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THIS REPORT CONTAINS New data to paint a picture of Australia’s silent cholesterol burden Overturning Australia’s cholesterol complacency CODE RED:CARDIOVASCULAR DISEASE HAS NOT BEEN SOLVED. ONE OFTEN NEGLECTED RISK FACTOR IS ELEVATED CHOLESTEROL NEW DATA SHOWS THAT NEARLY ONE IN TWO HIGH-RISK PEOPLE WHO HAVE HAD A CARDIOVASCULAR EVENT MAY NOT MEET THE RECOMMENDED TARGET FOR LDL-C OR ‘BAD’ CHOLESTEROL THROUGH OPTIMAL CHOLESTEROL MANAGEMENT LIVES COULD BE SAVED CARDIOVASCULAR EVENTS PREVENTED SAVED IN HEALTHCARE COSTS OVER THE NEXT FIVE YEARS $1.55 BILLION $66.6m 13,742 3,738 56% OF WOMEN WHO HAVE HAD A CARDIOVASCULAR EVENT ARE NOT BEING OPTIMALLY MANAGED FOR LDL-C OR ‘BAD’ CHOLESTEROL. THIS COMPARES TO 42% OF MEN. WHEN IT COMES TO CHOLESTEROL WE NEED GREATER EDUCATION FOR CLINICIANS AND PATIENTS ABOUT THE IMPORTANCE OF TREATING HIGH-RISK PEOPLE TO TARGET IN 2017, LOST PRODUCTIVITY DUE TO DEATHS OF WORKING-AGE AUSSIES FROM CONSEQUENCES OF HIGH CHOLESTEROL WAS ESTIMATED AT FIRST NEW CHOLESTEROL DATA IN A DECADE EXAMINING AUSTRALIAN ADULTS MOST AT RISK OF CARDIOVASCULAR DISEASE SHOWS WE ARE FAILING MANY OF THESE PEOPLEThis report was developed by Associate Professor Melinda Carrington Dr Tina Cao Dr Tilahun Haregu Dr Lan Gao (Deakin University) Professor Marj Moodie (Deakin University) Dr Stephanie Yiallourou Professor Tom Marwick Any enquiries or comments about this publication should be directed to Preclinical Disease and Prevention Baker Heart and Diabetes Institute 75 Commercial Road, Melbourne Vic 3004 Australia Telephone +61 3 8532 1638 PO Box 6492, Melbourne, Vic 3004 Australia https://baker.edu.au/research/ laboratories/preclinical-disease- prevention Suggested reference Carrington MJ, Cao T, Haregu T, Gao, L, Moodie M, Yiallourou SR and Marwick T. CODE RED: Overturning Australia’s cholesterol complacency. May 2020, Baker Heart and Diabetes Institute, Melbourne, Australia. Amgen Australia Pty Ltd provided funding for this research and procured the services of VentureWise Pty Ltd, who contracted Baker Heart and Diabetes Institute to produce this Report. VentureWise is an independently run, wholly owned commercial subsidiary of NPS MedicineWise. None of these companies were involved in the design, analysis or interpretation of the data but they were given the opportunity to review this Report prior to it being placed in the public domain. Foreword 2 Abbreviations 4 Executive summary 6 Key findings 8 Objectives 9 Introduction 11 What is cholesterol? 11 The main types of lipoproteins 11 Risk of elevated cholesterol for CVD 12 The benefit of lowering cholesterol 14 Controlling blood lipids 16 Management of elevated cholesterol for secondary prevention 16 Elevated cholesterol in high risk individuals in Australia 19 The economic burden of elevated lipids in Australia 20 Methodology 24 Data source 24 Data governance and ethics 25 Consent 25 Study design and setting 25 Study population 26 Variables 26 Study size 28 Data analyses 29 Findings 32 Cholesterol management and attainment of goal LDL-C levels 35 Health economic analyses for the estimation of burden of disease 41 Strengths and limitations 43 The patient perspective 44 Conclusions 46 Call to action 49 Acknowledgement 50 References 51 BAKER HEART & DIABETES INSTITUTE 1 Contents2 CODE RED: OVERTURNING AUSTRALIA’S CHOLESTEROL COMPLACENCY Foreword While scientists and health professionals have made major advances in the prevention and management of cardiovascular disease, the high morbidity and mortality statistics remain. What makes this worse is that many of the deaths that occur each year are preventable. Put simply, we need to do more now. This report, led by clinical and research experts at Baker Heart and Diabetes Institute and Deakin University, shines a light on a critically important aspect of cardiovascular disease, cholesterol, a known risk factor that, if left untreated, can lead to devastating outcomes. Many of us know something about cholesterol, the type of fat found in our bloodstream. We are familiar with ‘good’ and ‘bad’ cholesterol. We understand we need some cholesterol for our body to work effectively but that problems arise when there is too much. Too much cholesterol can clog the arteries supplying blood to the heart and other parts of the body, and lead to critical events such as a heart attack or stroke. So how is Australia faring when it comes to cholesterol? What is the impact of elevated cholesterol and how much is it costing the community? For the first time in nearly a decade, this 'CODE RED' report provides new and important data from the MedicineInsight program that highlights the extent of the cholesterol problem observed in patients receiving medical care from a general practice in our country. This report focuses on the cholesterol levels and treatment of Australians with prior cardiovascular disease, who we know are at greater risk of further cardiovascular events such as a heart attack or stroke. These new data, based on the examination of more than 107,000 patients over a 10 year period from 2010 to 2019, highlight cause for concern. Cardiovascular disease is our nation’s biggest killer, and has been for decades. In terms of the costs of treating cardiovascular disease on our nation’s health system, it is also the most expensive disease group in Australia. This new report reveals that whilst most of Australia’s high risk patients are being treated for elevated cholesterol, worryingly, almost half had a LDL cholesterol result that did not meet recommended target levels, leaving them vulnerable to more cardiovascular events that could result in further disability or death. More women were documented as not achieving recommended target levels compared to men, raising warning signs for women in particular. Our analysis also looked to understand what could be achieved