3.1 Risk factors Updated
3.2 The concept of risk and why it matters Minor update
3.3 Risk scoring systems Completely revised
3.4 What is meant by high risk? Completely revised
4.1 Assessing risk Updated
4.2 Recording risk factor information Updated
4.3 Using risk assessment tools Updated
4.4 How to determine cardiovascular risk Updated
5.1.1 Total and saturated fat Updated
5.1.2 Omega-3 supplementation Updated
5.3 Fruit and vegetable intake Minor update
5.4.2 Folate supplementation Completely revised
5.4.3 Stanol esters and plant sterols Updated
5.5 Dietary patterns New
5.6 Giving dietary advice Minor update
5.7 Weight reduction and cardiovascular risk Completely revised
5.8 Metabolic syndrome Updated
6.1 Definitions (physical activity) Updated
6.2.1 Physical inactivity as an independent risk factor Minor update
6.2.2 Levels of physical activity Minor update
6.2.3 Vigorous and high-intensity physical activity New
6.2.4 Risks of sedentary behaviour New
6.2.5 Effects of physical activity on other key risk factors Minor update
7.1.1 Active smoking Minor update
7.2.1 The general population (smoking cessation interventions) Updated
7.2.2 Electronic cigarettes New
7.2.3 Special populations Updated
8.1 Alcohol and cardiovascular risk Updated
8.1.1 Effects of alcohol consumption levels on cardiovascular disease mortality
and morbidity Updated
8.1.2 Methods of modifying alcohol consumption Minor update
9.1 Antiplatelet agents for people with established cardiovascular disease Minor update 9.2 Antiplatelet agents for people without cardiovascular disease Completely revised 9.3 Antiplatelet agents for people with diabetes Completely revised 9.4 Antiplatelet agents for people with hypertension Completely revised 9.5 Antiplatelet agents for people with chronic kidney disease New
10.1 The role of total and low-density lipoprotein cholesterol in cardiovascular
disease Minor update
10.2 Measuring lipid levels Updated
10.3 Lowering cholesterol to reduce cardiovascular risk Updated
10.4.1 The effects of statins on LDL cholesterol Completely revised 10.4.2 The effects of statins on cardiovascular end points New
10.4.3 Statin therapy for individuals without cardiovascular disease Updated
10.4.4 Statin therapy for individuals with established cardiovascular disease Completely revised
10.4.5 Safety of statin therapy Updated
10.4.6 Reported intolerance to statin therapy New
10.4.7 Benefits and harms of statin therapy New
10.5.1 People with diabetes Updated
10.5.2 Familial hypercholesterolaemia Updated
10.5.4 Older people Updated
10.5.5 Sex New
10.5.6 Chronic kidney disease New
10.6.1 Bile acid sequestrants Minor update
10.6.2 Ezetimibe Updated
Risk estimation and the prevention of cardiovascular disease 1 • Introduction
10.6.3 Fibrates Updated
10.6.4 Nicotinic acid Updated
10.6.5 PCSK9 inhibitors New
10.7 Management of combined dyslipidaemia Updated
11.1 Blood pressure thresholds for intervention with drug therapy Updated 11.1.1 Blood pressure thresholds for individuals with symptomatic cardiovascular
disease Completely revised
11.1.2 Blood pressure thresholds for individuals without symptomatic
cardiovascular disease Completely revised
11.1.3 Blood pressure thresholds for specific groups at high cardiovascular risk New
11.2 Target values for blood pressure lowering Updated
11.2.1 Type 2 diabetes New
11.2.2 Chronic kidney disease New
11.2.3 Dialysis New
11.2.4 Conclusions (target values for blood pressure lowering) New
11.3 Selection of antihypertensive therapy Minor update
11.3.1 The British Hypertension Society algorithm Updated
12.1 The impact of psychological wellbeing on cardiovascular risk Updated
12.2.1 Psychological interventions Updated
12.2.2 Pharmacological interventions for depression New
13 Provision of information Updated
14 Implementing the guideline Updated
1.3 RISK ESTIMATION
For many health professionals the calculation of absolute cardiovascular risk is the starting point for the development of CVD prevention strategies.
