scholarly journals Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline

Neurology ◽  
2020 ◽  
Vol 95 (3) ◽  
pp. e320-e331 ◽  
Author(s):  
Joanne Ryan ◽  
Elsdon Storey ◽  
Anne M. Murray ◽  
Robyn L. Woods ◽  
Rory Wolfe ◽  
...  
Keyword(s):  
Cognitive Decline ◽  
Low Dose ◽  
Controlled Trial ◽  
Verbal Learning ◽  
Cognitive Change ◽  
Community Dwelling ◽  
Older Individuals ◽  
Dose Aspirin ◽  
Low Dose Aspirin

ObjectiveTo determine the effect of low-dose aspirin vs placebo on incident all-cause dementia, incident Alzheimer disease (AD), mild cognitive impairment (MCI), and cognitive decline in older individuals.MethodsAspirin in Reducing Events in the Elderly (ASPREE) was a double-blind, placebo-controlled trial of low-dose aspirin. In the United States and Australia, community-dwelling individuals aged ≥70 years (US minorities ≥65 years) and free of cardiovascular disease, physical disability, and diagnosed dementia were enrolled. Participants were randomized 1:1–100 mg daily aspirin or placebo. The Modified Mini-Mental State Examination, Hopkins Verbal Learning Test–Revised, Symbol Digit Modalities Test, and Controlled Oral Word Association Test assessed cognition at baseline and over follow-up. Additional cognitive testing was performed in participants with suspected dementia (“trigger”) based on within-study assessments or clinical history. Dementia was adjudicated according to DSM-IV criteria. National Institute on Aging–Alzheimer’s Association criteria were used for AD and MCI subclassification.ResultsA total of 19,114 participants were followed over a median 4.7 years and 964 triggered further dementia assessments. There were 575 adjudicated dementia cases, and 41% were classified as clinically probable AD. There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91–1.17), probable AD (HR, 0.96; 95% CI, 0.74–1.24), or MCI (HR, 1.12; 95% CI, 0.92–1.37) between aspirin and placebo. Cognitive change over time was similar in the aspirin and placebo groups.ConclusionsThere was no evidence that aspirin was effective in reducing risk of dementia, MCI, or cognitive decline. Follow-up of these outcomes after initial exposure is ongoing.Classification of evidenceThis study provides Class II evidence that for healthy older individuals, low-dose aspirin does not significantly reduce the incidence of dementia, probable AD, MCI, or cognitive decline.Clinicaltrials.gov identifierNCT01038583.

scholarly journals The effect of low-dose aspirin on frailty phenotype and frailty index in community-dwelling older adults in the ASPirin in Reducing Events in the Elderly study

2021 ◽  
Author(s):  
Sara E Espinoza ◽  
Robyn L Woods ◽  
A R M Saifuddin Ekram ◽  
Michael E Ernst ◽  
Galina Polekhina ◽  
...  
Keyword(s):  
Older Adults ◽  
Low Dose ◽  
Controlled Trial ◽  
Frailty Index ◽  
The Elderly ◽  
Community Dwelling ◽  
Study Endpoint ◽  
Double Blind ◽  
Dose Aspirin ◽  
Low Dose Aspirin

Abstract BACKGROUND 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. METHODS In the U.S and Australia, 19,114 community-dwelling individuals aged ≥70 years (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 100mg daily aspirin versus placebo. Frailty, a pre-specified study endpoint, 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 hazards 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. RESULTS Over a median 4.7 years, 2252 participants developed incident Fried frailty, and 4451 had incident frailty according to the frailty index. Compared with placebo, aspirin treatment did not alter the risk of incident frailty (Fried frailty HR: 1.04, 95% 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. CONCLUSIONS 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.

scholarly journals Low-Dose Aspirin and Sporadic Anovulation in the EAGeR Randomized Trial

2016 ◽  
Vol 102 (1) ◽  
pp. 86-92 ◽  
Author(s):  
Rose G. Radin ◽  
Lindsey A. Sjaarda ◽  
Neil J. Perkins ◽  
Robert M. Silver ◽  
Zhen Chen ◽  
...  
Keyword(s):  
Pregnancy Loss ◽  
Low Dose ◽  
Controlled Trial ◽  
Double Blind ◽  
Menstrual Cycles ◽  
Spot Urine ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
History Of

