Is the concept of getting cholesterol down to a particular level evidence-based?

This week there’s been a big cardiological meeting (the European Society of Cardiology) going on in Amsterdam in the Netherlands. One of the studies presented at the meeting is reported here. The research compared the number of patients achieving recommended LDL-cholesterol levels in the UK with those in Germany.

It turns out that the numbers in the Germany were far lower in than those in the UK. This, it is said, may have something to do with the fact that in the UK doctors are remunerated for ‘controlling’ their patients’ cholesterol levels. This does not happen in Germany, where such practises may be positively discouraged on the basis of cost-effectiveness (from what I can make out). So, the UK-system is better at getting people to have lower cholesterol, but is this actually better for them?

First of all, just how effective is cholesterol control? We know that low-fat diets that reduce cholesterol levels are ineffective for the purposes of prevention of heart attacks or stroke and also for reducing the risk of death.

Also, even when drugs get used, the results are far from impressive for most people. For example, if we take a group of individuals with no prior history of cardiovascular disease and treat them with a statin for 5 years, 98 per cent of them stand to gain no benefit whatsoever. But a significant number (maybe up to about 20 per cent) will have potentially debilitating side-effects such as fatigue, muscle pain, liver damage, kidney damage or diabetes. In short, for many people, statins just don’t make much sense at all.

But also, is the idea that treating people to achieve a specific cholesterol target even evidence-based?

This idea is actually based on ‘epidemiological’ evidence. For example, data drawn from studies in which individuals have been treated with, say, statins may find that lower cholesterol are found to be associated with lower risk of cardiovascular disease. From this, the conclusion is drawn that lower cholesterol levels are better and desired.

There are fundamental weaknesses in this sort of data, though. Firstly, statins reduce cholesterol, but they do other things too. They have, for example, anti-inflammatory and ‘blood thinning’ effects that might reduce the risk of cardiovascular disease. So, the cholesterol reduction they achieve may be incidental, in which case it does not necessarily make sense to use a specific cholesterol level as a goal.

The evidence base for treating to a specific LDL-cholesterol target has been comprehensively reviewed  [1]. In this review, the authors found only one study which allowed them to assess the idea that greater LDL-cholesterol reduction produces better outcomes. In this study, individuals were initially treated with a statin (simvastatin) at a fixed dose (40 mg). The benefits seen in individuals who saw relatively small LDL-reductions was the same as those who saw big reductions [2]. The logical conclusion one would draw from this is that the degree of clinical benefit is independent of the degree of cholesterol reduction.

The authors of the review also draw our attention to what is known as the ‘healthy volunteer’ effect. This relates to the fact that some people are more compliant with regard to medication-taking than others. Those who take medication tend to be more health-conscious than those who don’t. So the apparent benefits of a drug may not necessarily be due to the drug at all, but due to factors related to increased health-consciousness (e.g. healthier eating and regular exercise).

This is another major reason why the data linking lower cholesterol with improved health outcomes is unreliable. And its another example of why the idea that people should have their cholesterol controlled to a certain level is not evidence-based at all.

References:

1. Hayward RA, et al. Narrative review: lack of evidence for recommended low-density lipoprotein treatment targets: a solvable problem. Ann Int Med 2006;145:520-530

2. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002;360:7-22

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17 Responses to Is the concept of getting cholesterol down to a particular level evidence-based?

  1. Michael 6 September 2013 at 12:43 am #

    It is perplexing that so little is known about exactly what (singular or multiple) causes CVD and why our bodies produce such a diversity of lipids (type, number and size). The lipidologists think they have it sussed, but it seems to me, they and everyone else are basing their theories on statistics and what they think are logical conclusions. The statistics can be questionable, but the theories are stated as fact.

    We can point to as many studies as we like about people having heart attacks with varying degrees of cholesterol, the proponents of mainstream theory will always point to the people who die young and happen to have Familial Hypercholesterolemia (while ignoring those that live to old age). We’ll say it’s stress, inflammation, too many PUFAs, too much sugar – they’ll staunchly claim LDL is the body’s inherent masochistic weapon against itself.

