scholarly journals RATIONALE FOR ASPREE DISABILITY-FREE SURVIVAL PRIMARY OUTCOME AND OVERVIEW OF PRIMARY OUTCOME RESULTS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S633-S633
Author(s):  
John McNeil
Keyword(s):  
Physical Disability ◽  
Primary Outcome ◽  
Low Dose ◽  
Primary Outcome Measure ◽  
Negative Effects ◽  
Vascular Events ◽  
Free Survival ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Preventive Drug

Abstract Disability-free survival (DFS), defined as survival free of disability and dementia was the primary outcome measure of the ASPREE clinical trial. As previously reported, there was no benefit of low dose aspirin on the primary end point of dementia, physical disability or death, but bleeding risks were increased. In total, 1,835 participants reached the primary endpoint, confirmed amongst approximately 3,000 who had triggered for one of the end-points. Dementia was the most labor intensive component of DFS. Several previous primary prevention aspirin studies had identified a reduction of vascular events counterbalanced by an increase in serious bleeding, leaving the question of net outcome to an intuitive decision. DFS was chosen because it balances the positive and negative effects of a preventive drug such as aspirin. It also encapsulates the primary purpose of a preventive drug in older people i.e., to prolong a healthy lifespan rather than prevent a defined disease.

scholarly journals POTENTIAL IMPLICATIONS OF ASPREE ON ASPIRIN PRIMARY PREVENTION GUIDELINES

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S633-S634
Author(s):  
Anne M Murray
Keyword(s):  
Primary Prevention ◽  
Physical Disability ◽  
Low Dose ◽  
Free Survival ◽  
Healthy Elderly ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Secondary Endpoints ◽  
Prevention Guidelines

Abstract The 2016 USPSTF guidelines for aspirin to prevent CVD and colorectal cancer noted insufficient evidence to assess the balance of benefit and harm in those 70 and older. The long-awaited ASPREE trial, conducted in healthy elderly aged 70 and older (65 for US minorities), evaluated aspirin’s effect on disability-free survival, a composite of death, dementia, or persistent physical disability. CVD and cancer were pre-specified secondary endpoints, positioning ASPREE’s results to substantially inform the evidence gap noted in the USPSTF guidelines. Low-dose aspirin over 5 years did not lower CVD events or colorectal risk, but significantly increased bleeding. The ASPREE-XT observational follow-up study over the next 5-7 years will observe for potential legacy effects of aspirin on the primary and secondary outcomes of ASPREE, thus adding further evidence to define the risk-benefit profile of aspirin for primary prevention in healthy elderly.

Aspirin for primary prevention in diabetes mellitus: from the calculation of cardiovascular risk and risk/benefit profile to personalised treatment

2015 ◽  
Vol 114 (11) ◽  
pp. 876-882 ◽  
Author(s):  
Francesca Santilli ◽  
Pasquale Pignatelli ◽  
Francesco Violi ◽  
Giovanni Davì
Keyword(s):  
Diabetes Mellitus ◽  
Primary Prevention ◽  
Low Dose ◽  
Meta Analysis ◽  
Individual Variability ◽  
Vascular Events ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Personalised Treatment ◽  
Cox 1

SummaryType 2 diabetes mellitus is characterised by persistent thromboxane (TX)-dependent platelet activation, regardless of disease duration. Low-dose aspirin, that induces a permanent inactivation of platelet cyclooxygenase (COX)-1, thus inhibiting TXA2 biosynthesis, should be theoretically considered the drug of choice. The most up-to-date meta-analysis of aspirin prophylaxis in this setting, which includes three trials conducted in patients with diabetes and six other trials in which such patients represent a subgroup within a broader population, reported that aspirin is associated with a non-significant decrease in the risk of vascular events, although the limited amount of available data precludes a precise estimate of the effect size. An increasing body of evidence supports the concept that less-than-expected response to aspirin may underlie mechanisms related to residual platelet hyper-reactivity despite anti-platelet treatment, at least in a fraction of patients. Among the proposed mechanisms, the variable turnover rate of the drug target (platelet COX-1) appears to represent the most convincing determinant of the inter-individual variability in aspirin response. This review intends to develop the idea that the understanding of the determinants of less-than-adequate response to aspirin in certain individuals, although not changing the paradigm of the indication to low-dose aspirin prescription in primary prevention, may help identifying, in terms of easily detectable clinical or biochemical characteristics, individuals who would attain inadequate protection from aspirin, and for whom different strategies should be challenged.

