NICE and wider use of statins?

In the UK it is currently recommended that a statin should be prescribed to lower cholesterol for a
patient in whom the risk of developing cardiovascular disease in the next 10 years is 20% ie 1 in 5.

NICE - the National Institute for Health and Care Excellence - is now consulting on its proposal to reduce the threshold for prescribing a statin to a 10% ie 1 in 10 risk of cardiovascular disease in the next 10 years.

Here are my comments within the 12th February 2014 Science  Media Centre briefing on this new draft guidance from NICE:

"Heart disease, strokes and other serious disorders of the circulation are a major cause of premature ill health and death. 

Statins can help to prevent and reduce the severity of these serious medical problems. 

This initiative from NICE is important in extending to many more people protection from serious cardiovascular risk. 

Clear information will need to be made available on two key points: the need to combine statin use with a healthy lifestyle and addressing the other risk factors commonly present in people with high cholesterol, and information on the balance of risk versus benefit for these powerful medicines."

More comments from the SMC briefing.

The NICE draft proposal on statins.

Sharpening memory and cocoa - how interested should you be?

Farzaneh Sorond and colleagues from Harvard and the Mass. General Hospital have attracted worldwide interest in their study published in the US journal Neurology "Neurovascular coupling, cerebral white matter integrity, and response to cocoa in older people". 

Listen to interview on the story on BBC local radio
 
The theme of the interest - from the LA Times to the Belfast Telegraph - is that cocoa "not only soothes the soul, but might also sharpen the mind'.

Fruit of the theobroma cocoa tree: Corti et al. Circulation 2009 

Why even think that it might? The authors drew on two background concepts:
- Earlier research using sophisticated brain imaging had reported that cocoa intake is associated with an increase in blood flow to the brain; and brain blood flow is linked to intellectual capacity.
- And cocoa contains flavonols, bioactive chemicals present in many foods associated with measures of healthy cardiovascular health, including increasing blood flow to the gray matter of the brain.
The question asked by the researchers was whether previous interest in chocolate containing products and better brain function might be explained by flavonol effects. 
To address this they carried out a study in which the design was high quality with regard to a possible effect of flavonols on 2 measures - brain blood flow and a test they used to assess memory.
What did they find? No difference in the effects of flavonol-rich vs low in flavonol cocoas as 2 cups per night for 30 days.
However, they reported a significant improvement in blood flow and in the intellectual function test by 30 days.
Should we all now start drinking large amounts of cocoa? Not yet based in this interesting but small study. To consider my question in a different way, key points arising from this work are:
- does cocoa sharpen the mind?
- does it protect from dementia?
- does it help people with dementia?
With these points in mind:
- the study was small - only 60 participants included and only 18 of these were noted to have improvements with regular cocoa
- the study was only for 30 days - more work would be needed to show whether these apparent benefits would be sustained
- the study was performed in older people - average age 73, who already had risk factors for cardiovascular disease - not safe to generalise study findings to other age groups and to people without cardiovascular risk factors.
- the 70% of volunteers who had normal blood flow and managed the test well at baseline should no improvement with cocoa
- the study was designed to test an effect of flavonols. However there was no time control for the effect of cocoa - e.g. vs other hot drinks. The authors cannot therefore rule out a time effect on their results e.g. people not managing the test well at the start doing better simply through  the initial practice
- the tests of brain function were 'Trailing Making Tests' ie involved a timed 'joining the dots' test. It would be important to confirm that more real world aspects of brain function were also improved
- no patients with dementia were included - further studies would be needed to show whether patients with dementia would also benefit and that any benefits were helpful for activities of daily living 
Thus results of the study could be explained as an artefact of the study design - ie not be due to the cocoa. At best they only applied to people with identified cardiovascular factors who also already had impaired brain blood flow and difficulty in performing the type of mental activity tests used by the researchers. 
And the concern about large amounts of cocoa is the associated increase in dietary sugar and fat intake of typical Western milky cocoa drinks. Neither are good for cardiovascular health, as they increase risk of overweight, high cholesterol, diabetes and high blood pressure. To compensate for those risks, the researchers under the strict conditions of the study made sure their volunteers made appropriate adjustments in other parts of the diet to balance sugar and fat intake over the month. In real world use, even if cocoa were confirmed to be helpful for the brain, it would be very important that people increasing their cocoa intake were very careful to avoid these unintended consequences of increased cocoa intake. Of note the researchers were not studying cocoa with added cream and marshmallows - not good for the circulation.
What about different sources of chocolate in cocoa? Not addressed by the researchers - except that they appeared to show at least that any benefits were not related to the types of flavonol they studied.
And how about eating chocolate instead? Again - not studied by the researchers. And in previous observational research on chocolate, there was an apparent benefit on heart disease protection from very small amounts (chocolate 1-3 times per month) with larger amounts reported to be harmful for the heart.
As a final thought, one of the reported uses by ancient Aztecs and Incas of chocolate drinks was as sedatives in religious rituals. Another explanation for the study findings is that calming effects of cocoa ('soothing the soul') reduced anxiety during the tests as a contribution to the observed improvements in brain blood flow and test performance with the drinks.

