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Individual and population benefits of daily aspirin therapy: a proposal for personalizing national guidelines.

ABSTRACT: Clinical practice guidelines that help clinicians and patients to understand the magnitude of expected individual risks and benefits would help with patient-centered decision-making and prioritization of care. We assessed the net benefit from taking daily aspirin to estimate the individual and public health implications of a more individualized decision-making approach.We used data from the National Health and Nutrition Examination Survey representing all US persons aged 30 to 85 years with no history of myocardial infarction and applied a Markov model based on randomized evidence and published literature to estimate lifetime effects of aspirin treatment in quality-adjusted life years (QALYs). We found that treatment benefit varies greatly by an individual's cardiovascular disease (CVD) risk. Almost all adults have fewer major clinical events on aspirin, but for most, events prevented would be so rare that even a very small distaste for aspirin use would make treatment inappropriate. With minimal dislike of aspirin use (disutility, 0.005 QALY per year), only those with a 10-year cardiac event risk >6.1% would have a net benefit. A disutility of 0.01 QALY moves this benefit cut point to 10.6%. Multiple factors altered the absolute benefit of aspirin, but the strong relationship between CVD risk and magnitude of benefit was robust.The benefits of aspirin therapy depend substantially on an individual's risk of CVD and adverse treatment effects. Understanding who benefits from aspirin use and how much can help clinicians and patients to develop a more patient-centered approach to preventive therapy.

SUBMITTER: Sussman JB

PROVIDER: S-EPMC4039386 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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Individual and population benefits of daily aspirin therapy: a proposal for personalizing national guidelines.

Sussman Jeremy B JB Vijan Sandeep S Choi HwaJung H Hayward Rodney A RA

Circulation. Cardiovascular quality and outcomes 20110412 3

<h4>Background</h4>Clinical practice guidelines that help clinicians and patients to understand the magnitude of expected individual risks and benefits would help with patient-centered decision-making and prioritization of care. We assessed the net benefit from taking daily aspirin to estimate the individual and public health implications of a more individualized decision-making approach.<h4>Methods and results</h4>We used data from the National Health and Nutrition Examination Survey representi ...[more]

PMID: 21487091

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Project description:BACKGROUND: Biology, biomedicine and healthcare have become data-driven enterprises, where scientists and clinicians need to generate, access, validate, interpret and integrate different kinds of experimental and patient-related data. Thus, recording and reporting of data in a systematic and unambiguous fashion is crucial to allow aggregation and re-use of data. This paper reviews the benefits of existing biomedical data standards and focuses on key elements to record experiments for therapy development. Specifically, we describe the experiments performed in molecular, cellular, animal and clinical models. We also provide an example set of elements for a therapy tested in a phase I clinical trial. FINDINGS: We introduce the Guidelines for Information About Therapy Experiments (GIATE), a minimum information checklist creating a consistent framework to transparently report the purpose, methods and results of the therapeutic experiments. A discussion on the scope, design and structure of the guidelines is presented, together with a description of the intended audience. We also present complementary resources such as a classification scheme, and two alternative ways of creating GIATE information: an electronic lab notebook and a simple spreadsheet-based format. Finally, we use GIATE to record the details of the phase I clinical trial of CHT-25 for patients with refractory lymphomas. The benefits of using GIATE for this experiment are discussed. CONCLUSIONS: While data standards are being developed to facilitate data sharing and integration in various aspects of experimental medicine, such as genomics and clinical data, no previous work focused on therapy development. We propose a checklist for therapy experiments and demonstrate its use in the 131Iodine labeled CHT-25 chimeric antibody cancer therapy. As future work, we will expand the set of GIATE tools to continue to encourage its use by cancer researchers, and we will engineer an ontology to annotate GIATE elements and facilitate unambiguous interpretation and data integration.

Project description:Importance:Antiviral therapy cannot erase hepatocellular carcinoma (HCC) risk in patients with chronic hepatitis B, and it is not indicated for most hepatitis B virus (HBV) carriers. Another effective way of reducing HCC risk needs to be developed. Aspirin may prevent cancer development, but clinical evidence in patients with HBV-related HCC remains limited. Objective:To investigate the association of daily aspirin therapy with HBV-related HCC risk. Design, Setting, and Participants:In this Taiwan nationwide cohort study, we screened 204 507 patients with chronic hepatitis B for the period January 1, 1997, to December 31, 2012. After excluding patients with confounding conditions, 2123 patients who continuously received daily aspirin for 90 or more days (treated group) were randomly matched 1:4 with 8492 patients who had never received antiplatelet therapy (untreated group) by means of propensity scores, consisting of the follow-up index date, baseline characteristics, and potentially chemopreventive drug use during follow-up. Data were analyzed from August 1 to November 30, 2018. Exposures:Daily aspirin therapy during the study period. Main Outcomes and Measures:Both cumulative incidence of and hazard ratios (HRs) for HCC development were analyzed after adjusting patient mortality as a competing risk event. Results:Of the 10 615 patients included in the analysis, 7690 (72.4%) were men; mean (SD) age was 58.8 (11.8) years. The cumulative incidence of HCC in the treated group was significantly lower than that in the untreated group in 5 years (5.20%; 95% CI, 4.11%-6.29% vs 7.87%; 95% CI, 7.15%-8.60%; P < .001). In the multivariable regression analysis, aspirin therapy was independently associated with a reduced HCC risk (HR, 0.71; 95% CI, 0.58-0.86; P < .001). Sensitivity subgroup analyses also verified this association (all HRs <1.0). In addition, older age (HR, 1.01 per year; 95% CI, 1.00-1.02), male sex (HR, 1.75; 95% CI, 1.43-2.14), and cirrhosis (HR, 2.89; 95% CI, 2.45-3.40) were independently associated with an increased HCC risk, but nucleos(t)ide analogue (HR, 0.54; 95% CI, 0.41-0.71) or statin (HR, 0.62; 95% CI, 0.42-0.90) use was correlated with a decreased HCC risk. Conclusions and Relevance:Daily aspirin therapy may be associated with a reduced risk of HBV-related HCC.

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Individual and population benefits of daily aspirin therapy: a proposal for personalizing national guidelines.

Publications

Individual and population benefits of daily aspirin therapy: a proposal for personalizing national guidelines.

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