Events In Chinese Patients Research Articles

Real-world hematological adverse events in Chinese patients with advanced ovarian cancer treated with an individualized starting dose of niraparib.

BackgroundThis work set out to examine the hematological adverse events (AEs) of an individualized starting dose (ISD) of niraparib in Chinese patients with ovarian cancer (OC).MethodsThe medical records of 43 patients with OC who were treated with an ISD of niraparib at the Cancer Hospital of The University of Chinese Academy of Sciences between February 2019 and January 2020 were retrospectively reviewed. Treatment-emergent hematological AEs were analyzed.ResultsOf the 43 patients with OC, 28 (65.1%) had hematological AEs of ≥ grade 1, including thrombocytopenia (39.5%), leukopenia (37.2%), and anemia (34.9%). Ten (23.3%) patients developed grade 3/4 hematological AEs, including thrombocytopenia (11.6%), leukopenia (9.3%), and anemia (7.0%). Among the individuals who developed AEs during treatment, 9 (32.1%) patients had their treatment interrupted, with treatment being restarted in 8 (28.6%) cases, and 4 (14.3%) patients had the drug dose decreased. No deaths were reported. The median times to the occurrence of any-grade leukopenia, anemia, and thrombocytopenia were 30 (range, 7 to 162), 34 (range, 7 to 108), and 20 (range, 13 to 180) days, respectively. Most AEs occurred within the first 3 months of treatment (93.8% leukopenia, 80.0% anemia, and 76.5% thrombocytopenia). Treatments for AEs included supplementation of recombinant human granulocyte colony-stimulating factor (n=5, 17.9%), erythrocytes (n=2, 7.1%), and recombinant human thrombopoietin (n=5, 17.9%).ConclusionsThe incidence of adverse hematological reactions to an ISD of niraparib in Chinese patients with advanced OC is relatively lower in the real world than in the phase III clinical trials PRIMA (also an ISD) and NOVA. These hematological AEs can be managed through dose adjustment and symptomatic therapy.

Relationship between small dense low density lipoprotein and cardiovascular events in patients with acute coronary syndrome undergoing percutaneous coronary intervention

BackgroundResidual risk remained significant despite effective low density lipoprotein cholesterol (LDL-C) lowering treatment. Small dense low density lipoprotein cholesterol (sdLDL-C) as part of LDL-C has been found to be predictor of coronary heart disease (CHD) and cardiovascular (CV) events in patients with stable CHD independently of LDL-C. However, to date, few studies have explored the role of sdLDL-C in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). Accordingly, this study aimed to evaluate the association of sdLDL-C with CV events in patients with ACS undergoing PCI.MethodsPatients hospitalized with ACS undergoing PCI were enrolled and followed up for 18 months. The risk of sdLDL-C for CV events was compared according to sdLDL-C quartiles. The primary outcome was major cardiovascular and cerebrovascular adverse events (MACCE), which was the composite of all cause of death, nonfatal myocardial infarction (MI), nonfatal stroke or unplanned repeat revascularization. A Cox proportional hazards regression model was performed to estimate the risk of CV events. Subgroup analysis according to diabetes status and LDL-C were performed separately for MACCE.ResultsA total of 6092 patients were included in the analysis (age: 60.2 ± 10.13 years, male: 75.3%, BMI: 25.9 ± 3.33 kg/m2, dyslipidemia: 74.1% and diabetes: 44.5%). During 18 months of follow-up, 320 (5.2%) incident CV events occurred. Compared to the lowest sdLDL-C quartile group, patients in the highest quartile had a greater risk of CV events after multivariable adjustment (HR 1.92; 95% CI 1.37–2.70). In addition, it was mainly due to the increase of unplanned repeat revascularization. In the subgroup analyses, significant association was observed regardless of level of LDL-C and diabetes status.ConclusionsPatients with elevated sdLDL-C have a higher risk of CV events in Chinese patients with ACS undergoing PCI, providing additional value for better risk assessment.

