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NICE lipid target levels – only for some
- Martin Duerden (9 June 2008)
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BNF printed risk charts - clarification required
- Jim C P Newmark (16 June 2008)
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Martin Duerden, GP and Medical Director Conwy Local Health Board, Princes Park, Colwyn Bay, LL29 8PL, UK
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The commentary on the lipid modification guideline from the National Institute for Health and Clinical Excellence (NICE) by Cappuccio says, “….for secondary prevention, the guidance reaffirms the need to increase statin doses until total cholesterol is <4.0 mmol/l, or low density lipoprotein cholesterol is <2.0 mmol/l, as in the Joint British Societies’ JBS 2 guidelines”.[1] This may be the perception but it is not the case and I think this needs highlighting. My interpretation is that NICE actually advise a dose of simvastatin 80mg daily (or a drug of similar efficacy or acquisition costs) for maximum intensity to see if the ‘4 and 2’ levels can be achieved. They clearly state that this will not happen in more than 50% of patients. In fact the costing report indicates that 63% will not attain these levels with this treatment.[2] There is some ambiguity as to whether NICE accept atorvastatin 80mg in acute coronary syndrome. It would help to have this clarified. This raises another issue, that the role of ezetimibe for higher intensity treatment remains elusive in the NICE guideline and this follows on from similar vagueness in the license indication and the Technology Appraisal of ezetimibe from November 2007.[3] This states that it should be used for primary hypercholesterolaemia (heterozygous familial or non- familial) but I cannot find a satisfactory definition of this or advice to general practitioners and others on how to identify these people. This is important as ezetimibe may otherwise be seen as a means to attain the ‘4 and 2’ levels in all patients. When does the risk factor of raised cholesterol become the disease ‘primary hypercholesterolaemia’? The mean total cholesterol in the overall adult population is around 5.6mmol/L.[3] Using the conventional definition of normality, cholesterol only becomes abnormally high in the 2.5% with the highest level. One commonly used threshold for ‘very high cholesterol’ is greater than 7.8mmol/L. In the National Diet and nutritional survey of people aged 19 to 64 in Great Britain, where the mean total cholesterol was 5.2mmol/L, 2% of men and 3% of women had a higher level than this.[4] Maybe this defines a place for ezetimibe? It is hard to understand how the health economic benefit of ezetimibe can have been evaluated without clear information on which patients should receive treatment, particularly given the uncertainties created by lack of any hard clinical outcome data for this drug.[5] Incidentally, NICE also say in their lipid modification guideline, “When considering lipid modification therapy in primary and secondary prevention, drugs are preferred for which there is evidence in clinical trials of a beneficial effect on CVD morbidity and mortality”.[2] In summary, NICE recommends simvastatin 80mg daily as the highest intensity treatment for secondary prevention in stable cardiovascular disease to see if ‘4 and 2’ levels can be reached for a few, but the place of ezetimibe remains obscure. [1] Cappuccio FP. Commentary: Controversies in NICE guidance on lipid modification for the prevention of cardiovascular disease. BMJ 2008;336:1248-1249. [2] National Institute for Health and Clinical Excellence. Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. London: NICE, 2008. www.nice.org.uk/ CG67. [3] National Institute for Health and Clinical Excellence. Hypercholesterolemia - ezetimibe. London: NICE, 2008. www.nice.org.uk/ TA132. [4] National Diet and Nutritional Survey 2004. www.food.gov.uk/science/dietarysurveys/ndnsdocuments/ Accessed 7 June 08 [5] Lenzer J. News: Unreported cholesterol drug data released by company. BMJ 2008; 336: 180-181. Competing interests: None declared |
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Jim C P Newmark, Salaried GP for Asylum Seekers, Refugees, and Homeless Bevan House Primary Care Centre, 152 Sunbridge Road, Bradford BD1 2LT
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We are drowning in guidance and guidelines on lipid management. As a doctor with a small role in teaching these things to other adult learners, I am now aware that I am beginning to confuse myself as well as my students. I THOUGHT I understood the rationale for (although did not necessarily agree to) the very simplified risk charts at the back of the BNF in assuming that ALL those under 50 years old could be treated as aged 49 years. This was so that we could justifiably treat with statins those who were younger and at high relative risk but low absolute risk purely because of their age. And a similar rationale applied to those over 60 years old and could be treated as aged 69 years and at high risk. I have always had considerable doubt about this rather odd way of thinking, as my experience has been that the charts are rarely understood properly by professionals (and never explained properly to patients) so they became a mechanism for over-prescribing statins. These printed charts now seem to have been quietly forgotten about in the use of the true Framingham risk now universally available on our computers, which, to my mind, is fair enough. So can we now all remove those charts from the back of our BNFs and remove at least one source of confusion? Competing interests: None declared |
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