    It is quite fascinating to witness the anger and vehemency with which certain internet personalities claim LDL is the ultimate villain. Especially those that were quite happy with the results they obtained from eating a certain way, but then see their LDL numbers climb and throw any sort of clear reasoning out the window.

    Not sure what the point of my comment is, other than to say I admire your tenacity and patience in promoting these messages. Please keep at it.

    I have a dream that one day the low carbers will be able to join hands with the low fatters and we shall all know the truth about why our bodies work the way they do.

  2. GT 6 September 2013 at 7:16 am #

    It does concern me that some doctors (based on my own experience and anecdotal evidence on various forums) seem somewhat “statin happy” and fixated on cholesterol. I saw a GP recently to discuss test results (for fatigue and persistent aches and pains that have become more acute over the past few months). The doctor immediately jumped on my cholesterol as it has increased (from about 6 to about 7 over a good few years). They immediately gave me dietary advice without actually asking how or what I eat (I’m overweight so I can only guess they made assumptions based on that). I tried to query the “received wisdom” – saying that many factors can influence the result, that higher cholesterol isn’t necessarily a portent of doom, that eating red meat isn’t the cause of raised cholesterol, that as a woman of 45 with no history of heart disease I’m unlikely to benefit from statins, etc. That of course was tantamount to heresy and I got ticked off like a naughty child. So now I’ve been given three months to “fix” it with dietary changes or they want to prescribe statins (which I have absolutely no intention of taking). Later on, I looked into Vitamin D (my level is 28, which the doctor wasn’t that concerned by, although they did agree to testing my calcium levels) and discovered that there’s a link between low Vitamin D and high cholesterol. It took me just minutes to find and read up on the basics of this, yet it seems my GP would rather just pounce on the cholesterol issue and get me on to statins, sidelining my original complaint (fatigue and pain) in the process.

  3. Magarietha 6 September 2013 at 8:18 am #

    AND, the little bit of anti-inflammatory benefit is negated by the massive breaking down of muscle, which in turn causes rhabdomyolisis. it seems South Africa has the motherload of people “suffering” from HFH so all of our people (some whites, some Indians and Ashkenazi? Jews) are on lipid lowering drugs. Everyone I’ve spoken to complain about arm, leg, buttock and back muscle pains – some have a changed gait and all of their GP’s apparently think THIS is nothing to worry about, it’ll get better in time. Wha-at? My one family member was rushed to hospital with hugely compromised kidney function out of the blue (never takes pain tablets or any such) only STATINS, throughout here “KIDNEY DISEASE” no-one took notice of her excruciating muscle aches. Not a single doctor at the hospital told her to stop the statins. Her kidneys were treated for beter or worse and she was told to stay on her statins. HOW, Dr. Briffa, is it possible that doctors can be so sweapingly ignorant about a possible fatal side-effect. Surely rhabdomyolisis can be fatal? My family tend to do research – we have scientists aplenty and they are aware of the consequences, but medical doctors here? They seem to think those muscles breaking down is just 6 of one and a dozen of the other – no worries. I’m cross. I think I have the only enlightened GP in this neck of the woods. He is aware of all of this. My 82 year old mother went to an orthopedic surgeon this week, she was certain she’d need a hip replacement and turns out for her age her bones are absolutely intact. A little bit of anti-inflammatory is what’s needed. So the doctor looks a bit puzzled that she needs a walking ring and that her pain is so bad. I kept quiet about the lipid lowering drug because I wouldn’t want to burden him with something not within his specialised field. My guess is that all of her pain is due to Bezafibrate. And hey Doc, isn’t it amazing that she’s otherwise so well with HFH at 82! She’s to old to question the doc’s knowledge or lack thereof. She will not be listening to me and I have a feeling this bezafibrate is unnecessary at 82 and it’ll probably kill her off if she stays on it. Sorry about the book I wrote here.

  4. Gregory Barton 6 September 2013 at 9:28 am #

    “The logical conclusion one would draw from this is that the degree of clinical benefit is independent of the degree of cholesterol reduction.”

