Absolute Cardiovascular Risk Research Articles

A Cross-sectional Survey to Assess the Risk Factors of Cardiovascular Disease among College Students

Abstract Introduction: Cardiovascular diseases (CVDs) are the number one cause of death globally which claim an estimated 17.9 million lives each year. It is a major cause of disability and premature death throughout the world and contributes substantially to the escalating costs of health care. Modification of risk factors has been shown to reduce mortality and morbidity in people with diagnosed or undiagnosed CVDs. Prior assessment is found to be helpful in predictions of absolute cardiovascular risks among young adults. Objectives: The objective of the study was to assess the risk factors of cardiovascular diseases among college students. Materials and Methods: A descriptive survey was conducted among 207 college students at Najath College of Science and Technology, Karuvarakundu, Kerala from October 10, 2019, to October 18, 2019. Convenient sampling method was used to select the samples. Structured risk factor assessment Pro forma and Biophysical measurements were used as tools. Result: The study identified 40.57% of students as at moderate risk and 5.31% were at high risk for developing cardiovascular diseases. The study reported that 6.2% of students were overweight, whereas 45% had elevated blood pressure. It was found that 64.25% of the students had a family history of chronic illnesses such as diabetes, hypertension, stroke, and obesity. The 8.21% of students were smokers out of these, 17.39% were using smokeless tobacco, whereas 31.88% were exposed to passive smoking and 12.56% of students were drinkers. In terms of physical activity, 62.31% of the students were sedentary. The food habits of 98.56% of students were nonvegetarian and 46.85% of them were consuming red meat. Conclusions: Periodic assessment and comprehensive health awareness would be helpful to modify unhealthy habits and minimize the risk of cardiovascular problems among the college students.

Women living with HIV: identifying and managing their menopause, age-related, and psychosocial health needs in a metropolitan sexual health service in Sydney, Australia.

Background Aging women living with HIV are significantly affected by menopause and comorbidities, yet international and Australian HIV guidance on the management of women is scarce. This study aimed to identify gaps in clinical management of menopause, age-related comorbidities, and psychosocial health of women living with HIV attending our metropolitan sexual health service. Methods A clinical audit of all cisgender women who attended Sydney Local Health District Department of Sexual Health Medicine for ongoing routine HIV care between 1 January 2021 and 1 January 2023 was undertaken. Results Twenty-seven patient files were examined. Half (13/27, 48.1%) of women were age 45years and older, of whom 6/13 (46.2%) were postmenopausal and 4/13 (30.8%) did not have menopause status recorded. In the prior 12months, most women had their blood pressure (19/27, 70.4%), total cholesterol (21/27, 77.8%), glycated haemoglobin (21/27, 77.8%), estimated glomerular filtration rate (27/27, 96.3%), and liver function tests (26/27, 96.3%) measured. Smoking and alcohol intake was documented for less than half of women (13/27, 48.1%; and 12/27, 44.4%; respectively). In women aged 45years and older, absolute cardiovascular disease risk was calculated in 2/13 (15.4%), and none had a Fracture Risk Assessment Tool score or cognitive screen performed in the prior 12months. One-fifth (5/27, 18.5%) had a documented history of depression or anxiety. Of those screened, half (4/8, 50.0%) disclosed past intimate partner violence. Conclusions Our service has now implemented a reference tool to guide routine monitoring of women living with HIV, with sections dedicated to reproductive health and psychological wellbeing. Australian HIV management guidelines would benefit from specific guidance for women.

Cardiometabolic Risk in a University Community: An Observational Study.

The highest prevalence of cardiovascular risk factors has been associated with obesity, sedentary lifestyle, and elevated blood pressure due to high workload and work stress. This study aimed to analyze the cardiometabolic risk and lifestyles among the health sciences university academics and campus administrators at a private university in Spain. A cross-sectional study was conducted during the 2018-2019 academic year by the Nursing Department, using a self-administered questionnaire and face-to-face assessments of anthropometric variables related to cardiovascular risk in university personnel. The variables measured included sociodemographics, cardiovascular risk history, comorbidities, toxic habits, Mediterranean diet adherence, physical exercise, psychosocial stress, and physical, anthropometric, and analytical data. Cardiovascular risk was categorized into relative (<40 years), absolute, and vascular age (>40 years). Among the 101 participants, 61.4% were women, with a mean age of 41.3 years ± 9 years. The smoking prevalence was 21.8% (68.2% women), 27.7% were sedentary, and 51.0% adhered to the Mediterranean diet, with higher adherence among the academics. Emotional risk was present in 32.7% of the participants. A prior diagnosis of hypertension was significantly more frequent in the men (15.4%) compared to the women (3.2%). The blood pressure measurements were mostly optimal across both genders and professional groups, but the proportion of hypertension grade 1 was significantly higher among the academics (10%) compared to the administrators (4.5%) and among the men (11.1%) compared to the women (5.9%). The absolute cardiovascular risk among the university employees was generally low, but the men exhibited a more moderate risk compared to the women. It is necessary for the university to promote health within its community, with the Nursing Department playing a key role in health promotion and research.