Long-term persistence to low-dose aspirin for cardiovascular prevention in routine clinical practice in United Kingdom and Germany

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Vora ◽  
M Soriano-Gabarro ◽  
B Russell ◽  
H Morgan Stewart
Keyword(s):  
Index Date ◽  
Low Dose ◽  
Aspirin Therapy ◽  
Routine Clinical Practice ◽  
Vascular Events ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Cvd Prevention

Abstract Background Low-dose aspirin is effective in the prevention of ischemic vascular events and studies have shown a preventative effect on colorectal cancer (CRC). Discontinuation of low-dose aspirin is associated with increased risk of ischaemic vascular events. However, data on long-term persistence to low-dose aspirin from routine clinical practice are limited. Purpose To assess the long-term persistence to low-dose aspirin therapy in the primary and secondary cardiovascular (CVD) prevention population Methods This retrospective cohort study used data from United Kingdom (UK) – The Health Improvement Network database and Germany (DE) – IQVIA Disease Analyzer and analyzed using an adaptation of Observational Health Data Sciences and Informatics (OHDSI) ATLAS Tool. Patients 18 years or older, with at least two prescriptions of low-dose aspirin (75–100mg) within the first year of index date during the study period between 2007 and 2018, and with at least 12 months of observation before and after the index date were included in the study. The patients with a CVD diagnosis or a CABG/PCI procedure before the index date or a prescription of dual antiplatelet at index date were classified as secondary CVD prevention. The remaining patients were classified as potential primary CVD prevention. The index date was first prescription of low-dose aspirin. Persistence was calculated if the gap between two prescriptions exceeds 60 days. Patients with such gaps still receiving prescription after 60 days were plotted based on the number of gaps identified during the follow-up and if no prescription was recorded then they were considered discontinued. Results The total number of patients receiving low-dose aspirin was 327,806 (183,089 in UK and 144,717 in DE with up to 10 years of follow-up). A total of 112,887 and 101,704 received low-dose aspirin for secondary CVD prevention; 70,202 and 43,013 potentially for primary CVD prevention in UK and DE, respectively. Persistence at two years with a few gaps was 67% and 59% in UK and DE for secondary CVD prevention; 57% and 53% for primary CVD prevention, respectively. With multiple Gaps, 50% and 36% still receive prescription low-dose aspirin for 10 years in UK and DE, respectively for secondary CVD prevention. For Primary prevention, 36% and 32% receive prescription of aspirin for 10 years with multiple gaps in UK and DE (Figure). Conclusion After the initial drop in persistence the patients tend to continue their low-dose aspirin treatment for long-term, although with multiple gaps. Overall, the persistence was higher in secondary compared to primary CVD prevention. Improving persistence to low-dose aspirin therapy in the initial years may help in continuity of their treatment over long-term. Persistence might be underestimated due to potential over the counter use of low-dose aspirin. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer AG

scholarly journals Effects of Celecoxib and Low-dose Aspirin on Outcomes in Adjuvant Aromatase Inhibitor–Treated Patients: CCTG MA.27

2018 ◽  
Vol 110 (9) ◽  
pp. 1003-1008 ◽  
Author(s):  
Kathrin Strasser-Weippl ◽  
Michaela J Higgins ◽  
Judith-Anne W Chapman ◽  
James N Ingle ◽  
George W Sledge ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Low Dose ◽  
Statistical Tests ◽  
Univariate Analysis ◽  
Multivariable Analysis ◽  
Random Assignment ◽  
Distant Disease ◽  
Free Survival ◽  
Dose Aspirin ◽  
Low Dose Aspirin

Abstract Background Celecoxib and low-dose aspirin might decrease risk of breast cancer recurrence. Methods In the Canadian Cancer Trials Group MA.27, postmenopausal hormone receptor–positive breast cancer patients were randomly assigned (2 × 2) to adjuvant exemestane or anastrozole, and celecoxib or placebo. Low-dose aspirin of 81 mg or less was a stratification factor. Due to concerns about cardiac toxicity, celecoxib use was stopped in December 2004, while stratification by aspirin use was removed through protocol amendment. We examined the effects of celecoxib and low-dose aspirin on event-free survival (EFS), defined as time from random assignment to time of locoregional or distant disease recurrence, new primary breast cancer, or death from any cause; distant disease–free survival (DDFS); and overall survival (OS). All statistical tests were two-sided. Results Random assignment to celecoxib (n = 811, 50.0%) or placebo (n = 811, 50.0%) was discontinued after 18 months (n = 1622). At a median of 4.1 years’ follow-up, among 1622 patients, 186 (11.5%) patients had an EFS event: 80 (4.9%) had distant relapse, and 125 (7.7%) died from any cause. Celecoxib did not statistically significantly impact EFS, DDFS, or OS in univariate analysis (respectively, P = .92, P = .55, and P = .56) or multivariable analysis (respectively, P = .74, P = .60, and P = .76). Low-dose aspirin use (aspirin users n = 476, 21.5%; non–aspirin users n = 1733, 78.5%) was associated in univariate analyses with worse EFS (hazard ratio [HR] = 1.48, 95% confidence interval [CI] = 1.12 to 1.96, P = 0.006) and worse OS (HR = 1.87, 95% CI = 1.35 to 2.61, P < .001). After adjusting for baseline characteristics and treatment arm, aspirin use showed no statistical association with EFS (P = .08) and DDFS (P = .82), but was associated with statistically worse OS (HR = 1.67, 95% CI = 1.13 to 2.49, P = .01). Conclusion Random assignment to short-term (≤18 months) celecoxib as well as use of low-dose aspirin showed no effect on DDFS and EFS in multivariable analysis. Low-dose aspirin increased “all-cause” mortality, presumably because of higher preexisting cardiovascular risks.