    Does this conclusion imply that there is no evidence for reducing cholesterol to certain levels, which is the point of the article?

  5. Sandy Angove 6 September 2013 at 9:31 am #

    I’m confused! In your second paragraph, did you mean Germany’s cholesterol levels are ‘lower’ than in the UK? Following your article, should that not be ‘higher’…? I have high cholesterol and stopped taking statins, to the horror of my Nurse and GP. But I feel so much better!

  6. William L. Wilson, M.D. 6 September 2013 at 9:34 am #

    John:

    I see you were included in my friend Jimmy Moore’s new book “Cholesterol Clarity–What the HDL is Wrong with my Numbers?” The book is an excellent summary of the issue of cholesterol and health and I encourage everyone to read it. Jimmy manages to interview some of the world’s best known experts on cholesterol and health (including you) and he presents a compelling argument why you should ignore most physician’s advice when it comes to cholesterol and lipids.

  7. Dr John Briffa 6 September 2013 at 9:34 am #

    Gregory

    Yes, I think so.

    Sandy

    “did you mean Germany’s cholesterol levels are ‘lower’ than in the UK?” No, the number of people achieving cholesterol targets is lower in Germany.

  8. Judy Barnes Baker 7 September 2013 at 3:32 am #

    Prescriptions for statins come with an insert that tells patients to eat a low-fat and low-cholesterol diet while taking the drugs. (There is a word for something that causes the very thing it is intended to treat, but I can’t remember what it is.) No doubt all the studies done on statins were done on people who were required to eat a low-fat diet for the duration of the study period. Even the small number who seemed to benefit from taking a statin would probably have done much better on a healthful diet than on the drug.

  9. Martha 7 September 2013 at 4:39 pm #

    I was on statin for many years. Last June 2012, I went to my GP and asked if I was able to stop taking the statins as it was causing me terrible joint pain. My blood glucose had also increased since taking statins. The doctor who I had been with for many many years told me I had to stay on statins because of my “high” cholesterol levels. So, I was switched to a different statin brand but the joint pain didn’t go away, it just got worse. In fact, they made me change the statin brand 3 times but made no difference. I was diagnosed as pre-diabetic which is when I decided to look for a 2nd opinion. I eventually found a GP who agreed that it was up to me if I wanted to come off statins. I was so glad that I found and joined Primal Retreat boot camp as they gave me a better insight about Paleo food and living a healthy Paleo lifestyle. Stuart & Lorraine who run the retreat really helped me to see that what you eat can change your health. I have lost a lot of weight and my health has improved. Since I stopped taking statins last year in June, my joint pain disappeared. I went to see my GP this year and had a blood test which found all my health markers were excellent.

  10. Mark 7 September 2013 at 4:51 pm #

    @GT

    With your Vitamin D Level at 28 (I assume that’s 28nmol/L) your non-specific aches and pains could be down to something as simple as osteomalacia. Look it up. Either get in some bright mid-day sunshine everyday for half an hour (if you’re lucky enough to live in such a country!) or take 3-5000 IUs of Vitamin D a day. And change GP!

  11. GT 7 September 2013 at 5:59 pm #

    Thanks, Mark – all advice much appreciated. Osteomalacia is something I’ve been investigating as it is a strong possibility. I’m indoors most of the day (I work from home, so I don’t even get the sun exposure of a daily commute, and I don’t always break for an outdoor stroll at lunchtime) and being a fair-skinned Celt who’s prone to sunburn, I tend to slap high-SPF cream on any skin that isn’t covered with clothing when I do go out. I’m in the UK so supplements it’ll probably have to be! And yep, I’m intending to change GP!

  12. Tony Kerstein 7 September 2013 at 10:12 pm #

    As well as the muscle pains etc. statins cause memory loss. When I was on them I thought I was getting Alzheimer’s disease. Over a year after I gave them up I suffered a haemorrhagic stroke which I recovered from almost at once. Being an anti coagulant they are contra indicated in this case, so since I was already on low dose aspirin I believe the outcome would have been far worse, perhaps even fatal if I had still been on them. I do voluntary work with older people and the fittest (many who are volunteers themselves mostly seem to have ‘high cholesterol’ (one very fit and young looking 85 year old has a level of 10 mmol. A small French study of residents of an old age home showed similar results.

