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Poynter. J, Gruber. S, Higgins. P, M.D. Almog. R, Bonner. J, Rennert. H, Low. M, Greenson. J, and Rennert. G, 2005,

Statins and the Risk of Colorectal Cancer, N. Engl. J. Med., 352;2184-2192

Law. M. R., Wald. M. J., Rudnicka. A. R., 2003, Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis, BMJ, 326:1423

Jick. H., Zornberg. G.L., Jick. S.S., Seshadri. S., Drackman. D.A., 2000,

Statins and the risk of dementia, The Lancet, 357(9255);562

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Statins and the risk of dementia - ScienceDirect

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The study encompassed 284 cases with dementia and 1 080 controls. Among controls 13% had untreated hyperlipidaemia, 11% were prescribed statins, 7% other LLAs, and 69% had no hyperlipidaemia or LLA exposure.

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164 short term trials of statins and LDL cholesterol reduction

We searched Medline, Cochrane Collaboration, and Web of Science databases (see www.smd.qmul.ac.uk/wolfson/bpchol for details and webextra for full list of references w1-w164). We included all double blind trials, irrespective of participants' age or disease. Participants in most trials were healthy with above average lipid concentrations. In some trials they had high blood pressure, diabetes, or IHD. We excluded trials that had no placebo group, lasted less than two weeks, used variable doses (titrating), or used cholesterol lowering drugs in combination, and trials in which the order of treatment and placebo periods in crossover trials was not randomised or patients had chronic renal failure or organ transplantation.

We defined drug efficacy as the reduction in LDL cholesterol concentration for a given dose, expressed as the change in the treated group minus that in the placebo group (in crossover trials end treatment minus end placebo concentration). Methods for calculating standard errors and the statistical analyses are described in the accompanying paper. 14

58 randomised trials of serum cholesterol reduction (by any means) and IHD events

We expanded the literature search to include methods of reduction of serum cholesterol concentrations other than statins; 33 more recent trials and 25 reported in 1994 6 met inclusion criteria. We excluded trials in which risk factors other than lipids were changed, LDL cholesterol reduction was < 0.2 mmol/l, fewer than five IHD events were recorded, or there was no untreated control group. We calculated the absolute change in serum LDL cholesterol concentration in the treatment group minus that in the placebo group. In 17 of the 25 earlier trials LDL cholesterol was not measured so we used total serum cholesterol concentration. We defined IHD events as IHD death or non-fatal myocardial infarction, ignoring subsequent events in an individual and excluding "silent" infarcts. In each trial we determined the numbers of IHD events and the changes in LDL cholesterol (adjusted for placebo) separately for years one, two, three to five, and six or more after trial entry. We recorded disease events and the average reduction in LDL cholesterol concentration in all randomised participants regardless of compliance (assuming LDL concentration reverted to baseline when participants left the trial).

We combined the odds ratios (treated/placebo) of disease events, stratified according to duration of scheduled treatment, to yield summary estimates using a random effects model. 15 After the effects of reduction in LDL cholesterol and duration of treatment were taken into account there was no significant residual heterogeneity. We standardised each trial result to an LDL cholesterol reduction of 1.0 mmol/l by raising the observed odds ratio to the power of (1.0 divided by the observed LDL cholesterol reduction).

Nine cohort studies and 58 randomised trials of serum cholesterol and stroke

We identified nine cohort studies of serum cholesterol concentration and stroke that distinguished thromboembolic and haemorrhagic strokes using computed tomography or postmortem findings. We used Medline (1980 to October 2002; key and text words blood cholesterol and [cerebral haemorrhage or intracranial haemorrhages or subarachnoid haemorrhage or cerebral infarction]). We determined the difference in incidence for a difference in LDL cholesterol of 1.0 mmol/l adjusted for regression and surrogate dilution bias. 12 Data on stroke from the 58 randomised trials were combined by using a random effects model. 15 There was no significant heterogeneity.

164 short term trials of statins and LDL cholesterol reduction

Table 1 shows details of the 164 trials. There were about 24 000 treated and 14 000 placebo participants (individual trial data on can be found on www.smd.qmul.ac.uk/wolfson/bpchol).

