No 64: Randomly Improving Statin Prescribing and Heart Attack Prevention
TL:DR - Dumb Idea Number Two is where I lay out a suggestion for how every patient in the UK should be randomised to taking a statin or not. This is based on the new NICE proposal from Jan 2023.
Dumb questions – these are questions that are often “too simple” to ask. Such as:
How do statins really work?
Do they prolong life?
Do they prevent fatal heart attacks and strokes?
Do they prevent non-fatal MIs?
Do they work for everyone? Or only some people?
Do they increase coronary artery calcification? Or is that plaque stabilisation?
Do they work by lowering cholesterol? Or do they work by stabilising plaques?
Should everyone be on them?
Do we have the right risk score for working out who is at risk and who should be taking them?
Does the QRISK2 or 3 underestimate someone’s life time risk?
Does measuring someone’s cholesterol and then using the QRISK count as a “screening study”?
Do we need better studies? (Always YES!)
Some of the answers to the above questions can be found in this previous article above.
Why do we need to care about statins?
Cardiovascular disease (CVD) is the leading cause of death worldwide.
High LDL is associated with increased risk of MI.
Statins lower LDL and probably reduce MIs in some people.
Roughly 25% of UK deaths are caused by a cardiovascular cause (MI, stroke, heart failure)
https://www.bhf.org.uk/-/media/files/research/heart-statistics/bhf-cvd-statistics---uk-factsheet.pdf
If you have a “low” risk of heart disease then studies have found no statistically significant mortality benefit from taking low dose statins for a number of years - https://www.thennt.com/nnt/statins-persons-low-risk-cardiovascular-disease/
1 in 217 avoided a nonfatal heart attack (myocardial infarction) [NNT = number needed to treat]
1 in 313 avoided a nonfatal stroke
1 in 83 were helped (life saved) https://www.thennt.com/nnt/statins-for-heart-disease-prevention-with-known-heart-disease/ - If 80 people with known heart disease taken a statin for 5 years then 1 person might avoid a fatal heart attack.
1 in 39 were helped (preventing non-fatal heart attack)
1 in 125 were helped (preventing stroke)
The current guidance from NICE for primary prevention can be found here:
https://cks.nice.org.uk/topics/lipid-modification-cvd-prevention/prescribing-information/statins/
https://gpnotebook.com/simplepage.cfm?ID=x20060329134717258590
Statins used to be used for secondary prevention, then primary prevention for everyone, then only if the QRISK was over 20% and then if it was over 10% and now, the guidelines are proposed to change again….
The New NICE Proposal 12 January 2023
“NICE estimates that, with this new recommendation, for every 1,000 people with a QRISK3 score of 5% over the next ten years who take a statin, an average of 20 fewer people will get heart disease or have a stroke.” = 20/1000 = 2/100
The new proposal is to expand statin use not because of new evidence of efficacy but because the side effects are apparently less common and less severe than previously thought. It is therefore more of a “hey, it wont do any harm so why not?” kind of strategy.
The new proposal is that anyone who is happy to take a statin could be prescribed atorvastatin 20mg for primary prevention even with a minimal QRISK.
Dumb Idea Number One - We Need a Better Score
One little smart arse comment – If 25% of the UK population are dying from a CVD cause then the QRISK as a “minimum” should have a “lifetime” risk as 25% and over. Unless someone has a particularly low risk profile.
The QRISK only gives a 10 year risk of a heart attack, this is not a good tool to use on anyone below the age of 60. We need a better life time scoring system to use on people aged 40, or 30 or 20 so that we can give evidence based recommendations to younger people who have time to implement lifestyle changes.
The Bell Curve of Health - How much should we medicalise normal to achieve “better” health?
Dumb Idea Number Two - We Should Randomise People
Currently, some experts would argue that statins are the best thing since sliced bread. Other experts think we are over “medicalising” the general population and pumping up the profits of big pharma. Who is right?
That’s called equipoise … the idea that we really don’t know the answer and there are strongly held beliefs either way. That means that we need to do a randomised trial to produce an answer. No other method is going to break the deadlock.
This new policy is ideal, as a foundation for a new large scale, real-world RCT of statins.
Every patient over the age of 40 who visits a doctor could be entered into the trial.
Firstly, they are randomised to be included or not.
Those included have their cholesterol bloods done and their QRISK calculated and coded.
Next they are randomised again, to a statin or not.
Then they are randomised again to annual follow up or 5 yearly follow up, or randomised to titrating the dose to achieve a cholesterol target or just put on the minimum tolerated dose.
Then these patients are followed up on the GP electronic health record for the next 20 years or until they have died. Just like any other patient who visits their GP.
This would be easy to do with the help of System One and EMIS. You would cover 90% of the UK population. It would involve 1 template, with a “randomisation” button and a readcode and an automatic prescription. Nothing more.
This sort of study should probably go through an ethics committee, but it would not necessarily require much additional funding, or training or time. Simply, do what the NICE guidance is already recommending, but randomised and then someone following it up through a national audit every few years.
In 10 or 20 years time, we may actually know the answer to all those dumb questions I listed above. In 5 years time, we might actually build a healthcare model where studies like this are common, everyday events and medicine progresses rapidly!