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Statins, cholesterol, side effects… is there an alternative?

Cholesterol and heart disease have become synonymous; having a high cholesterol being associated with a high risk of heart disease. While arguments rage on regarding this cause and effect relationship what is known is that heart disease is a multi-factorial issue. In other words, a mixture of age, sex (being male or female that is!), being a smoker, having high blood pressure, being diabetic, not exercising much along with having an elevated cholesterol are all in the mixing bowel when it comes to heart disease. Cook this over a gentle heat of an ill-determined collection of individual genetic traits and the growing knowledge of environment and emotional stress influences and it becomes very evident that just altering the cholesterol level may be easily measurable and important but it is by far just one modifiable risk factor. Despite this, the cholesterol business is booming. Special spreads to help lower cholesterol are appearing and retired cricketers are spouting the heart protective virtues of wholegrain breakfast cereals… Along side this onslaught we now have a range of powerful drugs that floor cholesterol levels within a very short space of time; the infamous ‘statins’.

I find it interesting that back in 2000 the Journal of the American Heart Association stated that “Statins are well tolerated and have an excellent safety record “, and by 2010 the UK medical journal Heart was commenting that “…studies have found that patients starting statins are at increased risk of adverse effects, including liver dysfunction, myopathy, acute renal failure and cataracts.”

Today, statins are one of the commonest prescribed drug which prompted a large scale investigation of the available information by a team from Cambridge University, followed by their publication in the highly respected journal Archives of Internal Medicine. After the careful analysis of 11 key clinical trials involving 65,229 participants their conclusions rocked the statin world; “ …analysis did not find evidence for the benefit of statin therapy.” So…, confusion all round!

If we look at heart disease as an end point then its not surprising that simply shifting one factor is not the answer. Statin therapy or other cholesterol lowering approaches may be important in individuals at high risk, such as those with diabetes or previous heart attacks, but slapping all those with a low risk or simply a mild elevation in total cholesterol may need some rethinking when all the potential list of side effects are taken into account. With their tendency to cause side effects another problem arises when lowering cholesterol is needed but the user simply can’t tolerate any of the statins prescribed. Reliable estimates show that as many as 40% of those who receive a prescription for a statin are thought to take it for less than 1 year. Possible reasons include the  adverse effects, poor explanations of their benefits by their doctor, and patients’ reluctance to take prescription or long-term medications. This may help explain the growth in the use of Red Yeast Rice (RYR) powder as a food supplement which, in the USA, rose by 80% from 2005 to 2008. RYR has been shown to reduce cholesterol levels and in a recent study demonstrated the ability to reduce cholesterol levels in those previously affected statin related side effects, such as muscular pains, to the point where they had to stop statin therapy! RYR powder in capsules may be the way forward for those needing to trim their levels. Often just 2 capsules (1200mg) daily is all that’s needed!

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Growing support for Red Yeast Rice extract

There is a growing and considerable amount of research involving the use of Red Yeast Rice by those people who can’t tolerate the side effects from the statin group of cholesterol lowering drugs. In 2009 a paper was published that looked at this very issue in which the authors commented that muscle pain and inflammation was cited it some 1023 articles (between July 1993 – April 2009) and affected some 10% of statin users. The onset of muscle pain was also noted to start from 1 week through to 48 months after starting the medication. The study went on to test red yeast rice (RYR) in those people who could not tolerate the side effects associated with their statins. Although the study only ran for 6 months the results were impressive and highlighted that, over the 6 months, the RYR supplement did not trigger muscle pains and was very well tolerated by those who previously endured statin related muscle pains. The RYR also had significant cholesterol lowering effects. In a follow up study published this year in the American Journal of Cardiology RYR was again used in those people who has previous adverse reactions to statins and again the same positive result was seen; RYR was well tolerated and achieved a comparable reduction of cholesterol in those previously intolerant to statins.