Absolute cardiovascular risk assessment using ‘real world’ clinic blood pressures compared to standardized unobserved and ambulatory methods: an observational study

Clinic blood pressure (BP) is recommended for absolute cardiovascular disease (CVD) risk assessment. However, in ‘real-world’ settings, clinic BP measurement is unstandardised and less reliable compared to more rigorous methods but the impact for absolute CVD risk assessment is unknown. This study aimed to determine the difference in absolute CVD risk assessment using real-world clinic BP compared to standardised BP methods. Participants were patients (n = 226, 59 ± 15 years; 58% female) with hypertension referred to a BP clinic for assessment. ‘Real-world’ clinic BP was provided by the referring doctor. All participants had unobserved automated office BP (AOBP) and 24-h ambulatory BP monitoring (ABPM) measured at the clinic. Absolute CVD risk was calculated (Framingham) using systolic BP from the referring doctor (clinic BP), AOBP and ABPM, with agreement assessed by Kappa statistic. Clinic systolic BP was 18 mmHg than AOBP and daytime ABPM and 22 mmHg higher than 24-h ABPM (p < 0.001). Subsequently, absolute CVD risk scores using clinic BP were higher compared to AOBP, daytime ABPM and 24-h ABPM (10.4 ± 8.1%, 7.8 ± 6.4%, 7.8 ± 6.3%, and 7.3 ± 6.1%, respectively, P < 0.001). As a result, more participants were classified as high CVD risk using clinic BP (n = 89, 40%) compared with AOBP (n = 44, 20%) daytime ABPM (n = 38, 17%) and 24-h ABPM (n = 38, 17%) (p < 0.001) with weak agreement in risk classification (κ = 0.57[0.45–0.69], κ = 0.52[0.41–0.64] and κ = 0.55[0.43–0.66], respectively). Real-world clinic BP was higher and classified twice as many participants at high CVD risk compared to AOBP or ABPM. Given the challenges to high-quality BP measurement in clinic, more rigorous BP measurement methods are needed for absolute CVD risk assessment.

The use of imputation in clinical decision support systems: a cardiovascular risk management pilot vignette study among clinicians

Abstract Aims A major challenge of the use of prediction models in clinical care is missing data. Real-time imputation may alleviate this. However, to what extent clinicians accept this solution remains unknown. We aimed to assess acceptance of real-time imputation for missing patient data in a clinical decision support system (CDSS) including 10-year cardiovascular absolute risk for the individual patient. Methods and results We performed a vignette study extending an existing CDSS with the real-time imputation method joint modelling imputation (JMI). We included 17 clinicians to use the CDSS with three different vignettes, describing potential use cases (missing data, no risk estimate; imputed values, risk estimate based on imputed data; complete information). In each vignette, missing data were introduced to mimic a situation as could occur in clinical practice. Acceptance of end-users was assessed on three different axes: clinical realism, comfortableness, and added clinical value. Overall, the imputed predictor values were found to be clinically reasonable and according to the expectations. However, for binary variables, use of a probability scale to express uncertainty was deemed inconvenient. The perceived comfortableness with imputed risk prediction was low, and confidence intervals were deemed too wide for reliable decision-making. The clinicians acknowledged added value for using JMI in clinical practice when used for educational, research, or informative purposes. Conclusion Handling missing data in CDSS via JMI is useful, but more accurate imputations are needed to generate comfort in clinicians for use in routine care. Only then can CDSS create clinical value by improving decision-making.

