3 Research recommendations
The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of research recommendations is detailed in the full guideline.
What is the effectiveness of age alone and other routinely available risk factors compared with the formal structured multifactorial risk assessment to identify people at high risk of developing CVD?
Current risk assessment tools rely on a complex set of data derived from demographic, lifestyle, physiological and biochemical parameters. The principal determinant of CVD risk is age, and this may be sufficient to identify high‑risk populations. However, focusing on age alone may result in people being missed who are at higher risk as a result of other factors that do not require access to intensive resources, such as smoking status, family history and deprivation. It is important therefore to assess age against validated simplified and complex CVD risk tools when predicting people at high risk.
What is the improvement in the cost‑effectiveness metrics for statin therapy in reducing CVD that can be obtained when using a complete individual patient‑based outcomes meta‑analysis data set compared with using published outcomes data?
This guideline development process uses published summary data from trials in a meta‑analysis to inform the clinical efficacy of statins. This use of aggregate data has limitations. The use of individual patient data would allow use of time to event statistics and allow investigation of interaction with baseline risk. Such an approach can be used to validate the current approach and would provide useful information on limitations of use of summary data.
What is the effectiveness of statin therapy in older people?
The UK population is ageing and atherosclerosis is an age‑associated process. Few trials assessing cardiovascular outcomes have recruited many people older than 80 years yet the important effect of age on CVD risk suggests that all people in this group should be offered statin therapy. However, there is no evidence to validate the CVD benefits and side effects of statin therapy such as effect on muscle and renal function in this age group. Controversy also exists about the efficacy of statins in preventing or promoting other chronic diseases of ageing such as dementia, Parkinson's disease, or age‑related macular degeneration.
What is the effectiveness of statins and/or other LDL‑cholesterol‑lowering treatment in people with type 1 diabetes?
Why this is important
People with type 1 diabetes have increased CVD risk derived from age, sex, glycaemia, blood pressure, renal function and lipid levels as identified in epidemiological studies. Long‑term glycaemic control is associated with better outcomes but no trial has investigated the efficacy of statin therapy or other LDL‑cholesterol‑lowering therapies exclusively in people with type 1 diabetes.
What is the clinical effectiveness and rate of adverse events of statin therapy using atorvastatin 20 mg per day compared with atorvastatin 40 mg per day and atorvastatin 80 mg per day in people without established CVD?
This guideline has established that atorvastatin 20 mg is clinically and cost effective for the primary prevention of CVD and should be recommended for those at 10% risk of cardiovascular events as assessed using the QRISK2 calculator. However, this analysis looked at the effectiveness of treatment shown by 'high‑intensity' statins as a group, as it was not possible to establish the relative effectiveness of atorvastatin 20 mg, 40 mg and 80 mg using trial data. Trial data with clinical outcomes exists for atorvastatin 80 mg against atorvastatin 10 mg only. The rates of adverse events resulting from different doses of atorvastatin in routine clinical practice are also uncertain and would need to be considered in combination with effectiveness in assessing the relative costs and benefits of different doses of atorvastatin.