(DALLAS) Sept. 2, 2008 – Study results discussed today at the European Society of Cardiology meeting and published in the New England Journal of Medicine reiterate findings from July’s early release of the SEAS trial, showing the effects of the combination cholesterol-lowering medicine ezetimibe and simvastatin (Vytorin) on aortic stenosis and coronary heart disease in 1873 patients. These results raised a safety question about the combination drug, and a subsequent meta-analysis (statistical pooling) of this and two larger, ongoing studies, as well as an editorial were also reported and published today in the NEJM.

Reducing cholesterol is critical for treating coronary heart disease and reducing heart attack risk. American Heart Association guidelines have long recommended a healthy lifestyle and, if needed, medications for lowering cholesterol. Statins are highly effective and generally are the initial medication given. The Association recommends that people who are taking prescribed cholesterol-lowering medicines should not stop them without first consulting their healthcare provider, because it could put them at higher risk for having a heart attack or other cardiovascular event.

In the SEAS study results, researchers found that while the drug did significantly reduce low-density lipoprotein (LDL cholesterol), it did not affect the progression of aortic stenosis – a narrowing of the valve that lets blood exit from the heart’s main pumping chamber. This was the study’s primary endpoint, which was not met.

In the safety analysis of the drug in this study, there was a significant increase in cancers in patients taking the drug versus those taking a placebo. However, the meta-analysis of SEAS and 2 other ongoing clinical trials (IMPROVE-IT and SHARP), including more than 21,000 patients, showed no indication of an increase in the overall risk of cancer. The chairpersons of the three research studies have come to the conclusion that there is currently not sufficient evidence to demonstrate that the combination drug shows a significant increase in the overall risk of cancer. The American Heart Association supports the continuation of SHARP and IMPROVE-IT, as they will determine whether ezetimibe is safe and effective in patients with chronic kidney disease and with acute coronary syndromes, respectively. It is important to identify drugs that can safely lower cholesterol in patients who are intolerant of statins or in whom cholesterol lowering targets cannot be achieved with statins alone and to determine whether they produce improved outcomes in patients.
 
Patients who need to lower their cholesterol should adhere to all the recommendations of their healthcare providers. If patients have concerns, they should contact their healthcare providers to make an informed decision about their specific healthcare needs. The American Heart Association bases its recommendation for cholesterol lowering on the available scientific evidence. Because the evidence is most robust for statins, we recommend that statins be used as the first line agents for cholesterol-lowering, and that the statin drugs and doses be maximized to achieve the cholesterol target before considering secondary drugs. There are a number of other drugs that have demonstrated efficacy for improving outcomes, including fibrates, niacin and cholestyramine, that can be used as the next line of therapy to achieve cholesterol targets. Until the results of the IMPROVE-IT and SHARP trials have determined whether the cholesterol lowering produced by ezetimibe leads to improved outcomes for patients, patients should be guided by their healthcare providers as to whether ezetimibe alone or in combination with a statin is a suitable choice for lowering their cholesterol.

For more information on heart disease such as coronary heart disease and aortic stenosis and risk factors such as high cholesterol, visit http://www.americanheart.org.

Questions patients should ask their doctor:

• Do I need to take a medication for lowering my cholesterol? Is a medication necessary, or could I make my cholesterol normal with diet and exercise?
• My doctor has prescribed two medications (or a combination medicine) to help me lower my cholesterol – why am I taking two medications instead of one?
• If I need a second medicine, which one should I take?
• If I am taking Vytorin and am going to continue to take it, am I at greater risk of developing cancer?

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The American Heart Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events.  The association has strict policies to prevent these relationships from influencing science content.  Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.

CONTACT:
Maggie Francis – (214) 706-1382