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Background: Integrative medicine is commonly used in China. Researchers prefer to report efficacy outcomes rather than safety outcomes in clinical trials; thus, evidence regarding safety in integrative medicine is unclear. Developing a core outcome set (COS) for safety outcomes is necessary. In this study, a representative example of the methodology for developing COS to assess safety outcomes of cardiovascular diseases in clinical trials investigating integrated medicine will be developed., Methods and Analysis: Safety information will be extracted from package inserts and through systematic reviews of treatments for cardiovascular diseases (including angina pectoris, myocardial infarction, heart failure, arrhythmia, and hypertension) to develop an extensive list of safety outcomes, which will then be categorized according to whether subjective or objective outcomes. Questionnaires for clinician-reported safety outcomes and patient-reported safety outcomes will be developed. Two rounds of the Delphi survey will then be conducted for different stakeholders (traditional Chinese medicine clinicians and researchers in cardiovascular diseases, Western medicine clinicians and researchers in cardiovascular diseases, integrated medicine clinicians and researchers of cardiovascular diseases, pharmacologists, methodologists of evidence-based medicine, and patients). After round 2 of the Delphi analysis, a face-to-face consensus meeting will be held to determine the final COS for assessing safety outcomes in cardiovascular diseases., Discussion: A COS for safety outcomes in cardiovascular diseases may improve the consistency of reporting results and will help identify potential bias of selective reporting in the future., Trial Registration: This study was registered in the Core Outcome Measures in Effectiveness Trials database as study 1564 ., (© 2022. The Author(s).)

Cardiovascular disease (CVD)-related mortality and morbidity are among the most critical disease burdens worldwide. CVDs encompass many diseases and involve complex pathogenesis and pathological changes. While research on these diseases has advanced significantly, treatments and their efficacy remain rather limited. New therapeutic strategies and targets must, therefore, be explored. Tissue transglutaminase (TG2) is pivotal to the pathological development of CVDs, including participating in the cross-linking of extracellular proteins, activation of fibroblasts, hypertrophy and apoptosis of cardiomyocytes, proliferation and migration of smooth muscle cells (SMCs), and inflammatory reactions. Regulating TG2 activity and expression could ensure remarkable improvements in disorders like heart failure (HF), pulmonary hypertension (PH), hypertension, and coronary atherosclerosis. In this review, we summarize recent advances in TG2: we discuss its role and mechanisms in the progression of various CVDs and its potential as a diagnostic and therapeutic target., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background The detrimental effects of increased variability in systolic blood pressure (SBP) on cardiovascular disease (CVD) and mortality risk in patients with diabetes mellitus remains unclear. This study evaluated age-specific association of usual SBP visit-to-visit variability with CVD and mortality in patients with type 2 diabetes mellitus. Methods and Results A retrospective cohort study investigated 155 982 patients with diabetes mellitus aged 45 to 84 years without CVD at baseline (2008-2010). Usual SBP variability was estimated using SBP SD obtained from a mixed-effects model. Age-specific associations (45-54, 55-64, 65-74, 75-84 years) between usual SBP variability, CVD, and mortality risk were assessed by Cox regression adjusted for patient characteristics. After a median follow-up of 9.7 years, 49 816 events (including 34 039 CVD events and 29 211 mortalities) were identified. Elevated SBP variability was independently, positively, and log-linearly associated with higher CVD and mortality risk among all age groups, with no evidence of any threshold effects. The excess CVD and mortality risk per 5 mm Hg increase in SBP variability within the 45 to 54 age group is >3 times higher than the 70 to 79 age group (hazard ratio, 1.66; 95% CI, 1.49-1.85 versus hazard ratio, 1.19; 95% CI, 1.15-1.23). The significant associations remained consistent among all subgroups. Patients with younger age had a higher association of SBP variability with event outcomes. Conclusions The findings suggest that SBP visit-to-visit variability was strongly associated with CVD and mortality with no evidence of a threshold effect in a population with diabetes mellitus. As well as controlling overall blood pressure levels, SBP visit-to-visit variability should be monitored and evaluated in routine practice, in particular for younger patients.