Figure 1 shows the dose-response relations for the five statins across the doses tested (2.5-80 mg/day). The straight lines fit the data well. With simvastatin the linear trend is unconvincing above 20 mg/day, but one study (excluded from our meta-analysis because it had no placebo group) confirmed greater efficacy at higher doses. 16

Table 2 shows the estimated reductions in LDL cholesterol, according to statin and dose, calculated from the straight lines and standardised to the average pretreatment LDL cholesterol concentration in these trials (4.8 mmol/l; about the average in people having an IHD event). Rosuvastatin 5 mg/day, atorvastatin 10 mg/day, and lovastatin or simvastatin 40 mg/day reduced LDL cholesterol concentrations by about 35% (1.8 mmol/l), but fluvastatin and pravastatin produced smaller reductions even at the highest doses tested (80 mg/day). Rosuvastatin 10 mg/day, atorvastatin 20 mg/day, and lovastatin or simvastatin 80 mg/day reduced concentrations by about 45% (2.1 mmol/l) and rosuvastatin 80 mg/day by about 60% (2.8 mmol/l).

Statins significantly lowered LDL cholesterol from all pretreatment concentrations. The absolute reductions (in mmol/l) were greater in those with higher pretreatment concentrations. The percentage reductions were independent of pretreatment concentrations and therefore more generalisable, but we adopted absolute reductions because the relations with disease events were quantified by using absolute cholesterol reductions. 6 If the pretreatment concentration was 1 mmol/l higher (5.8 mmol/l), LDL cholesterol reduction was on average 0.28 mmol/l greater. No effect of age was apparent, but there was little variation in average age across trials.

In these 164 trials atorvastatin and rosuvastatin were taken in the morning but the other statins in the evening. In four randomised comparisons in three trials w77 w137 w153 the average reduction was 0.20 mmol/l smaller with morning dose than with evening dose (95% confidence interval 0.05 mmol/l to 0.44 mmol/l smaller). Doubling the dose has a similar effect (about 0.20 mmol/l) and so would counter this. The greater effect of evening dose arises because of short biological half life (peak cholesterol synthesis occurs at night). Atorvastatin and rosuvastatin have longer half lives and avoid this problem; lipid changes with atorvastatin were similar with morning and evening dose. 17

The reductions in total and LDL cholesterol concentrations were highly correlated across trials ( r=0.83). On average, a reduction in LDL cholesterol of 1.0 mmol/l was associated with a total cholesterol reduction of 1.20 mmol/l (1.10 mmol/l to 1.31 mmol/l). If only total serum cholesterol reduction were measured, we would expect the absolute reduction in LDL cholesterol to be 17% less (1.0 minus 1.0/1.20). The reduction in VLDL cholesterol was on average 10% of the reduction in LDL cholesterol shown in table 2. Statins increased HDL cholesterol by 0.07 mmol/l (0.06 mmol/l to 0.08 mmol/l) on average, with no detectable effect of dose.

58 trials of serum cholesterol reduction and IHD events

These 58 trials included 76 359 participants allocated treatment and 71 962 controls, with 5440 and 7102 IHD events respectively: 52% of participants had known vascular disease on entry. See webextra tables A and B for details.

Table 3 shows the reduction in IHD events by duration of treatment; each trial result is standardised to a reduction in LDL cholesterol of 1.0 mmol/l (about the average reduction in the trials). In the first year the reduction was 11%, in the second 24%, and in the first and second years combined 13%. Data from 12 trials with event numbers published for the first two years but not the first and second years separately yielded a similar result. The reduction in the third, fourth, and fifth years combined was 33%, and the sixth and subsequent years was 36%. After standardisation for reduction in LDL cholesterol and duration of treatment, risk reduction was similar for fatal and non-fatal IHD events, for different methods of reducing serum cholesterol (fibrates, resins, niacin, statins, or dietary change), and in participants with and without known IHD on entry (showing that the proportional risk reduction model applies regardless of initial risk).

Table 4 shows the combined effect of duration of treatment and reduction in LDL cholesterol directly. The trials tend to cluster into three groups, with mean reductions of LDL cholesterol of 0.5 mmol/l (n=21), 1.0 mmol/l (n=24), and 1.6 mmol/l (n=5). Across these groups, the greater the reduction in LDL cholesterol the greater the reduction in IHD events. With a reduction in LDL cholesterol of around 1.6 mmol/l the reduction in IHD events after two or more years' treatment was 51%.

