New Report Shows Cholesterol Treatment Guidelines Vary Significantly Throughout Europe

Main Category: Cholesterol
Also Included In: Statins;  Cardiovascular / Cardiology
Article Date: 14 Jun 2007 - 1:00 PDT

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A new Cholesterol Guidelines Report by the Policy Analysis Centre, launched today at the European Atherosclerosis Society (EAS) meeting in Helsinki, Finland, shows that more needs to be done to improve implementation of the Third European Joint Taskforce Guidelines for LDL ("bad") cholesterol (LDL-C) in Europe. Adherence to the European guidelines varies from country to country. Results highlight poor management of high risk patients, limited LDL-C screening and insufficient use of lipid lowering drugs and newer treatments, such as the cholesterol absorption inhibitors1.

In preparation for the Fourth European Joint Task Force on CVD Prevention guidelines being announced in September of 2007, the Cholesterol Guidelines Report examines guidelines within 10 European countries* in order to determine the level of adherence to the Third European Joint Task Force on CVD Prevention guidelines published in 2003. The report concludes that there is a clear and significant time lag between the incorporation of clinical trial evidence into pan-European standards of best practice and their subsequent incorporation into national and local practice across Europe1. "The findings of the report are concerning, considering the urgent need to reduce the large incidence of cardiovascular disease (CVD) in Europe, which alone causes over four million deaths each year and is associated with a total cost of approximately €169 billion,2 " said Tony Hockley, Director of the Policy Analysis Center, London, UK. "When we look at the total cost of CVD in Europe, the burden of under treatment is centered heavily on hospital budgets with potential savings from more effective management of cardiovascular risk factors, like LDL-C. The findings of our report emphasize the necessity for national government and professional organizations to cooperate, to ensure that patients throughout Europe meet the LDL-C goals set out within the European Joint Taskforce Guidelines."

Failure to achieve LDL-C targets despite increasingly aggressive LDL-C guidelines

The report highlights that LDL-C goals in some countries are more than 30 percent below the standards set in the European Guidelines, and more than 80 percent below the level suggested in the latest US NCEP (ATP) III guidelines for high risk patients, such as those with diabetes and CHD. The 2003 European guidelines state that "LDL cholesterol should be below 3mmol/l. For patients with CVD or diabetes, the treatment goals should be lower: LDL cholesterol <2.5mmol/l". However, the report found that in the treatment of these high risk patients, the target for LDL-C varies from <1.8 mmol/l recommended by an independent expert group in Austria, to <3.3mmol/l recommended by Italian guidelines.1

Large scale Pan European surveys like EUROASPIRE I & II and REALITY show that many patients in Europe are not achieving LDL-C targets. EUROASPIRE II showed that only 51 percent of patients on lipid lowering therapy were achieving LDL-C goals set out by the European guidelines.3

The Policy Analysis Centre stresses that the treatment gap between evidence-based clinical practice and European clinical reality may widen further when the Fourth Joint Taskforce Guidelines are announced in September 2007. "It is anticipated the European guidelines will be revised to expand their scope and apply more aggressive LDL-C targets in response to the growing need for more patients to achieve lower LDL-C goals to reduce the increasing burden of LDL-C in Europe." said Tony Hockley.

* NCEP ATP III is the U.S. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, a set of guidelines for effective patient identification, assessment, diagnosis, and treatment.

Need for guidelines to include newer treatments to bring patients to LDL-C goals

Studies such as REALITY have shown that at least 60 percent of patients treated with statins did not reach their cholesterol goal.4 The report cites that there are already a number of countries recommending the use of EZETROL as second-line drug therapy to enable high risk patients to achieve their LDL-C goals. With more aggressive LDL-C targets anticipated in Europe later this year, there will be a need for local and national guidelines to recognize the role of newer treatments, like EZETROL, in helping patients reach their LDL-C goal.

Commenting on the report findings, Professor Michel Farnier, Point Medical Clinic, Dijon, France said: "It is likely that the 4th European Joint Taskforce Guidelines being launched later this year will demand lower LDL-C goals - this cannot be achieved by statins alone. Aside from dietary and lifestyle intervention, adopting new treatments such as ezetimibe will enable countries to give patients added opportunity to achieve their LDL-C goals."

