"Everyone over 40 years old should take a statin - men and women." Those are not my words but those of Professor Sir Magdi Yacoub who is one of the world's most eminent heart surgeons. Interviewed on the Today program this morning he, with typical surgical aplomb, stated his opinion. When asked if every man over 50 should be on a statin he replied. "Definitely, I would say every man over 40" and what about for women Justin Webb asked, "Yes women too." So that's clear according to the Professor everyone over 40 should have a statin and not to do this he said was lunacy. We are in a statin war, being played out on the media battlefield. Each side lobbing studies and statistics at each other across the 7 million people who take these drugs every day and the millions more who some think ought to. People are confused by these disagreements between the doctors as the two sides rage against each other. Into this toxic mix there is distrust of pharmaceutical companies, conflicts of interest and self-promotion amongst researchers and the wider social issues about the medicalization of the population. Today was an minor assault by the Statinistas. Deploying a "big gun" in the form of Sir Magdi to state the case for statins. A generous dose of eminence-based medicine was administered aurally. Yacoub said that if the cholesterol is low then this would result in not only reduced rates of heart attack and strokes but also reduction in dementia and cancer. He said "If the cholesterol is extremely low then people look very young at an old age and lead a long and happy life, so not to take statins is a disaster." Linking observations made in people with a very rare genetic cause of extremely low cholesterol (PCSK-9 deficiency) to the effects you would expect from taking statins seems somewhat absurd and stretches the evidence on statins into new orbits. Even the most ardent trialists would be likely to agree that currently body of statin data does not support Yacoub's views. But rather than speculation about the a cure for cancer or dementia the most provocative statement he made was that everyone over 40 should be on a statin. This is a debate about risk versus benefit. A debate about populations versus individuals. There is the strongest evidence that statins reduce the risk of heart attack and stroke. That cannot be denied. The reduction in risk is about 30%. The benefit is not dependent on the baseline level of cholesterol. If your risk is high you get a lot of benefit, if your risk is low, you benefit, but not so much. A simple way to express this is the "Number Needed to Treat" or NNT. If the NNT is large then the treatment is not very effective in that group of patients and may approach the Number Needed to Harm. In other words if you treat a large group of people at low risk then you may help a few and harm a few. The problem here is deciding at what level of risk to offer treatment. For statins in primary prevention the NNT is 60 for heart attack and 260 for stroke. In people with established heart disease the NNT is 39 to prevent a heart attack, 125 to prevent a stroke and 83 to save a life. To the individual patient these seem like high numbers but when you consider that millions of people are on statins then they rapidly multiply making the reduction in heart attacks, stroke and death look impressive. But we also need to keep in mind that giving statins for prevention where the risk is low is totally different from using them in high risk people. If we expose a large number of people to a small risk from the statin treatment then this is likely to yield more problems than if we were to expose a small number to a much bigger risk. The classical argument about treating populations was put forward by Geoffrey Rose in his book and articles on the Strategy of Preventative Medicine. Rose argues that a mass approach is the only ultimate answer to the problems of a mass disease. But, however much it offers to the population as a whole, it benefits each participating individual very little. Take the example of diphtheria immunisation. 600 children need to be immunised in order that one life would be saved. In other words 599 wasted immunisations were given. The same case may be made over seat belts where the number of times a seat belt needs to be worn to prevent one fatality is about 25,000. This is the prevention paradox. The effectiveness you have to accept in mass medicine where the measure applied to many will actually benefit few. A measure that brings large benefits to the community offers little to each participating individual. As Rose says: "We should not expect too much from health education as people won't be motivated to take the advice because there is little in it for them especially in the short term." So should you take a statin if your over 40 years old. Well it depends on your risk of cardiovascular disease compared to the average 40 year old. If you are at low risk because you don't smoke, your cholesterol and blood pressure are normal and you are otherwise healthy your benefit is very small. You may wish to take a statin and in that case either your doctor will prescribe it or you can buy 10mg simvastatin over the counter - it's your choice. If you are at increased risk compared to the average 40 year old because of raised blood pressure or elevated cholesterol then your benefit is higher and you are likely to be advised by your doctor to take a statin. Again it's your choice but the choice needs to be made after a proper discussion and the advice individualised and explained by someone with expertise in guiding the patient thought the arguments. Simply telling everyone over 40 to take statins is in the words of the Professor lunacy.
