LONDON, September 17 /PRNewswire/ -- The National Institute for Health and Clinical Excellence
(NICE) has today issued a Final Appraisal Determination ('FAD') that
recommends ezetimibe for the treatment of high cholesterol in certain
patients: the document confirms that ezetimibe can be used in combination
with a statin in patients whose cholesterol levels remain above national
targets, even with a low cholesterol diet and the use of initial statin
therapy which has been titrated appropriately(1); the therapy can also be
taken on its own ('monotherapy') by patients who can not take a statin
because of intolerance or contraindication.(1)
The NICE Committee highlights that the UK population has one
of the highest average cholesterol concentrations in the world.(1) 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, H.E.A.R.T. UK, commented "We are
delighted with the decision made by NICE to recommend ezetimibe in England
and Wales. The impact of high cholesterol is huge and too many patients are
still being put at risk of premature death - over 4,000 people die every week
of cardiovascular disease in the UK because of high cholesterol, smoking,
physical inactivity and poor diet. Prescribing ezetimibe will be of great
benefit to those who currently find it very difficult to reach their
cholesterol target."
How the therapy works
There are two main sources of cholesterol in our blood -
cholesterol absorbed from the intestine(i) and cholesterol made in the
liver.(ii),(2) Ezetimibe has a unique mode of action as it selectively blocks
the absorption of cholesterol in the intestine, even in those patients who
are already on a low cholesterol diet.(2) When ezetimibe is combined with a
statin, there is a 'dual inhibition' of the two main sources of cholesterol
in the body: the statin inhibiting cholesterol production in the liver and
ezetimibe inhibiting cholesterol absorption from the intestine.(2)
Reaching recommended cholesterol levels
National guidelines recommend a total cholesterol target of
less than 5 mmol/l (millimoles per litre) and a 'bad' cholesterol (LDL-C)
target of less than 3 mmol/l.(3) However, despite the availability of
effective medications, about 35% of patients with coronary heart disease are
not reaching these targets.(4)
Dr John Pittard, a GP from Staines in Surrey, commented
"Primary care treats thousands of high risk patients to reduce their
cholesterol. Many patients don't fully respond or tolerate statins -
ezetimibe is really useful in these cases and doctors will welcome this
sensible advice from NICE."
Today's FAD guidance states that adding ezetimibe to initial
statin therapy as a treatment option is a cost-effective choice for patients
who have not reached national targets, when compared with switching to an
alternative statin.(1) The guidance also states that doctors may add
ezetimibe when appropriate dose titration is limited by intolerance to the
initial statin therapy.(1) The 'FAD' 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)
Ezetimibe is licensed to treat high cholesterol - either
inherited (familial heterozygous hypercholesterolemia) or not inherited
(non-familial primary hypercholesterolemia) - in patients who have already
been prescribed a statin and whose cholesterol levels remain uncontrolled.(5)
Implementation of the NICE HTA Guidelines
The recommendation issued today forms the basis of the final
ezetimibe guidance for the NHS in England and Wales, which is expected to be
formally issued in November. Within 3 months of this formal guidance
publication, the NHS is required by the Secretary of State to provide funding
and resources for medicines and treatments recommended through this appraisal
process.(1)
Notes to Editors
The increasing burden of cardiovascular disease (CVD)
- CVD is the main cause of death in the UK accounting for just
over 216,000 deaths a year.1 Nearly half of these deaths are from coronary
heart disease (CHD) - the result of atherosclerosis of the arteries
surrounding the heart.(6)
- CVD is also one of the main causes of premature death in the
UK (death before the age of 75). 31% of premature deaths in men and 23% of
premature deaths in women are from CVD.(6)
Cholesterol and the reduction of cardiovascular risk
- Cholesterol is one of the most important risk factors for
CHD(7) and raised LDL cholesterol is related to an increase in cardiovascular
risk.(8)
- There is no set 'normal' range for blood lipid
concentrations due to population variation, but the UK currently has one of
the highest average cholesterol concentrations in the world.(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
(i) Estimated to be 1000 mg per day total, composed of dietary (300 mg
per day) and biliary (700 mg per day)2
(ii) Estimated to be 800 mg per day8
(1) National Institute for Health and Clinical Excellence (NICE). Final
Appraisal Documentation for Ezetimibe in hypercholesterolaemia:
http://guidance.nice.org.uk/
(2) Shepherd J. The role of the exogenous pathway in
hypercholesterolaemia. Eur Heart J Suppl, 2001:3. Suppl. C: E2-E5.
(3) Department of Health, National Service Framework for Coronary Heart
Disease, 2000. London: DoH
(4) Brady AJB, Norrie J, Ford I. Statin prescribing: is the reality
meeting the expectations of primary care? Br J Card 2005;12:397-400.
(5) Ezetrol Summary of Product Characteristics,
http://emc.medicines.org.uk/ (Accessed 08.08.07)
(6) British Heart Foundation. Coronary Heart Disease statistics. 2007
edition
(7) British Heart Foundation - Any Questions? LDL Apheresis for familial
hypercholesterolaemia. http://www.bhf.org.uk/faqs.aspx?qid=7820. (Accessed on
08.05.07)
(8) Expert Panel on Detection, Evaluation and Treatment of High Blood
Cholesterol in Adults: Executive Summary of the Third Report of the National
Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation
and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel
III). Available at: www.nhlbi.nih.gov/guidelines/cholesterol/index.htm
Merck Sharp & Dohme Ltd and Schering Plough
