Re: Lipid modification and cardiovascular risk assessment NICE guidance - beyond fire and forget
While the debate about the threshold for statins in primary prevention might well continue, we welcome aspects of the new NICE guidance on lipid modification  as moving towards more careful clinical practice, and away from the ‘fire and forget’ approach. Some people are happy to accept statins following their doctor's recommendation without further reflection, others may have concerns. Some may be prepared to take the risk of side effects to reduce their CVD risk. Others may not. While it is appropriate for organisations like NICE to take a population perspective, clinicians need to respond to the individual in negotiating statin use, as Ben Goldacre has reminded us .
The guidance group is to be commended for acknowledging that clinicians need to enter into conversations with potential statin patients, and that adherence is likely to be an issue. Non-adherence may be explicitly discussed with doctors, but we suspect there will be large numbers who engage in practices like ‘drug holidays’ or not getting repeat prescriptions without such discussion. If clinicians want their patients to continue to take statins then we there needs to be space to talk about this - not least to avoid waste. When we interviewed people offered statins for moderate CVD risk (as part of an ESRC funded qualitative study ), many were mystified that their doctor did not want to follow up by ongoing cholesterol monitoring and discussion. We think the guideline group is right to advise that doctors ‘provide annual medication reviews for people taking statins’ to discuss adherence and risk, and ‘consider an annual non-fasting blood test for non-HDL-cholesterol to inform the discussion’ .
We would also urge doctors to be honest about the proven side effects of statins and (critically) ongoing uncertainty about this, which was highlighted in this journal last week . There is evidence that GPs (like opinion leaders) fall into camps ‘for and against’ statins in primary prevention . Our own interviews identified both types and their different responses to patients’ concerns about the effects of drugs. Thus one retired patient described two very different reactions from two GPs to the conviction that statins were causing cramp: ‘Well the cramp was absolutely appalling. I was leaping round the bedroom at night… I really didn’t feel all that well. I just felt there was something hovering over me you know that wasn’t right. ... And it was getting worse and worse. But I went to see my GP and explained it to him so he said “Well we’ll just wait and see.” And then we changed over [doctor] and [this one] just ripped the prescription up and said stop it...'
We suggest that both patient and professional concerns are likely to have been heightened by the latest skirmish in the statin wars, and the guideline group’s efforts to advise doctors on how to respond to the inevitable reports of side effects don’t go far enough. Though the suggestion that doctors should be looking to identify ‘the maximum tolerable dose’ acknowledges this issue, and clinicians are also advised to make use of creatine kinase testing to identify myopathy , we worry about where this leaves patients who do not have raised creatine kinase but feel that the drugs are causing muscle pain or other symptoms, and are anxious about continuing the drugs. Such discussions must continue to negotiate ongoing uncertainty surrounding the adverse effects of statins as a class, and of different preparations or groups within them, as well as who might be most at risk for such effects.
We think it is a great shame that the authors of your 'state of the art review'  discussed potential benefits alongside the attempt to clarify the evidence on negative side effects. People are being offered the drugs to reduce CVD risk, not in the vague hope of improving erectile dysfunction or reducing pancreatic or COPD. It would have been more helpful for clinicians and patients if they had highlighted those side effects that appear reversible and those that are not. Though the authors suggest that ‘renewed emphasis on individualised cardiovascular risk assessment promotes an evidence-based discussion of the risks and benefits of statin use between patients and clinicians’ , it is hard to see how the material cited in the review could contribute to such discussion while they wait for the promised ‘patient decision aid’ from NICE .
Our recent study underscores that patients are unlikely to be reassured if they think their doctor has dismissed their concerns out of hand. A doctor’s duty should surely be to take any harms suffered by individuals seriously, and act to reduce or reverse them, harms which include both physiological side effects of drugs and the anxiety generated by medicine use or expert debates. Statin prescription must be much more than a matter of ‘fire and forget’.
1 Rabar, S., Harker, M., O’Flynn, N., Wierzbicki, A., on behalf of the Guideline Development Group (2014) Lipid modification and cardiovascular risk assessment for the primary and secondary prevention of cardiovascular disease: summary of updated NICE guidance. BMJ 2014;349:g4356.
2 Goldacre, B. (2014) Adverse effects of statins. BMJ 2014;348:g3306
4 Desai, C.S., Martin S.S., Blumenthal, R.S. (2014) Non-cardiovascular effects associated with statins. BMJ 2014;349:g3743.
5 Gale N, Greenfield S, Gill P, Gutridge K, Marshall T. (2011) Patient and general practitioner attitudes to taking medication to prevent cardiovascular disease after receiving detailed information on risks and benefits of treatment: a qualitative study BMC Family Practice 2011, 12: 59.
Competing interests: No competing interests