PHILADELPHIA, PA., March 3, 2003 — GlaxoSmithKline announced that the FDA has approved Avandia (rosiglitazone maleate) for use in combination with insulin for the treatment of type 2 diabetes.
As an adjunct to diet and exercise, Avandia now can be used in four therapeutic regimens: as monotherapy or as combination therapy with metformin, sulfonylureas or insulin to improve glycemic control in patients with type 2 diabetes.
“GlaxoSmithKline is very pleased with the new indication for Avandia,” said David Pernock, Senior Vice President, General Pharmaceutical Business Unit at GlaxoSmithKline. “Clearly, people with type 2 diabetes need therapeutic options at each stage of their disease to help ensure tight glucose control. It is our hope that this new indication may help people to better manage their type 2 diabetes.”
The progressive nature of 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) generally start to fail over time and produce progressively 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 may result. To reach blood sugar levels recommended by experts, many people with type 2 diabetes may need to take a combination of therapies, possibly including the addition of insulin.
Avandia in combination with insulin
The approval of Avandia in combination with insulin was based upon data from four 26-week trials in patients with type 2 diabetes. Approximately 1,100 patients participated in clinical studies programs, which included two fixed-dose combination trials, one insulin reduction study and one study in patients with chronic kidney disease. The studies demonstrated the safety and efficacy of Avandia at 4 mg daily in combination with insulin. In fact, in patients receiving Avandia 4 mg daily plus insulin, there was a significant drop in blood sugar levels and approximately 40 percent of patients in the two fixed-dose trials were able to reduce their insulin dose.
Avandia for type 2 diabetes
Avandia is an insulin sensitizer that works by making the cells in the body more sensitive to its own natural insulin. Since the FDA approval of Avandia in May 1999, more than 22 million prescriptions have been written and more than three million patients have been treated in the United States.
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 other hypoglycemic agents, like sulfonylureas or insulin, patients may be at 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
Avandia, like other thiazolidinediones, 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 treated with Avandia and insulin should discuss with their doctor important symptoms of which to be aware and whether or not the combination is helping to control their blood sugar. 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 Avandia 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 the patient is nursing, pregnant or thinking about becoming pregnant, or is a premenopausal woman who is not ovulating, she should talk to her doctor before taking Avandia.
Source: GlaxoSmithKline
Product Description
Most important information about Avandia
Pharmacokinetics
Possible Side Effects
More information about AVANDIA (Rosiglitazone):
AVANDIA (Rosiglitazone): What You Should Know
Can Avandia or other drugs prevent diabetes?
Actos beats Avandia in sugar, fat control: study
Avandia approved for combination with insulin in type 2 diabetes treatment
Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent
EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)
GSK Revises US Labeling for Avandia
Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile
Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
Texas Family Sues GlaxoSmithKline (GSK) Over Man’s Heart Attack Death Following Avandia Use
To buy AVANDIA click HERE: My Family Drugstore