(006) GENITAL VASCULAR RESISTANCE AS A PREDICTOR OF CARDIOVASCULAR RISK ACCORDING TO THE ANALYSIS OF THE PROGETTO CUORE IN PREMENOPAUSAL WOMEN

Abstract Introduction Gender disparity persists in the relationship between sexual dysfunction and cardiovascular risk (CV). It is well- known that erectile dysfunction (ED) represents a sign of subclinical CV pathology and that alterations in color Doppler penile ultrasound parameters serve as predictive markers of major CV events. Female sexual dysfunction (FSD) is a complex condition that involves psychological and organic components, including the cardiovascular system, and affects the quality of life of over a third of women. However, despite its high prevalence, little attention has been paid to the vascular system responsible for blood supply to the female genital apparatus. In men, the hypothesis of penile artery size is a proposed pathophysiological mechanism to address the relationship between the onset of ED symptoms and cardiovascular disease. In recent years, it has also been highlighted that compromised genital vascularization may be a precursor to cardiovascular diseases in women. Objective Our ami gas to investigate the association between clitoral pulsatility index (PI), evaluated through Clitoral color Doppler ultrasound (CDU), and cardiometabolic risk factors in women referred to the Andrology, Women’s Endocrinology and Gender Incongruence Unit, Careggi University Hospital, Florence, Italy. Methods In an observational study, a total of 361 women with a mean age of 45.1 (±13.3) years were evaluated. All patients underwent a thorough medical history assessment, an evaluation of anthropometric parameters, blood sampling for measurement of metabolic and hormonal parameters and a Doppler ultrasound of the clitoral cavernous artery to measure the PI. Results 23.5% of the patients were overweight and 11.6% were obese, 16.3% had hypertension, and 18.6% had metabolic syndrome. In the multivariate analysis, after adjusting for age, the PI was positively correlated with body mass index (BMI) (ß=0.160, p=0.003) and waist circumference (ß=0.186, p=0.002). Furthermore, all women underwent cardiovascular risk assessment, as indicated by Progetto CUORE, assigning a score based on the presence of risk factors (blood pressure, cholesterol levels, smoking, diabetes, age, gender) to estimate the absolute global cardiovascular risk over the next 10 years. We observed that, particularly in women of reproductive age, the clitoral PI was positively correlated with the Progetto CUORE score (r=0.136, p=0.035). Conclusions Clitoral PI increases in relation to several cardiometabolic risk factors. It is therefore relevant to understand how common cardiometabolic alterations may influence vascular function in the female genital tract and whether treating these alterations leads to an improvement in clitoral ultrasound indices, especially in young premenopausal women. Disclosure No.

Implementing absolute cardiovascular disease risk assessment into pathology collection services.

Pathology services represent an ideal setting to integrate absolute cardiovascular disease (CVD) risk estimation when patients attend for routine cholesterol testing. This study aimed to explore the process of implementing CVD risk estimation into point-of-care service delivery by pathology staff to inform future implementation and sustainability. A new service for CVD risk estimation via a self-directed screening station was implemented into 14 pathology service sites across Tasmania, Australia. Before implementation, observations at pathology services (n = 26) and semi-structured interviews were undertaken with 26 pathology staff (88% female, 77% aged 41-60 years) to identify factors that could impact implementation of the service. The process of implementation was then evaluated using participant observations and clinical trial recruitment data. Transcripts and field notes were analysed thematically according to the Medical Research Council Framework and used to develop a programme logic model to understand how the service could be adapted to be successfully integrated into routine workflow at pathology services. Eight key themes were identified during the pre-implementation phase as important factors that could impact upon integration of CVD risk estimation into pathology services. Themes related to factors within the organisation, including available resources, logistics and workflow, as well as having sufficient time to complete the intervention. Additional factors related to the individual motivations of staff, collaborative leadership and patient characteristics. Success of implementation varied among sites, requiring the trialling of different strategies to support uptake of the service and patient recruitment. Implementing CVD risk estimation into point-of-care pathology services required an understanding of the core implementation components specific to each context, and for implementation strategies to be targeted to the individual and organisational contexts. The generated programme logic model may be useful in guiding future implementation endeavours within these services and aiding the selection of apt implementation strategies. ClinicalTrials.gov Identifier: NCT04896021, registered 19/05/2021, https://clinicaltrials.gov/study/NCT04896021.

Australian and New Zealand Living Guideline cholesterol-lowering therapy for people with chronic kidney disease (CARI Guidelines): Reducing the evidence-practice gap.

