Fact sheets
Fact sheets

HEART UK has produced a range of diet and medical fact sheets for you to use and refer to.

 
Inherited cholesterol facts
  • People with familial hypercholesterolemia (FH) are at greater rish of heart disease
  • At least 1 in 500 people are believed to have FH but may be more as in other European countries
  • Of the 120,000 people in the UK with FH only 15% – less than 1 in 5, know they have the condition
  • At least 28,000 children in the UK have FH but only 600 of these are known
Got a question? (supporter)
Got a question?

If you have a question about becoming a supporter of HEART UK then please contact us; call 01628 777 046 or email development@heartuk.org.uk

The Statin Conundrum 

The debate over who should take a statin and whether the doctor should offer a statin or not continues.   On this page we set out the answers to your commonly asked questions so that you can make an informed decision.  If you are taking a statin you may find it helpful to talk to your doctor about any remaining concerns you have, what alternatives there are and the possible health risks of either taking or not taking a statin.  Our Cholesterol Helpline is also available to help with any further questions you might have.  

Q

Do statins work?

A

Well-designed randomised controlled trials, meta-analysis (a combining of results from different studies) and clinical guidelines underpin the use of statins in preventing cardiovascular disease (CVD).

The Cholesterol Treatment ’ Collaboration (CTTC), which reviewed over 90,000 participants, clearly demonstrated the benefits for individuals (with or without history of CVD) who are prescribed statins.  Not only were they shown to significantly lower LDL cholesterol levels, but for every 1mmol/L drop in LDL cholesterol there was a significant reduction in the patient’s 5-year risk of CVD.

The meta-analysis demonstrated the following reductions in risk of:

  • All major cardiovascular events (including heart attacks and strokes) by 21%
  • Major coronary events by 24%
  • Stroke by 15%
  • Death from any cardiovascular disease by 12%
  • Coronary revascularisation (coronary artery bypasses and balloon angioplasty) by 24%
  • Death from coronary heart disease by 19%
  • Non-fatal heart attacks by 26%

References
CTTC. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: a meta-analysis of individual data from 27 randomised trials. Lancet 2012;380(9841):581-590. Free access at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3437972/
CTTC Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis1681:Fee access at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61350-5/fulltext

Q

What are the guidelines?

A

The threshold for offering to prescribe a statin has recently changed.  Health professionals use risk calculators to determine the overall risk of having a heart attack or stroke within a 10 year period. This risk level is expressed as a percentage.

The threshold for offering to prescribe a statin was 20% (1 in 5 chance of having a heart attack or stroke in the next 10 years) and has now changed to a lower 10% threshold (a 1 in 10 chance and greater of having a heart attack or stroke in the next 10 years).  This means that drug therapy is now available earlier for someone (who for example) is currently at 19% or 15% risk rather than waiting for them to reach the upper level of risk in a few years.

The National Institute for Health and Care Excellence set the guidance for treating raised blood cholesterol in England and Wales.  They have recently assessed the health benefits of this lowered threshold against any possible adverse effects and have concluded that the overall health benefits prevail and are also cost effective.

Q

Why prescribe a statin for someone at below 20% risk?

A

The new guidance will give GPs the flexibility and confidence to prescribe statins for people with a rather lower risk of having a heart attack or stroke in the next 10 years but whose risk of having a heart attack in the next 10-20 years or more is quite high.

For example a woman aged 35 years who has raised cholesterol and one other risk factor such as smoking, high blood pressure or type 2 diabetes may have a low risk over the next ten years but her risk of an early heart attack or stroke in her 50s or 60s is high.  By treating with a statin at age 35 the age of her first event can be significantly delayed.  The consequence of not treating is that she may not make it to retirement as more than 1 in every 5 first heart attacks are fatal.

The Joint British Society Consensus Guidelines (JBS3), launched in 2015, also recommended that cardiovascular risk is assessed based on both the short term 10 year risk and also on lifetime risk.     

Reference
Consensus recommendation for the prevention of cardiovascular disease (JBS3)  Heart 2014; 100:ii1-ii67. Doi:10.1136/heartjnl-2014-305693  Free access at http://heart.bmj.com/content/100/Suppl_2/ii1.full

Q

Are statins safe?

A

It is to be expected that some people will experience side effects from taking any medication.  In clinical trials, where patients were either given a statin or a placebo under blinded conditions (patients, researchers and treatment manufacturers did not know which patients were receiving), the side effects reported were similar in both groups, suggesting that statins were generally well tolerated by the study populations.