Short report: depression and anxiety symptoms as predictors of adverse cardiovascular events in Chinese patients after percutaneous coronary intervention

ABSTRACT Depression and anxiety often co-occur in coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). This study was conducted to examine the predictive value of depression, anxiety, and their combination on the prognosis of Chinese PCI patients. A multicenter prospective study was undertaken with a sample of 309 primary PCI patients. The Hospital Anxiety and Depression Scale (HADS) was completed at baseline to assess anxiety and depression symptoms. Major adverse cardiovascular events (MACEs) were recorded for 12 months after PCI . Days from baseline to the first MACE was the outcome variable. MACEs occurred in 26 (8.4%) patients. After adjustments for socio-demographic and clinical characteristics, a Cox proportional hazards regression model revealed that depression (HR = 2.70, 95% confidence interval [CI] 1.22–5.95; p =.014) and anxiety (HR = 2.56, 95% CI 1.18–5.54; p =.017) symptoms were independent predictors of MACEs. A subanalysis showed that the cumulative event-free survival curves did not differ among depressed and anxious patients and depressed but non-anxious patients (Log Rank p =.52). In conclusion, depression is associated with an increased risk for MACEs post-PCI, independent of anxiety. Although anxiety is associated with MACEs, it has no additional predictive value when co-occurring with depression.

Association of -344C/T polymorphism in the aldosterone synthase (CYP11B2) gene with cardiac and cerebrovascular events in Chinese patients with hypertension.

ObjectiveSeveral recent studies have shown that the aldosterone synthase gene (CYP11B2) −344C/T polymorphism is related to cardiovascular diseases. However, whether the −344C allele influences the incidence of cardiovascular diseases in Chinese patients with hypertension is unclear.MethodsChinese patients with essential hypertension were genotyped for the −344C/T polymorphism in CYP11B2 (n = 755; CC, n = 112; CT, n = 361; TT, n = 282) and followed for 11 years for major adverse cardiovascular events (MACEs), including stroke, onset of coronary artery disease (CAD), and CAD-related death. Established cardiovascular risk factors were used to adjust the multivariate Cox analysis.ResultsAfter a mean follow-up period of 7.60 ± 1.12 years, a significantly higher incidence of MACEs was seen in patients with the CC genotype than in those with the CT and TT genotypes. The CC variant was significantly and independently predictive of MACEs (hazard ratio = 2.049), CAD (hazard ratio = 1.754), and stroke (hazard ratio = 2.588), but not CAD-related stroke or death.ConclusionThe CYP11B2 −344 CC genotype is a risk factor for CAD and stroke, independent of other established cardiovascular risk factors in Chinese patients with hypertension.

Education Level and Long-term Mortality, Recurrent Stroke, and Cardiovascular Events in Patients With Ischemic Stroke.

BackgroundEpidemiological studies have reported discrepant findings on the relationship between education level and outcomes after stroke. We aimed to prospectively investigate the relationship between education level and mortality, recurrent stroke, and cardiovascular events in Chinese patients with ischemic stroke.Methods and ResultsWe included 3861 participants from the China Antihypertensive Trial in Acute Ischemic Stroke. Education level was categorized as illiteracy, primary school, middle school, and college. Study outcomes were all‐cause mortality, stroke‐specific mortality, recurrent stroke, and cardiovascular events within 2 years after ischemic stroke. A meta‐analysis was conducted to incorporate the results of the current study and previous other studies on the association of education level with outcomes after stroke. Within 2 years after ischemic stroke, there were 327 (8.5%) all‐cause deaths, 264 (6.8%) stroke‐specific deaths, 303 (7.9%) recurrent strokes, and 364 (9.4%) cardiovascular events, respectively. The Kaplan–Meier curves showed that patients with the lowest education level had the highest cumulative incidence rates of all‐cause mortality, stroke‐specific mortality, and cardiovascular events (log‐rank P≤0.01). After adjusted for covariates, hazard ratios and 95% CIs of illiteracy versus college education were 2.79 (1.32–5.87) for all‐cause mortality, 3.68 (1.51–8.98) for stroke‐specific mortality, 2.82 (1.20–6.60) for recurrent stroke, and 3.46 (1.50–7.95) for cardiovascular events. The meta‐analysis confirmed the significant association between education status and mortality after stroke (pooled relative risk for lowest versus highest education level, 1.24 [95% CI, 1.05–1.46]).ConclusionsLow education level was significantly associated with increased risk of mortality, recurrent stroke, and cardiovascular events after ischemic stroke, independently of established risk factors.RegistrationURL: https://www.clini​caltr​ials.gov; Unique identifier: NCT01840072.

Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials.

