The National Heart Foundation of Australia’s summary of the recommendations for Cholesterol Management This document summarises the evidence for: 1. Secondary prevention. Secondary prevention describes reducing the risk of a repeat heart event (such as a heart attack) or worsening heart disease among people with established heart disease. 2. Primary prevention. Primary prevention describes reducing the risk of a heart event or heart disease among people who do not have heart disease. 1. The Heart Foundation’s recommendations for management of secondary prevention of coronary heart disease Cholesterol lowering drugs, in particular statins are a very effective way of reducing the risk of having a heart attack, particularly for people who have heart disease. The Heart Foundation recommends that all individuals who have had a heart attack or who have a diagnosis of coronary heart disease (CHD) receive lipid lowering therapy, namely statins (1). This recommendation is strongly supported by other peak health organisations. After a heart attack, treatment with a statin is first-line, evidence-based management (1). Some of the largest studies ever conducted in medicine have demonstrated that statins decrease further heart attacks and save lives. Scientific consensus Our position aligns with the World Health Organisation, American Heart Association, American College of Cardiology, the National Collaborating Centre for Primary Care, European Society of Cardiology, New Zealand Heart Foundation and British Heart Foundation, to name a few. - - - The World Health Organisation http://www.who.int/cardiovascular_diseases/publications/atlas_cvd/en/index.h tml American Heart Association and American College of Cardiology http://circ.ahajournals.org/content/124/22/2458 British Heart Foundation http://www.bhf.org.uk/ National Collaborating Centre for Primary Care and Royal College of General Practitioners, United Kingdom http://www.nice.org.uk/nicemedia/live/11008/30495/30495.pdf European Society of Cardiology http://www.escardio.org/guidelinessurveys/esc-guidelines/GuidelinesDocuments/guidelines-CVD-prevention.pdf New Zealand Heart Foundation http://www.heartfoundation.org.nz/programmes-resources/healthprofessionals/guidelines-and-patient-resources Heart Foundation summary of recommendations for Cholesterol Management 1 Since 1994, large, multi-centre trials including more than 170,000 people have shown that people taking statins to lower their low-density (LD) cholesterol have fewer major coronary events (non-fatal heart attack or death from CHD)(2). - Major coronary events are reduced by a quarter (24%) - 1 in 5 coronary deaths are prevented (i.e. 20% reduction) - Death from any-cause is reduced by 10% - Coronary artery surgery and coronary angioplasty is reduced by a quarter (25%) and nearly a third (28%) respectively.(3) The benefits can be seen with every 1.0 mmol/L reduction in LDL cholesterol. The most recent Cholesterol Treatment Trialists’ Collaboration (CTT) meta-analysis of 26 trials involving approximately 170,000 people confirmed this benefit seen with every 1.0 mmol/L reduction in LDL cholesterol (4). A meta-analysis involving 13 individual trials and in excess of 91,000 patients showed that treating 255 patients with a statin for 4 years led to the prevention of 5.4 cardiovascular events and one extra case of diabetes (5). The strongest predictors of whether a patient will develop diabetes are older age, increased weight and higher blood sugar, regardless of statin use. Key Heart Foundation guidance on secondary prevention - Reducing risk in heart disease: an expert guide to clinical practice for secondary prevention of coronary heart disease (2012). http://www.heartfoundation.org.au/SiteCollectionDocuments/Reducing-risk-inheart-disease.pdf Heart Foundation summary of recommendations for Cholesterol Management 2 2. The Heart Foundation’s recommendations for management of primary prevention of coronary heart disease Assessment of cardiovascular disease (CVD) risk on the basis of the combined effect of multiple risk factors (absolute CVD risk) is more accurate than the use of individual risk factors, because the cumulative effects of multiple risk factors may be additive or synergistic (6). The Heart Foundation recommends that all individuals over the age of 45 years (or 35 years for Aboriginal and Torres Strait Islander peoples) have their risk assessed using the National Vascular Disease Prevention Alliance (NVDPA) absolute CVD risk calculator (found here http://www.cvdcheck.org.au/). Why the absolute CVD risk approach is important In Australia, 64% of the adult population have three or more modifiable risk factors (7). As CVD is largely preventable, an approach focusing on comprehensive risk assessment will enable effective management of identified modifiable risk factors through lifestyle changes and, where needed, pharmacological therapy. In Australia, the National Vascular Disease Prevention Alliance (NVDPA) produces the guidelines for assessment and management of absolute cardiovascular disease risk. These guidelines