Serum cholesterol and stroke

Adverse effects

Forty eight of the 164 trials of statins and LDL cholesterol reported the number of participants with one or more symptoms possibly caused by the drug (1063/14197 allocated to statins and 923/10568 allocated to placebo). Meta-analysis of these data showed no excess risk in people allocated to statins. On average 1% fewer treated patients than placebo patients reported symptoms (95% confidence interval 3% fewer to 1% more in treated patients). The prevalence of each of 12 specific symptoms, including muscle pain and various gastrointestinal symptoms, was similar in treated and placebo patients, even for the highest daily dose tested (80 mg for all six statins). The upper confidence limits excluded the possibility that statins caused any symptom in more than 2% of treated patients.

The only known serious adverse effects of statins are rhabdomyolysis and liver failure from hepatitis. The absolute risks are low. In the trials of statins and adverse events, with about 35 000 people and 158 000 person years of observation in both treated and placebo groups (see webextra table A), rhabdomyolosis was diagnosed (variable criteria) in eight treated and five placebo patients, none with serious illness or death. Raised serum creatine kinase activity (≥ 10 times the "upper limit of normal," used to recognise rhabdomyolysis) was reported in 55 treated patients (0.17%) and 43 placebo patients (0.13%); muscle symptoms were present in 13 and 4 respectively. From the first marketing of statins in 1987 to May 2001 the Food and Drug Administration recorded 42 deaths from rhabdomyolysis attributable to statins (other than cerivastatin, which was not used in these trials) in the United States, 19 a rate of one per 10 million prescriptions dispensed 19 or (as a prescription is typically for one month's supply 20) about one per million person years of use. There were no cases of liver failure in the trials. Raised alanine aminotransferase activity (≥ 3 times the upper limit of normal, used to recognise hepatitis) was reported in 449 treated (1.3%) and 383 placebo patients (1.1%) (see webextra table A). From 1987 to May 2000 the Food and Drug Administration recorded 30 cases of liver failure attributable to statins, 21 again about one per million person years of use.

Concern over hazards from serum cholesterol reduction was resolved by earlier studies. 9 13 Data from the 58 randomised trials of cholesterol reduction and disease events confirm this. The odds ratios (treated/placebo) for a 1.0 mmol/l decrease in serum cholesterol were 0.87 (0.73 to 1.03; 675 deaths) for circulatory diseases other than IHD and stroke, 1.06 (0.96 to 1.16; 2293 deaths) for cancer, 0.94 (0.72 to 1.23; 324 deaths) for injuries and suicide, and 0.88 (0.78 to 1.01; 1363 deaths) for diseases other than circulatory diseases and cancer.

Reasons for underestimation of effect on IHD

Why are the current estimates of effect so low? Firstly, five of the seven largest statin trials used pravastatin, which is relatively less effective ( table 2). Secondly, risk falls relatively little within the first two years, and inclusion of these early events underestimates the preventive effect. Thirdly, a particular problem for the statin trials was the extent to which the intention to treat analysis underestimated the true preventive pharmacological effect because of non-adherence to the protocol (treated patients not taking their tablets and placebo patients taking statins). This last problem was partially overcome by relating the reduction in disease events to the average LDL cholesterol reduction in all randomised participants (treated and placebo). In this way non-adherence to the protocol was reflected in both a smaller than expected difference in LDL cholesterol concentration and a smaller than expected difference in the number of IHD events between the two groups. While this yields an accurate estimate of the risk reduction for the observed difference in LDL cholesterol it underestimates the effect of a given dose of the statin.

Effects of LDL cholesterol reduction on stroke

The estimated overall reduction in stroke of 10% (relative risk 0.90) for a 1.0 mmol/l reduction in LDL cholesterol is equivalent to a 17% (9% to 25%) reduction in stroke for a 1.8 mmol/l reduction LDL cholesterol, readily achievable with a statin (as 0.90 1.8/1 = relative risk of 0.83). In people with existing vascular disease the reduction is 36% (0.78 1.8 = 0.64) The interpretation of the cohort study result showing a higher incidence of haemorrhagic stroke for a lower LDL cholesterol concentration is uncertain. Too few haemorrhagic strokes were identified in the randomised trials to resolve the uncertainty. An increased risk cannot be excluded, but this should not preclude the use of statins in the prevention of cardiovascular disease.