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The old saying goes you should breakfast like a King, lunch like a Prince and dine like a pauper. Breakfast may be the most important meal of the day but now it turns out that it's effects reach far beyond the breakfast table. What you eat for breakfast influences not only how full you feel at the time but how much food you eat for lunch and dinner. So what's the best breakfast? A poached egg, a bowel of cereal and a slice of toast or something more continental - a croissant with butter and jam perhaps? Researchers at the University of Surrey have been looking at whether what you eat at breakfast alters how hungry you feel later in the day. They randomly assigned three groups of students to different breakfasts all containing 330 kilocalories. The breakfasts were either two poached eggs on a slice of white toast or a bowl of cornflakes with semi-skimmed milk, a slice of white toast or a croissant with butter and jam and orange juice. For lunch the students were offered a buffet of cheese sandwiches, plain crisps and water. For dinner they were offered a buffet of pasta and a tomato sauce and cheese and water. The amount of lunch and dinner they took from the buffet was recorded as were scores of hunger and fullness during the day. Their results showed that the egg breakfast made people feel significantly fuller for longer and reduced the amount of lunch and dinner taken from the buffet. The proportion of fat and protein in the egg breakfast was higher and the carbohydrate content lower than the other breakfasts. It is known that high-protein foods make you feel fuller than high fat or carbohydrate ones and show the importance of food choice at breakfast. But hold on I hear you say can a cardiologist really be recommending that people eat eggs. In the 1960's the Egg Marketing Board ran a highly successful campaign called "Go to work on an Egg" but with the demonization of saturated fat in the 1970's and 80's, eggs with their high cholesterol content were rejected in favour of high carbohydrate breakfast cereals. Well it turns out that your more likely to raise your cholesterol by eating butter on your toast than from the cholesterol in an egg. In a large meta-analysis published in the BMJ looking at 17 reports on data from 4 million people there was no evidence of an association between egg consumption and risk of coronary heart disease or stroke and now even the British Heart Foundation is now promoting the consumption of eggs. So this means you can go to work on an egg if you want to and it might well help you lose weight by reducing the size of your lunch and dinner. Bergamot a member of the citrus family which is found in the Calabria region of southern Italy. The fruit is a source of essential oils which when added to Earl Grey tea result in the unique scented flavour of this drink. Yesterday national newspapers articles appeared suggesting that Earl Grey tea was as "effective as statins in the fight against heart disease." Is this too good to be true? The newspapers reported a study in rats published in the Journal of Functional Foods. The authors from Italy showed that extract of bergamot fruit reduced cholesterol levels in these animals and that it was as effective as simvastatin. Now if you want to write a story for the newspaper it's only a few steps of logic before you can claim that drinking Earl Grey tea is a possible substitute for a statin. This conclusion goes way beyond the experimental data but some patients I talked to yesterday were clearly ready to give up their statin and try the natural approach. Is there any evidence that bergamot can treat heart disease? Bergamot fruit contains high concentrations of polyphenols. This is usually thought of as a good thing but really we are not sure what these chemicals do. They are in a group called anti-oxidants and since oxidation is bad these chemicals are thought of as good. This is a vast over-simplification of a complex and poorly understood area of biology. The anti-oxidant potential of bergamot is found in other fruits such as pomegranates and blueberries. These are commonly referred to as super-foods in the pages of popular magazines and their beneficial properties are often promoted. There are several human studies reporting potent effects of bergamot extract on cholesterol levels. In one study LDL, or so called bad, cholesterol levels were reduced as much as in people taking 20mg of rosuvastatin. This is very interesting and if reproduced is quite an astounding effect. But wait, what of outcome trials, where is the data that these fruit extracts reduce heart attacks and save lives? Of course this is completely lacking and there will never be any large clinical trials to prove effectiveness in reducing cardiovascular disease. This is because such studies cost millions of pounds and at the end even if it proved effective there is no prospect of a patentable medicine. Doctors usually demand strong evidence before they prescribe drug treatment and this is true in the field of cholesterol lowering drugs or is it? Every year millions of doses of a cholesterol lowering drug called ezetimibe are prescribed for patients intolerant of statins or in whom cholesterol cannot be reduced enough by statins. Ezetimibe definitely lowers cholesterol but is there is scant evidence that it reduces heart attacks or deaths from heart disease. The IMPROVE-IT trial (simvastatin versus a combination of simvastatin/ezetimibe) started years ago and the results are still awaited. Meanwhile doctors continue to prescribe ezetimibe with enthusiasm. Apart from more evidence that it lowers cholesterol there isn’t too much difference between ezetimibe and bergamot fruit extract when it comes to outcome trials. Patients often favour a natural approach but is important to remember that fruit extracts simply contain chemicals and chemicals sometimes have unwanted effects. For example pomegranate juice can interact with drugs like warfarin leading to serious consequences as we previously reported. So where do we go from here? If you enjoy Earl Grey tea continue to enjoy it as a drink but not for its medicinal properties. If you don’t like Earl Grey tea, no problem because there is almost certainly no health benefit in drinking it. If your statin is working, keep taking it. If your statin isn’t working or you are getting unacceptable side effects such as severe muscle aches which have been proven to be due to the statin by a period of withdrawal and re-challenge then you might discuss taking an alternative with your doctor. Whether this involves the recommendation of bergamot extract or ezetimibe is a matter of opinion. |
Dr Richard BogleThe opinions expressed in this blog are strictly those of the author and should not be construed as the opinion or policy of my employers nor recommendations for your care or anyone else's. Always seek professional guidance instead. Archives
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