IntroductionGastrointestinal (GI) events are a common side effect of glucagon-like peptide 1 (GLP-1) receptor agonists (RA) class. This post hoc analysis assessed the characteristics of GI adverse events in Chinese patients with type 2 diabetes (T2D) who were treated with once-weekly dulaglutide from two randomized clinical trials.MethodsChinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included. Descriptive statistics were used to present the data. The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.ResultsA total of 787 Chinese patients with T2D were included in this analysis. Up to week 26, 225 patients (28.6%) reported at least one GI treatment-emergent adverse event (TEAE). The most frequently reported GI TEAEs were diarrhea (13.1%), nausea (6.6%), abdominal distension (6.4%), and vomiting (3.0%), with most being categorized as mild to moderate in severity in proportions of 92%, 88%, 94%, and 83%, respectively. A total of 12 patients (1.5%) discontinued the dulaglutide treatment as a result of GI TEAEs. The median duration of the first reported GI TEAEs was 4.0, 5.0, 12.5, and 4.0 days for diarrhea, nausea, abdominal distension, and vomiting, respectively. The incidence of GI TEAEs was more frequent during the first 2 weeks of dulaglutide treatment; however, the incidence declined rapidly after 2 weeks and remained low until week 26.ConclusionsMost of the GI TEAEs associated with once-weekly dulaglutide (1.5 mg and 0.75 mg) were mild to moderate in severity. The incidence of GI TEAEs was more pronounced during the first 2 weeks of dulaglutide treatment but declined rapidly as treatment continued, and was low at week 26, indicating that dulaglutide was well tolerated in Chinese patients with T2D.Trial RegistrationNCT01648582 and NCT01644500.

Impact of Plasma Exposure of Statins and Their Metabolites With Major Adverse Cardiovascular Events in Chinese Patients With Coronary Artery Disease.

The selection of optimum statin intensity is inconclusive, and the association of plasma exposure of statins and metabolites with major adverse cardiovascular events (MACEs) is unclear. This study sought to compare the effect of low (quartile 1), intermediate (quartiles 2 and 3), and high (quartile 4) plasma exposure of statins and metabolites on MACE, re-ischemia events and death in patients with coronary artery disease (CAD) at 5 years. A total of 1,644 patients in atorvastatin (AT) cohort and 804 patients in rosuvastatin (RST) cohort were included, and their plasma concentration of statins and metabolites was categorized as low-, mid-, or high-group. The association between the plasma levels of statins and metabolites and the incidence of primary endpoint in patients was assessed by Cox proportional hazard models. Intensive AT exposure (Q4 > 5.32 ng/ml) was significantly associated with increased risk of death compared with low (hazard ratio [HR]: 1.522; 95% confidence interval [CI]: 1.035–1.061; P = 0.0022) or moderate exposure (HR: 2.054; 95% CI: 1.348–3.130; P = 0.0008). This association was also found in AT’s five metabolites (all P < 0.01). In patients with RST treatment, moderate RST concentration (0.53–4.29 ng/ml) versus low concentration had a significantly lower risk of MACE and re-ischemia events. (HR: 0.532, 95% CI: 0.347–0.815, P = 0.0061 and HR: 0.505, 95% CI: 0.310–0.823, P = 0.0061, respectively). A higher plasma exposure of AT and metabolites has a significantly higher risk of death, and moderate RST exposure has a significantly lower risk of MACE and re-ischemia events in Chinese patients with CAD. The harms of high plasma exposure should be considered when prescribing statins to patients because it may be a risk factor for having poor prognosis in patients with CAD.

Warfarin therapy in Chinese patients with atrial fibrillation treated with percutaneous coronary intervention: a 5 year follow-up retrospective cohort study

Objective: To evaluate warfarin use in Chinese patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) by investigating the stroke and major adverse cardiac and cerebral events (MACCEs) and bleeding events.Methods: Retrospective cohort study of the 5 year follow-up of 1134 patients with AF who underwent PCI. The patients were grouped according to whether they received warfarin or not. Baseline characteristics and the occurrence of MACCEs and bleeding events were compared between the two groups using the CHA2DS2-VASc and HAS-BLED scoring. Cox regression analysis was used to identify factors related to the occurrence of MACCEs and bleeding.Results: Overall MACCE (p = .008) and mortality (p = .004) rates were significantly lower in the warfarin group compared with the non-warfarin group. Major bleeding, minor bleeding and overall bleeding were comparable in the two groups. Recurrent myocardial infarction (HR = 10.129, 95% CI = 4.737–21.655; p < .001) and a baseline CHA2DS2-VASc score >4 (HR = 2.035, 95% CI = 1.121–3.692; p = .019) were independent predictors of MACCEs in the warfarin group. A baseline HAS-BLED score ≥3 (HR = 5.498, 95% CI = 3.773–8.013; p < .001) and previous bleeding (HR = 3.058, 95% CI = 1.319–7.088; p = .009) were independent predictors of bleeding.Conclusions: Warfarin reduces the incidence of MACCEs but does not increase bleeding events in Chinese patients with AF who underwent PCI. For patients taking warfarin, recurrent myocardial infarction and a baseline CHA2DS2-VASc score >4 were related to MACCE occurrence.