Abstract Context: Among women with a single, recent pregnancy loss, daily preconception low-dose aspirin (LDA) increased the live birth rate with no effect on pregnancy loss. Ovulation is a potential mechanism underlying this effect. Objective: We estimated the effect of LDA on the per-cycle risk of anovulation among eumenorrheic women. Design: Multicenter, randomized, double-blind, placebo-controlled trial of daily LDA on reproductive outcomes. Preconception follow-up lasted 1 to 6 menstrual cycles (ClinicalTrials.gov, NCT00467363). Setting: Four US medical centers during 2007 to 2011. Patients or Other Participants: Healthy women (n = 1214), age 18 to 40, were attempting pregnancy, had regular menstrual cycles (21 to 42 days), and had a history of 1 to 2 documented pregnancy losses, ≤2 live births, and no infertility. All participants completed at least 1 menstrual cycle of follow-up; none withdrew due to adverse events. Intervention: Aspirin (81 mg) daily for 1 to 6 menstrual cycles. Main Outcome Measure: Per-cycle risk of anovulation, defined as the absence of both a positive spot-urine pregnancy test and a luteinizing hormone (LH) peak (2.5-fold increase in daily urinary LH). Hypothesis formulation preceded data collection. Results: Among 4340 cycles, LDA was not associated with anovulation (LDA: 13.4%, placebo: 11.1%; risk ratio = 1.16, 95% confidence interval, 0.88 to 1.52). Results were similar among women with a single, recent loss. Conclusions: Daily LDA had no effect on anovulation among women with a history of 1 to 2 pregnancy losses. LDA may affect fertility via other pathways, and these warrant further study.

scholarly journals The Effect of Low-Dose Aspirin on Frailty in Older Adults in the Aspirin in Reducing Events in the Elderly Study

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 825-825
Author(s):  
Sara Espinoza ◽  
A R M Saifuddin Ekram ◽  
Robyn Woods ◽  
Michael Ernst ◽  
Galina Polekhina ◽  
...  
Keyword(s):  
Older Adults ◽  
Low Dose ◽  
Controlled Trial ◽  
Frailty Index ◽  
The Elderly ◽  
Community Dwelling ◽  
Deficit Accumulation ◽  
Double Blind ◽  
Dose Aspirin ◽  
Low Dose Aspirin

Abstract There are no widely accepted pharmacologic treatments for frailty prevention. Since frailty is associated with inflammation, aspirin has the potential to reduce frailty. We investigated whether low-dose aspirin reduces incident frailty in participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial. In the U.S and Australia, 19,114 healthy community-dwelling individuals aged ≥70 years (U.S. minorities ≥65 years) were enrolled in ASPREE, a double-blind, placebo-controlled trial of 100mg daily low-dose aspirin vs. placebo. Frailty was defined according to a modified Fried frailty definition, and a frailty index which used a deficit accumulation model. Competing risk Cox proportional hazards models were used to compare time to incident frailty for aspirin vs. placebo. At baseline, 2.2% and 8.1% met criteria for frailty by Fried and frailty index criteria, respectively. Over a median of 4.7 years of follow-up, 2252 participants developed incident frailty according to Fried classification, and 4376 according to the frailty deficit accumulation index. There was no difference in the risk of incident frailty between individuals randomized to aspirin versus placebo according to either criteria (Fried frailty HR: 1.03, 95% CI 0.97-1.09, p=0.41; frailty index HR: 1.03, 95% CI 0.97-1.10, p=0.29). Change in frailty over time was not different between the aspirin and placebo treatment arms. The results were consistent across a series of sub-groups, including baseline frailty status. Based on these results, aspirin use in healthy older adults does not reduce incident frailty.

The Safety of Low-Dose Aspirin on the Mode of Delivery: Secondary Analysis of the Effect of Aspirin in Gestation and Reproduction Randomized Controlled Trial

2020 ◽  
Author(s):  
Allison A. Eubanks ◽  
Carrie J. Nobles ◽  
Sunni L. Mumford ◽  
Keewan Kim ◽  
Micah J. Hill ◽  
...  
Keyword(s):  
Vaginal Delivery ◽  
Live Birth ◽  
Low Dose ◽  
Controlled Trial ◽  
Mode Of Delivery ◽  
Secondary Analysis ◽  
Clinical Effects ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Intent To Treat

Objective This study aimed to examine whether prenatal low-dose aspirin (LDA) therapy affects risk of cesarean versus vaginal delivery. Study Design This study is a secondary analysis of the randomized clinical effects of aspirin in gestation and reproduction (EAGeR) trial. Women received 81-mg daily aspirin or placebo from preconception to 36 weeks of gestation. Mode of delivery and obstetric complications were abstracted from records. Log-binomial regression models estimated relative risk (RR) of cesarean versus vaginal delivery. Data were analyzed among the total preconception cohort, as well as restricted to women who had a live birth. Results Among 1,228 women, 597 had a live birth. In the intent-to-treat analysis, preconception-initiated LDA was not associated with risk of cesarean (RR = 1.02; 95% confidence interval [CI]: 0.98–1.07) compared with placebo. Findings were similar in just women with a live birth and when accounting prior cesarean delivery and parity. Conclusion Preconception-initiated daily LDA was not associated with mode of delivery among women with one to two prior losses. Key Points

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