Created: Wednesday, March 17, 2010 12:00 a.m. CST
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Targeting two important risk factors for cardiovascular disease

By (ARA)

(ARA) - It's well known that the prevalence of diabetes is on the rise. According to the Centers for Disease Control and Prevention (CDC), about 23.6 million, or nearly 8 percent of people in the United States, have diabetes, and 1.6 million new cases are diagnosed each year in people aged 20 and older. Type 2 diabetes is the most common form, accounting for about 90 to 95 percent of those diagnosed, and occurs when the body either does not produce enough insulin or does not respond to insulin.

But something that many people may not know is that in addition to having diabetes, 70 percent of adults with type 2 diabetes also have high LDL cholesterol (LDL-C), the "bad" cholesterol that can cause build-up in the arteries, greatly increasing their risk for cardiovascular disease. Cholesterol is needed for the body to function normally, but when there is too much LDL-C in the bloodstream, it is deposited in arteries, including those of the heart, which can limit blood flow and lead to heart disease.

The American Diabetes Association (ADA) and the American College of Cardiology (ACC) emphasize that it is critical to control both cholesterol and blood sugar levels. The ADA recommends that patients with type 2 diabetes aim for an A1C level, which reflects your average blood sugar level for the past two to three months, of less than 7 percent. The National Cholesterol Education Program (NCEP) ATP III recommends that patients with type 2 diabetes target an LDL-C goal of less than 100 mg/dL.

Treating these two diseases can take a combination of efforts, including a healthy diet and increased exercise. Medications are also sometimes needed. While there are many drugs approved by the U.S. Food and Drug Administration (FDA) to treat type 2 diabetes and others available to lower LDL-C, a drug called Welchol (colesevelam HCl) is the first and only medication approved as an adjunct to diet and exercise to reduce both A1C in adults with type 2 diabetes and LDL-C in adults with elevated cholesterol. Welchol addresses both of these chronic health conditions with one medication and offers the convenience of two formulations, Welchol tablets and Welchol for Oral Suspension. Welchol can be taken alone or with other cholesterol lowering medications known as statins and can be added to other anti-diabetic medications (metformin, sulfonylureas, or insulin).

"For patients with type 2 diabetes and high LDL cholesterol, it is important to manage both conditions," said Yehuda Handelsman, MD, FACP, FACE, Medical Director of the Metabolic Institute of America in Tarzana, Calif. "Welchol reduces these two risk factors for cardiovascular disease in adults with type 2 diabetes by significantly lowering A1C and LDL-C or 'bad' cholesterol, providing a unique therapeutic option."

It is important to note that the effect of Welchol on cardiovascular morbidity and mortality has not been determined.

Important information about Welchol (colesevelam HCl)

Welchol, along with diet and exercise, lowers LDL or "bad" cholesterol. It can be taken alone or with other cholesterol-lowering medications known as statins.

Welchol, along with diet and exercise, also lowers blood sugar levels in adult patients with type 2 diabetes mellitus when added to other anti-diabetic medications (metformin, sulfonylureas, or insulin).

Welchol should not be used to treat type 1 diabetes or diabetic ketoacidosis. Welchol has not been studied with all anti-diabetic medications.

Welchol is not for everyone, especially those with an intestinal blockage, those with blood triglyceride levels of greater than 500 mg/dL, or a history of pancreatitis (inflammation of the pancreas) due to high triglyceride levels.

Welchol has not been shown to prevent heart disease or heart attacks. Tell your doctor if you have high triglycerides (greater than 300 mg/dL).

Tell your doctor if you have stomach or intestinal problems, including gastroparesis (when the stomach takes too long to empty its contents), abnormal contractions of the digestive system, major gastrointestinal tract surgery, if you have trouble swallowing, or if you have vitamin A, D, E, or K deficiencies.

Welchol has known interactions with glyburide (a drug for diabetes), levothyroxine (a drug used to treat an underactive thyroid) and certain birth control pills. Welchol has not been studied with all combinations of drugs and supplements. Please tell your doctor about all medications and supplements you may be taking before beginning Welchol, as your doctor may tell you to take your other medications and supplements four hours before taking Welchol.

Remember to tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

Welchol for Oral Suspension should not be taken in its dry form. Welchol for Oral Suspension is recommended, but not limited to, any patient who has difficulty swallowing.

Phenylketonurics: Welchol for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose.

In clinical trials, the adverse reactions observed in greater than or equal to 2 percent of patients, and more commonly with Welchol than placebo ("sugar pill"), regardless of investigator assessment of causality, seen in:

-Adult patients with high LDL ("bad" cholesterol) were: constipation (11.0 percent vs 7.0 percent), indigestion (8.3 percent vs 3.5 percent), nausea (4.2 percent vs 3.9 percent), accidental injury (3.7 percent vs 2.7 percent), weakness (3.6 percent vs 1.9 percent), sore throat (3.2 percent vs 1.9 percent), flu-like symptoms (3.2 percent vs 3.1 percent), runny nose (3.2 percent vs 3.1 percent) and muscle aches (2.1 percent vs 0.4 percent).

-Adult patients with type 2 diabetes were: constipation (8.7 percent vs 2.0 percent), inflamed nasal passages and throat (4.1 percent vs 3.6 percent), indigestion (3.9 percent vs 1.4 percent), low blood sugar (3.0 percent vs 2.3 percent), nausea (3.0 percent vs 1.4 percent) and high blood pressure (2.8 percent vs 1.6 percent).

Ask your doctor if Welchol is right for you. For more information about Welchol please visit www.Welchol.com or call 1-800-374-7763.

Please see Important Information about Welchol at www.Welchol.com or call 1-800-374-7763.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For patients having difficulty affording their Welchol medication, please call the Daiichi Sankyo Open Care Patient Assistance Program at 1-866-268-7327 for more information or visit www.dsi.com.

Courtesy of ARAcontent

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