PCV54 COST-EFFECTIVENESS OF ASPIRIN FOR PRIMARY PREVENTION OF CARDIOVASCULAR EVENTS IN CHINESE PATIENTS WITH DIABETES

Aspirin use was recommended for prevention of initial vascular events, especially in patients at high-risk of cardiovascular disease. Long-term use of aspirin was associated with increased risks of gastrointestinal and extracranial bleeds. The present study aims to examine the clinical and economic outcomes of aspirin for primary prevention of cardiovascular events in Chinese patients with diabetes. A lifelong Markov model was designed to simulate two strategies (receiving aspirin 100mg daily or no treatment) in a hypothetical cohort of 60-year-old patients with diabetes. Model inputs were mainly derived from published literature and sensitivity analyses were performed to evaluate the robustness of model results. Direct medical costs, quality-adjusted life-years (QALYs) gained, and incremental cost-effectiveness ratio (ICER) were primary outcomes included in the study from the perspective of Chinese healthcare system. All costs and QALYs were discounted to year 2019 with an annual rate of 3%. Base-case results showed receiving aspirin for primary prevention gained more QALYs (14.4183 QALYs versus 14.2133 QALYs) at higher cost (USD2,455 versus 1,995 USD) at) compared to no treatment. Receiving aspirin was cost-effective with ICER of 2,244 USD/QALY less than 9,860 USD/QALY (1*GDP per capita in China) of the willingness-to-pay threshold. One-way sensitivity analysis found aspirin use was not cost-effective when the odds ratio of all-cause death of aspirin versus no treatment in patients with diabetes exceeded from 0.94 to 1.011. In probabilistic sensitivity analysis, aspirin use was USD451 (95% CI: USD449-USD453, p<0.01) more costly and gained 0.1869 (95% CI: 0.1847-0.1891, p<0.01) higher QALYs compared to no treatment. Aspirin use was cost-effective in 93.43% of 10,000 Monte Carlo simulations. Aspirin use for primary prevention of cardiovascular events appears to be a cost-effective strategy in Chinese patients with diabetes.

Plasma Lipoprotein(a) Concentration Is Associated With the Coronary Severity but Not With Events in Stable Coronary Artery Disease Patients: A Chinese Cohort Study

Although lipoprotein(a) (Lp(a)) has been regarded as an independent risk factor for atherosclerotic cardiovascular disease (ASCVD), its predictive role in outcomes in stable coronary artery disease (CAD) has been undetermined. The aim of the present study was to investigate the relations of Lp(a) to the coronary severity and events in Chinese patients with angiography-proven stable CAD. A total of 3,278 patients with stable CAD were consecutively enrolled and the coronary severity was evaluated by the Gensini Score (GS) system. Patients were divided into two groups according to the median of GS: high GS group (n=1,585) and low GS group (n=1,693). The associations of continuous Lp(a), Lp(a) ≥300mg/L, and tertiles of Lp(a) with GS and events were respectively evaluated. Patients in the high GS group had significantly higher concentrations of Lp(a). In addition, the multivariate Cox regression analysis indicated that elevated Lp(a) (odds ratio: 1.164, 95% confidence interval: 1.005-1.349), Lp(a) ≥300mg/L (odds ratio: 1.200, 95% confidence interval: 1.028-1.401), and the highest tertile of Lp(a) (odds ratio: 1.205, 95% confidence interval: 1.010-1.438) were statistically associated with GS after adjusted for potential confounders. However, although 215 (6.56%) events were established during a median of follow-up over 10,170 patient-years, no relationship between Lp(a) and events was found. In this Chinese cohort study on stable CAD with moderate sample size and follow-up duration, data showed that Lp(a) was significantly associated with the coronary severity while not with cardiovascular events, similar to several studies, suggesting that further study is needed regarding the role of Lp(a) in ASCVD.

