Late-life depression is common and often inadequately managed using existing therapies. Depression is also associated with increased markers of inflammation, suggesting a potential role for ...anti-inflammatory agents. ASPREE-D is a sub-study of ASPREE, a large multi-centre, population-based, double-blind, placebo-controlled trial of aspirin vs placebo in older Australian and American adults (median follow-up: 4.7 years) of whom 1879 were depressed at baseline. Participants were given 100 mg daily dose of aspirin or placebo. Depressive symptoms were assessed annually using the validated, self-rated short version of the Center for Epidemiological Studies Depression scale. There was a significant increase in depressive scores (0.6; 95% CI 0.2 to 0.9; χ
(1) = 10.37; p = 0.001) and a decreased score in the mental health component of a quality of life scale (-0.7; 95% CI -1.4 to -0.1; χ
(1) = 4.74; p = 0.029) in the aspirin group compared to the placebo group. These effects were greater in the first year of follow-up and persisted throughout the study, albeit with small to very small effect sizes. This study failed to demonstrate any benefit of aspirin in the long-term course of depression in this community-dwelling sample of older adults over a 5-year period, and identified an adverse effect of aspirin in the course of depression in those with pre-existing depressive symptoms.
There are no primary prevention trials of aspirin with relevant geriatric outcomes in elderly people. ASPirin in Reducing Events in the Elderly (ASPREE) is a placebo-controlled trial of low-dose ...aspirin that will determine whether 5 years of daily 100-mg enteric-coated aspirin extends disability-free and dementia-free life in a healthy elderly population and whether these benefits outweigh the risks.
Set in primary care, this randomized double-blind placebo-controlled trial has a composite primary endpoint of death, incident dementia or persistent physical disability. Participants aged 70+ years (non-minorities) or 65+ years (U.S. minorities) were free of cardiovascular disease, dementia, or physical disability and without a contraindication to, or indication for, aspirin. Baseline data include physical and lifestyle, personal and family medical history, hemoglobin, fasting glucose, creatinine, lipid panel, urinary albumin:creatinine ratio, cognition (3MS, HVLT-R, COWAT, SDMT), mood (CES-D-10), physical function (gait speed, grip strength), Katz activities of daily living and quality of life (SF-12).
Recruitment ended in December 2014 with 16,703 Australian and 2,411 U.S. participants, a median age of 74 (range 65-98) years and 56% women. Approximately 55% of the U.S. cohort were from minority groups; 9% of the total cohort. Proportions with hypertension, overweight, and chronic kidney disease were similar to age-matched populations from both countries although lower percentages had diabetes, dyslipidemia, and osteoarthritis.
Findings from ASPREE will be generalizable to a healthier older population in both countries and will assess whether the broad benefits of daily low-dose aspirin in prolonging independent life outweigh the risks.
Background
Social health reflects one’s ability to form interpersonal relationships. Poor social health is a risk factor for cardiovascular disease (CVD), however an in‐depth exploration of the link ...through CVD risk factors is lacking.
Aim
To examine the relationship between social health (social isolation, social support, loneliness) and CVD risk factors among healthy older women and men.
Methods
Data were from 11,498 healthy community‐dwelling Australians aged ≥70 years from the ASPirin in Reducing Events in the Elderly (ASPREE) trial and the ASPREE Longitudinal Study of Older Persons sub‐study. Ten‐year CVD risk was estimated using the Atherosclerotic CVD Risk Scale (ASCVDRS) and the Framingham Risk Score (FRS).
Results
Physical inactivity and experiencing depressive symptoms were the only CVD risk factors that consistently differed by all three social health constructs. Loneliness was associated with greater ASCVDRS (women: β = 0.01, p < 0.05; men: β = 0.03, p < 0.001), social isolation with greater FRS (women: β = 0.02, p < 0.01; men: β = 0.03, p < 0.01) and the social health composite of being lonely (regardless of social isolation and/or social support status) with greater ASCVDRS (women: β = 0.01, p = 0.02; men: β = 0.03, p < 0.001). Among men, loneliness was also associated with greater FRS (β = 0.03, p < 0.001) and social support with greater ASCVDRS (β = 0.02, p = 0.01). Men were more socially isolated, less socially supported and less lonely than women.