As the author of both papers sums up; Statin-associated myalgia (muscle pain) is an important clinical problem that will likely become more prevalent owing to the ever expanding indications for statin use. Although no definitive conclusions could be drawn, our data showed that the red yeast rice was as well tolerated as pravastatin and achieved similar and clinically significant levels of LDL cholesterol reduction in a population with previous statin intolerance.’

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What to do when “Statins” just don’t suit you?

The association between heart disease and cholesterol has enjoyed a long and sometimes rather volatile relationship. Without doubt, those with certain genetic defects causing their cholesterols to rocket into double figures have a predisposition to clogged arteries and heart disease well before their time but controversy rages on regarding the true impact of cholesterol on coronary artery disease; does simply reducing the cholesterol level really play such an important role when off set against the growing list of side effects experienced by users of cholesterol lowering drugs known as statins.
A number of recent studies have thrown a shroud or confusion over the whole cholesterol issue. In a large study involving over 1800 people with existing arterial disease just lowering their bad cholesterol (LDL) for 4 years made no difference to the progression of the disease. However, what did become apparent was that 105 unexpected cases of cancer occurred in the drug treated group compared to 70 cases in the non-drug treated group. To date, no one can confidently point a finger at the drug as a trigger for the cancer cases but it does raise suspicion that needs further investigation. The drug being tested was a combination of simvastatin and ezeimibe known as Inegy.
Other less serious but now well documented side effects from statin therapy include muscle pain and weakness (myopathy) and damage to the liver. Some experts dismiss these side effects as rare and not significant compared to their effectiveness in lowering cholesterol but if simply lowering the cholesterol is not the main issue could thousands of statin users be exposing themselves to unnecessary side effects and misery. Interestingly, Professor Beatrice Golomb of the University of California San Diego agrees. She found that muscle symptoms are far from rare with statin drugs. Professor Golomb comments that “there’s a multibillion-dollar industry ensuring that you hear all the good things about statins, but no interest group ensuring that you hear the other side.” On her research based web site, http://www.statineffects.com, Professor Golomb outlines why she is particularly concerned with the effect of statins on moods and memory describing how “it’s common to find patients on the drugs who report trouble finding the right word or forgetting what task they are supposed to be doing.” Supporting this alternative view on cholesterol is the Danish physician and cholesterol expert Dr Uffe Ravnskov who also publishes a cholesterol information web site that can be found at www.ravnskov.nu. Dr Ravnskov commented in the British Medical Journal that two of the big statin trials deliberately excluded patients who had suffered side-effects in pre-trial tests, and then claimed that the number of side-effects reported was low.
However we can’t avoid the fact that heart disease is a real problem in the UK. The British Heart Foundation state that collectively, heart and circulatory diseases cause more than a third (36%) of all deaths in the UK, accounting for over 208,000 deaths each year. With statistics like this being circulated and our obsession with cholesterol levels it comes as no surprise that the food supplement products known as Red Yeast Rice (RYR) hit the headlines. The news that a 600mg dose of RYR taken morning and evening significantly reduced blood fats (lowering total cholesterol, triglycerides and LDL) while raising the healthy cholesterol levels known as HDL was just what the growing army or statin intolerant people wanted to hear. The study (published in the June 2008 issue of the American Journal of Cardiology) involves some 5000 people over a time period of four and a half years. What was even more interesting was the fact that al those in the study has suffered a previous heart attack and were taken off all conventional drugs before starting the RYR trial. Unlike the study involving the drug combination mentioned at the start of this feature the RYR intake group demonstrated a reduction in disease reoccurrence and no associated side effects.
For those wishing to try a RYR product consider Red Yeast Rice Gold, a certified organic food supplement known to be free from impurities. It is not recommended that you combine RYR with statin drugs. It would make sense to avoid Grapefruit juice since this may increase the risk of side effects and avoid St Johns wort since this may reduce the effectiveness of RYR. Because there are no studies to the contrary, the use of RYR products during pregnancy and breast feeding is not recommended. For a good overview of RYR and its actions and interactions click here.

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