Elevated plasma lipoprotein(a) levels were associated with increased risk of cardiovascular events in Chinese patients with stable coronary artery disease

Recent studies have suggested that lipoprotein(a) [Lp(a)] is associated with cardiovascular disease (CVD). However, the contribution of Lp(a) to residual risk of CVD has not been determined in Chinese populations. We conducted a prospective study to evaluate the association between Lp(a) and the risk of major adverse cardiovascular events (MACEs) in patients with stable coronary artery disease (CAD) who received optimal medication treatment (OMT). The study enrolled 1602 patients with stable CAD from 5 hospitals in China. The baseline clinical characteristics and follow-up MACE data for the patients were recorded. Coronary lesion severity was assessed by the Gensini scoring system. All-cause death, non-fatal myocardial infarction, non-fatal stroke and unplanned coronary revascularization were considered MACEs. We found that plasma Lp(a) levels were positively associated with coronary lesion severity at baseline (p < 0.001). During a mean follow-up period of 39.6 months, 166 (10.4%) patients suffered MACEs. There were significant differences in the adjusted event-free survival rates among the Lp(a) quartile subgroups (p = 0.034). The hazard ratio for MACEs was 1.291 (95% confidence interval: 1.091–1.527, p = 0.003) per standardized deviation in the log-transformed Lp(a) level after adjustment for traditional cardiovascular risk factors. Therefore, Lp(a) was an independent predictor of MACEs in Chinese patients with stable CAD who received OMT.

Effect of PEAR1 Genetic Variants on 1-Year Outcomes in Chinese Patients with Acute Myocardial Infarction After Percutaneous Coronary Intervention.

Aims: Platelet endothelial aggregation receptor-1 (PEAR1) is a platelet transmembrane protein that plays an important role on platelet aggregation. The aim of this study was to investigate whether PEAR1 genetic variations are associated with 1-year outcomes in Chinese patients with acute myocardial infarction after percutaneous coronary intervention.Methods: A total of 647 consecutive Chinese patients with acute myocardial infarction that underwent percutaneous coronary intervention and that were exposed to standard dual antiplatelet therapy with aspirin and clopidogrel were enrolled in this study. Six single nucleotide polymorphisms of PEAR1 were detected using the ligase detection reaction method. The follow-up period was 12 months.Results: Overall, 66 (10.2%) adverse ischemic events occurred. Multivariate Cox regression analysis showed that carriage of the PEAR1 rs56260937 minor allele was an independent predictor of revascularization events (OR = 2.15, 95% CI 1.12–4.15, p = 0.022) after adjusting for confounding factors.Conclusions: Genetic testing for PEAR1 variants can be helpful in predicting adverse ischemic events in Chinese patients with acute myocardial infarction after percutaneous coronary intervention.

Safety and Incidence of Cardiovascular Events in Chinese Patients with Acute Coronary Syndrome Treated with Ticagrelor: the 12-Month, Phase IV, Multicenter, Single-Arm DAYU Study

PurposeTicagrelor is an orally administered, reversibly binding, direct-acting P2Y12 receptor antagonist previously evaluated in several phase III trials. This phase IV, multicenter, single-arm trial assessed the safety and incidence of cardiovascular (CV) events with ticagrelor in Chinese patients experiencing an acute coronary syndrome (ACS).MethodsPatients hospitalized with an ACS received ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) plus low-dose aspirin (75–100 mg/day) for up to 12 months. Safety was evaluated via PLATO-defined bleeding events, adverse events (AEs), serious AEs, and laboratory measurements. The incidence of major CV events was also evaluated.ResultsThe safety population included 2001 patients. During ticagrelor treatment, 426 (21.3%) patients had at least one PLATO-defined bleeding AE, mainly minimal bleedings (n = 333). Major bleeding events occurred in 27 (1.3%) patients, including fatal/life-threatening bleeding in 17 (0.8%) patients and other major bleeding in 11 (0.5%) patients, with a Kaplan-Meier estimate of patients with the event (95% CI) of 1.6% (1.1–2.3%). In total, 784 (39.2%) patients had at least one non-bleeding AE, the majority of which were mild in severity. The composite endpoint of CV death, myocardial infarction, and stroke occurred in 83 (4.1%) patients.ConclusionsTicagrelor plus low-dose aspirin for up to 1 year was associated with a low rate of major bleeding events and a low incidence of major CV events (CV death, myocardial infarction, stroke) in Chinese patients with ACS. The overall safety profile of ticagrelor in this population was in line with current prescribing information.