Conclusion
Social isolation, social support and loneliness displayed diverse relationships with CVD risk factors and risk scores, emphasising the importance of distinguishing between these constructs. These findings inform on potential avenues to manage poor social health and CVD risk among older adults.
Key points
There is limited understanding of how the relationship between social health and cardiovascular disease (CVD) may be mediated through CVD risk factors.
Physical inactivity and experiencing depressive symptoms were the only CVD risk factors that consistently differed by social isolation, social support and loneliness status among healthy older adults.
Loneliness and social isolation were each associated with greater ten‐year risk of developing CVD, calculated by the Atherosclerotic Cardiovascular Disease Risk Scale and the Framingham Risk Score respectively.
Knee replacements are increasingly performed in older adults but uncertainty remains regarding their benefits in the context of age-related decline in physical function and other comorbidities. This ...study aimed to examine (1) the effect of knee replacement on functional outcomes in the context of age-related decline in physical function and (2) the factors associated with minimal important improvement in physical function after knee replacement in community-dwelling older adults aged ≥ 70 years.
This cohort study was performed within the ASPREE trial, with 889 participants undergoing knee replacement during the trial and 858 age- and sex-matched controls without knee or hip replacement identified from 16,703 Australian participants aged ≥ 70 years. Health-related quality of life was assessed annually using the SF-12, including its physical and mental component summary (PCS and MCS). Gait speed was measured biennially. Multiple linear regression and analysis of covariance were used to adjust for potential confounders.
Participants with knee replacement had significantly lower pre- and post-replacement PCS scores and gait speed compared with age- and sex-matched controls. Participants with knee replacement had significant improvement in PCS score following knee replacement (mean change 3.6, 95% CI 2.9-4.3) while PCS score remaining unchanged in age- and sex-matched controls (-0.02, 95% CI -0.6 to 0.6) during follow-up period. The greatest improvements were observed for bodily pain and physical function. Following knee replacement, 53% of participants experienced minimal important improvement in PCS score (increased by ≥ 2.7), while 24% experienced worsened PCS score (reduced by > 2.7). Participants experiencing improved PCS score postoperatively had significantly lower PCS and higher MCS scores pre-surgery.
Although community-based older adults experienced a significant improvement in PCS scores after knee replacement, their postoperative physical functional status remained significantly lower than age- and sex-matched controls. The degree of preoperative physical function impairment was a strong predictor of functional improvement, suggesting that this could be an important consideration when identifying older people most likely to benefit from knee replacement surgery.
Frailty is associated with chronic inflammation, which may be modified by aspirin. The purpose of this study was to determine whether low-dose aspirin reduces incident frailty in healthy older adult ...participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial.
In the United States and Australia, 19 114 community-dwelling individuals aged ≥70 and older (U.S. minorities ≥65 years) and free of overt cardiovascular disease, persistent physical disability, and dementia were enrolled in ASPREE, a double-blind, placebo-controlled trial of 100-mg daily aspirin versus placebo. Frailty, a prespecified study end point, was defined according to a modified Fried frailty definition (Fried frailty) and the frailty index based on the deficit accumulation model (frailty index). Competing risk Cox proportional hazard models were used to compare time to incident frailty by aspirin versus placebo. Sensitivity analysis was conducted to include frailty data with and without imputation of missing data.
Over a median 4.7 years, 2 252 participants developed incident Fried frailty, and 4 451 had incident frailty according to the frailty index. Compared with placebo, aspirin treatment did not alter the risk of incident frailty (Fried frailty hazard ratio HR: 1.04, 95% confidence interval CI 0.96-1.13; frailty index HR: 1.03, 95% CI 0.97-1.09). The proportion of individuals classified as frail, and the trajectory in continuous frailty scores over time, were not different between the aspirin and placebo treatment groups. The results were consistent across a series of subgroups.
Low-dose aspirin use in healthy older adults when initiated in older ages does not reduce risk of incident frailty or the trajectory of frailty.