A full list of references and two extra tables can be found on bmj.com

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View Abstract

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Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis

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We searched Medline, Cochrane Collaboration, and Web of Science databases (see www.smd.qmul.ac.uk/wolfson/bpchol for details and webextra for full list of references w1-w164). We included all double blind trials, irrespective of participants' age or disease. Participants in most trials were healthy with above average lipid concentrations.

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But in 2014 the threshold was lowered to 10 per cent, partly because of the increasing affordability of the daily pills.

The new research, led by Birmingham University, looked at data from 1.4 million patients aged over 40 across 248 GP practices across England and Wales between 2000 and 2015.

Among those with a risk score recorded before 2014 more than third - 36.7 per cent - of high-risk patients were prescribed statins.

But after the Nice guidance was issued - calling for far more widespread uptake of the drugs - this figure dropped sharply, to 33.1 per cent.

The researchers said most patients who had a risk score calculated were not offered a statin in the subsequent two months, even those deemed to be high risk.

They also found there could be "significant over-treatment" of statin therapy among patients who have less than a 10% chance of developing cardiovascular disease within 10 years

The study found there had been "increased focus on the adverse effects of statins...which may have influenced both the clinicians' decision to prescribe and the patients' decision to accept treatment."

Helen Stokes-Lampard, Chair of the RCGP, said: "This study emphasises the importance of calculating an accurate risk score which can then help healthcare professionals have an honest discussion with their patients about the benefits and risks which are unique to them.

"As with any drug, taking statin medication has potential side-effects, and taking any medication long-term is a substantial undertaking for patients who need to be monitored by healthcare professionals.

"Many don't want to take statins once they have learned all the facts - and GPs will respect patient choice."

New prescriptions of statins peaked in 2006 following the drug's patent running out, and therefore becoming more affordable, in 2003.

Statins reduce deaths from heart disease by around 28 per cent, according to a study published in Circulation last month, while a Lancet report last year found that fears of side-effects were "exaggerated".

It found that if 10,000 patients were treated with the drug for more than five years, only 200, or two per cent, would experience negative side-effects.

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Patients most at risk of heart attack and stroke less likely to get statins

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But in 2014 the threshold was lowered to 10 per cent, partly because of the increasing affordability of the daily pills. The new research, led by Birmingham University, looked at data from 1.4 million patients aged over 40 across 248 GP practices across England and Wales between 2000 and 2015.

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Almost every older person should be taking statins, a new study has found.

Millions of people in the UK are eligible for and would benefit from taking the cholesterol-lowering drugs, the research found.

Almost all men over 60 and women over 75 should be taking the drugs, the research found. And more than a third of people between 30 and 84 should be allowed to do so.

The sweeping findings could suggest that GPs will be asked to prescribe the drugs to the majority of their patients, leading to huge strain on doctors.

But professional groups have warned that the relationship between a patient and their doctor remains the most important, and that the physician will still make the ultimate decision on what their patients should be prescribed, despite the findings of the study.

The research looked to investigate the effects of guidance that was set by the National Institute of Health and Care Excellence (Nice) in 2014. That controversial ruling allowed many more people to receive statin therapy on the NHS, since it suggested that anyone with cardiovascular disease should be given the drug, and anyone with a more than 10 per cent chance of developing it in the next 10 years should take it too.

The latest study, published in the British Journal of General Practice, examined the algorithm endorsed by Nice for the assessment of CVD risk and compared it to data from the 2011 Health Survey for England to estimate the number of people who are eligible for statin therapy under the guidance.

"Under the guidelines, 11.8 million (37 per cent) adults in England aged 30-84 years, including almost all males over 60 years and all females over 75 years, would be eligible for statin therapy," the authors wrote.

Of these, 9.8 million would be offered the medication as a preventative measure, the researchers discovered.

They found most adults who were eligible or treated for primary prevention were in older age groups.

Just 4 per cent of men and 2 per cent of women aged 30 to 44 were deemed to be eligible to be offered the medication, but this figure increased with age.

Among men, 33 per cent of those aged 45 to 59 would be eligible according to the risk assessment tool.