define risk stratification based on the likelihood of having a cardiovascular event in the next 5 years (6). The guidelines recommend lifestyle intervention for all individuals, as well as pharmacological therapy in some cases, depending on the level of risk. A breakdown of the risk stratification is as follows: Low risk (<10% risk of CVD within the next 5 years) – lifestyle intervention Moderate risk (10-15% risk of CVD within the next 5 years) – lifestyle intervention initially, consider pharmacological therapy after 6-12 months review High risk (>15% risk of CVD within the next 5 years) – lifestyle intervention and pharmacological therapy Guidelines currently recommend risk assessment is repeated every 2 years. Statins and Absolute CVD risk The use of statins as first line lipid-lowering therapy for the management of absolute cardiovascular disease risk is at the highest evidence level (Grade A)1 (8, 9, 10). This recommendation is strongly supported by other peak health organisations Grade A evidence is defined as a body of evidence that can be trusted to guide practice. High plasma cholesterol is a well-known, modifiable risk factor for CVD. A 10% increase in total cholesterol is associated with a 27% increase in the incidence of coronary heart disease (11), and the relationship persists, irrespective of smoking status, the presence or absence of elevated blood pressure, or a history with or without vascular disease (12-15). Lipid lowering therefore plays an important role in the prevention of cardiovascular events. Most of the cholesterol in blood plasma is carried by low-density lipoprotein (LDL) cholesterol and the strong relationship between total cholesterol and CVD suggests 1 Level of evidence is based on National Health and Medical Research Council (NHMRC) Levels of Evidence and Grades for Recommendations for Developers of Guidelines (2009). Heart Foundation summary of recommendations for Cholesterol Management 3 that LDL cholesterol is a powerful risk factor (16). Moreover, the results of epidemiological studies, as well as trials with clinical endpoints, confirm that a reduction in LDL cholesterol must be the primary concern in the prevention of CVD (17). This section summarises the evidence for lowering blood lipids from systematic reviews and meta-analyses considered for the primary prevention of cardiovascular events. The mass of evidence suggests that, compared with placebo, statins reduce the risk of death or cardiovascular events in populations without a history of CVD, irrespective of age and gender and across a wide range of cholesterol levels (8, 9, 10, 18, 19, 20, 21). As with every guideline, a clinical decision still needs to be made between a patient and their treating doctor, taking into account their risk level and individual patient factors, about what the right approach to treatment is. Endorsement The Guidelines for the assessment and management of absolute cardiovascular disease risk were endorsed by the Australian Government through the National Health and Medical Research Council (NHMRC) as well as the Royal Australian College of General Practitioners and other members of the NVDPA – Diabetes Australia, Kidney Australia and the Stroke Foundation. The NVDPA’s Absolute cardiovascular disease risk management guidelines were endorsed by the NHMRC in 2012 after exhaustive literature review and expert review (over 700 reviewers) and contain in excess of 350 individual references to numerous studies. The guidelines are reviewed every five years, or as needed. International comparison The process of absolute cardiovascular risk screening has already been implemented in New Zealand with 60% of the eligible population (those aged 45 and over) being screened in the past five years (22). They are moving toward a goal of 90% of the eligible population screened by the end of next year. Already, anecdotal evidence suggests a decrease in disease progression as a result of the intervention. Key Heart Foundation guidance on primary prevention - National Vascular Disease Prevention Alliance. Guidelines for the assessment of Absolute cardiovascular disease risk (2009). http://www.heartfoundation.org.au/SiteCollectionDocuments/guidelinesAbsolute-risk.pdf - National Vascular Disease Prevention Alliance. Guidelines for the management of Absolute cardiovascular disease risk (2012). http://strokefoundation.com.au/site/media/AbsoluteCVD_GL_webready.pdf Scientific consensus Our position aligns with the National Health and Medical Research Council and other members of the National Vascular Disease Prevention Alliance, as well as the World Health Organisation, American Heart Association, American College of Cardiology, New Zealand Heart Foundation, British Heart Foundation, National Heart Foundation summary of recommendations for Cholesterol Management 4 Institute of Health and Clinical Excellence, and the European Society of Cardiology to name a few. - - The World Health Organisation http://www.who.int/cardiovascular_diseases/publications/Prevention_of_Cardi ovascular_Disease/en/index.html American Heart