Purpose
Health-related quality of life (QoL) is poor after stroke, but may be improved with comprehensive care plans. We aimed to determine the effects of an individualized management program on QoL ...in people with stroke or transient ischemic attack (TIA), describe changes in QoL over time, and identify variables associated with QoL.
Methods
This was a multicenter, cluster randomized controlled trial with blinded assessment of outcomes and intention‐to‐treat analysis. Patients with stroke or TIA aged ≥ 18 years were randomized by general practice to receive usual care or an intervention comprising a tailored chronic disease management plan and education. QoL was assessed at baseline and 3, 12, and 24 months after baseline using the Assessment of Quality of Life instrument. Patient responses were converted to utility scores ranging from − 0.04 (worse than death) to 1.00 (good health). Mixed-effects models were used for analyses.
Results
Among 563 participants recruited (mean age 68.4 years, 64.5% male), median utility scores ranged from 0.700 to 0.772 at different time points, with no difference observed between intervention and usual care groups. QoL improved significantly from baseline to 3 months (
ß
= 0.019;
P
= 0.015) and 12 months (
ß
= 0.033;
P
< 0.001), but not from baseline to 24 months (
ß
= 0.013;
P
= 0.140) in both groups combined. Older age, females, lower educational attainment, greater handicap, anxiety and depression were longitudinally associated with poor QoL.
Conclusion
An individualized management program did not improve QoL over 24 months. Those who are older, female, with lower educational attainment, greater anxiety, depression and handicap may require greater support.
Clinical trial registration
https://www.anzctr.org.au
. Unique identifier: ACTRN12608000166370.
OBJECTIVE:To extensively investigate long-term unmet needs in survivors of stroke or TIA and to identify factors associated with these unmet needs.
METHODS:Community-dwelling adults were invited to ...participate in a survey ≥2 years after discharge for stroke/TIA. Unmet needs were assessed across 5 domainsactivities and participation, environmental factors, body functions, post–acute care, and secondary prevention. Factors associated with unmet needs were determined with multivariable negative binomial regression.
RESULTS:Of 485 participants invited to complete the survey, 391 (81%) responded (median age 73 years, 67% male). Most responders (87%) reported unmet needs in ≥1 of the measured domains, particularly in secondary prevention (71%). Factors associated with fewer unmet needs included older age (incident rate ratio IRR 0.62, 95% confidence interval CI 0.50–0.77), greater functional ability (IRR 0.33, 95% CI 0.17–0.67), and reporting that the general practitioner was the most important in care (IRR 0.69, 95% CI 0.57–0.84). Being depressed (IRR 1.61, 95% CI 1.23–2.10) and receiving community services after stroke (IRR 1.45, 95% CI 1.16–1.82) were associated with more unmet needs.
CONCLUSIONS:Survivors of stroke/TIA reported considerable unmet needs ≥2 years after discharge, particularly in secondary prevention. The factors associated with unmet needs could help guide policy decisions, particularly for tailoring care and support services provided after discharge.
•Social health is an established risk factor for cardiovascular disease, however, the potential causal pathway between cardiovascular disease (and shared risk factors) is yet to be clearly ...established.•As social health is modifiable, intervention may be a potential avenue for reducing the burden of poor health outcomes such as CVD.•There is also a higher likelihood of reverse causation; poor social health could result from CVD and CVD risk factors.
Cardiovascular disease (CVD) is the greatest contributor to global morbidity and mortality. Poor social health plays a critical role in CVD incidence. Additionally, the relationship between social health and CVD may be mediated through CVD risk factors. However, the underlying mechanisms between social health and CVD are poorly understood. Certain social health constructs (social isolation, low social support and loneliness) have complicated the characterisation of a causal relationship between social health and CVD.
To provide an overview of the relationship between social health and CVD (and its shared risk factors).
In this narrative review, we examined published literature on the relationship between three social health constructs (social isolation, social support, and loneliness) and CVD. Evidence was synthesised in a narrative format, focusing on the potential ways in which social health affects CVD, including shared risk factors.
The current literature highlights an established relationship between social health and CVD with a likelihood for bi-directionality. However, there is speculation and varied evidence regarding how these relationships may be mediated through CVD risk factors.