People with chronic kidney disease experience high rates of cardiovascular disease. Cholesterol-lowering therapy is a mainstay in the management but there is uncertainty in the treatment effects on patient-important outcomes, such as fatigue and rhabdomyolysis. Here, we summarise the updated CARI Australian and New Zealand Living Guidelines on cholesterol-lowering therapy in chronic kidney disease. We updated a Cochrane review and monitored newly published studies weekly to inform guideline development according to international standards. The Working Group included expertise from nephrology, cardiology, Indigenous Health, guideline development and people with lived experience of chronic kidney disease. The guideline recommends people with chronic kidney disease (eGFR ≥15 mL/min/1.73 m2) and an absolute cardiovascular risk of 10% or higher should receive statin therapy (with or without ezetimibe) to reduce the risk of cardiovascular events and death (strong recommendation, moderate certainty evidence). The guidelines also recommends a lower absolute cardiovascular risk threshold (≥5%) for Aboriginal and Torres Strait Islander Peoples and Māori with chronic kidney disease to receive statin therapy (with or without ezetimibe) (strong recommendation, low certainty evidence). The evidence was actively surveyed from 2020-2023 and updated as required. No changes to guideline recommendations were made, with no new data on the balance and benefits of harms. The development of living guidelines was feasible and provided the opportunity to update recommendations to improve clinical decision-making in real-time. Living guidelines provide the opportunity to transform chronic kidney disease guidelines.

Association between Hearing Aid Use and Cognitive Function in Persons with Hearing Impairment Stratified by Cardiovascular Risk.

The purpose of this study was to conduct a cross-sectional analysis of the association between hearing aid use and cognitive decline in community-dwelling older adults with hearing impairment, stratified by cardiovascular risk level. This cross-sectional study covers 1857 hearing-impaired individuals selected among 10,674 community-dwelling older adults (≥65 years of age) in Japan. We investigate the association between hearing aid use and cognitive decline stratified by cardiovascular risk level, by assessing self-reported hearing impairment and hearing aid use, absolute cardiovascular risk, cognitive function, and potential confounding factors. The association between hearing impairment severity and increased cardiovascular risk, and the benefit of hearing aid use in preventing cognitive decline, were examined in a binomial logistic regression analysis, with the presence of cognitive decline as the objective variable. In the low cardiovascular risk group, hearing aid users had a lower odds ratio for decline in executive function than non-users (odds ratio = 0.61, 95% confidence interval: 0.39-0.98). However, there was no significant association between hearing aid use and cognitive decline in the high cardiovascular risk group (p > 0.05). Among older adults with hearing impairment, hearing aid use was associated with the maintenance of executive function in individuals of low cardiovascular risk.

Unexplained Residual Risk In Type 2 Diabetes: How Big Is The Problem?

What is new? Cardiovascular disease (CVD) is the leading cause of mortality in type 2 diabetes (T2D) individuals. Of the major risk factors for CVD, less than 10% of T2D people meet the American Diabetes Association/American Heart Association recommended goals of therapy. The present review examines how much of the absolute cardiovascular (CV) risk in type 2 diabetes patients can be explained by major CV intervention trials. Multiple long-term cardiovascular (CV) intervention trials have examined the effect of specific target-directed therapies on the MACE endpoint. Only one prospective study, STENO-2, has employed a multifactorial intervention comparing intensified versus conventional treatment of modifiable risk factors in T2D patients, and demonstrated a 20% absolute CV risk reduction. If the absolute CV risk reduction in these trials is added to that in the only prospective multifactorial intervention trial (STENO-2), the unexplained CV risk is 44.1%. What are the clinical implications? Potential explanations for the unaccounted-for reduction in absolute CV risk in type 2 diabetes (T2D) patients are discussed. failure to take into account synergistic interactions between major cardiovascular risk factors is responsible for the unexplained CV risk in T2D patients. Simultaneous treatment of all major CV risk factors to recommended AHA/ADA guideline goals is required to achieve the maximum reduction in CV risk.

Making predictions under interventions: a case study from the PREDICT-CVD cohort in New Zealand primary care.

