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expert reaction to a study which claims eligibility for statins has risen but benefits may fall

Research published in BJGP argues that increasing eligibility for statins and related ‘number needed to treat’ figures mean that decisions to take and reimburse statins should be considered on the basis of expected cost-effectiveness and acceptability to patients.

Prof Stephen MacMahon, Principal Director, The George Institute for Global Health, said:

“There are three major limitations of this analysis.  First, estimates of the benefits of statins should not be limited to a 5-year period. In this country, the average age of people suffering a heart attack or a stroke is around 70, so for people starting statin treatment in their 40s or 50s, the full benefits will not be seen for 20-30 years.

“Second, it is suggested that statins cause a range of side effects that would detract from their benefits, but there is very clear evidence from clinical trials that the most widely prescribed statins do not produce such effects.

“Third, it is suggested that there is uncertainty about benefits of statins in women and older people, but once again there is unequivocal evidence from clinical trials of benefits in these large, important patient groups. 

“Statins are increasingly inexpensive and given their clear benefits and safety, they should remain a major component of our efforts to reduce cardiovascular disease, which remains the UKs leading cause of premature death.”

Professor Jeremy Pearson, Associate Medical Director at the British Heart Foundation (BHF), said: 

“There’s no doubt that statins substantially reduce the likelihood of a heart attack, in those who are already at risk. That’s why threshold guidelines have become wider and more people than ever are now offered the drug.  

“This study shows that one in 25 untreated people at high risk of a heart attack will suffer an event in five years, whereas only one in several hundred low risk individuals will do so. However, when it comes to cost, NICE suggests that both low and high risk individuals being prescribed statins could lead to economic benefit in the long term.   

“Ultimately, everyone has control over the medications they choose to take. When weighing up whether to take statins, consult your GP. After assessing your personal risk and advising on lifestyle changes, they will help you make an informed decision.”

Prof Tim Chico, Professor of Cardiovascular Medicine and Honorary Consultant Cardiologist, University of Sheffield, said:

“Previous and existing guidelines do not recommend anyone must be treated with statins; they explain for which patients it is appropriate to consider statins. Since pretty much any adult can have a heart attack, particularly as they get older, this means unfortunately most of us would have our risk slightly lowered by statin treatment. Unfortunately, we cannot currently estimate someone’s risk of a future heart attack very accurately, which means many people in the UK will have a heart attack today who would have been estimated to be at low risk yesterday.

“Whether or not a person decides to take statins depends on what their risk of a heart attack is, how much a statin will lower this, how acceptable they find taking regular tablets, and whether they get side effects.  This is a very individual decision, and a doctor’s job is to explain these issues and allow a person to make the right decision for them as an individual.”

Prof Kausik Ray, Professor of Public Heath, Imperial College London, said:

“This is misleading research.  

“There are 4 groups all global guidelines recommend statins to with very different NNTS

  1. Established vascular disease. Highest risk smallest NNTS
  2. Diabetes intermediate risk intermediate NNTS
  3. Genetically elevated LDL intermediate risk and intermediate NNTs
  4. None of the above but primary prevention global risk vent rates potential lower than above at population level but highest NNTS. This makes up the highest proportion eligible for statins

“The paper refers to the last group although I could not see whether those with diabetes were excluded. Also the threshold for FH is 4.9 not 6 mmol/L so the numbers quoted in the paper as being potentially eligible in group 4 overlap considerably with groups 2 and 3 above so eligible numbers based on group 4 alone which is the purpose of the paper is overestimated. Statins work across the board but 5 year NNTS vary. The question is are we looking at 5 years or a longer time horizon of 10 or 20 years. These drugs are cheap <£100 per year at current prescription prices. Ireland may have a different price structure to the UK so uncertain how these would apply here. Furthermore use of ESC risk assessment tool  predicts deaths from vascular disease not fatal and non-fatal events like NICE and most other guidelines. So even low risk is low risk of 10 year case fatalities. The NNTs being quoted are based on theoretical risk rather than observed risk. So it is unclear whether the event rate is higher than predicted. If so the NNTs fall from those in the paper? Secondly it is unclear how the authors converted predicted case fatalities which is what the SCORE risk predicts to prevented non-fatal and fatal event rates which are usually much higher thus affecting NNTs.    

“The guidelines are based on evidence and health economics. These should not change. There is a misconception that doctors force patients to take medications. They do not. During consultation risks benefits are discussed and depending on a patients understanding of risks / benefits/ how risk averse they are or often how much they are against taking medications most arrive at the right decision for them. This is analogous to buying insurance. Many will not need to make a claim but whether someone chooses to buy it depends upon risk perception. That is a different concept to denying what trials have shown where the benefits are irrefutable.”

‘Statins for primary prevention of cardiovascular disease’ by Byrne et al. was published in BJGP at 00:05 UK time on Wednesday 24th April 2019.

Declared interests

Prof Chico: “No conflicts”

Prof. Ray: “I have consulted for companies developing therapies for cholesterol management, diabetes and anti-platelet therapies to prevent cardiovascular disease.”

None others received

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