1.3.1 DEFINTIONS
Absolute risk is also known as total risk or global risk. This risk is defined as the percentage chance of an individual having a CVD event over a given period of time, for example a ten-year risk of 20%. The specific factors used to estimate absolute risk in the ASSIGN (Assessing cardiovascular risk using SIGN guidelines to ASSIGN preventive treatment) score are age, sex, smoking, systolic blood pressure, total cholesterol, HDL cholesterol, family history of premature CVD, diagnosis of diabetes, diagnosis of rheumatoid arthritis and deprivation (see section 3.3 for further information on ASSIGN). While these are the most significant risk factors which predict cardiovascular risk, other risk calculators include a wide range of other factors including antihypertensive treatment, atrial fibrillation, chronic kidney disease, ethnicity and body mass index. Relative risk refers to the risk of someone who has risk factors having a CVD event compared with an individual of the same age and sex without risk factors.
In a similar way, results from randomised intervention trials may be presented as absolute or relative changes to the outcomes of interest, depending on whether the result from participants within the trial who received the intervention is subtracted from the result of those who do not receive the intervention (absolute effect) or divided by it (relative effect). Although the relative effects of a treatment is the same regardless of baseline risk, patients with a lower baseline risk will have a lower absolute chance of benefiting and a lower residual risk. Patients with a greater baseline risk will have a greater absolute chance of benefiting but also a greater residual risk. While absolute event rates can be useful to communicate the impact of a treatment to patients, trial selection may influence the apparent rates due to differences in baseline risk in the populations, and so the potential benefits or hazards when the trial results are applied in current practice may be different.
1.3.2 RISK SCORES
Risk scores cannot perfectly predict absolute risk. They are extremely useful in assessing or estimating risk and in prioritising treatment on an equitable basis.
In Scotland, absolute CVD risk is usually calculated from electronic decision support tools based on the ASSIGN algorithm (see section 3.3).
1.4 STATEMENT OF INTENT
This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results.
The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at through a process of shared decision making with the patient, covering the diagnostic and treatment choices available. It is advised, however, that significant departures from the national guideline or any local guidelines derived from it should be documented in the patient’s medical records at the time the relevant decision is taken.
1.4.1 INFLUENCE OF FINANCIAL AND OTHER INTERESTS
It has been recognised that financial interests in, or close working relationships with, pharmaceutical companies may have an influence on the interpretation of evidence from clinical studies.
It is not possible to completely eliminate any possible bias from this source, nor even to quantify the degree of bias with any certainty. SIGN requires that all those involved in the work of guideline development should declare all financial interests, whether direct or indirect, annually for as long as they are actively working with the organisation. By being explicit about the influences to which contributors are subjected, SIGN acknowledges the risk of bias and makes it possible for guideline users or reviewers to assess for themselves how likely it is that the conclusions and guideline recommendations are based on a biased interpretation of the evidence.
Signed copies of declaration of interests forms are retained by the SIGN Executive and a register of interests is available in the supporting material section for this guideline at www.sign.ac.uk
1.4.2 PRESCRIBING OF LICENSED MEDICINES OUTWITH THEIR MARKETING AUTHORISATION
Recommendations within this guideline are based on the best clinical evidence. Some recommendations may be for medicines prescribed outwith the marketing authorisation (MA) also known as product licence.
This is known as ‘off-label’ use.
Medicines may be prescribed ‘off label’ in the following circumstances:
y for an indication not specified within the marketing authorisation y for administration via a different route
y for administration of a different dose y for a different patient population.
An unlicensed medicine is a medicine which does not have MA for medicinal use in humans.