This increased to 95 per cent of men aged 60 to 74 years and 100 per cent of men aged 75 to 84.

One in 10 women aged 45 to 59 would be eligible, increasing to 66 per cent of women aged 60 to 74 and 100 per cent of women aged 75 to 84.

Among the 9.8 million deemed to be at risk of CVD, the researchers said 6.3 million were eligible for treatment but not currently on statins.

Among this group there will be a projected 1.16 million cardiovascular events - including heart attacks and strokes - over the next decade, they estimated.

The authors calculated that if all these people were taking statins 290,000 of these events could be prevented.

But they added: "It is, however, unlikely that all eligible adults will receive statins.

"The 2014 Nice guidelines recommend an informed risk/benefit discussion between the physician and the patient. A treatment recommendation will therefore not necessarily lead to treatment initiation."

Professor Mark Baker, director of the centre for guidelines at Nice, said: "Heart disease and stroke are largely age-related, killing one in three of us and disabling many more.

"To make progress in the battle against heart disease and stroke, we must encourage exercise, improve our diets still further, stop smoking, and where appropriate offer statins to people at risk.

"Their use in people who have established cardiovascular disease is not controversial. Their use to prevent the development of cardiovascular disease in well people is a more recent role but is equally widespread and robustly evidence-based.

"NICE's guidance on reducing cholesterol recommends that doctors should offer statins to people with a 10 per cent risk of developing cardiovascular disease over 10 years. The purpose is to reduce further the numbers of people suffering heart attacks and strokes.

"But people, including older people, should not take statins instead of making the lifestyle adjustments that those at risk of cardiovascular disease need to make - such as stopping smoking, being more active, drinking less alcohol, eating more healthily and losing weight."

Commenting on the paper, professor Helen Stokes-Lampard, chairwoman of the Royal College of GPs, said: "Statins have been found to be highly effective drugs at preventing cardiovascular disease by reducing cholesterol levels of patients, and extensive research has shown that taking them is safe.

"But our patients should only take medication if they need to, and specifically they are at high-risk of developing conditions that statins can help prevent.

"We need to get the risk scores right. If we find that all men over 60 and all women over 75 are going to be eligible for statins with new risk scoring, regardless of any other risk factor, then it should ring alarm bells - because it is not clear that every 60 year old man or 75 year old woman is going to benefit from statin therapy.

"As with any drug, taking statin medication has potential side-effects, and taking any medication long term is a substantial undertaking for patients.

"Many don't want to take statins once they have learned all the facts - and GPs will respect patient choice."

She added: "We also need to remember that whilst clinical guidelines are useful tools for GPs when developing a treatment plan for patients, they are not tramlines.

"GPs are highly trained to prescribe based on the individual circumstances of the patient in front of them - obviously taking age into account, but also any other medication that the patient is using, and all the physical, psychological or social factors that may be impacting their health."
Additional reporting by Press Association
Reuse content

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You probably should be taking statins, major study finds

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Almost every older person should be taking statins, a new study has found. Millions of people in the UK are eligible for and would benefit from taking the cholesterol-lowering drugs, the research found. Almost all men over 60 and women over 75 should be taking the drugs, the research found.

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Statins cut the risk of dying from heart disease by 28% among men, according to the longest study of its kind.

The 20-year project examined data from 2,560 men taking part in a randomised clinical trial to test the effects of statins versus a placebo.

All the men had very high levels of LDL, or "bad" cholesterol, (higher than 4.9mmol/L) but had no evidence of heart disease at the start of the study.

Researchers from Imperial College London and the University of Glasgow found impressive results among those on statins, who were given the widely-prescribed type pravastatin.

They found that compared with the placebo, there was a 27% reduced risk of coronary heart disease, a 28% reduced risk of dying from coronary heart disease, and a 25% reduced risk of coronary "events" such as a heart attack.

There was also an 18% reduced risk of dying from any cause over the 20-year period.

Senior author Professor Kausik Ray, from Imperial's School of Public Health, said: "For the first time, we show that statins reduce the risk of death in this specific group of people who appear largely healthy except for very high LDL levels.

"This legitimises current guidelines which recommend treating this population with statins."

Ray said people with lower levels of cholesterol, around 4mmol/L, who otherwise appear healthy, should also be treated with statins.

