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New Data Show Rosiglitazone May Reduce Risk for Type 2 Diabetes and Cardiovascular Disease in African Americans, Hispanics

ORLANDO, Fla., June 6 /PRNewswire-FirstCall/ -- New data presented today at the 64th Scientific Sessions of the American Diabetes Association suggest that, in certain ethnic populations with, and predisposed to, type 2 diabetes, the insulin sensitizer Avandia® (rosiglitazone maleate) may reduce the risk for developing diabetes and diabetes-related cardiovascular disease.

In one study, data suggest that Avandia may delay and prevent progression to type 2 diabetes and premature cardiovascular disease, specifically in African American patients with impaired glucose tolerance (IGT), commonly referred to as pre-diabetes. In a separate study of African American and Hispanic American patients with type 2 diabetes, treatment that included Avandia led to substantial improvements in blood sugar control and insulin sensitivity, which may reduce the risk for cardiovascular disease.

"Despite the fact that diabetes and its related complications, such as cardiovascular disease, disproportionately affect African Americans and Hispanic Americans, there have been few clinical trials evaluating treatment approaches in these populations," stated Mary Ann Banerji, M.D., associate professor of medicine, State University of New York Health Science Center and lead investigator of one of the studies. "These data suggest that African American and Hispanic American patients may benefit from using Avandia earlier and more aggressively to manage their risk for type 2 diabetes and diabetes- related cardiovascular disease."

Cardiovascular disease is the leading cause of diabetes-related death among people with type 2 diabetes. The risk for cardiovascular disease is also substantially increased in people with IGT/pre-diabetes. Impaired glucose tolerance/pre-diabetes occurs when blood sugar levels are higher than normal, but not high enough for a patient to be diagnosed with diabetes. Over time, IGT/pre-diabetes often leads to type 2 diabetes.

Diabetes affects African Americans and Hispanic American populations at alarming rates. Both populations are at least 1.5 times more likely to have diabetes than non-Hispanic whites. There are 2.7 million African Americans and 2 million Hispanic Americans with diabetes, and it is estimated that more than one million are currently undiagnosed. African Americans and Hispanic Americans also experience higher rates of many diabetes-related complications, including cardiovascular disease, blindness, kidney failure and lower limb amputation.

Avandia Improves IGT State

In the study entitled "Rosiglitazone Improves Postprandial Glycemia, Insulin Resistance and LDL Buoyancy in African American Subjects with Impaired Glucose Tolerance," researchers evaluated whether treatment with Avandia would help improve factors associated with IGT/pre-diabetes, a precursor condition for type 2 diabetes and a risk factor for developing cardiovascular disease.

Twenty-three IGT/pre-diabetes patients (more than 90 percent of whom were African American) were randomized to receive Avandia (4 mg bid, n=11) or placebo (n=12) for 26 weeks. Findings showed that, compared to baseline values, Avandia significantly decreased postprandial (non-fasting plasma glucose) glucose levels (-43.89 plus or minus 43.30), fasting plasma glucose (-11 plus or minus 9.48) and C-peptide levels (-0.138 plus or minus 0.134). Consistent with an improvement in insulin sensitivity, patients demonstrated an increase in subcutaneous adipose tissue and no change in visceral fat. Also noteworthy were the significant shifts in small, dense LDL-cholesterol (or "bad" cholesterol) to potentially less atherogenic, and therefore, potentially less harmful, large buoyant LDL-cholesterol (0.03 plus or minus 0.021). The adverse events observed in the study were similar to those commonly seen with thiazolidinedione therapy, as described in the Avandia label.

This research suggests that Avandia may help delay or prevent the progression of IGT to overt type 2 diabetes, as well as premature cardiovascular disease in type 2 diabetes patients.

"With the incidence of diabetes on the rise, especially in African American populations, healthcare professionals should pay close attention to patients in a pre-diabetic state with impaired glucose tolerance and address the condition early to reduce the risk for serious complications, such as cardiovascular disease," said Dr. Banerji.

Key Benefits Seen with Avandia Combination Therapy

Results from a study entitled "Rosiglitazone Added to Sulfonylurea Improves Glycemic Control and Insulin Sensitivity in African American and Hispanic American Subjects with Type 2 Diabetes" showed that Avandia added to sulfonylurea therapy significantly improved fasting blood sugar levels and insulin sensitivity in African American and Hispanic American patients when compared to sulfonylurea monotherapy.

In this study, African and Hispanic American subjects who were previously treated for at least two months and were inadequately controlled with a sulfonylurea were switched to an equivalent dose of glyburide. After evaluating patients' blood sugar control over a four-week period, patients with inadequate blood sugar control on glyburide alone (FPG greater than or equal to 140mg/dl, less than or equal to 270 mg/dl) were randomized to double- blind treatment with either Avandia (8mg qd, n=117) or placebo (n=116) in combination with open-label glyburide for 24 weeks. Avandia in combination with glyburide provided significant improvements in HbA1c (-1.39 %, p

"These data suggest that by significantly improving glycemic control and insulin sensitivity, and by reducing levels of certain cardiovascular risk markers in African American and Hispanic American populations, Avandia may offer potential benefits to these high-risk patients," stated John C. Campbell, lead clinical scientist for GlaxoSmithKline. "GlaxoSmithKline is committed to conducting robust clinical research to improve the understanding of effective treatments and outcomes in ethnic populations."

Type 2 Diabetes and Cardiovascular Disease

Cardiovascular disease is one of the most serious complications of type 2 diabetes, and is attributed to 80 percent of diabetes-related deaths. People with diabetes are two to four times more likely to suffer from heart disease or stroke, and, in many cases, the impact of heart disease is more severe in people with diabetes. Research also suggests that insulin resistance is a common link between cardiovascular disease and type 2 diabetes. Insulin resistance occurs when the body does not respond properly to its own natural insulin, a hormone critical for blood sugar to enter the body's cells and be stored or converted into energy, and is associated with an increased risk for heart disease and stroke. African Americans and Hispanic Americans are at a higher risk for developing insulin resistance.

Avandia For Type 2 Diabetes

Avandia, along with diet and exercise, helps improve blood sugar control. It may be prescribed alone, with metformin, sulfonylureas, or insulin. When taking Avandia with sulfonylureas or insulin, patients may be at increased risk for low blood sugar. Ask your doctor whether you need to lower your sulfonylurea or insulin dosage when used in combination with Avandia.

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

Avandia 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 Avandia, talk to your doctor immediately. In combination with insulin Avandia may increase the risk of other heart problems.

Ask your doctor about important symptoms and if the combination continues to work for you. Avandia is not for everyone. Avandia is not recommended for patients with severe heart failure or active liver disease.

Also, blood tests to check for serious liver problems should be conducted before therapy, and periodically thereafter as determined by your doctor. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, stomach problems, dark urine or yellowing of skin while taking Avandia.

If you are nursing, pregnant or thinking about becoming pregnant, or premenopausal and not ovulating, talk to your doctor before taking Avandia.

Source: GlaxoSmithKline

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