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Effectiveness of statins

This group of drugs has saved many lives (see below**) which justifies the high cost to the NHS (£642 million in 2003 expected to rise to £2.1 billion by 2010). Statins very effectively lower bad cholesterol (LDL) and reduce deaths from all conditions linked to atherosclerosis. Using statins to lower the level of bad cholesterol to less than 3 reduces heart attack deaths by over 42% over a 5 year period (but with a measurable effect noticeable at one year) in those who have already had a heart attack. 30% of heart attack victims die before reaching hospital so preventing attacks is very important in reducing deaths.

Unfortunately, there is evidence that statins are not taken regularly by many of those who would benefit the most. In the US, just 42% are still taking statins 2 years after starting them. However, many have to pay the full cost of the drugs which must be a factor, particularly as they do not make people feel as if there is a benefit. In your practice we monitor regularly the levels of LDL in all patients taking statins in order to demonstrate the continued benefit as LDL is a proxy for artery damage.

**From 1995 when statins usage became more common, deaths from cardiovascular disease fell by more than 23% by 2002.

Current UK guidelines for statin use

Department of Health National Service Framework for Coronary Heart Disease. London: Stationery Office 2000

bulletpeople with diagnosed CHD or other occlusive arterial disease
bulletpeople without diagnosed CHD or other occlusive arterial disease with a CHD event risk greater than 30% over 10 years

Statin therapy should aim to lower total cholesterol below or = 5mmol/l or reduce by 20-25% whichever would result in the lowest level.

Your practice uses the more accurate measure of LDL (bad) cholesterol aiming for 3 mmol/l or less or reduction by 30%. We also suggest treatment at a risk level of only 15% over 10 years. The result of this policy is a high cost of statin drugs but with a corresponding high reduction in CHD events including reduced CHD death.

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The Lancet and AstraZeneca's Crestor

In October 2003, a public exchange took place about the marketing of AstraZeneca's statin Crestor (rosuvastatin) under the title: The statin wars: why AstraZeneca must retreat. Click here for the editor's attack
http://www.thelancet.com/journal/vol362/iss9393/full/llan.362.9393.editorial_and_review.27581.1 . Also click on the link on that page for AstraZeneca's response.
Dr Causer does not use rosuvastatin yet as the evidence available is insufficient to  demonstrate that the drug is superior to the statins already in use.

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Over the counter statins

One of the statins, simvastatin brand name Zocor, is going to be made available to buy over the counter in 10mg strength from pharmacies without prescription. The best monitoring is likely to involve purchase of self testing kits for total cholesterol but this is not enough for those at significant risk (see above regarding bad cholesterol). If the whole population took a low dose statin then the incidence of heart attacks and strokes would reduce but the rare side effects would affect more individuals. The right balance here is unknown.

As your practice is using prescription statins at the lower 15% risk level, it is unlikely that purchase over the counter will be necessary. Along with the statin comes the regular monitoring of bad (LDL) cholesterol plus a check on liver function and the muscle enzyme creatinine kinase looking for early identification of serious side effects. In our experience very few people are controlled on 10mg so taking 10mg over the counter will probably lead to inadequate control and therefore unnecessarily high risk of heart disease.

Before putting yourself on this regime, please talk to us.

The British Heart Foundation recognises the value of 10mg simvastatin in primary prevention of coronary heart disease but has concerns that the person may be undertreated and/or lulled into a false sense of security and not address important lifestyle changes such as stopping smoking and taking more exercise. For more information visit the British Heart Foundation website: http://www.bhf.org.uk/

Monday 24th May 2004: Department of Health expects us to turn away patients with heart disease risk
When we heard about statins being made available over the counter, we did not know that the Department of Health expects us to turn away most patients with a 10-year heart disease risk between 15% and 30% and tell them they can but statins over the counter. This is at odds with advice from cardiologists and may lead to undertreatment even if the statin is purchased as only the 10mg dose is available. NICE will issue guidance in autumn 2005 but may support the Department of Health on cost grounds. We will continue to issue statins on prescription until directly ordered to stop doing so.

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Watchdog accused over heart drug sales
Source: The Guardian
Date: 08/06/2005
Sarah Boseley, the Guardian's Health Editor, reports that the Medicines and Healthcare Products Regulatory Authority (MHRA) has apologised over its ruling that patients could buy a statin, Zocor Heart-Pro (generally known as simvastatin), without first consulting a doctor. It has emerged that the MHRA misrepresented the results of a public consultation it held on whether to allow the drug to be sold without a prescription. Following a battle with the consumer publication Drug and Therapeutics Bulletin, the MHRA has conceded that the figures it had previously announced following the consultation in 2003 were incorrect. It had previously said that two-thirds of the organisations and individuals which had responded in the consultation backed the selling of the drug by pharmacies, however in reality only one-third of respondents agreed unequivocally with the change of status of the drug. The Royal College of Paediatrics and Child Health has expressed concern that neither GPs nor pharmacists would know what drugs a patient was taking, whilst the editor of the Drug and Therapeutics Bulletin has criticised the MHRA for its closeness to the pharmaceutical industry, saying that too many decisions were being made behind closed doors.

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