Statins work on the liver to inhibit cholesterol production, while cholesterol absorption inhibitors work by lowering the absorption of dietary and biliary cholesterol by the intestine, where cholesterol is absorbed into the bloodstream.

Need for lower LDL-C targets for patients with diabetes

It is predicted that the diabetic population of Europe will increase from 23 million in 2000 to 30 million in 2020.5 Type 2 diabetes is associated with a two- to fourfold increased risk for CVD, 6 and one study showed that up to 80 percent of adult type 2 diabetic patients die from CVD.7 However, intensive lipid lowering therapy can be beneficial for diabetes patients and using the UKPDS risk engine model, it was calculated to contribute approximately 70 percent of the total calculated risk reduction in CVD events in a multi-factorial interventional study in type 2 diabetics with microalbuminuria.8,9

The report found that all guidelines within the countries studied include diabetes as a risk factor, with the most rigorous target for LDL-C being provided by Austria (<1.8mmol/l, the same as the NCEP (ATP) III guidelines). Most other countries set a similar target to the current European guidelines (approximately 2.6 mmol/l). The weakest targets were found in the UK National Health Service (NHS), which applies the same LDL-C targets (≤3mmol/l) to all patients, whether diabetic or in any other risk group. The report also shows that high risk patients in the UK and Norway have the same LDL-C targets as those patients who show no signs of risk (3 mmol/l).1

Lack of LDL-C testing

The study shows that out of the 10 countries researched, routine LDL-C testing of all adults only existed in three countries: Austria, Germany and Slovenia. It was also highlighted that France states that every adult should be tested every five years but no system exists to ensure this happens. In addition, even countries that do offer some level of cholesterol testing, the intervals of testing are reduced as a patient gets older or develops CVD, when cholesterol testing becomes more important to assess a patients' risk of a cardiovascular event.1

One specific anomaly identified within the report was that the contract for General Practitioners (GPs) in England can reward a physician more than £1,400 (€2000) for cholesterol testing patients with established CVD or diabetes, but nothing at all for testing individuals not demonstrating any signs of high LDL-C, regardless of their risk profile.1

The Policy Analysis Centre is an independent public policy research consultancy based in Westminster. The Policy Analysis Centre report was made possible through a grant from Merck Sharp & Dohme and Schering-Plough. The conclusions of the report and the views expressed are independent of the sponsors.

About Merck

Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., which operates in many countries as MSD (Merck Sharp & Dohme), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

About Schering-Plough

Schering-Plough is a global science-based health care 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 the physicians, patients and customers served by its more than 33,500 people around the world. The company is based in Kenilworth, N.J., and its website is http://www.schering-plough.com.

*Countries surveyed and included within the report: Austria, Finland, France, Germany, Italy, Norway, Slovenia, Spain, Sweden, UK

References:

1. Hockley T et al. A Policy Analysis Centre Study on Cholesterol Guidelines. European Cholesterol Guidelines Report. June 2007
2. European Cardiovascular Disease Statistics 2005. British Heart Foundation & European Heart Network
3. Lifestyle and risk factor management and the use of drug therapies in coronary patients from 15 countries. Principle results from EUROASPIRE II. European Heart Journal 2001; 22:554-572. Quoted in: Hockley T et al. Cholesterol: The public policy implications of not doing enough. Stockholm Network, London, 2006, page 12
4. Van Ganse E et al Lipid-modifying therapy and attainment of cholesterol goals in Europe: the Return on Expenditure Achieved for Lipid Therapy (REALITY) study. Current Medical Research Opinion 2005;21:1389-1399
5. Pollard, S et al. A Stockholm Network Study on Cholesterol. Cholesterol: The Public Policy Implications of Not Doing Enough. November 2005
6. American Diabetes Association. Dyslipidemia management in adults with diabetes. Diabetes Care 2004;27(Suppl. 1): S68-S71
7. Laakso M, Lehto S. Diabetes Rev 1997;5:294-315
8. Gaede, P, Pedersen O. Intensive, Integrated Therapy of Type 2 Diabetes Implications for Long-Term Prognosis, Diabetes. 2004;53(Suppl 3):S39-S47
9. Stevens RJ et al. The UKPDS Risk Engine: A Model for the Risk of Coronary Heart Disease in Type 2 Diabetes (UKPDS 56), Clinical Science. 2001;101,671-679