Translating cholesterol guidelines for the treatment of patients at high risk of cardiovascular disease into practice

Current guidelines for primary and secondary prevention of CVD

Current guidelines for primary and secondary prevention were the subject of this Group’s debate during the forum. An important cause for concern identified during this discussion was that no single, unified set of multidisciplinary guidelines is used by hospitals, primary care trusts (PCTs), networks, regions and strategic health authorities. Individual hospitals or PCTs use a range of guidelines and cholesterol targets (see table 1).^1–3 The participants – all hospital consultants – reported that they would like to be able to select the lipid targets and treatment according to the needs of each patient.

New guidelines: what’s important?

Patient groups

The discussants considered that any new, standardised local guideline should encompass both primary and secondary prevention for patients with established cardiovascular disease (CVD) and ‘secondary prevention equivalents’. Current guidelines concur on the value of secondary prevention in patients with CVD – defined as coronary heart disease (CHD), transient ischaemic attack (TIA)/ stroke or peripheral arterial disease (PAD) – but concern was expressed during the debate that, although these differing presentations are manifestations of the same disease process, intervention may be less aggressive in some groups of patients, such as those with PAD.

Discussants recommended that:

• Primary prevention should be directed towards people with an estimated 10-year risk of CVD
  ≥ 20% according to Joint British Societies’ (JBS 2) risk calculation charts¹
• Intervention should be focused particularly on people with type 2 diabetes or hypertension since it may be impractical to identify all eligible patients within the general population
• Identification and treatment should be the responsibility of primary care since these patients can be readily identified through Quality and Outcomes Framework (QOF) registers
• If a 10-year 20% CVD risk were the only criterion, almost everyone aged over 65 would be eligible for primary prevention. This makes it essential to take into account biological age, life expectancy and the presence of co-morbidities and other cardiovascular (CV) risk factors when considering primary prevention in older patients.

‘For primary prevention, intervention should be focused particularly on people with type 2 diabetes or hypertension’

Secondary prevention ‘equivalents’ are patients with type 2 diabetes, some hypertensive patients and some with chronic kidney disease (CKD). The Group recommended that all diabetes patients aged 40 years and above should receive lipid-lowering therapy, regardless of their cholesterol levels. Hypertensive patients, however, should only receive treatment after an overall risk assessment that aims to identify patients who have a 20% or greater 10-year risk of developing CVD.⁴ Similarly, while some CKD subgroups, such as diabetic patients, should be considered for treatment if thought to be at higher risk⁵, there is, as yet, no consensus within the renal community on the management of other patient subgroups, such as those with glomerulonephritis. The Group noted that clarification on the role of lipid-lowering therapy in CKD is expected from the National Institute for Health and Clinical Excellence (NICE) later in 2008.

Guideline compilation

The ultimate aim in guideline compilation should be to avoid local inconsistencies and to ensure consistent practice across the region. Guidelines are most appropriately compiled by an expert multidisciplinary team that includes specialists in lipidology, biochemistry, pharmacy, pharmacology, cardiology and diabetology to help ensure secondary care acceptance, but the Group emphasised the importance of involving both medical and pharmacy representatives from primary care.

The development of guidelines should consider the current evidence base, choice of treatment, economic issues, and QOF and/or NICE targets, while drawing on best practice outlined in existing local or national guidelines. Concern was expressed about the challenge presented by the perceived conflict of interest between best clinical practice and economic realities. The Group concluded that the balance between these sometimes competing values can only be achieved through consensus discussion involving stakeholders from primary care, secondary care, PCT management
and pharmacy.

‘All diabetes patients aged 40 and over should receive lipid-lowering therapy, regardless of cholesterol levels’

An example guideline

To better understand the process of compilation, an example guideline looking at the primary or secondary prevention of established CHD was discussed. While it was agreed that reducing low-density lipoprotein (LDL) cholesterol is increasingly accepted as being equivalent to reducing risk, it was emphasised that the underlying aim of treatment is to address each patient’s CVD risk, not to treat the biochemistry. The Group agreed that there is general agreement among clinicians that the initial step in this instance should be to prescribe generic simvastatin 40 mg daily but there was less consensus about what steps to take if, for example, a patient does not achieve target cholesterol, is intolerant of treatment, or if a statin is contra-indicated. Consequently, a guideline must focus on subsequent steps in the treatment algorithm.

Implementing new guidelines

Identify a clinical champion

If implementation is not driven by a PCT, the Group agreed that a clinical lead or champion is invaluable – someone who can take local responsibility, by convening other disciplines or by driving implementation. This person must have credibility to both primary and secondary care – an ideal candidate would be a clinical pharmacologist, as they are seen as non-partisan and able to promote guidelines across medical disciplines. Since many areas do not have a clinical pharmacologist, in practice a clinical champion is likely to be a member of the multidisciplinary clinical team working in close co-operation with pharmacy.

