NICE Recognises Role Of High Intensity Statin Therapy In Patients With Familial Hypercholesterolaemia, UK

Main Category: Cholesterol
Also Included In: Cardiovascular / Cardiology;  Regulatory Affairs / Drug Approvals
Article Date: 29 Aug 2008 - 2:00 PDT

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AstraZeneca welcomes the recommendations by the National Institute for Health and Clinical Excellence (NICE) on the treatment of Familial Hypercholesterolaemia (FH) 1, a genetic condition resulting in high cholesterol levels. As part of its comprehensive review on the identification and management of people with FH, NICE has recommended that adults with the condition be treated with high intensity statins in order to reduce LDL-cholesterol (LDL-C) levels by 50%.

Michael Livingston, Director of H.E.A.R.T UK - The Cholesterol Charity, stated: "About one person in every 500 has FH in the UK - in fact it's one of the most frequently occurring inherited conditions. This means that more than 110,000 people in Britain have the condition. However, many people with FH go undetected with often tragic consequences. The next step for us will be to ensure this guidance is implemented on the ground".

People with FH have a substantially increased cardiovascular risk in comparison with the general population, due to their raised cholesterol levels, which can sometimes be in excess of 20 mmol/l. The average total cholesterol level for middle aged men is around 5 mmol/l. Men with FH have a greater than 50% chance of developing coronary heart disease (CHD) by the time they reach 50. Women with FH face a 30% CHD risk by the time they reach 601. Comprehensive trial data from large clinical trials has shown that there is a linear relationship between the absolute reductions in LDL-C and the proportional reduction of coronary and other events. Lowering LDL-C by 1mmol/l reduces cardiovascular disease related events (including heart attack and stroke) by 21% and total mortality by 12%.

Dr Elizabeth Hughes, Consultant Chemical Pathologist and Honorary Senior Lecturer at the University of Birmingham, commented: "Too often patients are put on generic simvastatin, when first diagnosed with FH, only to have to keep going for repeat blood tests and consultations until they are eventually moved onto a more effective, higher intensity statin which in reality means either rosuvastatin or atorvastatin. This guidance has recognised that some adults with FH need to be put onto a high intensity statin immediately, particularly if their LDL-C levels need to be reduced by more than half".

When choosing which high intensity statin therapy is the most appropriate for the individual patient, clinicians should take into account the patient's informed preference, comorbidities, multiple drug therapy, and the benefits and risks of treatment. CRESTOR (rosuvastatin) has been shown to be highly effective at helping patients reduce their LDL-C levels. In over 15 head-to-head studies involving more than 12,000 patients, rosuvastatin has consistently demonstrated better LDL-C lowering in comparison with atorvastatin and simvastatin across the dose range.

The guideline makes a range of other recommendations on the identification and management of people with FH including the use of cascade testing to identify those individuals who will benefit from early treatment and the recommendation that doctors should provide patients with evidence-based information, such as the treatments that are currently available, lifestyle advice and how the FH may affect other members of the family.

About CRESTOR

CRESTOR has now received regulatory approvals in over 90 countries. Over 12 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

http://www.astrazeneca.com