Association and American College of Cardiology http://circ.ahajournals.org/content/100/13/1481.full New Zealand Heart Foundation http://www.heartfoundation.org.nz/ British Heart Foundation http://www.bhf.org.uk/heart-health/prevention/riskfactors.aspx National Institute for Health and Clinical Excellence (NICE), United Kingdom http://www.nice.org.uk/nicemedia/pdf/cg67niceguideline.pdf European Society of Cardiology http://www.escardio.org/guidelinessurveys/esc-guidelines/GuidelinesDocuments/guidelines-CVD-prevention.pdf http://www.escardio.org/guidelines-surveys/escguidelines/guidelinesdocuments/guidelines-dyslipidemias-ft.pdf Heart Foundation summary of recommendations for Cholesterol Management 5 References 1. National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand. Reducing risk in heart disease: an expert guide to clinical practice for secondary prevention of heart disease. Melbourne: National Heart Foundation of Australia, 2012. 2. Clinical Trial Service Unit and Epidemiological Studies Unit. CTT (Cholesterol Treatment Trialists’ Collaboration). Available at: http://www.ctsu.ox.ac.uk/research/meta-trials/ctt/ctt-website (accessed October 2013) 3. Cholesterol Treatment Trialists’ (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005; 366:126778. 4. Cholesterol Treatment Trialists’ (CTT) Collaboration, Baigent C, Blackwell L, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a metaanalysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376 (9753): 1670-1681. Available at http://www.ncbi.nlm.nih.gov/pubmed/21067804 5. Shah RV, Goldfine AB. Statins and risk of new-onset diabetes mellitus. Circulation 2012; 126:e282-e284. 6. National Vascular Disease Prevention Alliance. Guidelines for the management of absolute cardiovascular disease risk. Melbourne: National Stroke Foundation, 2012. 7. Australian Institute of Health and Welfare (AIHW). Health determinants: the key to preventing chronic disease. Cat No. PHE 157. Canberra: AIHW, 2011. 8. Brugts JJ, Yetgin T, Hoeks SE, Gotto AM, Shepherd J, Westendorp RG, et al. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials. BMJ. 2009;338:b2376. 9. Taylor F, Ward K, Moore TH, Burke M, Davey Smith G, Casas JP, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2011(1):CD004816. 10. Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. 11. Law MR, Wald NJ, Thompson SG. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ. 1994 Feb 5;308(6925):367-72. 12. Neaton JD, Wentworth D. Serum cholesterol, blood pressure, cigarette smoking, and death from coronary heart disease. Overall findings and differences by age for 316,099 white men. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jan;152(1):56-64. 13. Neaton JD, Blackburn H, Jacobs D, Kuller L, Lee DJ, Sherwin R, et al. Serum cholesterol level and mortality findings for men screened in the Multiple Risk Heart Foundation summary of recommendations for Cholesterol Management 6 Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jul;152(7):1490-500. 14. GD, Shipley MJ, Marmot MG, Rose G. Plasma cholesterol concentration and mortality. The Whitehall Study. JAMA. 1992 Jan 1;267(1):70-6. 15. Stamler J, Wentworth D, Neaton JD. Is relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? Findings in 356,222 primary screens of the Multiple Risk Factor Intervention Trial (MRFIT). JAMA. 1986 Nov 28;256(20):2823-8. 16. United States. National Heart, Lung, and Blood Institute. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III): final report. Washington; National Institutes of Health: 2002. [cited Feb 2011] Available from url: http://www.nhlbi.nih.gov/guidelines/cholesterol/ 17. Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, et al. European guidelines on cardiovascular disease prevention in clinical practice: executive summary. Fourth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts). Eur J Cardiovasc Prev Rehabil. 2007 Sep;14 Suppl 2:E1-40. 18. Ray KK, Seshasai SR, Erqou S, Sever P, Jukema JW, Ford I, et al. Statins and allcause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants. Arch Intern Med. 2010 Jun 28;170(12):1024-31. 19. Thavendiranathan P, Bagai A, Brookhart MA, Choudhry NK. Primary prevention of cardiovascular diseases with statin therapy: a meta-analysis of randomized controlled trials. Arch Intern Med. 2006 Nov 27;166(21):2307-13. 20. Ward S, Lloyd Jones M, Pandor A, Holmes M, Ara R, Ryan A, et al. A systematic review and economic evaluation of statins for the prevention of coronary events. Health Technol Assess. 2007 Apr;11(14):1-160, iii-iv. 21. Delahoy PJ, Magliano DJ, Webb K, Grobler M, Liew D. The relationship between reduction in low-density lipoprotein cholesterol by statins and reduction in risk of cardiovascular outcomes: an updated meta-analysis. Clin Ther. 2009 Feb;31(2):236-44. 22. Bramwell N. Call for routine CV health checks. Medical Observer 2013, 6 Aug. Available from url: http://www.medicalobserver.com.au/news/call-forroutine-cv-health-checks Heart Foundation summary of recommendations for Cholesterol Management 7
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