Most existing clinical prediction models do not allow predictions under interventions. Such predictions allow predicted risk under different proposed strategies to be compared and are therefore useful to support clinical decision making. We aimed to compare methodological approaches for predicting individual level cardiovascular risk under three interventions: smoking cessation, reducing blood pressure, and reducing cholesterol. We used data from the PREDICT prospective cohort study in New Zealand to calculate cardiovascular risk in a primary care setting. We compared three strategies to estimate absolute risk under intervention: (a) conditioning on hypothetical interventions in non-causal models; (b) combining existing prediction models with causal effects estimated using observational causal inference methods; and (c) combining existing prediction models with causal effects reported in published literature. The median absolute cardiovascular risk among smokers was 3.9%; our approaches predicted that smoking cessation reduced this to a median between a non-causal estimate of 2.5% and a causal estimate of 2.8%, depending on estimation methods. For reducing blood pressure, the proposed approaches estimated a reduction of absolute risk from a median of 4.9% to a median between 3.2% and 4.5% (both derived from causal estimation). Reducing cholesterol was estimated to reduce median absolute risk from 3.1% to between 2.2% (non-causal estimate) and 2.8% (causal estimate). Estimated absolute risk reductions based on non-causal methods were different to those based on causal methods, and there was substantial variation in estimates within the causal methods. Researchers wishing to estimate risk under intervention should be explicit about their causal modelling assumptions and conduct sensitivity analysis by considering a range of possible approaches.

For which patients do the latest lipid lowering treatments reduce cardiovascular events?

Dyslipidemia is a modifiable risk factor for cardiovascular diseases. Recommendations are based on achieving LDL-C target levels, but it is essential to assess the benefits of intensifying lipid-lowering therapy in terms of absolute risk reduction of cardiovascular events across different risk groups. Current data on the absolute benefits of the latest lipid-lowering treatments are more limited in comparison with statins. A recent analysis showed that adding a second lipid-lowering treatment only reduces the absolute cardiovascular risk in patients at very high and high cardiovascular risk, without a substantial benefit in patients at moderate or low cardiovascular risk, as mentioned in the recent recommendations free of conflict of interest and published in the British Medical Journal.

Managing hypercholesterolaemia.

Hypercholesterolaemia is one of the most common conditions treated by clinicians in Australia. Low-density lipoprotein cholesterol (LDL-C) plays a causal role in the development and progression of atherosclerosis and cardiovascular disease. Every 1 mmol/L reduction in LDL-C concentration is associated with a 21 to 25% reduction in the relative risk of prospective atherosclerotic cardiovascular events, and emerging evidence suggests this benefit increases over time. Absolute cardiovascular risk assessment identifies patients likely to derive the most benefit from lowering LDL-C concentration, and helps determine the intensity of their treatment regimens and targets. Optimal management of LDL-C may require combination treatment with multiple classes of drugs.

Circulating culprit or therapeutic bullseye: lipoprotein(a) in cardiovascular risk assessment and novel therapeutic prospects

Lipoprotein(a) [Lp(a)] has emerged as a significant player in the realm of cardiovascular disease (CVD), exerting a pivotal role in atherosclerotic cardiovascular disease (ASCVD), aortic valve stenosis (AVS), and overall cardiovascular (CV) and all-cause mortality. Since its discovery in 1963 by Kåre Berg, our understanding of Lp(a) has undergone significant evolution. This comprehensive review delves into the genetics, structure, assembly, and inter-population differences of Lp(a), shedding light on its intricate involvement in CVD. Genetically, Lp(a) is primarily influenced by variations in the LPA gene. The LPA gene encodes apo(a) and the variation in the kringle domains is the main determinant of plasma Lp(a) levels. Other genetic variants, such as SNPs in the LPA gene region, the pentanucleotide repeat polymorphism, and specific SNPs in the coding sequences of kringle domains, have also been associated with varying Lp(a) concentrations. Additionally, genes outside the LPA locus, including APOE, APOH, and CEPT gene regions, contribute to Lp(a) variability across different populations. Inter-population differences in Lp(a) levels are evident, with ethnicity and sex playing significant roles. Racial disparities in median Lp(a) concentration have been observed, with black individuals often displaying higher levels compared to their white counterparts. The review underscores Lp(a) as an independent, heritable CV risk factor in both primary and secondary settings. High Lp(a) levels are closely linked to the recurrence of myocardial infarction, AVS, and CV events. The necessity of measuring Lp(a) concentration at least once in life to assess an individual's absolute global CV risk is emphasized. Despite substantial progress, many questions remain unanswered about Lp(a), including its physiological role in the cardiovascular system and its involvement in inflammatory and thrombotic processes. Ongoing research holds promise for the development of therapeutic interventions, such as pharmacological agents and apheresis, to mitigate the cardiovascular risks associated with elevated Lp(a) levels. This review highlights the multifaceted nature of Lp(a) in the context of cardiovascular health, emphasizing the importance of continued research efforts to unravel its complexities and develop innovative strategies for managing its associated risks.

