Study suggests the early addition of Avandia ™ (rosiglitazone maleate) significantly improves blood sugar levels in elderly type 2 diabetes patients

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Study suggests the early addition of Avandia™ (rosiglitazone maleate) significantly improves blood sugar levels in elderly type 2 diabetes patients

Fifty percent of elderly patients reached and maintained recommended American Diabetes Association target blood sugar levels for two years

Philadelphia, PA, August 28, 2003 — Data presented at the 18th Annual International Diabetes Federation Congress (IDF) in Paris, France, showed that the early addition of Avandia to sulfonylurea (SU) therapy resulted in better blood sugar control compared to increasing the dose of an SU alone. The study showed that when Avandia, a commonly prescribed insulin sensitizer, was used in combination with glipizide, a traditional antidiabetic agent, more patients achieved the American Diabetes Association (ADA) A1C goal -- a measure of long-term blood sugar -- of less than 7 percent than glipizide alone and this effect was maintained for the full two year period of the study.

"We know that the effectiveness of traditional monotherapy declines over time. To compensate, the standard of care has been to continually increase the dose of the traditional therapy in an effort to maintain blood sugar control. This approach often fails and may also increase the chance of side effects for patients," said the lead investigators, Julio Rosenstock, M.D., Director of the Dallas Diabetes and Endocrine Center and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center in Dallas, Texas. "This study provides important evidence to physicians because it shows that adding rosiglitazone early may help patients attain and sustain target blood sugar over time."

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. When blood sugar levels are elevated over an extended period of time, serious diabetes-related complications may result, including heart attack, stroke, kidney damage and blindness. Avandia directly targets insulin resistance and helps improve blood sugar control.

Study Details

The study, (poster 2278) entitled, "Type 2 Diabetes in the Elderly: Reaching Durable Glycemic Goals with Combination Sulfonylurea and Rosiglitazone" (Rosiglitazone Early vs. Sulfonylurea Titration or the RESULT study) was a two-year, randomized, double-blind study involving 227 patients with type 2 diabetes who received Avandia or placebo in combination with glipizide. Doses of Avandia and glipizide could be increased to a maximum of 8 mg/day and 40 mg/day respectively*, in order to achieve target A1C levels of less than 7 percent and had to be increased if fasting plasma blood sugar levels reached 180 mg/dl or greater. The glipizide arm had a 29 percent withdrawal rate due to lack of efficacy whereas only 3 percent of patients receiving Avandia and glipizide withdrew due to lack of efficacy.

Researchers found that compared to glipizide plus placebo, Avandia plus glipizide treated group had significantly improved A1C levels. In fact, 50 percent of patients who received Avandia and glipizide achieved the ADA A1C goal of less than 7 percent, compared to only 22 percent in the glipizide group. Additionally, 50 percent of patients treated with Avandia plus glipizide were able to maintain their Avandia dose at 4 mg/day (the lowest dose) for the duration of the two-year treatment period. The incidence of adverse events for hypoglycemia was comparable between the two groups. Episodes of edema occurred in both groups (23 percent with Avandia plus glipizide group, versus 9 percent in glipizide group), which were mild to moderate in severity and generally did not lead to withdrawal from the study.

"To help minimize the risk of diabetes-related complications, it is imperative that physicians have the therapeutic tools to help patients keep blood sugar at or below the recommended A1C target levels. These data demonstrate that the combination of Avandia and sulfonylureas is an effective treatment option for patients," said Martin Freed, M.D., Vice President, Metabolism Therapeutic Area, Clinical Development and Medical Affairs, GlaxoSmithKline.

*Avandia, at doses greater than 4 mg, is not approved in combination with an SU.

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. Patients should ask their doctor whether they need to lower their sulfonylurea or insulin dosage.

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 patients should tell their doctor if they have a history of these conditions. If patients experience an unusually rapid increase in weight, swelling or shortness of breath while taking Avandia, they should talk to their doctor immediately. In combination with insulin Avandia may increase the risk of other heart problems. Patients should ask their doctor about important symptoms and if the combination continues to work for them. 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 and during therapy. Patients should tell their doctor if they have liver disease, or if they experience unexplained tiredness, stomach problems, dark urine or yellowing of skin while taking Avandia.

If patients are nursing, pregnant or thinking about becoming pregnant, or premenopausal and not ovulating, they should talk to their doctor before taking Avandia.

About GlaxoSmithKline

GlaxoSmithKline is committed to providing innovative treatment options for people with diabetes and researching new potential therapies. Avandia is the number one prescribed TZD in the United States, with retail prescriptions surpassing 26 million. GlaxoSmithKline takes pride in offering Avandia as part of the treatment arsenal for type 2 diabetes.

GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Media contacts:

GlaxoSmithKline

Bernadette King

215 751 7709

Cohn & Wolfe Healthcare

Megan James

212 798 9731

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