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      Individualised benefit–harm balance of aspirin as primary prevention measure – a good proof-of-concept, but could have been better…

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          Abstract

          Guidelines from different organisations regarding the use of aspirin for primary prevention vary despite being based on similar evidence. Translating these in practice presents a further major challenge. The benefit–harm balance tool developed by Puhan et al. ( BMC Med 13:250, 2015) for aspirin can overcome some of these difficulties and is therefore an important step towards personalised medicine. Although a good proof-of-concept, this tool has some important limitations that presently preclude its use in practice or for further research. One of the major benefits of aspirin that has become apparent in the last decade or so is its effect in preventing cancer and cancer-related deaths. However, this benefit is clear and consistent in randomised as well as observational evidence only for specific cancers. Additionally, it has long lag-time and carry-over periods. These nuances of aspirin’s effects demand a specific and a more sophisticated model such as a time-varying model. Further refinement of this tool with respect to these aspects is merited to make it ready for evaluation in qualitative and quantitative studies with the goal of clinical utility.

          Please see related article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0493-2

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          Effect of aspirin on long-term risk of colorectal cancer: consistent evidence from randomised and observational studies.

          Enrico Flossmann, Peter M. Rothwell (2007)
          Randomised trials have shown that aspirin reduces the short-term risk of recurrent colorectal adenomas in patients with a history of adenomas or cancer, but large trials have shown no effect in primary prevention of colorectal cancer during 10 years' follow-up. However, the delay from the early development of adenoma to presentation with cancer is at least 10 years. We aimed to assess the longer-term effect of aspirin on the incidence of cancers. We studied the effect of aspirin in two large randomised trials with reliable post-trial follow-up for more than 20 years: the British Doctors Aspirin Trial (N=5139, two-thirds allocated 500 mg aspirin for 5 years, a third to open control) and UK-TIA Aspirin Trial (N=2449, two-thirds allocated 300 mg or 1200 mg aspirin for 1-7 years, a third placebo control). We also did a systematic review of all relevant observational studies to establish whether associations were consistent with the results of the randomised trials and, if so, what could be concluded about the likely effects of dose and regularity of aspirin use, other non-steroidal anti-inflammatory drugs (NSAID), and the effect of patient characteristics. In the randomised trials, allocation to aspirin reduced the incidence of colorectal cancer (pooled HR 0.74, 95% CI 0.56-0.97, p=0.02 overall; 0.63, 0.47-0.85, p=0.002 if allocated aspirin for 5 years or more). However, this effect was only seen after a latency of 10 years (years 0-9: 0.92, 0.56-1.49, p=0.73; years 10-19: 0.60, 0.42-0.87, p=0.007), was dependent on duration of scheduled trial treatment and compliance, and was greatest 10-14 years after randomisation in patients who had had scheduled trial treatment of 5 years or more (0.37, 0.20-0.70, p=0.002; 0.26, 0.12-0.56, p=0.0002, if compliant). No significant effect on incidence of non-colorectal cancers was recorded (1.01, 0.88-1.16, p=0.87). In 19 case-control studies (20 815 cases) and 11 cohort studies (1 136 110 individuals), regular use of aspirin or NSAID was consistently associated with a reduced risk of colorectal cancer, especially after use for 10 years or more, with no difference between aspirin and other NSAIDs, or in relation to age, sex, race, or family history, site or aggressiveness of cancer, or any reduction in apparent effect with use for 20 years or more. However, a consistent association was only seen with use of 300 mg or more of aspirin a day, with diminished and inconsistent results for lower or less frequent doses. Use of 300 mg or more of aspirin a day for about 5 years is effective in primary prevention of colorectal cancer in randomised controlled trials, with a latency of about 10 years, which is consistent with findings from observational studies. Long-term follow-up is required from other randomised trials to establish the effects of lower or less frequent doses of aspirin.
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            Aspirin for the prevention of cardiovascular disease: U.S. Preventive Services Task Force recommendation statement.

            (2009)
            Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation about the use of aspirin for the prevention of coronary heart disease. Review of the literature since 2002, focusing on new evidence on the benefits and harms of aspirin for the primary prevention of cardiovascular disease, including myocardial infarction and stroke. The new evidence was reviewed and synthesized according to sex. Encourage men age 45 to 79 years to use aspirin when the potential benefit of a reduction in myocardial infarctions outweighs the potential harm of an increase in gastrointestinal hemorrhage. (A recommendation) Encourage women age 55 to 79 years to use aspirin when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage. (A recommendation) Evidence is insufficient to assess the balance of benefits and harms of aspirin for cardiovascular disease prevention in men and women 80 years or older. (I statement) Do not encourage aspirin use for cardiovascular disease prevention in women younger than 55 years and in men younger than 45 years. (D recommendation).
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              Role of aspirin in cancer prevention.

              Mangesh Thorat, Jack Cuzick (2013)
              Since its first synthesis in 1897, several medicinal roles and mechanisms of action of aspirin have become apparent; the latest among these being its role in cancer prevention and treatment. A large body of evidence supports aspirin's effect in reducing cancer incidence and cancer mortality, but duration of use needs to be at least 5 years. The beneficial effects are particularly large for colorectal, oesophageal and gastric cancers, with apparently smaller reductions for breast, prostate and lung cancer. The major harm is gastrointestinal bleeding, but serious sequelae are minimal at ages <70 years. It is very likely that use of prophylactic aspirin in the general population aged 50-70+ years will result in net overall benefit. Outstanding issues are: whether standard dose (~300 mg/day) can lead to greater net benefits than low dose (75-100 mg/day), the optimum duration of use, and appropriate ages for use in average-risk individuals.
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                Author and article information

                Contributors
                Mangesh A. Thorat: +44 (0)20 7882 3546 , m.thorat@qmul.ac.uk
                Journal
                Journal ID (nlm-ta): BMC Med
                Journal ID (iso-abbrev): BMC Med
                Title: BMC Medicine
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1741-7015
                Publication date (Electronic): 6 July 2016
                Publication date PMC-release: 6 July 2016
                Publication date Collection: 2016
                Volume: 14
                Electronic Location Identifier: 101
                Affiliations
                [ ]Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ UK
                [ ]Breast Services, Division of Surgery and Interventional Science, Whittington Hospital, Magdala Avenue, London, N19 5NF UK
                Article
                Publisher ID: 648
                DOI: 10.1186/s12916-016-0648-9
                PMC ID: 4936221
                PubMed ID: 27383519
                SO-VID: 8ca8cadf-0b48-4050-9c10-ed8f59d67305
                Copyright © © The Author(s). 2016
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 25 May 2016
                Date accepted : 23 June 2016
                Categories
                Subject: Commentary
                Custom metadata
                issue-copyright-statement © The Author(s) 2016

                ScienceOpen disciplines: Medicine
                Keywords: aspirin,prevention,cancer,cardiovascular disease,benefit–harm balance,bleeding,gastrointestinal,modelling,personalised medicine
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: aspirin, prevention, cancer, cardiovascular disease, benefit–harm balance, bleeding, gastrointestinal, modelling, personalised medicine

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