Aggrenox® (Extended-Release Dipyridamole and Low-Dose Aspirin in Combination): Protecting Platelets from Excessive Activation in Patients with Vascular Events

Heart Drug ◽  
2002 ◽  
Vol 2 (2) ◽  
pp. 93-104 ◽  
Author(s):  
Alex I. Malinin ◽  
Roswith M. Eisert ◽  
Dan Atar ◽  
Zinoviy Barkagan ◽  
Victor L. Serebruany
Keyword(s):  
Extended Release ◽  
Low Dose ◽  
Vascular Events ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Excessive Activation

scholarly journals Incidences, temporal trends and risks of hospitalisation for gastrointestinal bleeding in new or chronic low-dose aspirin users after treatment for Helicobacter pylori: a territory-wide cohort study

Gut ◽  
2019 ◽  
Vol 69 (3) ◽  
pp. 445-452 ◽  
Author(s):  
Chuan-Guo Guo ◽  
Ka Shing Cheung ◽  
Feifei Zhang ◽  
Esther W Chan ◽  
Lijia Chen ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Primary Outcome ◽  
Low Dose ◽  
Temporal Trends ◽  
Eradication Therapy ◽  
Dose Aspirin ◽  
Increased Risk ◽  
Low Dose Aspirin ◽  
Health Database ◽  
Adjusted Incidence

ObjectiveThe risk of GI bleeding (GIB) in aspirin users after Helicobacter pylori (HP) eradication remains poorly defined. We characterised the incidences and temporal trends of hospitalisations for all GIB in aspirin users after HP eradication therapy.DesignBased on a territory-wide health database, we identified all patients who had received the first course of clarithromycin-based triple therapy between 2003 and 2012. Patients were divided into three cohorts according to aspirin use: new users (commenced after HP eradication), chronic users (commenced before and resumed after HP eradication) and non-users. The primary outcome was to determine the risk of hospitalisation for GIB.ResultsWe included 6985 new aspirin users, 5545 chronic users and 48 908 non-users. The age-adjusted and sex-adjusted incidence of hospitalisation for all GIB in new, chronic and non-users was 10.4, 7.2 and 4.6 per 1000 person-years, respectively. Upper and lower GIB accounted for 34.7% and 45.3% of all bleeding, respectively. Compared with chronic users, new users had a higher risk of GIB (HR with propensity score matching: 1.89; 95% CI 1.29 to 2.70). Landmark analysis showed that the increased risk in new aspirin users was only observed in the first 6 months for all GIB (HR 2.10, 95% CI 1.41 to 3.13) and upper GIB (HR 2.52, 95% CI 1.38 to 4.60), but not for lower GIB.ConclusionNew aspirin users had a higher risk of GIB than chronic aspirin users, particularly during the initial 6 months. Lower GIB is more frequent than upper GIB in aspirin users who had HP eradicated.

scholarly journals Effect of Low-Dose Aspirin on Functional Outcome From Cerebral Vascular Events in Women

Stroke ◽  
2013 ◽  
Vol 44 (2) ◽  
pp. 432-436 ◽  
Author(s):  
Pamela M. Rist ◽  
Julie E. Buring ◽  
Carlos S. Kase ◽  
Tobias Kurth
Keyword(s):  
Functional Outcome ◽  
Low Dose ◽  
Vascular Events ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Cerebral Vascular

How I treat patients with polycythemia vera

Blood ◽  
2007 ◽  
Vol 109 (12) ◽  
pp. 5104-5111 ◽  
Author(s):  
Guido Finazzi ◽  
Tiziano Barbui
Keyword(s):  
Polycythemia Vera ◽  
Low Dose ◽  
Jak2 V617f ◽  
Vascular Events ◽  
Drug Of Choice ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
High Incidence ◽  
Risk Patients ◽  
Thrombotic Complications

AbstractThe clinical course of polycythemia vera (PV) is marked by a high incidence of thrombotic complications; fibrotic and leukemic disease transformations are additional causes of morbidity and mortality. Major predictors of vascular events are increasing age and previous thrombosis; leukocytosis and high JAK2 V617F allele burden are currently being investigated for additional prognostic value in this regard. Myelosuppressive drugs can reduce the rate of thrombosis, but there is concern that their use raises the risk of transformation into acute leukemia. To tackle this dilemma, a risk-oriented management strategy is recommended. Low-risk patients should be treated with phlebotomy and low-dose aspirin. Cytotoxic therapy is indicated in high-risk patients, and the drug of choice is hydroxyurea because of its efficacy in preventing thrombosis and low leukemogenicity. Interferon-alpha should be reserved for selected categories of patients due to high cost and toxicity. The demonstration of JAK2 V617F mutation in the vast majority of PV patients opens the avenue for the development of promising new molecularly targeted drugs.

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