Background The relationship between systolic blood pressure (SBP) and cardiovascular disease (CVD) among patients with diabetes mellitus remains unclear. The study aimed to explore age-specific associations between SBP and CVD. Methods and Results A population-based retrospective cohort study was conducted on 180 492 Chinese adults with type 2 diabetes mellitus in 2008-2010, with follow-up to 2017. Age-specific associations (<50, 50-59, 60-69, and 70-79 years) between the average SBP in the previous 2 years and CVD risk were assessed by adjusted Cox proportional hazards regression with age-specific regression dilution ratios and patient characteristics stratified by subgroups. During a median follow-up of 9.3 years (1.5 million person-years), 32 545 patients developed a CVD, with an incidence rate of 23.4 per 1000 person-years. A positive and log-linear association between SBP and CVD risk was observed among the 4 age groups without evidence of a threshold down to 120 mm Hg, but the magnitude of SBP effect on CVD attenuated with increased age. The CVD risk in the age group <50 years was ≈22% higher than the age group 70 to 79 years (hazard ratio [HR], 1.33 [95% CI, 1.26-1.41] versus HR, 1.09 [95% CI, 1.07-1.11]). Each 10-mm Hg higher SBP was associated with 12% (HR, 1.12 [95% CI, 1.10-1.13]), 11% (HR, 1.11 [95% CI, 1.10-1.13]), and 20% (HR, 1.20 [95% CI, 1.17-1.22]) higher risk of all composite CVD events, individual CVD, and CVD mortality, respectively. Conclusions There is a significant log-linear relationship between baseline SBP and the risk of CVD among patients with diabetes mellitus in China. The risk increases from an SBP of 120 mm Hg onward. Age influences this relationship significantly, with younger patients (<50 years) having a greater risk of CVD for a similar rise in SBP as compared with those who are older. These findings suggest that differential target blood pressures stratified by age maybe useful.

Existing studies have typically investigated only the association between single pollutants and health outcomes. However, in the real world, people are exposed to multiple air pollutants simultaneously. The effect of air pollutants on emergency department (ED) visits has not been previously studied in the Sichuan Basin, which is one of the most polluted areas. We collected nonaccidental, respiratory and cardiovascular daily ED visits and daily concentrations of PM 2.5 , PM c , CO, SO 2 , NO 2 and O 3 in Chengdu, China, from 2014 to 2016. A weighted variable for the combination of multiple air pollutants was constructed to assess the joint adverse health effects. Each air pollutant was assigned a health-related weight, which indicated the pollutant's relative contribution to the joint effect. The effects on specific subpopulations (males and females; 15–65 years old and >65 years old) were also examined. With an increase of 10 μg/m3 of the combined multiple air pollutants, the daily ED visits for nonaccidental, respiratory and cardiovascular causes increased by 0.96% (95% CI: 0.51%–1.39%), 1.19% (95% CI: 0.53%, 1.85%) and 4.36% (95% CI: 1.06%, 7.76%) at lag 1, respectively. Males presented more pronounced effects, except for cardiovascular disease, than females. Elderly individuals were found to be more sensitive than young individuals. For nonaccidental and respiratory diseases, the contributions of particulate matter (PM) were dominant among the air pollutants, whereas cardiovascular disease was mainly affected by gaseous air pollutants. The combination of multiple air pollutants was significantly associated with ED visits in the Sichuan Basin, China. The joint effect of the combination of multiple air pollutants was highest for cardiovascular disease at lag 1. The relative contributions of individual pollutants varied by disease and subpopulation. These findings suggest that under different pollution scenarios, preventive strategies should target those with different diseases and different subpopulations. Image 1 • The joint effects on emergency department visits were significant. • The contributions of pollutants varied by disease and subpopulation. • Particulate matter had dominant effect on nonaccidental and respiratory diseases. • Gaseous pollutants had important effect on cardiovascular disease. The joint effect of multiple air pollutants on ED visits was highest for cardiovascular disease at lag 1, and the contributions of pollutants varied by disease and subpopulation. [ABSTRACT FROM AUTHOR]