Pages

Thursday 24 July 2014

'More adults should be taking statins,' says NICE

reposted from: http://www.nhs.uk/news/2014/07July/Pages/More-adults-should-be-taking-statins-says-NICE.aspx
crabsallover highlightskey pointscomments / links.

Reading the peer-reviewed literature on statins and other reports, I've suspected, for more than a year, that this advice (20mg/day Atorvastatin if QRISK2 10-year risk of CVD is 10% or more) would  be recommended by NICE.

"Doctors have been told to offer cholesterol-lowering statins to millions more people," BBC News reports.
New guidelines from the National Institute for Health and Care Excellence (NICE) recommend lowering the bar for statin use in adults at risk of heart disease. 
NICE suggests up to 8,000 lives could be saved every three years if everyone with a 10% risk of developing cardiovascular disease within the next 10 years is offered one of the widely used cholesterol-lowering medications.
Cardiovascular diseases are diseases affecting the heart and blood vessels, such as heart disease and stroke.
NICE says the evidence clearly shows statins are safe and effective and would be a good use of healthcare resources if given to these people.
The announcement has been met with a variable response, with the Daily Mail saying up to half of all adults could now be eligible for the drugs, and that, "GPs warn of chaos" at being "told to trawl medical records to find at-risk patients".
On the other side of the argument, Professor Baker, director of the Centre for Clinical Practice at NICE, says the new recommendations would not create an additional workload for GPs.
On the NICE website, he said: "Most patients will already be under surveillance by their GPs, so this won't add any additional workload. But you can do the QRISK2 risk assessment yourself. It can be done online or via an app, so it doesn't need to be done by the GP."
You can assess your own risk online using a risk assessment tool based on factors such as smoking history, body mass index (BMI) and family history of heart disease.
The NICE guidelines have now been published, which means they will come into effect in the NHS in England. However, NICE still recommends preventable lifestyle measures, such as losing weight or stopping smoking, are addressed first before starting statin treatment.
Ultimately, the decision to take a statin – even if it is recommended – will always remain a choice that sits with the patient.

Statins and reporting bias

Visit any medical news forum or comment board, such as the Mail Online's health section, and search for statins, and you will see stories of statins causing terrible side effects – for example, how statins left a person "crippled with pain and brain fog".

While the issue of side effects should never be ignored, the bad press statins get online could be an example of reporting bias in action – where there is selective reporting (or suppression) of information.

In other words, people who tolerated statins poorly are more likely to report that fact than people who have been taking them for years with no adverse effects. Similarly, most UK newspapers are unlikely to run an "I took statins, I had no side effects, and they probably prevented a heart attack" story. Good news rarely shifts newspapers or gets clicks on websites.

What are statins?

Statins are usually the first medication of choice to reduce the levels of low-density lipoprotein (LDL, or "bad")cholesterol in the blood.
Cholesterol and other fatty substances can build up and clog the arteries in the heart and elsewhere in the body, leading to cardiovascular diseases. Reducing cholesterol levels helps reduce the risk of cardiovascular events such as heart attack or stroke.
Examples of statin drugs aresimvastatin and atorvastatin, which come as tablets. The recommended treatment course is to usually take a tablet once a day for life.

What is NICE recommending?

NICE has published an update to its previous clinical guideline on the cardiovascular risk assessment and management of lipids (fats in the blood, which includes cholesterol and triglycerides) in people who either already have cardiovascular disease (such as those who've had a heart attack or stroke), or people who are at risk of developing cardiovascular disease.
The main new recommendations are that:
  • A systematic strategy should be used in general practice to identify people who are likely to be at high risk for developing cardiovascular disease (CVD).
  • People should be prioritised for a full risk assessment if their estimated 10-year risk of CVD is 10% or more (using the QRISK2 assessment tool).
  • Before starting lipid-lowering medications for the prevention of CVD, at least one blood sample should be taken to measure total cholesterol, high-density lipoprotein (HDL, or "good") cholesterol, non-HDL cholesterol, and triglyceride concentrations.
  • In people who have a 10% or greater risk of developing CVD within the next 10 years, the recommended statin to start treatment with is atorvastatin, given at a dose of 20mg daily.
  • In people who already have established CVD (people who have heart disease or have had a stroke), the recommended starting dose of atorvastatin is 80mg daily (unless there are side effects or other contraindications).
For people at risk of developing CVD within the next 10 years, the recommendations to start 20mg atorvastatin applies to adults of all ages, including people over the age of 85 years (in very elderly people, statins may reduce the risk of a non-fatal heart attack). This advice stands unless there are other health-related factors that make statin treatment inappropriate.
NICE does make several important provisions around decisions to start treatment for the prevention of CVD in people considered to be at risk.
These are outlined below.