Link to interview 8.8.13 with Shane O'Connor on BBC local radio

Mediterranean diet and Cardiovascular Health

Ramon Estruch, a Spanish researcher on benefits of the Mediterranean diet, will speak in London at a Symposium on Cardiovascular Health on 5th December 2013.

Registration and abstract submission is now open for the Symposium.

Professor Estruch's theme will be outcomes of his multi-centre study reporting that, for patients who already are at high cardiovascular risk, a Mediterranean diet without calorie restriction is more effective than a low fat diet in reducing the occurrence of serious cardiovascular events.

His findings were published in the New England Journal of Medicine at the end of February 2013.

This event is one of a series of Symposia on Cardiovascular Health being held by the CVRT at the rooms of the Medical Society of London, one of the oldest continuing medical societies in the world.

Weblink for 5th December Symposium on Cardiovascular Research.

More on the research by Professor Estruch.

The symposium is being organised by  the Cardiovascular Research Trust.

Romeo's 'Sick health'

@HealthMed One of Romeo's string of oxymorons [Romeo and Juliet Act 1, Scene 1: reflecting on his heart sickness for fair Rosalind], 'sick health' illustrates the challenge of preventing more conventional heart disease - with its long prodrome of apparent health masking the development of sub-clinical disease from unrecognized risk factors, which may however be reversible if identified and addressed.

Why don't more people engage? Many reasons, including fear of finding a problem if tested, difficulty accessing advice/health checks, lack of interest or knowledge of outcomes of 'treatment', lack of confidence in self-efficacy to achieve supporting or first-line life-style changes, in diet, exercise, weight, smoking cessation, alcohol intake ...

To find out more on challenges and solutions for success in behaviour change, look for sources on Theory of Planned Behaviour e.g. this referenced link from the University of Twente.

See my previous blogs on smoking and alcohol.

Stopping smoking: why and how?

Hip fracture risk and smoking

Smoking: literary warnings

Alcohol: literary warnings

Alcohol and the French paradox

Why have a National Blood Pressure Week?

 In the UK, over 1,500 venues are offering free blood pressure checks during National Blood Pressure Week (12-18 September 2011). Why all that effort?   High blood pressure is a major preventable and treatable risk factor for serious heart diseases and stroke syndromes throughout the world. And even at the age of 20 around one in 20 people may already have high blood pressure, increasing to around 1 in 2 people by the age of 70.

An annual blood pressure week provides an important focus to remind the public and health professionals about risks of high blood pressure, how to prevent it, measure it accurately and use lifestyle and drugs in people in whom blood pressure is too high.

Blood pressure should be as low as possible, with, for adults, the upper level, when the heart has contracted, below 140mmHg and the lower level below 90mmHg, when the heart is relaxed between heartbeats. These thresholds should be much lower in people at increased risk of blood pressure complications, such as diabetics and people with kidney disease.

Provided people are otherwise healthy, the ideal blood pressure is now considered by international experts for the upper value to below 120, the lower below 80, recorded as ‘below 120/80mmHg’.

It is very important that patients help by following a healthy lifestyle. This is both helpful to prevent high blood pressure, and for patients with hypertension, to reduce its severity. People should aim for a healthy weight, using fresh foods as far as possible, keep salt intake low, and alcohol intake within healthy limits, be active and have regular good sleep.

This year it is timely the UK’s National Blood Pressure Week comes just after the launch of important new blood pressure guidelines prepared by the National Institute for Health and Clinical Excellence (NICE) advised by experts from the British Hypertension Society (BHS).

The NICE guidelines contain new advice on blood pressure measurement, including involvement of patients in their own management, supported by home blood pressure readings.

It is of course very important that any blood pressure monitor, whether for clinical or home use, should be accurate. A helpful list of accurate devices is on the British Hypertension Society's website.’

If you have high blood pressure, you should make sure that your doctor knows about any over the counter tablets or herbal remedies you are taking, as these can interfere with the actions of blood pressure tablets.

There are now seven major types of blood pressure treatments. For best blood pressure control, prescribers need to the right drug options for the right kind of patient, taking into account, for example, age, ethnicity and potential risks in pregnancy. If single drugs are not sufficient to control blood pressure, the NICE guidelines provide advice on which drug combinations are best to use.