ЭФФЕКТИВНОСТЬ ФИЗИОТЕРАПИИ У РАБОТНИКОВ РЕЧНОГО ТРАНСПОРТА, ИМЕЮЩИХ ДОКЛИНИЧЕСКИЕ СТАДИИ СЕРДЕЧНО-СОСУДИСТЫХ ЗАБОЛЕВАНИЙ, И ФАКТОРЫ РИСКА ИХ РАЗВИТИЯ

Aim. The primary objective of this study was to evaluate the effect of physical therapy on blood pressure, dyslipidemia, the level of somatic and mental health, and cardiovascular risk in river transport workers with preclinical stages of cardiovascular disease and risk factors for their development. Methods. Sixty-two employees of JSC "Tomsk Shipping Company" who were divided into 2 groups were studied. The first group consisted of riverboat workers with risk factors for cardiovascular disease, and the second group included workers with preclinical stages of cardiovascular disease and risk factors for their development. In the river transport crew, the correction of the main risk factors for cardiovascular disease was carried out following the DASH diet, moderate physical activity, application of physical factors, preventive talks, and biofeedback training. In preclinical forms of cardiovascular disease (AH of the 1st degree), complex hypotensive therapy was also applied. To study the effectiveness before and after physical therapy, BP was recorded, the level of somatic health and psychoemotional status was evaluated, the adaptation potential was calculated, the contents of total cholesterol and low density lipoprotein cholesterol, as well as absolute or relative cardiovascular risk were determined. Results. Therapeutic and prophylactic measures allow to increase adaptation and psychological capabilities of rivermen, to normalize blood pressure in all workers of the river transport crew under 40 years old, to reduce the degree of arterial hypertension in workers over 40 years old, to reach target values of total cholesterol and low density lipoprotein cholesterol in 18% of cases, to increase the level of somatic health in 1/3 of workers, and to reduce the level of cardiovascular risk in 38% of workers. Conclusion. The therapeutic and prophylactic measures carried out on the seafaring personnel had positive hypotensive, antispastic, antianginal, hemodynamic, lipid-correcting, and adaptogenic effects.

Efficacy and safety of bempedoic acid among patients with and without diabetes: prespecified analysis of the CLEAR Outcomes randomised trial

Statins reduce LDL cholesterol and cardiovascular events among those with or without diabetes but have been reported to increase new-onset diabetes. The CLEAR Outcomes trial demonstrated that bempedoic acid reduced the risk of major adverse cardiovascular events among statin-intolerant patients at high cardiovascular risk. In this prespecified analysis, our dual aims were to evaluate the cardiovascular benefits of bempedoic acid, an ATP-citrate lyase inhibitor, in individuals with diabetes, and to evaluate the risk of new-onset diabetes and HbA1c among those without diabetes in the CLEAR Outcomes trial. CLEAR Outcomes was a randomised, double-blind, placebo-controlled trial conducted across 1250 primary care and outpatient sites in 32 countries. Patients with or without cardiovascular disease who were unwilling or unable to take guideline-recommended doses of statins and an LDL cholesterol of 2·59 mmol/L or more were randomly assigned (1:1) in a double-blinded manner to either bempedoic acid 180 mg once per day or placebo. In this prespecified analysis, the efficacy endpoint was a time-to-event analysis of four-component major adverse cardiovascular event (MACE-4), which is the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularisation, using the intention-to-treat population stratified by baseline glycaemia status. The prespecified analysis of risk of new-onset diabetes and HbA1c increase was evaluated in patients without diabetes at baseline. The CLEAR Outcomes trial was completed on Nov 7, 2022, and is registered with ClinicalTrials.gov (NCT02993406). Between Dec 22, 2016, and Nov 7, 2022, 13 970 patients were screened and randomly assigned; 6373 (45·6%) with diabetes, 5796 (41·5%) with prediabetes, and 1801 (12·9%) with normoglycaemia. Over a median of 3·4 years follow up, patients with diabetes had significant relative and absolute cardiovascular risk reductions in MACE-4 endpoints with bempedoic acid (HR 0·83; 95% CI 0·72-0·95; absolute risk reduction of 2·4%) compared to placebo, with no statistical evidence of effect modification across glycaemic strata (interaction p=0·42). The proportion of patients who developed new-onset diabetes were similar between the bempedoic acid and placebo groups, with 429 of 3848 (11·1%) with bempedoic acid versus 433 of 3749 (11·5%) with placebo (HR 0·95; 95% CI 0·83-1·09). HbA1c concentrations at month 12 and the end of the study were similar between randomised groups in patients who had prediabetes and normoglycaemia. Placebo-corrected LDL cholesterol concentrations and high-sensitivity C-reactive protein at 6 months were reduced in each glycaemic stratum (diabetes, prediabtes, and normoglycaemia) for patients randomly assigned to bempedoic acid (all p<0·001). Among patients with diabetes, bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and risk of cardiovascular events. Patients without diabetes had no increase in new-onset diabetes or worsening HbA1c with bempedoic acid. The efficacy and cardiometabolic safety profile of bempedoic acid makes it a clinical option for those with and without diabetes. Esperion Therapeutics.