Social health can be considered an established risk factor for CVD. However, the potential bi-directional pathways of social health with CVD risk factors are less established. Further research is needed to understand whether targeting certain constructs of social health may directly improve the management of CVD risk factors. Given the health and economic burdens of poor social health and CVD, improvements to addressing or preventing these interrelated health conditions would have societal benefits.
Objective
To assess the factors that contributed to the successful completion of recruitment for the largest clinical trial ever conducted in Australia, the Aspirin in Reducing Events in the Elderly ...(ASPREE) study.
Design
Enrolment of GPs; identification of potential participants in general practice databases; screening of participants.
Setting, participants
Selected general practices across southeast Australia (Tasmania, Victoria, Australian Capital Territory, New South Wales, South Australia).
Major outcomes
Numbers of patients per GP screened and randomised to participation; geographic and demographic factors that influenced screening and randomising of patients.
Results
2717 of 5833 GPs approached (47%) enrolled to recruit patients for the study; 2053 (76%) recruited at least one randomised participant. The highest randomised participant rate per GP was for Tasmania (median, 5; IQR, 1–11), driven by the high rate of participant inclusion at phone screening. GPs in inner regional (adjusted odds ratio aOR, 1.45; 95% CI, 1.14–1.84) and outer regional areas (aOR, 1.86; 95% CI, 1.19–2.88) were more likely than GPs in major cities to recruit at least one randomised participant. GPs in areas with a high proportion of people aged 70 years or more were more likely to randomise at least one participant (per percentage point increase: aOR, 1.10; 95% CI, 1.05–1.15). The number of randomised patients declined with time from GP enrolment to first randomisation.
Conclusion
General practice can be a rich environment for research when barriers to recruitment are overcome. Including regional GPs and focusing efforts in areas with the highest proportions of potentially eligible participants improves recruitment. The success of ASPREE attests to the clinical importance of its research question for Australian GPs.
Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in old age. There is no proven intervention to prevent AMD and, apart from lifestyle, nutritional, and ...supplement advice, there is no intervention to delay its progression.
To determine the impact of long-term low-dose aspirin on the incidence and progression of AMD.
The Aspirin in Reducing Events in the Elderly-AMD (ASPREE-AMD) study was an Australian-based substudy of the ASPREE trial, a multicenter, international, randomized, double-masked, placebo-clinical trial investigating the efficacy of low-dose aspirin in prolonging disability-free survival among older individuals. Retinal photography was conducted at baseline from March 2010 to January 2015, then 3 and 5 years after randomization. AMD status was determined using color retinal images and treatment records. Australian participants in ASPREE aged 70 years and older without dementia, independence-limiting physical disability, cardiovascular disease, or chronic illness limiting 5-year survival and with gradable retinal images at baseline were included. Data were analyzed from December 2022 to December 2023.
Aspirin (100 mg daily, enteric coated) or placebo.
Incidence of AMD and progression from early/intermediate to late AMD. Outcomes were analyzed by modified intention-to-treat analysis.
A total of 4993 participants were enrolled in this substudy. Baseline characteristics were similar between groups. At the time of sponsor-determined trial termination, retinal follow-up data were available for 3208 participants, 3171 of whom were analyzed for AMD incidence and progression, with a median (IQR) age of 73.5 (71.5-76.4) years and even sex distribution (1619 51% female). Median (IQR) follow-up time was 3.1 (3.0-3.5) years. Cumulative AMD incidence was 195 of 1004 (19.4%) in the aspirin group and 187 of 979 (19.1%) in the placebo group (relative risk RR, 1.02; 95% CI, 0.85-1.22; P = .86). Cumulative progression from early/intermediate AMD to late AMD was observed in 14 of 615 (2.3%) participants in the aspirin group and 18 of 573 (3.1%) in the placebo group (RR, 0.72; 95% CI, 0.36-1.44; P = .36).
In this trial, low-dose aspirin administered for 3 years did not affect the incidence of AMD. The evidence was weaker for progression of AMD due to low number of progressed cases. Overall, these results do not support suggestion that low-dose daily aspirin prevents the development or progression of AMD.
anzctr.org Identifier: ACTRN12613000755730.
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