Useful websites:
British Hypertension Society – includes information on which blood pressure monitors are accurate  http://www.bhsoc.org
Blood Pressure Association – includes a list of venues for free blood pressure checks http://www.bpassoc.org.uk/
NICE guidance on hypertension for patients and carers: http://guidance.nice.org.uk/CG127/PublicInfo/pdf/English

Networks and personalized medicine for better drugs?

For more on this theme see 
- article with Andrew Marsh in the inaugural March 2012 issue of Health Policy and Technology
- article in the October 2011 issue of Public Service Review: Science and Technology Review.  

For many individual patients treatments may not exist, may not be very effective, or may result in unpleasant adverse effects. How can prescribers improve drug selection andreduce the harmful effects of medicines? Are there better ways to develop drugs for patients who are difficult to treat?  And what can we do to improve poor adherence to medicines? These elements underpin ‘personalized medicine’, in current use the concept that by considering differences among patients in genetics, disease burden and other factors, more effective and safer drugs can be developed. Personalizing medicine is a path to better disease prevention and control where limited treatment options exist, such as for many cancers, resistant infections and dementia syndromes, and better drug development for new medical challenges. These concepts have in recent years attracted interest from the Royal Society, the Nuffield Council on Bioethics and cognate international institutions.

It is clear that there needs to be consistent investment and support from policy makers and regulators to develop and sustain the academic and industry pharmacology expertise and activity needed for the long-term success of a personalized medicine strategy, so that we can continue to be able to improve the health of the public and individual patients.

NICE is an international leader in developing evidence-based treatment guidelines. Its reports increasingly recognize the need to refine drug choice based on patient characteristics. For example, updated national hypertension guidelines released in August 2011 advise drug selection guided by age, gender, ethnicity, and monitoring, with treatment modified depending on clinical response. NICE also recognizes the need for research on ways, tailored to patient preference, to improve long-term adherence to drug treatment.

Pharmacologists are developing two complementary approaches aimed at achieving “precision medicine” in as many patients as possible: better drug discovery combined with high definition biomarkers for drug selection and monitoring. Network pharmacology brings together sophisticated databases of genetic mechanisms for disease, pharmacological pathways, candidate drugs, and population data describing important variants among individuals in drug handling and responsiveness.  These methods also allow ways to find previously unexpected “off-target” actions of existing or new drugs, which may accelerate discovery of new treatments for serious diseases.

Diagnostic methods are increasingly being used to improve drug selection for individual patients. For example growth tyrosine kinase receptors can be blocked using the biological agent imatinib to treat particular patterns of Philadelphia chromosome-positive chronic myeloid leukaemia, and rare gastro-intestinal tumours. Understanding genes and drugs that influence enzymes that modify drugs in the body, improves accuracy in defining patients who will not respond to a given medicine, or may develop adverse effects.  For example, to minimize risk of serious harm, pharmacogenetic testing is recommended for variability in a specific liver enzyme before deciding whether or not to prescribe the anti-HIV drug abacavir. This knowledge also allows better prediction of a patient’s risk of harm from interactions between treatments, based on recognition of medicines and other remedies that interfere with how drugs are cleared by the body. 

See my previous blogs on 
- preventing adverse drug reactions
- new UK guidelines on managing high blood pressure

New UK guidelines on managing high blood pressure

High blood pressure is a major preventable and treatable risk factor for heart disease and stroke syndromes both in the developed and the developing world.

In an innovative partnership between a UK government agency - the National Institute for Health and Clinical Excellence (NICE) - and a professional organisation - the British Hypertension Society (BHS), NICE guidelines for managing hypertension in primary care were first issued in 2006. Key elements to those guidelines included a stepped care approach starting with different first line options for younger vs. older patients with a 55 year age boundary, and for patients of black African or Carribean origin compared to other ethnic groups. The 2006 guidelines also highlighted risks of new onset diabetes mellitus from beta-blocker treatment.

On 24th August, five years on, NICE, again supported by experts from the BHS, has released updated hypertension guidelines which include several key developments of interest to prescribers and patients. These include adding blood pressure measurements away from the clinical setting to confirm the diagnosis for patients with mild to moderate increases in clinic blood pressure readings. With even higher office readings, advice remains to treat based on those office readings. There is detailed advice both on blood pressure measurement using ambulatory devices as well as more systematic involvement of patients in their own management, supported by home blood pressure readings. It is of course important that any blood pressure monitoring device, whether for clinical or home use, should be validated. A helpful list of validated devices is is listed on the British Hypertension Society's website.

As an update on treatment options, the new 2011 guidelines now suggest systematic use of calcium channel blockers as first line treatment in older patients, with now specific, named diuretics as alternative options for specified indications. The 2011 guidelines for the first time also highlight the clinical and cost effectiveness of evidence-based treatment of hypertension in older patients, and in particular the over 80s.

For more information, see the summary documents and more detailed reports on the NICE website.

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