within the next two decades if cholesterol was managed according to Australia’s clinical guidelines, to save lives, prevent cardiovascular events, and reduce healthcare spending – and the figures are concerning. We must do better for high risk patients. This report provides motivation and renewed action of what can be achieved if we increase awareness, support and advocacy for optimal cholesterol management. FOR THE FIRST TIME IN NEARLY A DECADE, NEW DATA HIGHLIGHTS THE SIGNIFICANT OPPORTUNITY TO REDUCE DEATH AND DISABILITY VIA OPTIMAL CHOLESTEROL MANAGEMENT IN AUSTRALIANS WHO HAVE ALREADY EXPERIENCED A CARDIOVASCULAR EVENT BAKER HEART & DIABETES INSTITUTE 3 The Baker Heart and Diabetes Institute is grateful to the general practices and general practitioners who participate in the MedicineInsight program, and the patients who allow the use of their de-identified information for MedicineInsight. We also acknowledge the many individuals and organisations with clinical, research, epidemiological and health economic expertise in cholesterol management who have provided guidance and support to develop this report.4 CODE RED: OVERTURNING AUSTRALIA’S CHOLESTEROL COMPLACENCY CAD Coronary artery disease CONCORDANCE Cooperative National Registry of Acute Coronary care, Guideline Adherence and Clinical Events CVD Cardiovascular disease DALY Disability-adjusted life year FOURIER Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk GP General Practitioner HDL-C High density lipoprotein cholesterol IRSAD Index of Relative Socio-Economic Advantage and Disadvantage LDL-C Low density lipoprotein cholesterol MBS Medicare Benefits Schedule PBS Pharmaceutical Benefits Scheme PCSK9 Proprotein convertase subtilisin/ kexin type 9 PVD Peripheral vascular disease QALY Quality-adjusted life year VLDL-C Very low density lipoprotein cholesterol YLD Years lived with a disability YLL Years of life lost AbbreviationsBAKER HEART & DIABETES INSTITUTE 5 Many high-risk patients had a LDL cholesterol result that did not reach recommended target levels, making them vulnerable to further cardiovascular events6 CODE RED: OVERTURNING AUSTRALIA’S CHOLESTEROL COMPLACENCY The shadow of cardiovascular disease (CVD) continues to be troublesome for Australia despite survival rates from CVD improving over the past 50 years due to new devices, medical procedures and effective drug discovery. Death rates have also declined. Whilst this is good news, CVD remains our biggest killer and the most expensive disease group to treat. In Australia, more than one in four deaths in 2017 was due to CVD, which claims the life of one Australian every 12 minutes. CVD affects one in six Australians or 4.2 million people, and its impact is far reaching. One risk factor for CVD is elevated cholesterol. Many of us are aware of it, particularly given the impact of medicines such as statins in the past few decades. But while we are familiar with the topic, community knowledge about cholesterol and optimal management could be improved. Managing high cholesterol, which includes healthy eating and lifestyle modification, medications, general practice attendances, cholesterol testing and attributable hospital admissions, is already costing the Australian community $1.5 billion in direct healthcare costs each and every year. Difficulties in controlling elevated cholesterol occur in the context of a challenging backdrop of more Australians living with heart disease than ever before. This means more people are living with disability and their risk of further cardiovascular events, such as another heart attack or stroke, is significantly higher. Effective management of these high-risk Australians is essential. That is why we have focussed this report on the magnitude of elevated cholesterol in high-risk ‘secondary prevention’ patients with prior CVD. We also know that elevated LDL cholesterol levels (LDL-C) or ‘bad’ cholesterol levels are a major risk factor for the occurrence of significant cardiovascular events. Executive summary Cardiovascular disease has not been solved.BAKER HEART & DIABETES INSTITUTE 7 For the first time in nearly a decade, the ‘CODE RED’ report provides new data highlighting the potential extent of the cholesterol problem amongst high-risk patients in Australia. This report, which is based on the examination of MedicineInsight data of more than 107,000 patients with prior CVD attending general practice over a 10-year period from 2010, shows that 79% of secondary prevention patients had a prescription recorded for recommended lipid-lowering therapy. Of the 85,352 patients who were prescribed recommended treatment, 40% or 33,857 had a result recorded that did not With the availability of effective therapeutics and cholesterol management guidelines to implement them, significant potential for optimising cholesterol management has been identified in individuals with prior CVD. This should be cause to take action. The ‘CODE RED’ report clearly identifies the critical and timely opportunity to invest in greater awareness and support for cholesterol management in high-risk patients. meet the recommended target for LDL-C or ‘bad’ cholesterol. There were also likely gender differences, with women recording higher levels of LDL-C or ‘bad’ cholesterol than men. LDL-C levels were consistently above Australian guidelines over time and 56% of women had a record of not meeting the recommended target, compared to 42% of men. Importantly, the report reveals that more than 3,738 lives could be saved, over 13,740 CVD events like heart attacks and strokes prevented, and $66.6 million could be saved in healthcare costs over the next five years through optimal cholesterol management. NEW MODELLING SHOWS THAT OVER THE NEXT FIVE YEARS THROUGH OPTIMAL CHOLESTEROL MANAGEMENT: LIVES COULD BE SAVED CARDIOVASCULAR EVENTS PREVENTED SAVED IN HEALTHCARE COSTS 3,738 13,742 $66.6mNext >