Recently, a brief article appeared in the British Medical Journal about how to manage the muscle pain (myalgia) that can occur in takers of the cholesterol-reducing drugs known as statins. The article itself describes this symptom as ‘common’, quoting an incidence of 5-10 per cent in published studies. However, my experience in practice is that this side-effect is more common. This might have something to do with the fact that in many published studies those prone to side-effects are screened out prior to the actual study getting underway. Also, researchers sometimes only log problems once blood test results are extremely abnormal, setting the bar very high for what would be registered as a ‘adverse effect’. You can read more about this here.
The article about myalgia in statin-takers was followed by a letter from a UK-based general practitioner (family physician) who questions why the original article does not mention the strategy of giving the statin rosuvastatin once-weekly rather than daily. This, apparently, makes myalgia less likely in those who do not tolerate statins, and ‘has been used for many years’.
I don’t deny that giving a statin one-weekly rather than daily would reduce the risk of side-effects, but what effect may this dosing regimen have on the purported benefits of statins? Are we to assume that the benefits will remain unaffected? I emailed the author of the letter about this. He responded and admitted he was not aware of any research which has looked at clinical endpoints (such as heart attack or death), and even included reference to a study which acknowledges this fact [2]. And then he went on to say: “…but assuming a class effect for statins then it seems that once weekly is preferable to no statin. Probably better than ezetimibe alone.”
‘Class effect’ is a term used to describe the idea that similar drugs (in this case statins) have very similar benefits (and risks). But any positive evidence we have on statins is based on once-daily dosing, so it seems to me to be a stretch to assume that once-weekly can be assumed to confer benefit. As we know, the vast majority of people who take statins daily will not benefit. It seems likely to me that the generally piffling benefits of statins would fade into insignificance if the drug is given weekly rather than daily.
I responded to the doctor essentially pointing this out, and also suggested that claiming that once-weekly rosuvastatin is probably better than ezetimibe alone is not saying much, seeing as ezetimibe has not been shown to have benefits on clinical outcomes. If anything, some studies suggest it may actually worsen health outcomes. In light of these things, I asked the doctor if he thinks that one-weekly dosing of rosuvastatin is ‘evidence-based’. Here’s his response:
I still feel that it is likely that there is a class effect for statins and this is not “stretching it a bit”. I think it is unlikely that anyone would be able to fund a study looking for outcomes for once weekly rosuvastatin or recruit the numbers required.
However before denying patients statin treatment I feel they should at least be offered this intervention. As you point out there are studies where ezetimibe had a negative effect and this is the drug that doctors are most likely to use when statins fail.
To which I replied that we’d have to agree to disagree on the class effect thing, and that while it’s good he is aware of the possibly harmful effects of ezetimibe, the real point is that ezetimibe has never been shown to provide clinical benefit. I also pressed him for an answer to my question about whether once-weekly rosuvastatin is evidence-based or not, adding: “A simple yes or no will do.”
His response was:
I think there is enough circumstantial evidence to justify this approach.
That’s not exactly the straight answer I had hoped for. And I don’t blame him, seeing as ‘yes’ would not be accurate, and ‘no’ would mean straight admitting the lack of evidence for this approach.
I honestly have nothing in particular against this doctor, and I suspect he believes he does his best for his patients. But what I think is going on here is something that is endemic in modern-day medicine: We doctors increasingly have had it drummed into us that what we do must be ‘evidence-based’. The reality, for the most part, is nothing could be further from the truth.
I also think that perhaps this doctor has fallen into the trap of believing that cholesterol reduction by whatever means and to whatever extent is inherently good for health. It’s got to the level where some people now believe that we don’t need to prove the benefits of a treatment, just a belief that it works will do. This is not just true of drugs: it reminds me of the marketing of cholesterol-lowering margarines that have never, ever been proven to benefit health.
My sense is that the pharmaceutical and food industries have done a fantastic job of diverting our attention away from what is truly important (health) to other things they can sell (such as cholesterol). Another term for this is “brain washing.”
References:
1. Lasker SS, et al. Myalgia while taking statins. BMJ (Published 14 August 2012)
2. Ruisinger JF, et al. Once-a-week rosuvastatin (2.5 to 20 mg) in patients with a previous statin intolerance. Am J Cardiol 2009;103(3):393-4
