Doctors can help you get back on your statins, but does this help you?

The side-effects of statin drugs are well-recognised, and include muscle pain, fatigue, mental symptoms, kidney damage or liver damage. Some doctors and researchers have decided to change the nomenclature on these side-effects by referring to people who have them as ‘statin intolerant’. I may be wrong, but this seems to me to be a way to have the side-effects and very real hazards of statins to sound less bad than they are.

Anyhow, statin side effects are said to affect about 5-10 per cent of people from the clinical studies where individuals have been treated, say, with a statin or a placebo. Except that in many of those studies there was a ‘run-in’ period where all individuals who may end up entering the study are given. Those who are ‘statin intolerant’ are then identified and removed. This, of course, helps assure that statin side-effects will be low in the actual study and that the drugs are safer than they actually are.  If we look at populations of people taking statins (who have not been screened for ‘statin intolerance’), statin side effects appear to affect about 20 per cent of people taking them.

I was interested to read the summary of a paper based on the experiences of a major cardiological group based in North America (the Cleveland Clinic http://my.clevelandclinic.org/default.aspx).  The Cleveland Clinic has long offered a service for ‘statin intolerant’ individuals. It seems the service aims to get people back on their statins. This could mean, for example, a different statin, or giving the statin every other day (rather than daily).

The paper tells us that of 1,605 patients whose medical records they assessed, 72.5 per cent of them were able to go back to taking statins. The report tells how those who took alternate day dosing saw smaller reductions in LDL-cholesterol compared to those who took it every day, but still had levels lower than individuals who were off their statins for good.

I’ll be frank and say when I read reports such as these, my eyes glaze over a bit and sometimes I feel the will to live ebbing away. And that’s because the taking of statins and the impact that this has on people’s cholesterol levels is quite irrelevant. What we want to know is what the impact of all this is on health.

Health can be measured in many ways, but the supposed point of taking statins is to reduce the risk of ‘clinical’ events such as heart attacks. The single best way to gauge the overall impact of an intervention is to assess the impact it has on risk of death. Risk of death is 100 per cent for us all, eventually, of course. But if we follow people over a finite period of time, we can compare the number of people taking statins who die with the number of deaths in individuals not taking statins.

In this study, the researchers made this assessment over an 8-year period. Death rates over this time were not statistically lower in those taking statins compared to those who were not.

I think the authors of this study should be commended for measuring and disclosing this finding because, to be frank, it in no way justifies their attempts to get people back on their statins. It might be this last fact that caused them to describe their findings like this:

There was a trend toward a decrease in all-cause mortality at 8 years for patients on daily and intermittent statin dosing compared with those who discontinued statin (P = .08).

If you weren’t wary, you’d probably read take that as an indication that there were benefits for statin takers in terms of death risk. But, there was not. Make no mistake about it; terms like: ‘there was a trend toward’ are weasel words.

References:

1. Mampuya WM, et al. Treatment strategies in patients with statin intolerance: The Cleveland Clinic experience. Am Heart J 2013;166(3):597-603

 

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6 Responses to Doctors can help you get back on your statins, but does this help you?

  1. George @ the High Fat Hep C Diet 13 September 2013 at 10:38 am #

    Why oh why? Why would you?
    If a drug is as inefficient as this, why risk side-effects in so many patients? Why not use it as a drug of last resort until you work out how to get reliable benefits from it?
    Likely there will be benefits for some people eventually when some of the statins are prescribed with good, informed clinical judgement (unlike at present, when they simply have to be prescribed with good luck).
    It’s not about lowering serum cholesterol. If anything, the benefits of statins will come about through lowering intracellular cholesterol – when this is appropriate. And we will need to be sure that taurine doesn’t do a better job – it’s certainly much safer.

  2. robert 13 September 2013 at 11:55 am #

    “Those who are ‘statin intolerant’ are then identified and removed.” – I’d call that fraud. Definitely cherry-picking of the patients.

    Isn’t one purpose of a randomized study to closely match the real-word population, so issues that are likely to crop up in real patients can be identified and taken into account?

    Lets do a little though-experiment!

    Assumption: on average, young people with ‘raised cholesterol’ but otherwise healthy (not elite athletes) might tolerate statins a bit better (due to overall better health) than old people. At least for some time.

    Target group for statins: predominantly older people with raised cholesterol.

    With a cherry-picking study, older people would be more likely to be weeded out due to their ‘statin intolerance’. The result would be skewed by a greater number of younger folk experiencing less side effects, or tolerating them better.

    The study would conclude: statins are safe, side effects are ‘minor’, everybody should take them – best cradle to grave.

    Obviously this is flawed beyond help.

    That’s like testing a product containing nuts for its allergenicity, using a subset of the population that is known to be insensitive to nuts.

    So the little sheet of paper that comes with the pills would claim say a probability of 5% for side effect X – among the ‘statin tolerant’ people.

    What does your average burried-in-paper-work GP read? Maybe said thin sheet of paper, which makes the stuff appear to be as safe as a lollypop. And if people complain… you get to hear things like: “…that’s not likely…”, “…you’re getting old…”, “…just take this new pill here to compensate…”

    Found on the interwebs:

    “I take Aspirin for the headache caused by the Zyrtec I take for the hayfever I got from taking Relenza for the uneasy stomach and flu-like symptoms caused by Viagra for the erectile dysfunction from the Propecia for the hair loss caused by the Ritalin I take for my short attention span caused by the Scopoderm TTS I take for the motion sickness I got from the Lomotil which I take for the diarrhea caused by the Xenical I’m on for the uncontrolled weight gain caused by the Paxil I take for the anxiety I got from the Zocor I take for my high cholesterol…because exercise, a good diet, and regular chiropractic care are just too much trouble!”

    http://genesis-chiropractic.com/healthy-living-vs-lifestyle-drugs-reactions-side-effect-symptoms.html

  3. Stephen Rhodes 13 September 2013 at 8:01 pm #

    Given that most sudden cardiac deaths are caused by abnormal heart rhythms called arrhythmias, why is it that we are not tested for ‘Red Blood Cell’ Magnesium for potential Ca:Mg imbalance, rather than cholesterol which could only possibly result in arrhythmia if seriously depleted along with CoQ10 (which is one known result of taking statins)?

  4. Lorna 13 September 2013 at 9:25 pm #

    Can anyone explain what the difference is between ‘intercellular cholesterol’ (#George) and the serum cholesterol usually measured and acted upon when prescribing statins?

  5. SueG 14 September 2013 at 2:36 pm #

    Aw Stephen you just cheered me up, having recently had my homocysteine level checked and it being 8, there was I thinking I was far less likely to have a cardiac event caused by arrythmia and now you’re saying I was fooling myself :( Can you direct me to your source please so that I can frighten myself some more :)?

    p.s. does it help that I am already taking COQ10 and magnesium, amongst other things and I’m not diabetic?

  6. JP Sand 17 September 2013 at 3:27 pm #

    Dr. Briffa, thank you for your post.

    I noticed that you made an ERROR (sorry for the caps) in your reporting on the difference in cholesterol reduction between statin-intolerant patients who went back on intermittent statins versus statin-intolerant patients who went back on full-time statins.

    You reported that the intermittent statins users had smaller reductions in LDL-cholesterol than full-time statin users. That would appear to be the expected outcome; however, according to the study, the reverse was true.

    As HeartWire correctly noted in its coverage: “Interestingly, those on the intermittent strategy had a 27.7% reduction in LDL cholesterol, a drop that was significantly larger than the 21.3% reduction among patients rechallenged with a daily statin”.

    I believe this apparently paradoxical finding warrants some further attention.

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