Association analysis of SNPs present in plasma with adverse events and population pharmacokinetics in Chinese sunitinib treated patients with renal cell carcinoma.

BackgroundSunitinib is a tyrosine kinase inhibitor with effective therapeutic outcomes in patients with renal-cell carcinoma. The study were to analyze the association of single-nucleotide polymorphisms present in cell-free DNA and pharmacokinetics with sunitinib treatment-emergent adverse events in Chinese patients with renal-cell carcinoma.Materials and MethodsWe genotyped 8 keys SNPs in 6 candidate genes. The plasma concentrations of sunitinib and N-desethyl sunitinib were measured using a high performance liquid chromatography-tandam mass spectrometry method. Correlations between the single-nucleotide polymorphisms and adverse events were investigated by univariate and multivariate logistic regression and we quantitatively evaluated the effect of single-nucleotide polymorphisms on the pharmacokinetics of sunitinib by using a population PK model.ResultsNecessary dose reductions of sunitinib were significantly correlated with SNP rs1933437 in FLT3. A higher severity of AEs were collected with SNP rs2032582 in ABCB1 and rs1800812 in PDGFRα. Thrombocytopenia was collected with rs1800812 in PDGFRα. Our study provides a population PK model of sunitinib with the ABCB1 genotype as a predictive covariate for apparent oral clearance.ConclusionsOur study preliminarily confirmed the hypothesis that the pharmacokinetics of sunitinib is affected by the SNPs of enzyme in Chinese renal-cell carcinoma patients, and this affects the different distribution and severity of adverse events of sunitinib.

Relation of Carotid Artery Plaque to Coronary Heart Disease and Stroke in Chinese Patients: Does Hyperglycemia Status Matter?

To examine the association of carotid artery plaque with the incident coronary heart disease and stroke events in Chinese patients and explore whether the association differs between patients with and without hyperglycemia. We evaluated plaque, and blood pressure, total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, fasting serum insulin, fasting plasma glucose, 2 h postprandial glucose and Homeostasis model assessment of insulin resistance in 253 Chinese patients. T-test and X2 test were used to compare the clinical characteristics and Binary logistic regression was applied to analyze the association of coronary heart disease and stroke between patients with and without hyperglycemia. Among 253 patients, 162 patients had hyperglycemia (i. e., diabetes, impaired glucose regulation and stress induced hyperglycemia) and 155 (61.3%) patients had plaque. Fasting plasma glucose, 2 h postprandial glucose and Homeostasis model assessment of insulin resistance, triglycerides, plaque were significantly higher in the hyperglycemia group than non-hyperglycemia. The incident coronary heart disease and stroke events in patients with plaque were 2.254 (95%CI,1.203-4.224) and 2.437 (95%CI,1.042-5.701) times higher than those without plaque, respectively. Among hyperglycemia subgroup, plaque was an independent risk factor for coronary heart disease (OR,3.075,95%CI,1.353-6.992) and stroke (OR,3.571,95%CI,1.460-8.737). The slopes (associations between coronary heart disease/stroke and plaque) were steeper in the hyperglycemia group than those in the non-hyperglycemia group (coronary heart disease OR,3.075 vs. 2.614; stroke OR,3.571 vs. 3.307). The incident coronary heart disease and stroke events in patients with plaque were higher than those without plaque, and this difference was more pronounced for patients with hyperglycemia vs. those without hyperglycemia.

Prevalence of psychological disorders, sleep disturbance and stressful life events and their relationships with disease parameters in Chinese patients with ankylosing spondylitis.

