Advandment - A Diabetes Cocktail

[Guest guest]

my personal edition > diabetes > news

E-Mail this DGNews to a colleague

DGNews

FDA Approves GlaxoKline's Avandamet™ (rosiglitazone maleate and

metformin HCl), The Latest Advancement in the Treatment of Type 2

Diabetes

PHILADELPHIA, PA -- October 11, 2002 -- GlaxoKline announced

today that the U.S. Food and Drug Administration (FDA) approved

Avandamet™ (rosiglitazone maleate and metformin HCl) for the

treatment of type 2 diabetes, offering an exciting new option for

millions of Americans with the disease. Avandamet combines two

leading diabetes medications in one convenient pill. This combination

offers the opportunity to help people manage their type 2 diabetes

longer. Avandamet will be available to patients in approximately one

month.

" The combination of rosiglitazone and metformin provides two

different, yet complementary mechanisms of action to manage

diabetes, " said Barry Goldstein, M.D., Ph.D., Director, Division of

Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical

College of Jefferson University, Philadelphia. " Rosiglitazone

targets insulin resistance, an underlying cause of type 2 diabetes,

whereas metformin works to reduce the amount of blood sugar (or

glucose) produced by the liver. The two medications, when used in

combination, target core metabolic defects to help achieve better

blood sugar control than metformin alone, making this an important

option for patients with type 2 diabetes. "

Type 2 diabetes is characterized by high blood sugar levels that

occur when the body cannot make enough insulin and/or respond

normally to the natural insulin it makes (a condition called insulin

resistance). In patients with type 2 diabetes, beta cells (the cells

that make and release insulin in the pancreas) may become overworked

and eventually fail, producing less insulin. This may lead to

increased blood sugar levels and progressive worsening of the

disease. When blood sugar levels are elevated over an extended period

of time, serious complications can result, including cardiovascular

disease, kidney damage and blindness. To reach blood sugar levels

recommended by experts, many people with type 2 diabetes will need to

take a combination of therapies that treat the disease in different

ways.

" GlaxoKline is committed to developing novel diabetes therapies

to treat a disease that has reached epidemic proportion in the United

States and throughout the world, " said Brand, Vice President of

Metabolic/Endocrine Marketing, GlaxoKline U.S. " With Avandamet,

the latest addition to our diabetes portfolio, we hope to provide an

effective, convenient treatment option for people suffering from

uncontrolled type 2 diabetes and also to improve patient compliance.

This combination of rosiglitazone and metformin offers the

opportunity to help people manage their type 2 diabetes longer. "

Avandamet: The Latest Advancement in Diabetes Management

The use of rosiglitazone and metformin together as separate tablets

was first approved by the FDA in 1999 as safe and effective based on

two controlled clinical trials in people with type 2 diabetes

inadequately controlled on metformin alone. As an adjunct to diet and

exercise, Avandamet is indicated to improve blood sugar control in

people with type 2 diabetes who are already treated with

rosiglitazone and metformin as separate tablets, or who are not

adequately controlled on metformin alone. It is available in three

tablet strengths of rosiglitazone/metformin, respectively: 1 mg/500

mg, 2 mg/500 mg and 4 mg/500 mg. The additive effect of the

combination of rosiglitazone and metformin has been shown to

significantly reduce A1C levels compared to metformin alone. A1C

levels are the most effective measure of long-term blood sugar

control. Additionally, it has been shown to successfully impact core

defects of type 2 diabetes, resulting in improvements in both insulin

resistance and estimates of beta-cell function.

In fact, research has demonstrated that rosiglitazone and metformin

in combination significantly reduces and maintains blood sugar levels

for up to two years. The combination has been associated with a low

risk of hypoglycemia (low blood sugar). Avandamet, as a two-in-one

therapy, is the most economical thiazolidinedione (TZD) combination

on the market, offering simplified dosing.

Importance of Aggressive Diabetes Management

Diabetes experts are setting more stringent standards that reflect

the importance of maintaining tight glucose control. Based on the

United Kingdom Prospective Diabetes Study (UKPDS) showing that tight

blood sugar control can delay or prevent the complications of type 2

diabetes, the American Diabetes Association has established an A1C

level of no more than 7.0 percent as the therapeutic target. However,

recently, the American Association of Clinical Endocrinologists and

the American College of Endocrinology proposed an A1C target of 6.5

percent to help reduce the frequency of complications.

" More than 50 percent of people diagnosed with type 2 diabetes do not

meet target A1C levels. And, with every one percent above target A1C

levels, a person's risk for diabetes complications, such as

cardiovascular disease, increases, " said Hossein Gharib, M.D., FACE,

President of the American Association of Clinical

Endocrinologists. " Therefore, it is critical that we work to manage

diabetes early and aggressively to help ensure that blood sugar

levels are in control. "

Safety Information

A small number of people who have taken metformin, one of the

components of Avandamet, have developed a serious yet rare 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. In addition,

rosiglitazone (another component of Avandamet) may cause fluid

retention, especially if it is used with insulin. If left unchecked,

fluid retention could lead to or worsen heart failure.

Avandamet is not indicated for use with insulin. Avandamet should not

be used in patients with renal disease or dysfunction or with

congestive heart failure requiring medication. Before using

Avandamet, patients over the age of 80 should have their renal

function tested to assure that their kidney function is adequate.

Avandamet is not recommended for people with liver disease. Patients

should inform their doctor if they drink alcohol excessively. Tests

should be conducted before and while taking Avandamet to check for

liver problems.

About GlaxoKline

GlaxoKline is committed to providing innovative treatment

options for people with diabetes and researching new potential

therapies. Avandia® (rosiglitazone maleate) is the number one

prescribed TZD in the United States, with retail prescriptions

surpassing 20 million. GlaxoKline takes pride in offering both

Avandia and Avandamet as part of the treatment arsenal for type 2

diabetes.

GlaxoKline, with U.S. operations in Philadelphia, PA, and

Research Triangle Park, NC, is one of the world's leading research-

based pharmaceutical and healthcare companies and is committed to

improving the quality of human life by enabling people to do more,

feel better and live longer. For more information on Avandamet, visit

<http://www.avandamet.com> or call 1-.