Ray added: "This is the strongest evidence yet that statins reduce the risk of heart disease and death in men with high LDL.

"Our study lends support to LDL's status as a major driver of heart disease risk, and suggests that even modest LDL reductions might offer significant mortality benefits in the long-term.

"Our analysis firmly establishes that controlling LDL over time translates to fewer deaths in this population."

Professor Sir Nilesh Samani, medical director at the British Heart Foundation, said: "This research further demonstrates the benefits of statins for people who have high levels of cholesterol in their blood.

"It shows the enduring and long-term benefit of taking statins, including the extent to which they reduce the risk of dying from heart disease, which can only be seen in a study of this length.

"The role of cholesterol in causing heart disease has been disputed by some, but this paper provides yet more evidence of the link, and the benefits of statins to prevent heart disease."

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Statins cut the risk of heart disease death by 28% among men, study shows

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Statins cut the risk of dying from heart disease by 28% among men, according to the longest study of its kind. The 20-year project examined data from 2,560 men taking part in a randomised clinical trial to test the effects of statins versus a placebo.

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Statins are prescribed to lower the level of cholesterol in your blood. High levels of 'bad cholesterol' can lead to fatty deposits building up in your arteries

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Statins are a group of medicines that can help lower the level of low-density lipoprotein (LDL) cholesterol in the blood.
LDL cholesterol is often referred to as "bad cholesterol", and statins reduce the production of it inside the liver.

Why have I been offered statins?

Having a high level of LDL cholesterol is potentially dangerous, as it can lead to a hardening and narrowing of the arteries (atherosclerosis) and cardiovascular disease (CVD).

CVD is a general term that describes a disease of the heart or blood vessels. It's the most common cause of death in the UK.

The main types of CVD are:

coronary heart disease - when the blood supply to the heart becomes restricted

angina - chest pain caused by reduced blood flow to the heart muscles

heart attacks - when the supply of blood to the heart is suddenly blocked

stroke - when the supply of blood to the brain becomes blocked

A doctor may recommend taking statins if either:

you have been diagnosed with a form of CVD

your personal and family medical history suggests you're likely to develop CVD at some point over the next 10 years and lifestyle measures have not reduced this risk

Find out more about when statins may be recommended.

Taking statins

Statins come as tablets that are taken once a day.

For some types of statin it does not matter what time of day you take it, as long as you stick to the same time.

Some types of statin should be taken in the evening.

Check with your doctor whether there's a particular time of day you should take your statin.

You usually have to continue taking statins for life because if you stop taking them, your cholesterol will return to a high level within a few weeks.

If you forget to take your dose, do not take an extra one to make up for it. Just take your next dose as usual the following day.

If you accidentally take too many statin tablets (more than your usual daily dose), contact a doctor or pharmacist for advice or call NHS 111.

Cautions and interactions

Statins can sometimes interact with other medicines, increasing the risk of unpleasant side effects, such as muscle damage.

Some types of statin can also interact with grapefruit juice.

It's very important to read the information leaflet that comes with your medicine to check if there are any interactions you should be aware of.

If in doubt, contact a GP or pharmacist for advice.

Find out more things to consider when taking statins.

Side effects of statins

Many people who take statins experience no or very few side effects.

Others experience some troublesome, but usually minor, side effects, such as diarrhoea, a headache or feeling sick.

Your doctor should discuss the risks and benefits of taking statins if they're offered to you.

The risks of any side effects also have to be balanced against the benefits of preventing serious problems.

A review of scientific studies into the effectiveness of statins found around 1 in every 50 people who take the medicine for 5 years will avoid a serious event, such as a heart attack or stroke, as a result.

Find out more about the side effects of statins.

Alternatives to statins

If you're at risk of developing CVD in the near future, your doctor will usually recommend lifestyle changes to reduce this risk before they suggest that you take statins.

Lifestyle changes that can reduce your cholesterol level and CVD risk include:

Statins may be recommended if these measures do not help.

Read more about treating high cholesterol and preventing CVD.

Types of statin

There are 5 types of statin available on prescription in the UK:

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Statins are a group of medicines that can help lower the level of low-density lipoprotein (LDL) cholesterol in the blood. LDL cholesterol is often referred to as "bad cholesterol", and statins reduce the production of it inside the liver.