GlaxoSmithKline Announces the Approval and Availability of Avandaryl

GlaxoSmithKline Announces the Approval and Availability of Avandaryl (rosiglitazone maleate and glimepiride):

A New Fixed-Dose Combination Tablet to Treat Type 2 Diabetes

PHILADELPHIA, February 1, 2006 -- GlaxoSmithKline announces the availability of Avandaryl (rosiglitazone maleate and glimepiride), a new fixed-dose combination product for type 2 diabetes. Recently approved by the U.S. Food and Drug Administration (FDA), Avandaryl is the first and only tablet to combine a thiazolidinedione (TZD), rosiglitazone maleate - separately marketed as Avandia - with a sulfonylurea, glimepiride - separately marketed as Amaryl - to help improve blood sugar control. As an adjunct to diet and exercise, Avandaryl is indicated to improve blood sugar control in patients with type 2 diabetes who are already treated with a combination of rosiglitazone and sulfonylurea or who are not adequately controlled on a sulfonylurea alone or for those patients who have initially responded to rosiglitazone alone and require additional blood sugar control.

"An estimated 64 percent of type 2 diabetes patients are not well controlled on their current therapy. According to the United Kingdom Prospective Diabetes Study (UKPDS), many monotherapy treatments may fail to maintain blood sugar control over time. Combination therapy is often needed to help reach and maintain patients' blood sugar goals over time," said Barry Goldstein, M.D., Ph.D., director, Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College of Thomas Jefferson University, Philadelphia. "Avandaryl, a combination of rosiglitazone and a sulfonylurea, provides two different, yet complementary, mechanisms of action to treat diabetes by improving blood sugar control in patients with type 2 diabetes. The patient's treatment regimen combines these two medicines into one convenient tablet."

Over 18 million Americans have type 2 diabetes, the most common form of diabetes. Type 2 diabetes is characterized by high blood sugar levels that occur when the body does not produce enough insulin or does not respond properly to its own natural insulin, a condition called insulin resistance. When sugar builds up in the blood instead of going into the cells, it can starve the cells of energy and over time, high blood sugar levels can cause diabetes-related complications, affecting the eyes, kidneys, nerves or heart. To reach recommended blood sugar levels, many people with type 2 diabetes may eventually need to take more than one medicine to help treat the disease in different ways.

To manage diabetes, it is important for patients, along with their physicians, to set and meet A1c goals. The A1c test is a blood sugar test that reflects a person's average blood sugar levels over the previous two to three months. An A1c goal of less than 7.0% has been recommended by the American Diabetes Association (ADA). Joint guidelines released by the of Endocrinology (ACE) and the American Association of Clinical Endocrinologists (AACE) recommend an A1c goal of 6.5% or lower. Lowering blood sugar levels can help reduce the risk of diabetes-related complications. Some complications of diabetes include heart disease, stroke, blindness, loss of limbs, and kidney disease.

Avandaryl: A New, Convenient Treatment Option

Avandaryl is the first fixed-dose combination tablet containing a TZD and a sulfonylurea. This medication combines rosiglitazone, the most widely prescribed TZD compound, with glimepiride, a second-generation member of the sulfonylurea class of oral diabetes therapies. As an adjunct to diet and exercise, Avandaryl is indicated to improve blood sugar control in patients with type 2 diabetes who are already treated with a combination of rosiglitazone and sulfonylurea or who are not adequately controlled on a sulfonylurea alone or for those patients who have initially responded to rosiglitazone alone and require additional blood sugar control.

Rosiglitazone directly targets insulin resistance, an underlying cause of type 2 diabetes, and helps the body respond better to its own natural insulin. Sulfonylureas work primarily by helping the body release more of its natural insulin.

Significant Improvements in Glycemic Control with Rosiglitazone Combination Therapy

Adding an insulin sensitizer, such as rosiglitazone, to patients not achieving blood sugar control on a sulfonylurea alone may help patients achieve blood sugar control. Data have shown that the addition of rosiglitazone (4 mg or 8 mg) to a sulfonylurea significantly improved A1c and fasting plasma glucose compared to a sulfonylurea alone. In a two-year double-blind study, the effect of rosiglitazone plus a sulfonylurea on A1c and fasting plasma glucose was durable over the two-year period.

Avandaryl, which offers convenient dosing, is available in three tablet strengths of rosiglitazone/glimepiride, respectively: 4 mg/1 mg, 4 mg/2 mg and 4 mg/4 mg.

"GlaxoSmithKline is committed to researching new options for the treatment of type 2 diabetes, a disease that impacts a significant and growing number of individuals and their families," said Brian A. Lortie, vice president, Anti- Infective, Metabolic and Endocrine Marketing for GlaxoSmithKline. "Avandaryl, the newest addition to GSK's diabetes franchise, offers an effective and convenient treatment option to help patients manage type 2 diabetes."

Important Safety Information for Avandaryl

Avandaryl, along with diet and exercise, helps improve blood sugar control. Avandaryl is a combination of two drugs - rosiglitazone maleate and glimepiride.

Avandaryl may cause low blood sugar. Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. If you have kidney problems, you may need a lower dose of Avandaryl to reduce problems with low blood sugar. Talk to your doctor if low blood sugar is a problem for you.

Some people may experience tiredness, weight gain or swelling with Avandaryl.

Avandaryl may cause fluid retention or swelling, which could lead to or worsen heart failure, so you should tell your doctor if you have a history of these conditions. If you experience an unusually rapid increase in weight, swelling or shortness of breath while taking Avandaryl, talk to your doctor immediately.

In combination with insulin, rosiglitazone, one of the components of Avandaryl, may increase the risk of other heart problems. Avandaryl is not approved for use with insulin. Avandaryl is not recommended for patients with NYHA Class 3 and 4 cardiac status or active liver disease.

Blood tests should be used to check for liver problems before starting and while taking Avandaryl. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, stomach problems, dark urine or yellowing of skin while taking Avandaryl.

If you are nursing, pregnant or thinking about becoming pregnant, talk to your doctor before taking Avandaryl. Avandaryl may increase your risk of pregnancy.

Your doctor should check your eyes regularly. Very rarely, some patients have experienced vision changes due to swelling in the back of the eye while taking rosiglitazone, a component of Avandaryl.

The GSK diabetes franchise includes Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin HCl) and the newly approved Avandaryl.

For more information about Avandaryl, and other products in the GSK diabetes franchise, please visit www.avandia.com or call 1-888-825-5249.

Source: GlaxoSmithKline

Posted: February 2006


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