Generally ‘off-label’ prescribing of medicines becomes necessary if the clinical need cannot be met by licensed medicines within the marketing authorisation. Such use should be supported by appropriate evidence and experience.18
“Prescribing medicines outside the conditions of their marketing authorisation alters (and probably increases) the prescribers’ professional responsibility and potential liability”.18
Risk estimation and the prevention of cardiovascular disease 1 • Introduction
The General Medical Council recommends that when prescribing a medicine ‘off label’, doctors should:
y be satisfied that such use would better serve the patient’s needs than an authorised alternative (if one exists)
y be satisfied that there is sufficient evidence/experience of using the medicines to show its safety and efficacy, seeking the necessary information from appropriate sources
y record in the patient’s clinical notes the medicine prescribed and, when not following common practice, the reasons for the choice
y take responsibility for prescribing the medicine and for overseeing the patient’s care, including monitoring the effects of the medicine.
Non-medical prescribers should ensure that they are familiar with the legislative framework and their own professional prescribing standards.
Prior to any prescribing, the licensing status of a medication should be checked in the summary of product characteristics (www.medicines.org.uk). The prescriber must be competent, operate within the professional code of ethics of their statutory bodies and the prescribing practices of their employers.19
1.4.3 HEALTH TECHNOLOGY ASSESSMENT ADVICE FOR NHSSCOTLAND
Specialist teams within Healthcare Improvement Scotland issue a range of advice that focuses on the safe and effective use of medicines and technologies in NHSScotland.
The Scottish Medicines Consortium (SMC) provides advice to NHS boards and their Area Drug and Therapeutics Committees about the status of all newly-licensed medicines and new indications for established products.
NHSScotland should take account of this advice and ensure that medicines accepted for use are made available to meet clinical need where appropriate.
In addition, Healthcare Improvement Scotland reviews Multiple Technology Appraisals (MTAs) produced by the National Institute for Health and Care Excellence (NICE) and provides advice about their applicability in NHSScotland. If Healthcare Improvement Scotland advises that MTA guidance is applicable in Scotland, NHSScotland should take account of this and ensure that recommended medicines and treatment are made available to meet clinical need where appropriate.
NICE MTAs deemed valid for NHSScotland supersede extant SMC advice as they are generally underpinned by a larger and more recent evidence base.
SMC advice and NICE MTA guidance relevant to this guideline are summarised in section 14.4.
2 Key recommendations
The following recommendations were highlighted by the GDG as the key clinical recommendations that should be prioritised for implementation.
2.1 ESTIMATING CARDIOVASCULAR RISK
R
Individuals with the following risk factors should be considered at high risk of cardiovascular events:
y established cardiovascular disease, or
y stage 3 or higher chronic kidney disease or micro- or macroalbuminuria, or y familial hypercholesterolaemia, or
y who are over the age of 40 and have diabetes, or y who are under the age of 40 and have diabetes, and
– at least 20 years duration of disease, or
– target organ damage (eg proteinuria, micro- or macroalbuminuria, proliferative retinopathy or autonomic neuropathy), or
– significantly elevated cardiovascular risk factors.
2.2 DIET
R
Patients, and individuals at risk of cardiovascular disease, who are overweight or obese, should be targeted with interventions designed to reduce weight by at least 3 kg, and to maintain this reduction.
2.3 PHYSICAL ACTIVITY
R
Physical activity of at least moderate intensity (eg breathing faster than normal) is recommended for the whole population (unless contraindicated by an individual’s condition).
2.4 SMOKING
R
All people who smoke should be advised to stop and offered support to help facilitate this in order to minimise cardiovascular and general health risks.
2.5 ANTIPLATELET THERAPY
R Aspirin is not recommended for primary prevention of cardiovascular disease.
2.6 LIPID LOWERING
R
Adults who are assessed as being at high cardiovascular risk, but with no established CVD, should be offered treatment with atorvastatin 20 mg/day following an informed discussion of risks and benefits between the individual and their responsible clinician. In those already taking an alternative regimen due to reported intolerance with atorvastatin, there is no need to change their current regimen.
Risk estimation and the prevention of cardiovascular disease 2 • Key recommendations