, was used to investigate the predictive values of cSBP and pSBP for rate of cIMT change.

Joint Effect of Non-invasive Central Systolic Blood Pressure and Peripheral Systolic Blood Pressure on Incident Hypertension in a Chinese Community-based Population.

Central blood pressure level is not always consistent with peripheral blood pressure level, and especially their joint effect on incident hypertension is not well established. A total of 1607 non-hypertensive subjects from an atherosclerosis cohort in Beijing, China were included. Central systolic blood pressure (cSBP) was obtained using Omron HEM-9000AI machine and peripheral systolic blood pressure (pSBP) was measured using Omron HEM-7117 electronic sphygmomanometer, separately.

Associations of plasma homocysteine levels with peripheral systolic blood pressure and noninvasive central systolic blood pressure in a community-based Chinese population.

Previous studies indicated that homocysteine (Hcy) is associated with higher peripheral systolic blood pressure (pSBP). There have been few data on the relationship between Hcy and central SBP (cSBP). A total of 4,364 Chinese subjects from the Shijingshan community in Beijing were included.

Efficacy and tolerability of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension.

The present multicentre, prospective, open-label, single treatment arm study (Val-Perfect) examined the efficacy and tolerability of once-daily valsartan monotherapy (80 mg for two weeks, followed by 160 mg for eight weeks) in 195 Chinese patients with mild to moderate hypertension, using office, home, and ambulatory blood pressure (BP) monitoring. Significant mean reductions (P<0.0001) were observed in office BP from baseline to week 10, with mean sitting systolic BP (MSSBP) and mean sitting diastolic BP (MSDBP) values of 15.

Correlating the relationship between interarm systolic blood pressure and cardiovascular disease risk factors.

Interarm systolic blood pressure difference (IASBPD) can predict cardiovascular disease. To investigate the relationship between IASBPD and cardiovascular disease risk factors, a total of 1426 individuals were studied. Blood pressure was assessed simultaneously and IASBPD was expressed as the absolute difference value (|R-L|).

Noninvasive Central Systolic Blood Pressure Is More Strongly Related to Kidney Function Decline Than Peripheral Systolic Blood Pressure in a Chinese Community-Based Population.

This study aimed to investigate the association of noninvasive central aortic blood pressure with kidney function decline in a Chinese community-based population with normal kidney function at baseline. A total of 3153 Chinese participants from an atherosclerosis cohort were included in our analysis. The primary outcome was renal function decline defined as a drop in estimated glomerular filtration rate (eGFR) category accompanied by a ≥25% drop in eGFR from baseline; or a sustained decline in eGFR of >5 mL/min per 1.

[Efficacy comparison between 5 mg perindopril arginine salt and 4 mg perindopril tert-butylamine salt for patients with mild to moderate essential hypertension].

Objective: To compare the efficacy and safety of 5 mg perindopril arginine salt and 4 mg perindopril tert-butylamine salt for patients with mild to moderate essential hypertension.

Methods: The study was designed as multicenter, randomized, double-blind, active controlled trial with two parallel groups enrolling 524 participants with mild to moderate essential hypertension. After 2-week run-in period, 186 patients were enrolled and randomly treated with 5 mg perindopril arginine salt and 183 patients were enrolled and randomly treated with 4 mg perindopril tert-butylamine salt.

[Synergistic effect of hypertension and aging on left atrial volume and function].

Objective: To assess the effect of combined hypertension (HT) and aging on left atrial (LA) size and phasic function.

Methods: This evaluation was based on the data from a cross-sectional study including 738 subjects with high risk for cardiovascular disease from an urban community in Beijing. Subjects were divided into 3 groups according to age (41-59, 60-69 and ≥ 70 years) and further into HT and non-HT sub-groups.

[Relationship between high normal blood pressure and carotid artery atherosclerosis in Beijing residents].

Objective: To analyze the relationship between normal high blood pressure and carotid artery atherosclerosis.

Methods: This epidemiological survey was performed in two communities of Shijingshan District of Beijing from 2007 to 2008. A total of 3 324 people were enrolled in the study and 2 895 people with carotid ultrasound survey results were analyzed.

[Speckle tracking analysis of left atrial phasic function in patients with hypertension].

Objective: To assess left atrial (LA) phasic function in hypertension (HT) and to evaluate its relationship with left ventricular diastolic function.

Methods: Cross-sectional data of 738 population (149 non-HT as control, and 589 HT were further grouped into normal left ventricular diastolic function, mild diastolic dysfunction and moderate/severe diastolic dysfunction sub-groups) in an urban community of Beijing were used. LA global longitudinal strain in late diastole (Sa), early diastole (Se), and total strain (Stot = Sa+ Se), strain rate in late diastole (SRa), systole (SRs), and early diastole (SRe) were measured using off-line speckle-tracking echocardiography analyzing software, and were compared between non-HT and HT groups, and among HT sub-groups.

[Correlation between anthropometric parameters and arteriosclerosis biomarker in the middle-aged and the elderly].

Objective: To investigate the correlation between anthropometric indices and arteriosclerosis detection indicators in the middle-aged and the elderly.

Methods: A cross-sectional descriptive study was made of 1 626 individuals (diabetics patients 23.37%, hypertensive subjects 39.

[Relationship between radial augmentation index and other indices for evaluating arteriosclerosis].

Objective: To investigate the relationship between radial augmentation index (AI) and other noninvasive indices for evaluating arteriosclerosis.

Methods: From April to June 2010, a cross-sectional survey was performed in two communities of Shijingshan District, Beijing, China. This study involved 1 752 subjects (aged 23 to 90 years).