Our aim was to investigate the prevalence of psychological disorders, sleep disturbance, and stressful life events in Chinese patients with ankylosing spondylitis (AS) and healthy controls, to assess the correlation between psychological and disease-related variables, and finally to detect powerful factors in predicting anxiety and depression. AS patients diagnosed with the modified New York criteria and healthy controls were enrolled from China. Participants completed a set of questionnaires, including demographic and disease parameters, Zung self-rating anxiety scale (SAS), Zung self-rating depression scale (SDS), the Pittsburgh Sleep Quality Index questionnaire (PSQI), and the Social Readjustment Rating Scale (SRRS). The relationship between psychological and other variables was explored. Stepwise multiple regression was used to determine the contributors to each disorder. Of all the 2772 AS patients, 79.1% were male. Mean age was 28.99±8.87years. Prevalence of anxiety, depression, and sleep disturbance was 31.6% (95% CI, 29.9, to 33.4), 59.3% (95% CI, 57.5, to 61.2), and 31.0% (95% CI, 29.3, to 36.7), respectively. 35.3% had stimulus of psychological and social elements (SPSE). Compared with healthy controls, AS patients had more severe psychological disorders, sleep disturbance, and stressful life events (P<0.01). SDS, overall pain, BASFI, and sleep disturbance were significant contributors of the SAS scores (P<0.03). SAS, less years of education, and sleep duration were significant contributors of SDS (P<0.01). AS patients had more anxiety, depression, stressful life events, and sleep disturbance than healthy controls. Pain, functional limitation, sleep disturbance, and education were major contributors to psychological disorders.

D‐dimer to guide the intensity of anticoagulation in Chinese patients after mechanical heart valve replacement: a randomized controlled trial

Background Controversies remain regarding the optimal anticoagulation intensity for Chinese patients after mechanical heart valve replacement despite guidelines having recommended a standard anticoagulation intensity. Objectives To investigate whether D-dimer could be used to determine the optimal anticoagulation intensity in Chinese patients after mechanical heart valve replacement. Patients/Methods This was a prospective, randomized controlled clinical study. A total of 748 patients following mechanical heart valve replacement in Wuhan Asia Heart Hospital were randomized to three groups at a ratio of 1:1:1. Patients in two control groups received warfarin therapy based on constant standard intensity (international normalized ratio [INR], 2.5-3.5; n=250) and low intensity (INR, 1.8-2.6; n=248), respectively. In the experimental group (n=250), warfarin therapy was initiated at low intensity, then those with elevated D-dimer levels were adjusted to standard intensity. All patients were followed-up for 24months until the occurrence of endpoints, including bleeding events, thrombotic events and all-cause mortality. Results A total of 718 patients were included in the analysis. Fifty-three events occurred during follow-up. There was less hemorrhage (3/240 vs. 16/241; hazard ratio [HR], 0.18; 95% confidence interval [CI], 0.07-0.45) and all-cause mortality (4/240 vs. 12/241; HR, 0.33; 95% CI, 0.12-0.87) observed in the D-dimer-guided group than in the standard-intensity group. A lower incidence of thrombotic events was also observed in the D-dimer-guided group when compared with the low-intensity group (5/240 vs. 14/237; HR, 0.35; 95% CI, 0.14-0.85). Overall, the total events were less in the D-dimer-guided group (9/240) when compared with the other two control groups (24/241, 20/237; HR, 0.37, 0.44; 95% CI, 0.19-0.72, 0.21-0.90 Conclusions The D-dimer-guided adjustment of anticoagulation intensity could reduce adverse events in Chinese patients after mechanical heart valve replacement. NCT01996657; ClinicalTrials.gov.

Effects of acarbose on cardiovascular and diabetes outcomes in patients with coronary heart disease and impaired glucose tolerance (ACE): a randomised, double-blind, placebo-controlled trial

