Study warns statins may be overprescribed

Are statins overprescribed? Study warns the risks of the controversial drugs outweigh the benefits for millions of heart patients

  • Experts suggest the threshold for prescribing statins is too low in the UK and US
  • Although proven to save lives they can also cause unpleasant side effects 
  • Benefits do not outweigh harm until heart attack risk is ‘considerably higher’ 

The risks of taking cholesterol-busting statins outweigh the benefits for millions of patients, according to a study.

Researchers designed a computer model to compare the likelihood of side effects with that of dying among people taking statins.  

Whether people are eligible for statins depends on their risk of heart attack or stroke, and the research found the possible harms of the drug outweigh the benefits until someone’s risk is ‘considerably higher’ than the current threshold.

Guidelines in the UK and US both recommend prescribing a patient statins if they have a 10 per cent risk of heart disease within the next 10 years.

And, though the drugs are proven to save thousands of lives by lowering this risk, statins are controversial because of their potential side effects. 

Under the system which doles out statins to people whose risk of having a heart attack or stroke within 10 years, 11.8million Brits and 26.4million people in the US can be prescribed the drugs 

Researchers at the University of Zurich evaluated the risk of harms and benefits for men and women across various age groups.

Physicians use a tool called QRISK to estimate each patient’s individual risk of heart disease – the world’s leading killer.

The calculator jots up several risk factors to reveal a score – a 10-year risk of heart disease – including your age, BMI, where you live and other medical conditions.


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If you have a risk of 10 per cent or higher you are likely eligible for statins in most healthcare systems, but experts believe this may be too low.

In the US people aged over 40 with a 7.5 per cent risk are also included under American Heart Association guidelines.

Under this system, 11.8million Brits and 26.4million people in the US can be prescribed statins, which lower the amount of cholesterol made by liver.

But the Zurich researchers consistently found harms exceed the benefits until the 10-year heart disease risk thresholds were substantially higher.

ARE STATINS MORE GOOD THAN BAD? 

Statins are the most commonly prescribed drug in the world and an estimated 30 per cent of all adults over the age of 40 are eligible to take them.

The cholesterol-lowering drugs are given to people believed to have a 10 per cent or higher risk of developing cardiovascular disease or having a heart attack or stroke within the next 10 years. 

They are proven to help people who have suffered heart problems in the past, but experts say the thresholds might be too low, meaning benefits are outweighed by side effects for many people.  

Nearly all men exceed the 10 per cent threshold by age 65, and all women do so by age 70 – regardless of their health.

Commonly reported side effects include headache, muscle pain and nausea, and statins can also increase the risk of developing type 2 diabetes, hepatitis, pancreatitis and vision problems or memory loss.

Research published in the Pharmaceutical Journal last year found taking a daily statin for five years after a heart attack extends your life by just four days, new research reveals.

And Dr Rita Redberg, professor at the University of California, San Francisco told CNN in January that of 100 people taking statins for five years without having had a heart attack or stroke, ‘the best estimates are that one or two people will avoid a heart attack, and none will live longer, by taking statins.’

But the official view in the UK is a positive one. 

The Medicines and Healthcare products Regulatory Agency (MHRA) advises liberally prescribing the drugs. 

Its director Dr June Raine said: ‘The benefits of statins are well established and are considered to outweigh the risk of side-effects in the majority of patients.

‘The efficacy and safety of statins have been studied in a number of large trials which show they can lower the level of cholesterol in the blood and reduce the risk of cardiovascular disease and can save lives.’ 

For example, among men aged 70 to 75 deemed to have healthy hearts, the benefits did not outweigh harms until the risk was above 21 per cent. 

Less common but serious side effects known to be caused by statins include diabetes, hepatitis, pancreatitis, blurred vision, memory problems and fatigue.

Prescribing only for those at higher risk thresholds, however, would mean denying millions of eligible people of the medicine. 

And leading experts today urged caution over the findings, saying there was no need for a change in clinical practice.

Professor Kausik Ray, based at Imperial College London, claimed the study was ‘considerably limited’ because of the methodology.

He added: ‘Side effects listed in package inserts are broad but absolute rates small. Few are life-threatening or permanent.’

Dr June Raine, director of the Medicines and Healthcare products Regulatory Agency’s risk management of medicines division, also argued in favour of the drugs.

She said: ‘The benefits of statins are well established and are considered to outweigh the risk of side-effects in the majority of patients.

‘The efficacy and safety of statins have been studied in a number of large trials which show they can lower the level of cholesterol in the blood and reduce the risk of cardiovascular disease and can save lives.’ 

High levels of bad cholesterol can lead to a hardening and narrowing of the arteries and cardiovascular disease (CVD), which kills 150,000 people each year in the UK and 610,000 in the US.

Supporters of statins, including the UK health watchdog Nice, say the pills should be prescribed more widely to prevent thousands of early deaths.

But many medics are uneasy with the ‘overmedicalisation’ of the middle-aged, which sees statins doled out ‘just in case’ patients have heart problems in later life.

Yet they do agree that for high risk patients, such as heart attack victims, statins are proven lifesavers, slashing the chance of a second attack.

Roughly six million people in Britain are thought to take statins, while another six million should be taking the drugs but do not, according to estimates. 

The research was published in the scientific journal, the Annals of Internal Medicine. 

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