However because of the media hype surrounding statins; patients, and the healthcare professionals who treat them, are often too quick to blame any new symptoms developed whilst taking a statin, on the statin itself. In truth the majority of reports of statin induced side effects are unlikely to be caused by the statin, but may just happen co-incidentally.

Reference
Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?  Systematic review of randomised placebo-controlled trials to aid individual patient choice. European Journal of Preventive Cardiology 2014 21: 464
Free access at http://cpr.sagepub.com/content/21/4/464.full.pdf+html

Q

What are the possible side effects of statins?

A

The evidence suggests that most people won’t experience any genuine side effects. So, how do we explain the many patients who report side effects from statin use, such as insomnia, tiredness, constipation, headache, stomach upsets, loose stools, flatulence and nausea?  A recent systematic review of statin studies, with over 83,000 subjects, concluded that only a minority of the symptoms reported in these clinical trials were genuinely due to the statins as all of the above occurred just as frequently on the placebo. 

It should be said that study populations are very carefully chosen to exclude some people on other medications and with other medical conditions.  And in many of the study regimens lower doses of statins were used.  Study volunteers, being highly motivated, may also be less likely to report side effects.   So in real life situations it is possible that patients outside the criteria used for clinical trials might be expected to have slightly higher rates of adverse effects from statins.

Cramp, memory loss and bone pain were not specifically mentioned in the above review but are often reported in the press as common side effects of statins.  In reality these too are unlikely to be related to the statin in most cases, but because they occur relatively commonly in older people, the very audience that are taking statins, and because of the raised awareness of possible side effects by the media, they can be increasingly reported.  Doctors should be alert to looking for other causes.

Reference
Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?  Systematic review of randomised placebo-controlled trials to aid individual patient choice. European Journal of Preventive Cardiology 2014 21: 464
Free access at http://cpr.sagepub.com/content/21/4/464.full.pdf+html

Q

What about muscle related side effects?

A

For many people who are prescribed a statin there is a big concern that statin therapy causes muscle pain (myalgia), so it is important to understand the kind of muscle pain that statins cause.

The muscle symptoms related to statin use are typically a generalised muscle discomfort or pain, lasting more than a couple days (rather like the symptoms that we all may have when we get ‘flu).  It is usually generalised and not localised.  It is not joint pain or localised cramp.

Patients should not ignore these symptoms. They are fully and rapidly reversible in the vast majority of cases and are unlikely to result in significant muscle damage in patients who stop taking the statin. However patients should not stop taking their statins unless told to do so by their doctor, or in rare cases when the symptoms are very severe and access to your GP is limited by appointment times.

In rare cases muscle pain can progress to other muscle related problems such as myopathy (a muscle disease where the muscle no longer functions adequately), myositis (inflammation of the muscle) or very rarely rhabdomyolosis (where muscle cells are broken down).   

Myopathy and other serious muscle problems are rare complication in which more severe muscle symptoms such as tenderness or weakness are associated with a rise in the muscle enzyme Creatinine Kinase (CK).  If the GP suspects myopathy he or she should request a blood test to look for elevated levels of CK.  A modestly raised CK is not diagnostic as CK levels can be very variable, even in healthy individuals not on treatments, and may rise naturally with significant exercise.  Ideally the GP should compare the results of the new CK test with any baseline tests that were taken prior to statin use and this should help with a diagnosis and prevent the inappropriate discontinuation of the statin.  Occasionally muscle pain can be present without a raised CK.

Muscle related side effects are more likely to occur with higher doses of statins and where other drugs are also taken that are metabolised though the same chemical pathways in the body. For this reason your doctor may stop some statins or reduce the dose temporarily, for example with courses of certain antibiotics.

Reference
Graham DJ,  Staffa, JA, Shatin D, Andrade SE, Schech SD, La Grenade L, Gurwitz JH, Chan KA,  Goodman MJ, Platt R.  Incidence of hospitalised rhabdomyolsis in patient treated with lipid lowering drugs.  JAMA 2004;292 (21):2585-2590. doi:10.1001/jama.292.21.2585.  Free access at http://jama.jamanetwork.com/article.aspx?articleid=199906&resultClick=3

Q

Can statin therapy cause diabetes?

A

Research has shown that in a small number of in individuals, who are already at risk of getting diabetes, a statin can result in an earlier onset of diabetes.  In a systematic review of clinical trials of statins the rate of developing diabetes was 3% in the statin group compared to 2.4% in the placebo group.  This means that of all the new diabetics diagnosed about 1 in 5 were directly attributable to taking a statin.  

