Representation of Older Adults in Cardiovascular Disease Trials Since the Inclusion Across the Lifespan Policy.
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ABSTRACT:
SUBMITTER: Nanna MG
PROVIDER: S-EPMC7489390 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Multimorbidity is the most significant condition affecting older adults, and it impacts every component of health care management and delivery. Multimorbidity significantly increases with age. For individuals with a diagnosis of cardiovascular disease, multimorbidity has a significant effect on the presentation of the disease and the diagnosis, management, and patient-centered preferences in care. Evidence-based therapeutics have focused on cardiovascular focused morbidity. Over the next 25 years, the proportion of adults aged 65 and older is estimated to increase three-fold. The needs of these patients require a fundamental shift in care from single disease practices to a more patient-centered framework.
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Project description:ObjectiveTo examine Hispanic/Latino representation in diabetes cardiovascular outcomes trials for novel antidiabetic drugs.Research design and methodsWe compared Hispanic/Latino representation, age, gender and body mass index in diabetes cardiovascular outcomes trials published from January 2008 to October 2018 to Hispanic adults with diabetes in the National Health Examination and Nutrition Survey over the same time period.ResultsHispanics/Latinos comprised 18.5 % of trial subjects, which was similar to the proportion of US adults with diabetes who identify as Hispanic. Trial subjects were significantly younger, more likely to be female, and more obese than US Hispanics/Latinos. At least 10 different Latin American countries and territories were represented across the 10 trials.ConclusionsUS Hispanics/Latinos differ from subjects in diabetes cardiovascular outcomes trials, which may limit generalizability of trial results.
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Project description:Background Although disproportionately affected by cardiovascular disease, Black adults remain underrepresented in clinical trials. The National Institutes of Health recommends that studies define goals for recruitment of underrepresented populations. However, the extent to which cardiovascular trials incorporate evidence-based recruitment strategies in their protocols is understudied. Methods and Results We systematically reviewed National Institutes of Health-funded cardiovascular clinical trials registered in ClinicalTrials.gov between 2000 and 2019. Based on publicly available or requested protocols, we focused on enrollment of Black adults as well as the following recruitment strategies: community-based, electronic medical record-based, and provider-based recruitment. A total of 100 clinical trials focused on cardiovascular disease were included in our analysis, of which 62% had published protocols, and 46% of trials had enrolled populations that were <25% Black. In our analysis of available trial protocols, 21% of trials defined a recruitment target for underrepresented groups; however, only one study reported achieving its enrollment goal. While 13% of trial protocols referenced community-based recruitment strategies, 5% explicitly mentioned involving community members in the trial design process. Defining recruitment targets was associated with higher enrollment of Black participants. Conclusions Black adults are underrepresented in National Institutes of Health-funded cardiovascular trials, and the majority of these trials did not specify a Black enrollment target, did not meet targets, and largely did not report specific plans to enroll Black adults in their studies. Future interventions should target trial design and planning phases before study initiation to address these enrollment disparities.
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Project description:ObjectiveTo explore the association between giant cell arteritis (GCA) and subsequent cardiovascular disease in older adults.DesignPopulation based retrospective cohort study.SettingThe entire province of Ontario, Canada.ParticipantsPatients aged 66 years and older with newly diagnosed GCA (n = 1141), osteoarthritis (n = 172,953), or neither (n = 200,000). Patients with neither were randomly selected from the general population and formed the control group.Main outcome measuresThe primary composite outcome was based on a subsequent diagnosis or surgical treatment for coronary artery disease, stroke, peripheral arterial disease, or aneurysm or dissection of the aorta.ResultsThe composite end point was more common in seniors with GCA (12.1/1000 person-years) than in patients with osteoarthritis (7.3/1000 person-years) or neither condition (5.3/1000 person-years). The adjusted hazard ratio for cardiovascular disease was 1.6 (95% confidence interval (CI) 1.1 to 2.2) in patients with GCA versus patients with osteoarthritis, and 2.1 (95% CI 1.5 to 3.0) in patients with GCA versus unaffected controls.ConclusionsOlder adults with GCA appear to be at increased risk for developing cardiovascular disease. Whether an aggressive approach to cardiovascular risk factor modification is particularly beneficial in these patients remains to be determined.
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Project description:BACKGROUND:Current prevention guidelines recommend using the Pooled Cohort Equation (PCE) for 10-year atherosclerotic cardiovascular disease (CVD) risk assessment. However, the PCE has serious limitations in older adults: it excludes heart failure (HF) hospitalization, estimates 10-year risk, which may not be the most relevant time frame, and is not indicated for individuals age >79 years. OBJECTIVES:This study sought to determine whether adding biomarkers to PCE variables improves global CVD (coronary heart disease, stroke, and HF) risk prediction in older adults over a shorter time period. METHODS:Atherosclerosis Risk in Communities study participants without prevalent CVD including HF (n = 4,760; age 75.4 ± 5.1 years) were followed for incident global CVD events. Adding N-terminal pro-B-type natriuretic peptide, high-sensitivity cardiac troponin T, and high-sensitivity C-reactive protein to the PCE and a "lab model" with the biomarkers, age, race, and gender were assessed for prediction improvement. Area under the receiver operating characteristic curve (AUC) and net reclassification index (NRI) were calculated. RESULTS:Over median follow-up of ?4 years, incident HF was the leading CVD event (n = 193 vs. 118 coronary heart disease and 81 stroke events). Compared to the PCE, each biomarker improved risk prediction. The largest improvement in risk prediction metrics was with the addition of all 3 biomarkers (?AUC 0.103; continuous NRI 0.484). The lab model also performed better than the PCE model (?AUC 0.091, continuous NRI 0.355). CONCLUSIONS:Adding biomarkers to the PCE or a simpler "lab model" improves short-term global CVD risk prediction and may be useful to inform short-term preventive strategies in older adults.
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Project description:CD8+ T-cells provide robust anti-viral immunity, yet how epitope-specific T-cells evolve across the human lifespan is unknown. We defined CD8+ T-cell immunity directed at the prominent influenza epitope, HLA-A*02:01-M158-66 (A2/M158) across four age groups (newborns, children, adults and elderly) ex vivo at phenotypic, single cell sequence (transcriptomic), clonal and functional levels. We identified a linear differentiation trajectory from newborns to children then adults, followed by divergence and a clonal reset in older adults. Gene profiles in older adults closely resembled those observed in newborns and children, despite being clonally-different. However, only child- and adult-derived A2/M158+CD8+ T-cells had the potential to differentiate into highly cytotoxic epitope-specific CD8+ T-cells, which was linked to highly functional public TCRab-signatures. Suboptimal TCRab-signatures detected in older adults led to poorer proliferation, polyfunctionality, avidity and recognition of peptide mutants, although displayed no signs of exhaustion. Our study suggests that priming T-cells at different stages of life might greatly affect CD8+ T-cell responses towards viral infections.
2023-08-16 | GSE237817 | GEO
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