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Data Demonstrate Benefits of Initial Use of Rosiglitazone Maleate and Glimepiride Combination Tablet in People With Type 2 Diabetes

Glycemic Control and Improvements in Insulin Resistance Seen in People Taking Avandaryl

WASHINGTON, DC -- June 21, 2006 -- New research presented today at the 66th Annual Scientific Sessions of the American Diabetes Association (ADA) show the benefits of the initial use of Avandaryl in helping people with type 2 diabetes achieve blood sugar targets and improving insulin sensitivity.

These data suggest that treatment of drug-naive people with Avandaryl may be more efficacious than using one therapy alone. Avandaryl is the only therapy available that combines a thiazolidinedione (TZD), rosiglitazone maleate -- separately marketed as Avandia® -- with a sulfonylurea, glimepiride -- separately marketed as Amaryl® -- to treat type 2 diabetes.

"Given the progressive nature of type 2 diabetes, most patients will eventually need more than one therapy to effectively control blood sugar levels over time and reduce their risk of potentially serious diabetes-related complications, such as heart disease and stroke," said Barry Goldstein, M.D., Ph.D., director, Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College of Thomas Jefferson University, Philadelphia, and an author of one of the papers. "Using more effective treatment approaches earlier in the course of the disease, including the use of combination medications, is important for the management of type 2 diabetes."

In this study (presented as abstract: 541-P), "Rosiglitazone (RSG) and Glimepiride (GLIM) Fixed-Dose Combination (FDC) Provides Superior Glycemic Control Compared with GLIM and RSG Monotherapies in Drug-Naïve Individuals with Type 2 Diabetes (T2DM)," examined glycemic control as measured by A1C and fasting plasma glucose (FPG). In this study, people taking Avandaryl had a rapid reduction in FPG levels, seen as early as after 2 weeks.

Also, superior reductions in A1C levels were seen with Avandaryl compared to rosiglitazone or glimepiride, with significantly more patients reaching the A1C goals recommended by the ADA and the American Association of Clinical Endocrinologists (AACE). The ADA recommends an A1C of less than 7%, and AACE recommends an A1C of 6.5% or less. Of patients taking Avandaryl, up to 75% reached ADA's target A1C vs. 49% of patients taking glimepiride and 46% of patients taking rosiglitazone. Similarly, up to 56% of patients taking Avandaryl reached AACE's target A1C vs. 32% of patients taking glimepiride and 30% of patients taking rosiglitazone.

Among patients in the two Avandaryl treatment arms, the mean reductions from baseline in A1C levels were 2.4% to 2.5% vs. a mean reduction from baseline in A1C of 1.8% among patients taking rosiglitazone monotherapy and 1.7% among patients taking glimepiride monotherapy. At baseline, the patients studied had an A1C of 9% to 9.2%.

Other findings from this study (abstract 475-P), "Initial Treatment with Rosiglitazone (RSG) and Glimepiride (GLIM) Fixed-Dose Combination (FDC) Reduces Cardiovascular Risk Markers and Improves Insulin Sensitivity in Patients with Type 2 Diabetes (T2DM)," Avandaryl demonstrated effects in addition to glycemic control, including increases in estimates of beta-cell function and improvements in C-reactive protein and PAI-1, which are two cardiovascular inflammatory markers. Further, a reduction in insulin resistance was seen in patients taking Avandaryl or rosiglitazone, but not in those taking glimepiride monotherapy.

Avandaryl was generally well tolerated, with an adverse event profile similar to its component therapies. There was a similar incidence of confirmed hypoglycemic events with Avandaryl as compared to glimepiride. There was a low incidence of edema and anemia with Avandaryl. There was a small average weight gain with rosiglitazone and glimepiride, with more weight gain seen with Avandaryl.

The study is a 28-week, multi-center trial with 901 patients randomized to one of four treatment arms: glimepiride (1mg titrated up to 4mg OD), rosiglitazone (4mg up to 8mg), or one of the two rosiglitazone/glimepiride fixed-dose combination arms, (4mg/1mg up to 4mg/4mg in FDC A and 4mg/1mg up to 8mg/4mg in FDC B); 883 patients constituted the efficacy population.

"Avandaryl – and other combination medications that include rosiglitazone – are effective in managing type 2 diabetes," said Hubert Chou, M.D., Ph.D., senior director, CV Metabolism Medicine Development Center, GlaxoSmithKline. "Physicians need different therapies to adequately control their patients' blood sugar levels. GlaxoSmithKline is committed to providing convenient and effective treatment options to help the growing number of people with type 2 diabetes to manage their disease."

More than 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. Normally, insulin is released into the bloodstream from the beta-cells of the pancreas, however, when a person is insulin resistant, the pancreas produces more insulin in order to keep blood glucose levels under control. Eventually, the pancreatic beta-cells become exhausted and can no longer function properly. As type 2 diabetes progresses, the combined effects of insulin resistance and beta-cell dysfunction can make it increasingly difficult for a patient to control glucose levels. When sugar builds up in the blood instead of going into the cells, it can starve the cells of energy and over time, high blood sugar levels can cause diabetes-related complications, affecting the eyes, kidneys, nerves or heart.

Important Safety Information for Avandaryl
Avandaryl, along with diet and exercise, helps improve blood sugar control. Avandaryl is a combination of two drugs – rosiglitazone maleate and glimepiride.

Avandaryl may cause low blood sugar. Lightheadedness, dizziness, shakiness or hunger may mean that a patients' blood sugar is too low. If patients have kidney problems, they may need a lower dose of Avandaryl to reduce problems with low blood sugar. Patients should talk to their doctor if low blood sugar is a problem for them.

Patients should tell their doctor if they have heart problems or heart failure. Avandaryl can cause the 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 patients have swelling or fluid retention, shortness of breath or trouble breathing, an unusually rapid increase in weight, or unusual tiredness while taking Avandaryl, they should call their doctor right away.

Patients should not take Avandaryl if they have liver problems. Blood tests should be used to check for liver problems before starting and while taking Avandaryl. Patients should tell their doctor if they have liver disease, or if they experience unexplained tiredness, stomach problems, dark urine or yellowing skin while taking Avandaryl.

Patients should tell their doctor about all of the medicines they are taking.

Avandaryl may increase the risk of pregnancy. Patients should talk to their doctor before taking Avandaryl if they could become pregnant or if they are pregnant. If patients are nursing, they should not take Avandaryl.

Doctors should check their patients' eyes regularly. Very rarely, some patients have experienced vision changes due to swelling in the back of the eye while taking rosiglitazone, a component of Avandaryl.


SOURCE: GlaxoSmithKline

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