The U.S. Food and Drug Administration has approved the use of a new test to determine whether adults with severe FDA Approves Skin Cholesterol Test for Patients with Severe Heart Disease (dateline July 24, 2002) | Heart Disease News | Imaginis - The Women's Health & Wellness Resource Network

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FDA Approves Skin Cholesterol Test for Patients with Severe Heart Disease (dateline July 24, 2002)

The U.S. Food and Drug Administration has approved the use of a new test to determine whether adults with severe coronary artery disease have high cholesterol. Unlike a traditional blood test to measure cholesterol levels, the "Cholesterol 1,2,3" test determines a patient’s cholesterol in the skin using the palm of the hand. While the new test will not be routinely used on all patients, the FDA said it can provide helpful information in patients who are already at high risk of heart attack.

Heart disease is the leading cause of death in the United States and is a serious worldwide problem. Approximately 12,800,000 Americans suffer from coronary artery disease, and nearly 500,000 Americans die each year from heart attacks. Over 12 million Americans have a history of heart attack, chest pain (angina), or both. Risk factors for heart disease include high cholesterol, high blood pressure (hypertension), smoking, obesity, diabetes (Type II, adult onset), and lack of physical activity.

Typically, physicians monitor cholesterol by taking samples of a patient’s blood and measuring the amount of LDL ("bad") cholesterol, HDL ("good") cholesterol, and total cholesterol levels. According to the FDA, this standard method of measuring cholesterol will not change for the majority of Americans. However, a new skin cholesterol test will become available for patients will severe coronary artery disease, in which 50% of two or more arteries are completely blocked, significantly increasing the risk of heart attack. (A heart attack occurs when coronary artery is so severely blocked that there is a significant reduction or break in the blood supply, causing damage or death to a portion of the heart muscle).

The new skin cholesterol test, called Cholesterol 1,2,3, is made by Medical Innovations Inc. of Toronto, Canada. The test consists of a band-aid-like applicator pad that is placed on the palm of the hand. Drops of a special enzyme-containing liquid solution are added to the pad, which remains on the palm for three minutes. The medical provider uses a special handheld reader attached to a computer to read the amount of blue color in the pad. The results are displayed on the computer screen, with a deeper blue signaling high cholesterol.

Approximately 11% of cholesterol is found in the skin. Prior to approving the Cholesterol 1,2,3 test, FDA officials analyzed clinical trial results, including a study of 649 patients with a known degree of coronary artery blockages. In that trial, the skin cholesterol test, when used with a standard blood cholesterol test, helped identify patients with the most severe artery blockages. However, the test was administered mostly on White patients between the ages 40 to 82. The FDA cautioned that because of this limited pool, the test may be dependent on race and/or age.

While the overall favorable results on patients with severe heart disease led to FDA approval of the skin cholesterol test, the test was not found to be effective at identifying patients with less serious coronary artery disease. Thus, the test will not become a standard screening tool for the general public.

According to Medical Innovations Inc., the skin cholesterol test should be around $10. The company plans to begin selling Cholesterol 1,2,3 in Canada this summer. However, it is unclear when the test will become available in the United States.

High cholesterol is a serious health problem in the United States. Recently, government guidelines recommended a more aggressive approach for treating high cholesterol and preventing heart disease in millions of women and men. In addition to more emphasis on low-fat diets and exercise, the guidelines called for an increase in the number of people that need to take cholesterol-lowering drugs from 13 million Americans to an estimated 36 million.

Cholesterol can be reduced by limiting consumption of saturated fats (whole-fat dairy products, cheeses, red meats), increasing physical activity, and weight reduction when appropriate. Increased consumption of monounsaturated fats (olive oil, nuts, fatty fish) has been shown to reduce LDL cholesterol and increase HDL cholesterol, lowering heart disease risk. Types of drugs commonly used to help lower cholesterol in patients include statins, bile acid resins, nicotinic acid and fibrates.

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