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The new Australian Lipid Management Guidelines 2001,
published as a supplement with this issue of the Journal, provide an
excellent overview of the current evidence on the cardiovascular
disease (CVD) benefits of cholesterol lowering. They also signal the
acceptance by Australian experts that treatment decisions should be
driven primarily by a patient's estimated "absolute CVD risk" — the
probability of developing CVD over a specified time period — rather
than primarily by his or her blood lipid level.
The Guidelines comprehensively summarise the extensive evidence
showing the benefits of cholesterol-lowering interventions in
people with low-density lipoprotein (LDL) levels above about
2.5-3.0 mmol/L (equivalent to a total cholesterol level above about
4.5-5.0 mmol/L). But they don't tell us that over 90% of Australians
aged 45-75 years have a total cholesterol level above 4.5 mmol/L (Dr
Danny Liew, Department of Epidemiology and Preventive Medicine,
Monash University, VIC, unpublished analysis). The Guidelines
correctly emphasise the need to base treatment decisions primarily
on absolute CVD risk rather than on lipid levels, as the benefits of
cholesterol lowering are determined far more by individual absolute
risk than by pre-treatment level of LDL cholesterol. But the advice
provided on how to identify patients at high absolute risk,
particularly those without previous symptomatic disease, is rather
loose, as discussed below. Moreover, the potential size of the target
group for drug-based primary prevention is not mentioned.
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...it is estimated that this year statins will account for almost a fifth of the total Australian Pharmaceutical Benefits Scheme budget.
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Lipid-lowering drugs are appropriately recommended for secondary
prevention when the total cholesterol level is above 4 mmol/L, given
the high absolute risk and large potential benefit of treatment. This
patient group includes about 5% of Australians aged 30-79 years
(Professor Andrew Tonkin, National Heart Foundation Australia,
personal communication). Aboriginal people and Torres Strait
Islanders are appropriately identified as high-risk groups, as are
people with diabetes (types 1 and 2), although the recommended
treatment threshold for Indigenous people and people with diabetes
is unclear. If the cholesterol threshold for treatment is also 4
mmol/L in these groups, I estimate this will add at least another 5% of
the middle-aged and older Australian population to the numbers
eligible for treatment.
The authors of the Guidelines endorse the CVD risk charts used in New
Zealand for estimating absolute CVD risk.1 This brings Australian
lipid management recommendations more in line with those of the
international community. Similar charts or risk calculators, all
based on data from the Framingham Heart Study, are now included in most
major national and international CVD management
guidelines.2-6 The Guidelines state that
people with an estimated five-year absolute CVD risk of 10%-15% or
above (identified using risk charts) are the "at-risk" group who
should be targeted for treatment. Alternatively, for doctors who
don't use risk charts, the at-risk group includes everyone over 45
years of age with at least one of seven listed risk factors, some of
which are ill-defined in the Guidelines (ie, "hypertension" and
"overweight"), yet are very prevalent using some common
definitions. For people less than 45 years of age, having two listed
risk factors also places them in the at-risk group. This "count the
risk factors" definition of at-risk is an unnecessarily crude
approach and will identify some people with only a 5% five-year CVD
risk and exclude others with a five-year risk above 15%. It is also
difficult to find a clear statement in the Guidelines about when to
initiate drug treatment in this "at-risk" group, and no mention is
made of the potential size of the group. I estimate it will include at
least another 20% of Australians aged 45-75 years if the cut-off for
drug treatment is an LDL cholesterol level of 4 mmol/L or a total
cholesterol level of 6 mmol/L (Professor Michael Hobbs, Department
of Public Health, University of Western Australia, personal
communication).
The authors of the Australian guidelines are to be congratulated for
their high quality review of the evidence of effectiveness of both
population- and individual-level interventions, and for
explicitly linking the level of evidence with their
recommendations. However, they are remiss in not considering the
implications of implementing the recommendations. For example, it
is estimated that this year statins will account for almost a fifth of
the total Australian Pharmaceutical Benefits Scheme
budget.7 While this may or may not be
good value for money, it is increasingly accepted that clinical
leaders, as well as taking responsibility for individual patients,
must also consider the wider resource implications of their
recommendations. The practical implications and potential
alternative uses of the substantial dollar and people resources
required to implement these recommendations should have been
considered. For example, it may (or may not) be better value to fund
more coronary angioplasties, or to develop more comprehensive
rehabilitation programs for patients who have had a myocardial
infarction, than to give statins to hundreds of thousands of
Australians with a modestly raised risk of CVD. It would also be
illuminating to estimate the implications of these recommendations
for health professionals, particularly general practitioners and
dietitians.
It may be that the implementation costs of the new Lipid Management
Guidelines 2001 are justified by the magnitude of the benefits.
But recommendations that could result in the long-term treatment of
perhaps one million Australians, require a substantial amount of
general practitioner and dietitian time and consume a significant
proportion of the national pharmaceutical budget will require a
serious cost-benefit analysis if they are to be endorsed by
healthcare funders. Healthcare costs will be cut by insiders with a
scalpel or by outsiders with a meat axe.7 In their current form, these
Guidelines unfortunately present an exposed neck to a large axe.
Rodney T Jackson
Professor; and Head, Division of Community Health and Effective
Practice Institute, Faculty of Medical and Health Sciences,
University of Auckland, NZ
- Jackson R. Updated New Zealand cardiovascular disease
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Dyslipidaemia Advisory Group. 1996 National Heart Foundation
clinical guidelines for the assessment and management of
dyslipidaemia. N Z Med J 1996; 109: 224-232.
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Wood D, Durrington P, Poulter N, et al. Joint British
recommendations on prevention of coronary heart disease in clinical
practice. Heart 1998; 80 (Suppl 2):S1-S29.
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Wood D, De Backer G, Faergeman O, et al. Prevention of coronary heart
disease in clinical practice: recommendations of the Second Joint
Task Force of European and other Societies on Coronary Prevention.
Atherosclerosis 1998; 140: 199-270.
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Guidelines Subcommittee. 1999 World Health Organization -
International Society of Hypertension Guidelines for the
Management of Hypertension. J Hypertens 1999; 17: 151-183.
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Expert Panel on Detection Evaluation and Treatment of High Blood
Cholesterol in Adults. Executive Summary of the Third Report of the
National Cholesterol Education Program Expert Panel on Detection,
Evaluation and Treatment of High Blood Cholesterol in Adults.
JAMA 2001; 285: 2486-2497.
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Health Insurance Commission. Annual Report 1999-2000.
<www.hic.gov.au/statistics/dyn_pbs/forms/pbs_tab1.shtml>
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Eddy D. What do we do about costs? JAMA 1990; 264: 1161-1170.
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