However this small increase in diabetes does not diminish the benefits of statins in reducing cardiovascular disease.  Statins are also very commonly prescribed for individuals with diabetes, as the most common cause of death in diabetics is cardiovascular disease.   

Reference
Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?  Systematic review of randomised placebo-controlled trials to aid individual patient choice. European Journal of Preventive Cardiology 2014 21: 464
Free access at http://cpr.sagepub.com/content/21/4/464.fullpdf+html

Q

How can I find out more about the possible side effects from the statin I am taking?

A

You can see for yourself the side effect profile of your statin drug by looking at the product Information leaflet (PIL) in your statin packet.  This gives details of all the side effects that have been reported both in clinical trials and through the yellow card reporting system and how common or rare they are.  These are reflective of the reports that have been made and do not necessarily prove statins to be the cause.  

You can also find this information by visiting the Electronic Medicines Compendium and putting the name of your product in the search bar.  The website also allows you to see further details (not in the PIL) by looking at the Specification of Product Characteristics (SPC) for each product.

Q

Why are there arguments about statin safety?

A

Some healthcare professionals are concerned about the new National Institute for Health and Care Excellence (NICE) guidance which allows for the prescription of statins to those at a lower or moderate cardiovascular risk. 

However even when the risk of cardiovascular disease is lower, those individuals now prescribed a statin will get a similar percentage reduction in risk, but the absolute benefit is less with the risk of possible side effects being the same. 

NICE is saying it is appropriate to offer and discuss treatment here and some people will wish and some not wish to take treatment.  It is important that the pros and cons are discussed by the patient and doctor together, the doctor can provide guidance but ultimately it is the patient’s choice.

Q

Why are reports suggesting that side effects are common? 

A

Statins are given to many individuals many of whom are older and have other conditions.  From time to time all of us have aches and pains and other symptoms, often for no obvious reason.  If we have been taking any drug for a period of time it is inevitable to consider that the treatment is responsible even when it is blameless, and that applies to statins.

In the clinical trials many symptoms were reported but analysis shows that almost all of these are in the same numbers in both the patients receiving the statin and in those receiving the placebo.

Reference
Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?  Systematic review of randomised placebo-controlled trials to aid individual patient choice. European Journal of Preventive Cardiology 2014 21: 464
Free access at http://cpr.sagepub.com/content/21/4/464.full.pdf+html

Q

How can I report any side effects I experience?

A

If you suspect you are experiencing any side effects from a statin it is important to talk to your doctor before stopping the medication.  

All reports of side effects are taken extremely seriously by both the manufacturer and by the Medicines and Healthcare Products Regulatory Agency (MHRA). The yellow card scheme allows you to report suspected side effects of any medicine that you are taking.  See the yellow card scheme website for more details.

Q

What are the alternatives? 

A

In the few cases where the patient is found to be intolerant to the statin, there are some options available to them. Because different statins are metabolised differently, it is possible to change to a different statin in order to achieve better drug tolerance.  Alternatively it may be possible for the patient to tolerate a lower or intermittent (every other day) dose, or to use a combination therapy where a lower dose of statin is combined with a resin or with ezetimibe. A new class of drugs, PCSK9 inhibitors, will soon be available for patients who are at high risk but unable to tolerate a statin or not reaching their target cholesterol level on the statin alone.  

For a very small number of people, often with genetic conditions that result in life-long exposure to very high levels of cholesterol, there is a treatment called LDL apheresis, a form of blood transfusion.  This is only available for people who's cholesterol levels cannot be managed through drug treatment and who are at very high risk.  Even here most will also receive a statin and/or other drugs.

For individuals identified as low risk and where a statin is not indicated, the opportunity to improve diet, become more physically active and/or to stop smoking is encouraged to help lower their future risk.  Following a healthy diet and lifestyle is also important for those prescribed statins as not only does it lower the risk of other health benefits it can help ensure a lower statin dose is necessary.

Q

How do my chances of having a heart attack change when I take a statin?

A

This will depend upon may factors including your overall risk (the sum of all your risk factors), the dose of the statin, the length of time you have taken it for and any lifestyle and dietary changes you have been able to make.  It is important to be involved in making the decision about taking a statin so you might find it helpful to chat this through with your doctor, family and friends before making a choice.  The National Institute for Health and Care Excellence (NICE) have developed a guide to help you decide which you can download here.