Monitor adherence

Monitoring adherence to guideline standards and targets is crucial, and the Group recommended that the strategic health authority or network should be responsible for monitoring implementation across a large geographical area. In primary care, QOF targets help to support adherence to and implementation of guidelines, but there is no equivalent incentive in secondary care apart from a physician’s desire to maintain professional and clinical standards (which also applies in primary care). The Group thought that detailed discussion of the issue was outside its remit, but recommended that relevant professional organisations might explore the potential role of incentivisation to support guideline implementation in secondary care.

Major obstructions to progress

The main barrier to moving forward with guidelines identified by the Group was lack of professional ownership; conversely, if stakeholders feel strongly that they own the guidelines, they are more likely to drive implementation. The division of labour in guideline implementation must also be taken into account: while secondary care may set the targets or design the algorithms, delivery will predominantly take place in primary care within the limits of evidence, safety, tolerability and economics.

Facilitating guideline implementation

Education

Education, the Group felt, is the key to any guideline implementation– to include education of physicians in primary and secondary care, not only on general issues of implementation but also on specific areas where there is currently
a lack of clarity.

Individualised and general public health education is also essential. The Group recognised the benefit for patients of ‘knowing their numbers’, as well as the value of patient-held records, which can be used during a consultation to motivate patients to continue to adhere to treatment while noting that cholesterol is a health issue that should be addressed throughout the population at high CVD risk.

‘The potential conflict of interest between best clinical practice and economic reality needs to be addressed by consensus discussion’

Support posts

Local/regional risk factor or cardiovascular nurses can facilitate implementation by working within the community while still accountable to secondary care. Such nurses should be responsible for education, follow-up, drug titration, and monitoring of adherence and complications and not focus on a single aspect of management such as drug therapy. The Group suggested that, based on the model of Parkinson’s disease nurse specialists, these support posts could initially be supported by industry and/or charities but that ultimately funding should be taken over by the
Department of Health.

Drug pricing

Industry could also help to facilitate guideline implementation by reducing the cost of drugs and possibly by introducing a flat pricing structure for all doses of lipid-lowering therapy. The Group considered that the latter would be particularly relevant if biochemical targets were in future reduced to total cholesterol (TC) < 4.0 mmol/L and LDL-cholesterol < 2.0 mmol/L.

Discussion

Q: There appears to be no unified guideline on prevention across primary and secondary care. Is this a common experience?

A: PCTs are also looking carefully at the NICE guidelines on secondary prevention following myocardial infarction (MI).⁶ JBS 2 was confounded by the statement⁷ by the National Director for Heart Disease & Stroke that national targets are TC < 5.0 mmol/L and LDL-C < 3.0 mmol/L rather than, respectively, < 4.0 mmol/L and < 2.0 mmol/L. The situation will hopefully be clarified by the publication of the NICE guidelines on lipid modification.⁸

Q: Guidelines are important in educating doctors, but should treatment not depend on the doctor’s judgement of the needs of the patient?

A: Guidelines are designed for the vast majority of patients but should not restrict clinicians’ freedom to treat an individual patient’s exceptional needs. The issue is how to define the exceptions.

Q: The tracking or monitoring of guidelines is an important issue, isn’t it? Clinicians must have flexibility and non-clinicians should understand that a simple tick-box approach to targets is inappropriate. The people with whom we work, especially managers, also need to be aware that guidelines are not fixed and must be revised regularly according to evolving evidence.

A: Agreed.

References

1. JBS 2: Joint British Societies’ guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005;91(suppl V):v1–v59.
2. National Service Framework for Coronary Heart Disease. London: Department of Health, 2000.
3. National Prescribing Centre. GMS Contract: Quality and Outcomes Framework targets for cholesterol 2006/7. www.npc.co.uk/nat_campaigns/statins/Statin_1.pdf (accessed 28 December 2007).
4. Williams B, Poulter NR, Brown MJ et al. British Hypertension Society guidelines for hypertension management 2004 (BHS IV): summary. BMJ 2004;328:634–40.
5. Chronic kidney disease in adults. UK guidelines for identification, management and referral. Joint specialty committee on renal medicine of the Royal College of Physicians of London and the Renal Association. March 2006.
6. National Institute for Health and Clinical Excellence. MI: secondary prevention. Secondary prevention in primary and secondary care for patients following a myocardial infarction. May 2007.
7. Boyle R. National policy on statin prescribing. Department of Health. 7 November 2006. http://www.heart.nhs.uk/heart/Resources/EventPresentations/high_cost_statins/tabid/82/Default.aspx (accessed 28 December 2007).
8. National Institute for Health and Clinical Excellence. Clinical Guideline 67. Lipid Modification. Cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. May 2008.
9. National Institute for Health and Clinical Excellence. Clinical Guideline 66. Type 2 diabetes. May 2008.