Patient-doctor discussion

The decision whether to start a statin should be made after an informed discussion between the doctor and patient about the risks and benefits of treatment, taking into account factors such as:
  • possible benefits from lifestyle modifications (measures that could be tried first before starting a statin, such as exercising more, eating a healthier diet and stopping smoking)
  • patient preference
  • other medical illnesses
  • the problems of adding another tablet if the person is already taking a lot of daily medications
  • general frailty and life expectancy

Lifestyle changes

Before starting statin treatment, assessment should be made into other health and lifestyle factors that may need management, including:
  • smoking and alcohol consumption
  • blood pressure
  • BMI
  • diabetes
  • kidney or liver disease
The benefits of optimising all other modifiable lifestyle risk factors (for example, overweight/obesity or smoking) should be discussed, and people offered support for this if needed, such as exercise referral programmes.
Statin treatment may then be considered if lifestyle modifications don't work.

What is the rationale for lowering the threshold for the drugs?

Currently, one-third of deaths in the UK are caused by cardiovascular disease, accounting for around 180,000 deaths each year.
Cardiovascular disease is well known to have a significant burden of disability. It is believed £8 billion of healthcare resources are tied up in the disease.
Professor Mark Baker, director of the Centre for Clinical Practice at NICE, says: "Doctors have been giving statins to 'well people' since NICE first produced guidance on this in 2006. We are now recommending the threshold is reduced further.
"The overwhelming body of evidence supports their use, even in people at low risk of CVD. The effectiveness of these medicines is now well proven and their cost has fallen. The weight of evidence clearly shows statins are safe and cost effective for use in people with a 10% risk of CVD over 10 years."
Dr Anthony Wierzbicki, from Guy's and St Thomas' Hospitals, London, and chair of the Guideline Development Group, also commented on the new guidance: "We've been able to simplify the guideline so it's now much easier for patients to be assessed and for GPs and nurses to make sense of the results. There is greater clarity, a simpler framework, and a systematic way of identifying people who could benefit from treatment.
"We've got the best evidence base, huge numbers, and the biggest set of clinical trials ever done. Other areas of medicine would give their teeth for this evidence, it's that good. Statins work, they are very cheap, and are becoming considerably cheaper as they come off-patent, which, in a cost-limited health service, is a big consideration.
"That enables us to actually say that we should treat people with heart disease a lot more intensively because we know that will prevent further events. In people with diabetes or kidney disease, giving a statin will reduce heart attacks and strokes. For people at risk of heart disease, if lifestyle measures fail, we have a second option of giving them a statin if they want and require it."

Are there any risks or side effects with statins?

Statins are fairly safe drugs, though there are a range of possible side effects and groups of people who should use them with caution. This includes people with an underactive thyroid, kidney disease and liver disease. Women should also not take statins while pregnant or breastfeeding.
Possible side effects include headaches and dizziness, sleep disturbances, fatigue, tummy disturbances, altered sensation, and sensitivity reactions such as rash or itching.
Very rarely, statins have been associated with the risk of having a toxic effect on the muscles, causing muscle pain and weakness, and even a serious condition called rhabdomyolysis, where the muscle fibres start to break down.
However, the risks and benefits would be discussed and taken into account for any individual before a statin is prescribed, including their personal and family medical history.

How has the announcement been received by the media?

As the BBC News headline indicates, NICE's decision has been met with controversy. 
Professor Mark Baker, the director of the Centre for Clinical Practice at NICE is quoted as saying: "Prevention is better than cure. One of the mainstays of modern medicine is to use treatments to prevent bad things happening in the future. It's why we use vaccines and immunisation to prevent infectious disease, it's why we use drugs to lower blood pressure to prevent heart attacks, strokes, and kidney disease, and it's why we're using statins now."
Meanwhile, in opposing camps there is debate about "medicalising" a nation and encouraging people to just pop a pill rather than following a healthy lifestyle.
The British Medical Association's General Practitioner Committee is quoted as saying: "There is insufficient evidence of significant overall benefit to low-risk individuals to allow GPs to have confidence in the recommendation. The measure would distort health spending priorities and disadvantage other patients."
However, as quoted in the Daily Mail, Professor Baker responded: "It is ludicrous to suggest that we are overmedicalising the population when the whole point of using modern, safe and effective drugs in an economic way is to prevent bad things happening in the future."
Dr Chaand Nagpaul, chair of the British Medical Association's GP committee, feels NICE has not taken into account the additional pressures they'll be placing on GPs. "In making their decision, NICE has failed to take the current pressures on general practice into account, and the further impact this will have on already overstretched GPs and those patients requiring treatment for other illnesses."
Despite the extensive debate and opposition, as BBC News also highlights, the 10% threshold for statin treatment is comparable to that already used in other European countries.
As the president of the Academy of Medical Sciences, Professor Sir John Tooke, points out on the BBC News website: "Whether or not someone takes drugs to diminish their risk is a matter of personal choice, but it must be informed by accurate information on the balance of risk and benefit in their particular case. The weight of evidence suggests statins are effective, affordable and have an acceptable risk-benefit profile."