How to Use Janus Kinase Inhibitors in the Treatment of Rheumatoid Arthritis? A Clinical Assessment of Risks and Benefits.

To provide an updated understanding of risks and benefits of Janus kinase inhibitors (JAKi) versus biologic disease-modifying antirheumatic drugs (bDMARDs) in the management of rheumatoid arthritis (RA). Shared decision-making is needed in choosing between JAKi and bDMARDs. Cardiovascular disease, malignancy, and thromboembolic events guide this choice. In patients with active RA despite methotrexate use, tumor necrosis factor inhibitor is conditionally favored over JAKi for low-cardiovascular-risk patients and strongly favored in those with pre-existing cardiovascular disease or multiple cardiovascular risk factors.Suboptimal treatment of treatment-refractory RApatients may pose a greater absolute cardiovascular risk than with JAKi use. Use of aspirin and statin may be considered to reduce cardiovascular risk. New safety data on JAKi has redefined the treatment approach in RA. JAKi remains an important oral medication option in active RA despite treatment with bDMARDs, especially in those with low cardiovascular risk.

Cardiovascular disease incidence rates: a study using routinely collected health data

BackgroundThere is substantial evidence that systemic anticancer therapies and radiotherapy can increase the long-term risk of cardiovascular disease (CVD). Optimal management decisions for cancer patients therefore need to take into account the likely risks from a proposed treatment option, as well as its likely benefits. For CVD, the magnitude of the risk depends on the incidence of the disease in the general population to which the patient belongs, including variation with age and sex, as well as on the treatment option under consideration. The aim of this paper is to provide estimates of CVD incidence rates in the general population of England for use in cardio-oncology and in other relevant clinical, research and health policy contexts.MethodsWe studied a population-based representative cohort, consisting of 2,633,472 individuals, derived by electronic linkage of records from primary care with those of admitted-patient care in England during April 1, 2010, to April 1, 2015. From 38 individual CVDs available via the linked dataset we identified five relevant categories of CVD whose risk may be increased by cancer treatments: four of heart disease and one of stroke.ResultsWe calculated incidence rates by age-group and sex for all relevant CVD categories combined, for the four relevant categories of heart disease combined, and for the five relevant CVD categories separately. We present separate incidence rates for all 38 individual CVDs available via the linked dataset. We also illustrate how our data can be used to estimate absolute CVD risks in a range of people with Hodgkin lymphoma treated with chemotherapy and radiotherapy.ConclusionsOur results provide population-based CVD incidence rates for a variety of uses, including the estimation of absolute risks of CVD from cancer treatments, thus helping patients and clinicians to make appropriate individualized cancer treatment decisions.Graphical Graphical : Cardiovascular incidence rates for use in cardio-oncology and elsewhere: A presentation of age- and sex-specific cardiovascular disease (CVD) incidence rates for use in calculation of absolute cardiovascular risks of cancer treatments, and in other clinical, research and health policy contexts. Abbreviations– CVD: cardiovascular disease; y: years

Transformation to a patient-centred medical home led and delivered by an urban Aboriginal and Torres Strait Islander community, and association with engagement and quality-of-care: quantitative findings from a pilot study