    The NHS wastes 2 billion pounds on statins and cholesterol tests. Think what they can do with that.

  13. SueG 13 September 2013 at 3:02 pm #

    “yet it seems my GP would rather just pounce on the cholesterol issue and get me on to statins, ” Not just GPs either. I have been attending a coronary care unit, driven there by arrythmia that took on a more worrying phase. My cholesterol is 6. something, up from 5.7. Even before I had a halter fitted and the echocardiogram, the first words out of the SHOs mouth were “You cholesterol is high, you should be taking statins!” I could only utter “not likely” I was so surprised.

    I haven’t yet been back for the results of aforementioned tests (presumably having looked at them they decided there was no rush) but I have paid to have my homocysteine level checked and result was a level of 8, suggesting that I am not at risk of CVD. They don’t know this of course and I am debating whether or not to take the result with me, will they even care?

    In the meanwhile I have read Dr. Stephen Sinatra’s “Reverse Heart Disease Now”. He doesn’t rule out statins as being useful but not necessarily for their cholesterol lowering attributes, they have other useful effects he says. It’s an interesting read for sure.

    GT, you might want to check what’s in sun cream and revise how you deal with sun exposure. I haven’t used it for some years now, not even in high temperatures. I expose for no more than 20 minutes or so and then cover up :) Granted I’m not fair-skinned, I would say I’m about average.

  14. GT 14 September 2013 at 7:43 am #

    Thanks, Sue – what sunscreen I use tends to be on my face, but I don’t tend to expose much skin. (No sunshine holiday for years, so I haven’t been out in a swimsuit!) I’ll I’ll take a look at that book. All the very best to you for your treatment.

  15. ROBERT M 18 September 2013 at 3:21 pm #

    Comments on cholesterol & statins:

    1. Cholesterol by itself does not cause coronary heart disease based on my research.
    2. Low or Lowering of cholesterol levels causes serious medical problems.
    3. I am a medical researcher associated with a clinic that has EBT scanned over 40,000
    individuals. 48 % had no coronary artery disease in the LMAIN, LAD OR LCX arteries and
    another 8-10% had minimal disease. Why then is there any need for lowering cholesterol to dangerous low levels when cholesterol itself does not seem to cause disease.
    There are specific reasons why we need VLDL, IDL. LDL and HDL moieties that are not medically understood at present.
    4. Lowering cholesterol is the latest path to many lawsuits that are now underway as a result of statin drugs lowering cholesterol levels.

  16. Mike Wroe 14 October 2013 at 12:31 pm #

    Very interesting article in the BMJ 2013; 346 published 5th February. I hadn’t seen this before today.

    In this cohort, substituting dietary linoleic acid in place of saturated fats increased the risk of death from all causes, coronary heart disease, and cardiovascular disease! The authors pointed out that increasing dietary omega 6 linoleic acid in the place of saturated fats lowers total cholesterol and low density lipoprotein cholesterol.

    The add the comment that “The findings could have important implications for worldwide dietary advice”. The advice to substitute polyunsaturated fats for saturated fats is complete nonsense. Prescribing statins to lower cholesterol equally so.

  17. Jacqueline 19 June 2014 at 3:07 am #

    An interesting read.
    I have familial hypercholesterolemia, low calcium and vitamin d levels.
    I’ve been taking Rousuvastatin at a low dose for some time and have had frequent checks for liver damage.
    I cannot eat huge amounts of cheese due to a gall bladder removal and I’m a vegetarian so don’t consider myself to eat huge amounts of fatty food.
    If I stop taking the statins my levels go sky high with the bad cholesterol. I exercise regularly, eat well, get out and about in the sun and daylight, what else can I do? Or am I in the minority group the drugs are meant to help?

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