Conclusion

Despite somewhat hysterical media coverage to the contrary ("millions more to be given statins," according to the Daily Express), nobody will be forced to take statins.
If your GP does recommend statins, you should ask them to explain the benefits and risks for you personally of starting statin treatment. You may want to find out more about statins before making up your mind – the NHS Choices Health A-Z information on statins is a good place to start.
If you do experience troublesome side effects while taking statins, contact your GP or the doctor in charge of your care. It could be the case that adjusting your dosage or switching to a different type of statin could help relieve any side effects.
Analysis by Bazian. Edited by NHS ChoicesFollow Behind the Headlines on TwitterJoin the Healthy Evidence forum.

Wednesday 16 July 2014

Prediabetes label unhelpful, experts argue

reposted from: http://www.nhs.uk/news/2014/07July/Pages/Prediabetes-label-unhelpful-experts-argue.aspx
crabsallover highlightskey pointscomments / links.

“Pre-diabetes label ‘worthless’, researchers claim,” reports the BBC.
The headline is based on an opinion piece published in the British Medical Journal (BMJ) by John Yudkin and Victor Montori, both of whom are professors of medicine.
They argue that diagnosing people with “prediabetes” puts people at risk of unnecessary medicalisation and creates an unsustainable burden on healthcare systems.
The piece is part of an ongoing BMJ series called “Too much medicine”, which is examining what is known as over-medicalising  treating “problems” that don’t actually require treatment.
They argue that money would be better spent changing food, education, health and economic policies.
This is an opinion piece. Although the authors support their opinions with studies, other evidence available could contradict their views.

Not that one

One of the authors, John Yudkin, should not be confused with the nutritionist and anti-sugar campaigner of the same name – not least, because the latter died in 1995.

What is meant by ‘prediabetes’?

Prediabetes is used to describe people at risk of diabetes because they have impaired glucose metabolism, but who do not meet the criteria for diabetes and often have no noticeable symptoms.
It is a term that was introduced by the American Diabetes Association (ADA), but has not been accepted by other health organisations, such as the World Health Organization (WHO).
It may be defined as:
  • impaired glucose tolerance
  • above normal glucose blood concentration after fasting
  • above normal glycated haemoglobin (a marker of average blood glucose concentration)
Supporters of the term’s usage argue that it allows doctors to identify high-risk patients, so they can be treated in order to prevent diabetes from occurring.

What objections do the authors have about the use of the term?

The authors point out that there has been little support for the ADA’s prediabetes label from other expert groups, including WHO, the International Diabetes Federation and the UK’s National Institute for Health and Care Excellence (NICE).
The authors say this is because the ADA has lowered the thresholds for impaired fasting glucose and glycated haemoglobin. Because it encompasses all three aspects of impaired glucose metabolism (impaired glucose tolerance, above normal fasting blood glucose, above normal glycated haemoglobin), the lowered thresholds have created a large, poorly characterised and heterogeneous (mixed) category of glucose intolerance.
In other words, the diagnostic criteria are now so broad (in the opinion of the authors) that it is, essentially, useless.
The authors say that using the ADA’s definition of prediabetes would result in two to three times as many people being diagnosed with impaired glucose metabolism. This would lead to 50% of Chinese adults being diagnosed with prediabetes – over half a billion people.
The authors also question the value of diagnosing people with prediabetes.
They point out that the drugs used to treat people with prediabetes in order to stop them developing diabetes are often the same as the drugs they would take if they actually developed diabetes.
The side effects of these drugs must be measured against the fact that many people with prediabetes, who remain untreated, will not go on to develop the condition.
They also discuss the merits of lifestyle interventions, such as regular exercise and improved diet.
They point out that these types of interventions are of use for all adults, so they question the wisdom of only promoting these interventions to specific groups. A better use of campaigning would be to target all adults, they say.

What dangers or risks do they claim could occur by using the term?

The authors suggest that a label of prediabetes, while not causing any physical symptoms, could still cause:
  • problems with self-image
  • anxiety about future complications
  • challenges with insurance and employment
  • a need for medical care and treatment
  • increased healthcare costs
  • medication side effects, if prediabetes is treated with drugs
In their opinion, the diagnosis would cause more problems than it solves.

What do the researchers suggest instead?

The researchers say that the risk factors for developing a whole host of chronic diseases overlap, and that money would be better spent changing food, education, health and economic policies.

What should I do if I have been told I have prediabetes or that I am at high risk of developing diabetes?

If you have been told you have prediabetes, or that you have a high risk of developing diabetes, you can reduce your risk of developing the illness by:
Read more advice about lowering your diabetes risk.
Analysis by Bazian. Edited by NHS ChoicesFollow Behind the Headlines on TwitterJoin the Healthy Evidence forum.

Links to the headlines

Links to the science

Yudkin JS, Montori VM. The epidemic of pre-diabetes: the medicine and the politics. BMJ. Published online July 15 2014