BackgroundThe patient-centred medical home (PCMH) is a model of team-based primary care that is patient-centred, coordinated, accessible, and focused on quality and safety. In response to substantial population growth and increasing demand on existing primary care services, the Institute for Urban Indigenous Health (IUIH) developed the IUIH System of Care-2 (ISoC2), based on an international Indigenous-led PCMH. ISoC2 was piloted at an urban Aboriginal and Torres Strait Islander Community-Controlled Health Service in South-East Queensland between 2019–2020, with further adaptations made to ensure its cultural and clinical relevance to local Aboriginal and Torres Strait Islander people. Little is known on the implementation and impact of PCMH in the Australian Indigenous primary care setting. Changes in implementation process measures and outcomes relating to engagement and quality-of-care are described here.MethodsDe-identified routinely collected data extracted from electronic health records for clients regularly attending the service were examined to assess pre-post implementation changes relevant to the study. Process measures included enrolment in PCMH team-based care, and outcome measures included engagement with the health service, continuity-of-care and clinical outcomes.ResultsThe number of regular clients within the health service increased from 1,186 pre implementation to 1,606 post implementation; representing a small decrease as a proportion of the services’ catchment population (38.5 to 37.6%). In clients assigned to a care team (60% by end 2020), care was more evenly distributed between providers, with an increased proportion of services provided by the Aboriginal and Torres Strait Islander Health Worker (16–17% versus 10–11%). Post-implementation, 41% of clients had continuity-of-care with their assigned care team, while total, preventive and chronic disease services were comparable pre- and post-implementation. Screening for absolute cardiovascular disease risk improved, although there were no changes in clinical outcomes.ConclusionsThe increase in the number of regular clients assigned to a team and their even distribution of care among care team members provides empirical evidence that the service is transforming to a PCMH. Despite a complex transformation process compounded by the COVID-19 pandemic, levels of service delivery and quality remained relatively stable, with some improvements in risk factor screening.

Impact of lifestyle-based interventions on absolute cardiovascular disease risk: a systematic review and meta-analysis.

The objective of the review was to synthesize the evidence of the effectiveness of lifestyle-based interventions for mitigating absolute cardiovascular disease (CVD) risk. Evidence-based guidelines recommend employing an absolute CVD risk score to inform the selection and intensity of preventive interventions. However, studies employing this strategy have reported mixed results, hence the need for a systematic review of the current evidence. Studies published in English that included a lifestyle-based intervention to mitigate CVD risk were considered. Studies were eligible if they enrolled individuals aged ≥18 years, with no history of CVD at baseline. The primary outcome was change in absolute CVD risk score post-intervention. PubMed, Embase, and CINAHL searches were conducted from database inception to February 2022. The trial registers searched included Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov. Searches for unpublished studies/gray literature were conducted in ProQuest Dissertations and Theses Global, GreyLit Report, and OCLC First Search Proceedings. Two independent reviewers selected the studies and critically appraised them for methodological quality using JBI tools. Data extraction was performed for main outcome variables. Data were presented using separate pooled statistical meta-analysis for quasi-experimental and randomized clinical trials. Random effects models were employed in the analyses. Effect sizes (Cohen's d) were expressed as standardized mean difference at 95% CI. Heterogeneity was assessed via Cochran's Q statistic, and the inconsistency index ( I2 ) was used to describe variability in effect estimates due to heterogeneity rather than sampling error. Twenty-nine studies with a total sample of 5490 adults with no CVD at baseline were included. Fifteen were randomized controlled trials (RCTs; n=3605) and 14 were quasi-experimental studies (n=1885). The studies were conducted in Europe (n=18), the United States (n = 5), Asia (n=3), Mexico (n=1), Canada (n = 1), and Australia (n=1) and included the following lifestyle interventions: diet, physical activity, motivational interviewing, problem-solving, psychological counseling, cardiovascular risk assessment and feedback, health self-management education, and peer support. Six validated absolute CVD risk assessment tools were used to measure the study outcomes, including Framingham, SCORE, Heart Health Risk Assessment Score, Dundee, ASSIGN, and The UK Prospective Diabetes Study risk score. Overall, the methodological rigor of the RCTs and quasi-experimental studies was high. Of the 15 RCTs included in the meta-analysis, lifestyle intervention was favored over control in reducing absolute CVD risk score (Cohen's d = -0.39; P =0.032; Z= -2.14; I2 = 96). Similarly, in the 14 quasi-experimental studies, the absolute CVD risk score after lifestyle intervention was significantly lower compared to baseline (Cohen's d = -0.39; P <0.001; Z= -3.54; I2= 88). RCTs that combined diet and physical activity reported no significant impact on absolute CVD risk score, but those that used either intervention independently reported significant improvement in the absolute CVD risk score. There is evidence supporting the positive impact of lifestyle modification on absolute CVD risk score in adult populations without CVD. Our analysis further suggests that diet and physical activity had significant impact on absolute CVD risk, and a variety of validated screening tools can be used to monitor, evaluate, and communicate changes in absolute risk score after lifestyle modification. A Spanish-language version of the abstract of this review is available [ http://links.lww.com/SRX/A29 ].