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Study suggests early addition of Avandia significantly improves blood sugar levels in elderly type 2 diabetes patients

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 investigator, 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.

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

Posted: August 2003