NICE PUBLISHES GUIDANCE ON EZETROL®▼ (EZETIMIBE) FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERCHOLESTEROLEMIA

London, Wednesday 28 September 2007, 00:01 – The National Institute for Health and Clinical Excellence (NICE) has today published Guidance recommending that adding EZETROL®? (ezetimibe) to initial statin therapy is a treatment option for patients whose cholesterol is not appropriately controlled on the initial statin, after appropriate dose titration (according to national targets), when consideration is being given to changing from initial statin therapy to an alternative statin.

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.

Based on one of the cost-effectiveness analyses, which compared the addition of ezetimibe to initial statin therapy with switching from the initial statin therapy to atorvastatin, the NICE Guidance states that the addition of ezetimibe is a cost-effective use of NHS resources.1

Dr Stewart Findlay, GP and Practice Based Commissioning Chairman for the Durham Dales Locality of County Durham and Darlington PCT, commented, “This Guidance is a positive step for high risk CVD patients who have been unable to reach the appropriate target cholesterol levels on a statin alone.  PCTs and Practice Based Commissioners may now need to consider an increase in their prescribing budgets to account for the recommended use of ezetimibe.”

Statin intolerance is also defined in the NICE Guidance 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

Implementation of the NICE Guideline on ezetimibe
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

The price of simvastatin 40mg (x28 tablets) was £4.17 at the time of the NICE analysis (July 2006)[1] and is currently £1.31.[2] The price of ezetimibe 10mg (x28 tablets) has remained unchanged at £26.31.2,3.

Cholesterol, CHD and CVD in the UK
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

Although there are effective treatments for managing cholesterol, 35% of patients with CHD are not reaching the National Service Framework (NSF) and Quality and Outcomes Framework (QOF) target of 5mmol/L[3],[4] for total cholesterol (TC) on initial statin therapy.[5]  

Michael Livingston, Director, H.E.A.R.T UK – The Cholesterol Charity, commented, “We are delighted that NICE has given the go ahead for GPs to consider using this latest approach to managing cholesterol in high risk patients.”

Cholesterol production and absorption
Cholesterol comes from two main sources: production by hepatic and extra hepatic tissues and absorption in the intestine.[6] Ezetimibe selectively inhibits absorption of cholesterol in the intestine, while statins inhibit cholesterol production in the liver.7 In clinical trials, ezetimibe, co-administered with a statin, has been shown to provide greater LDL-C lowering efficacy to patients through the dual inhibition of two sources of cholesterol.7,[7] 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

-Ends-

Media Contacts:

 

Annabel Cowper             Harry Brady                               Mindy Dooa

Chandler Chicco Agency            Merck Sharp & Dohme               Schering Plough

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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® is a registered trademark of MSP Singapore Company, LLC.

References

[1] NHS Drug Tariff, July 2006: page 107

[2] NHS Drug Tariff, November 2007: page 123

[3] Department of Health, National Service Framework for Coronary Heart Disease, 2000. London:  DoH

[4] Department of Health Website: http://www.dh.gov.uk/en/Policyandguidance/Organisationpolicy/Primarycare/Primarycarecontracting/GMS/DH_4125636 Date accessed 21.11.07

[5] Brady AJB, Norrie J, Ford, I. Statin prescribing: is the reality meeting the expectations of primary care? Br J Card 2005;12:397-400.

[6] Shepherd J. The role of the exogenous pathway in hypercholesterolaemia. Eur Heart J;2001;3(Suppl E):E2-E5

[7] Pearson TA, Denke MA, McBride PE, et al. A community-based, randomized trial of ezetimibe added to statin therapy to attain NCEP ATP III goals for LDL cholesterol in hypercholesterolemic patients: the ezetimibe add-on to statin for effectiveness (EASE) trial. Mayo Clin Proc 2005; 80: 587–595

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