LONDON, November 28 /PRNewswire/ -- Patients who remain at high risk of cardiovascular disease because of high cholesterol levels may have greater access to the latest cholesterol lowering treatment as a result of National Institute for Health and Clinical Excellence (NICE) Guidance published today.(1)
The new Guidance recommends ezetimibe for use in combination with a statin in patients whose cholesterol levels remain above national targets, even with a low cholesterol diet and after taking initial statin therapy which has been titrated (increased in dose) appropriately, and where consideration is being given to changing from initial statin therapy to an alternative statin.(1)
The NICE Guidance Committee highlights that the UK population has one of the highest average cholesterol concentrations in the world1. It adds that cardiovascular disease is the most common cause of death in the UK, accounting for approximately 216,000 deaths in 2004, and it is a major cause of illness, disability and reduced quality of life.(1)
Michael Livingston, Director of H.E.A.R.T. UK - The Cholesterol Charity, commented "Over one third of the 2.6 million people in the UK with coronary heart disease are not reaching government cholesterol targets (5mmol/l) and are at significant risk of heart attack and stroke. We are therefore delighted by the publication of the NICE guidance on ezetimibe. This approach to managing high cholesterol could benefit thousands of people."
Reaching recommended cholesterol levels
National guidelines recommend a total cholesterol target of less than 5mmol/l (millimoles per litre) and a 'bad' cholesterol (LDL-C) target of less than 3mmol/l.(2) However, despite the availability of effective medications, about 35% of patients with coronary heart disease are not reaching these targets after initial therapy.(3) Just 1 mmol/l reduction in LDL-cholesterol ('bad cholesterol') is associated with a 23% reduction in the 5-year incidence of a first major coronary event such as a heart attack.(4)
The NICE Guidance Committee considered clinical evidence which showed that adding ezetimibe to statin therapy reduced LDL cholesterol by 23.2%, more than statin therapy alone.(1)
Doubling the dose of statin therapy or switching to an alternative statin generally leads to a further reduction in baseline LDL-cholesterol concentrations of approximately 6% and 8% respectively.(1)
According to NICE, now that this Guidance has been formally published, the NHS is required by the Secretary of State to provide funding and resources for medicines and treatments recommended through this appraisal process normally within 3 months.(1)
Working with statin therapy
Ezetimibe is a cholesterol absorption inhibitor that blocks the absorption of cholesterol in the intestine, so combining it with a statin, the conventional treatment which reduces cholesterol production in the liver, can lead to extra reductions in cholesterol.(5)
The Guidance defines intolerance to statin therapy as the presence of clinically significant adverse effects from statin therapy that are considered to represent an unacceptable risk to the patient or that may result in compliance with therapy being compromised.1 The NICE Guidance states that therapy with ezetimibe co-administered with a statin was found to have a similar adverse event profile to that of statin therapy alone.(1)
About Merck Sharp & Dohme and Schering-Plough
- Merck Sharp & Dohme Limited and Schering-Plough Limited are partners in the development and marketing of prescription medicines in cholesterol management.
- Merck Sharp & Dohme Limited is the UK subsidiary of Merck & Co. Inc., of Whitehouse Station, New Jersey, USA, a leading research-based pharmaceutical company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health.
- Schering-Plough is a global science-based healthcare company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of physicians, patients and customers served by its more than 33,500 people around the world.
EZETROL(R) is a registered trademark of MSP Singapore Company, LLC.
References
(1) National Institute for Health and Clinical Excellence (NICE). Technology Appraisal Guidance for Ezetimibe in hypercholesterolaemia. http://www.nice.org.uk/
(2) Department of Health, National Service Framework for Coronary Heart Disease, 2000. London: DoH
(3) Brady AJB, Norrie J, Ford, I. Statin prescribing: is the reality meeting the expectations of primary care? Br J Card 2005;12:397-400.
(4) Cholesterol Treatment Trialists' Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005; 366(9493): 1267-78
(5) Shepherd J. The role of the exogenous pathway in hypercholesterolaemia. Eur Heart J;2001;3(Suppl E):E2-E5
Media Contacts: Annabel Cowper, Chandler Chicco Agency, 151 Shaftesbury Avenue, London, WC2H 8AL, +44(0)2076-321-813, +44(0)7776-188-166; Harry Brady, Merck Sharp & Dohme, Hertford Road, Hoddeson, Hertfordshire, EN11 9BU, +44(0)1992-452-134, +44(0)7974-444-431; Mindy Dooa, Schering Plough, Falcon Way, Shire Park, Welwyn Garden City, ALZ 1TW, +44(0)1707-363-983, +44(0)7917-553-253
