FDA Approves Avandamet as Initial Therapy for Type 2 Diabetes

Avandamet Combines Two Oral Agents - Rosiglitazone, the Most Widely Used Insulin Sensitizer, with a Leading Diabetes Therapy, Metformin - To Help Patients Improve Blood Sugar Control

PHILADELPHIA, July 11, 2006 -- GlaxoSmithKline announced today FDA approval of Avandamet (rosiglitazone maleate and metformin HCl) for use as initial treatment of type 2 diabetes as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy -- it was indicated for use in patients who were uncontrolled on metformin monotherapy. Now, with this recent approval, physicians can start their type 2 diabetes patients on Avandamet.

Avandamet is the only combination of a thiazolidinedione, rosiglitazone maleate (separately marketed as Avandia and metformin HCl, with approved use as initial therapy of type 2 diabetes. Avandamet is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate.

The announcement of the FDA approval for Avandamet for use as initial therapy in type 2 diabetes coincides with GlaxoSmithKline’s announcement that its supply of Avandamet has been re-established.

"Many people with type 2 diabetes need to take more than one medication to treat the disease in different ways. The combination of rosiglitazone and metformin provides two complementary mechanisms of action," said Barry Goldstein, M.D., Ph.D., director, Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College of Thomas Jefferson University, Philadelphia. "Rosiglitazone targets insulin resistance, an underlying cause of type 2 diabetes, whereas metformin primarily works to reduce the amount of blood sugar (or glucose) produced by the liver. In fact, a clinical trial comparing Avandamet to both rosiglitazone alone and metformin alone showed that patients taking Avandamet achieved significantly lower blood sugar levels than with either monotherapy alone."

Nearly 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. To manage diabetes, it is important for patients to achieve the blood sugar goal set by their physicians. Blood sugar control is measured by the HbA1C test, or A1C, which reflects a person’s average blood sugar levels over the previous two to three months. The American Association of Clinical Endocrinologists recommends an A1C of 6.5% or lower. The American Diabetes Association recommends an A1C of less than 7%. Lowering blood sugar levels can help reduce the risk of diabetes-related complications, such as heart disease, stroke, blindness, loss of limbs and kidney disease.

"GlaxoSmithKline is committed to developing diabetes therapies to treat a disease that has reached epidemic proportions in the United States and throughout the world," said Anne M. Phillips, MD, vice president of Clinical for North America Cardiovascular-Metabolic, GlaxoSmithKline. "With the approval of Avandamet for use as initial therapy as an adjunct to diet and exercise, GSK offers this effective and convenient option now for initial treatment of type 2 diabetes. This combination of rosiglitazone and metformin can help patients get their blood sugar under control."

Importance of Aggressive Diabetes Management

Diabetes experts are setting more stringent standards that reflect the importance of maintaining tight blood sugar control. "Combination therapy with medications that work in different ways is often needed to help patients reach and maintain blood sugar goals," said Dr. Goldstein. "An advantage of Avandamet is that it combines two medications with complementary mechanisms of action in one convenient tablet."

Avandamet: Initial Therapy in Diabetes Management

Avandamet was originally approved in the U.S. in 2002, and is available in four tablet strengths of rosiglitazone/metformin, respectively: 2 mg/500 mg, 4 mg/500 mg, 2mg/1000mg, and 4mg/1000mg. Avandamet, as a two-in-one therapy, is the most economical thiazolidinedione (TZD)-metformin combination on the market.

Important Safety Information for Avandamet

Avandamet, along with diet and exercise, helps improve blood sugar control. It is a combination of two drugs - rosiglitazone maleate and metformin HCl.

A small number of people who have taken metformin, one of the components of Avandamet, have developed a rare yet serious condition called lactic acidosis (a buildup of lactic acid in the blood). Lactic acidosis occurs most often in people with kidney problems and can be fatal in up to one half of the cases. You should not take Avandamet if you have kidney problems. Tests should be used to check your kidneys before and while taking Avandamet. You should not drink alcohol excessively when taking Avandamet. If you are taking medicines for heart failure, you may be at increased risk of lactic acidosis.

Tell your doctor if you have heart problems or heart failure. Avandamet can cause your body to keep extra fluid which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. If you have swelling or fluid retention, shortness of breath or trouble breathing, an unusually rapid increase in weight, or unusual tiredness while taking Avandamet, call your doctor right away.

You should not take Avandamet if you have liver problems. Blood tests should be used to check for liver problems before starting and while taking Avandamet. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, stomach problems, dark urine or yellowing of skin while taking Avandamet.

Tell your doctor about all of the medicines you are taking.

Avandamet may increase your risk of pregnancy.

Talk to your doctor before taking Avandamet if you could become pregnant or if you are pregnant.

If you are nursing, you should not take Avandamet.

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

Source: GlaxoSmithKline

Posted: July 2006


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