The effect of the α-glucosidase inhibitor acarbose on cardiovascular outcomes in patients with coronary heart disease and impaired glucose tolerance is unknown. We aimed to assess whether acarbose could reduce the frequency of cardiovascular events in Chinese patients with established coronary heart disease and impaired glucose tolerance, and whether the incidence of type 2 diabetes could be reduced. The Acarbose Cardiovascular Evaluation (ACE) trial was a randomised, double-blind, placebo-controlled, phase 4 trial, with patients recruited from 176 hospital outpatient clinics in China. Chinese patients with coronary heart disease and impaired glucose tolerance were randomly assigned (1:1), in blocks by site, by a centralised computer system to receive oral acarbose (50 mg three times a day) or matched placebo, which was added to standardised cardiovascular secondary prevention therapy. All study staff and patients were masked to treatment group allocation. The primary outcome was a five-point composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospital admission for unstable angina, and hospital admission for heart failure, analysed in the intention-to-treat population (all participants randomly assigned to treatment who provided written informed consent). The secondary outcomes were a three-point composite outcome (cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), death from any cause, cardiovascular death, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, hospital admission for unstable angina, hospital admission for heart failure, development of diabetes, and development of impaired renal function. The safety population comprised all patients who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, number NCT00829660, and the International Standard Randomised Controlled Trial Number registry, number ISRCTN91899513. Between March 20, 2009, and Oct 23, 2015, 6522 patients were randomly assigned and included in the intention-to-treat population, 3272 assigned to acarbose and 3250 to placebo. Patients were followed up for a median of 5·0 years (IQR 3·4-6·0) in both groups. The primary five-point composite outcome occurred in 470 (14%; 3·33 per 100 person-years) of 3272 acarbose group participants and in 479 (15%; 3·41 per 100 person-years) of 3250 placebo group participants (hazard ratio 0·98; 95% CI 0·86-1·11, p=0·73). No significant differences were seen between treatment groups for the secondary three-point composite outcome, death from any cause, cardiovascular death, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, hospital admission for unstable angina, hospital admission for heart failure, or impaired renal function. Diabetes developed less frequently in the acarbose group (436 [13%] of 3272; 3·17 per 100 person-years) compared with the placebo group (513 [16%] of 3250; 3·84 per 100 person-years; rate ratio 0·82, 95% CI 0·71-0·94, p=0·005). Gastrointestinal disorders were the most common adverse event associated with drug discontinuation or dose changes (215 [7%] of 3263 patients in the acarbose group vs 150 [5%] of 3241 in the placebo group [p=0·0007]; safety population). Numbers of non-cardiovascular deaths (71 [2%] of 3272 vs 56 [2%] of 3250, p=0·19) and cancer deaths (ten [<1%] of 3272 vs 12 [<1%] of 3250, p=0·08) did not differ between groups. In Chinese patients with coronary heart disease and impaired glucose tolerance, acarbose did not reduce the risk of major adverse cardiovascular events, but did reduce the incidence of diabetes. Bayer AG.

Upper Gastrointestinal Complications and Cardiovascular/Gastrointestinal Risk Calculator in Patients with Myocardial Infarction Treated with Aspirin.

Background:Aspirin is widely used for the prevention of cardiovascular and cerebrovascular diseases for the past few years. However, much attention has been paid to the adverse effects associated with aspirin such as gastrointestinal bleeding. How to weigh the benefits and hazards? The current study aimed to assess the feasibility of a cardiovascular/gastrointestinal risk calculator, AsaRiskCalculator, in predicting gastrointestinal events in Chinese patients with myocardial infarction (MI), determining unique risk factor(s) for gastrointestinal events to be considered in the calculator.Methods:The MI patients who visited Shapingba District People's Hospital between January 2012 and January 2016 were retrospectively reviewed. Based on gastroscopic data, the patients were divided into two groups: gastrointestinal and nongastrointestinal groups. Demographic and clinical data of the patients were then retrieved for statistical analysis. Univariate and multiple logistic regression analyses were used to identify independent risk factors for gastrointestinal events. The receiver operating characteristic (ROC) curves were used to assess the predictive value of AsaRiskCalculator for gastrointestinal events.Results:A total of 400 MI patients meeting the eligibility criteria were analyzed, including 94 and 306 in the gastrointestinal and nongastrointestinal groups, respectively. The data showed that age, male gender, predicted gastrointestinal events, and Helicobacter pylori (HP) infection were positively correlated with gastrointestinal events. In multiple logistic regression analysis, predicted gastrointestinal events and HP infection were identified as risk factors for actual gastrointestinal events. HP infection was highly predictive in Chinese patients; the ROC curve indicated an area under the curve of 0.822 (95% confidence interval: 0.774–0.870). The best diagnostic cutoff point of predicted gastrointestinal events was 68.0‰, yielding sensitivity and specificity of 60.6% and 93.1%, respectively, for predicting gastrointestinal events in Chinese patients with MI.Conclusions:AsaRiskCalculator had a predictive value for gastrointestinal events in Chinese patients with MI. HP infection seemed to be an independent risk factor for gastrointestinal events caused by long-term aspirin treatment in Chinese patients with MI, and it should be included in the risk calculator adapted for Chinese patients.

Serum fibrinogen and cardiovascular events in Chinese patients with type 2 diabetes and stable coronary artery disease: a prospective observational study

ObjectivesThe aim of this study was to investigate the association of serum fibrinogen with cardiovascular events (CVE) in Chinese patients with type 2 diabetes mellitus (T2DM) and stable coronary artery...