The results of a randomized clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in children with type 2 diabetes show that children and adolescents treated with a combination of metformin and Avandia (rosiglitazone) had better glycemic control than children treated with metformin alone or with metformin and with an intensive lifestyle-intervention program.    The trial included 699 children with type 2 diabetes aged 10 -17 who were treated with metformin (at a dose of 1000...

It seemed like such an elegant solution at the time; activate the transcription of a glucose transporter in an insulin independent fashion. The goal of current diabetic treatments is to lower blood glucose levels to a point where the glucose no-longer damages other tissues. Insulin moves glucose out of the blood by increasing the presence of a glucose transporter (GLUT4) on the surface of most cells. Drugs like Avandia work by modulating the GLUT4 gene directly, increasing its expression and thus getting more GLUT4 protein to the...

Following an ongoing FDA review of  the diabetes drug Avandia (rosiglitazone) the FDA will require that GlaxoSmithKline (GSK) develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using...

I’m a 52-year-old type 2 diabetic woman. I’ve been taking Avandamet for several years. My A1c has improved, although I don’t follow a “strict” diabetic diet. My doctor says it’s safe to continue the medication, but given all of the recent press about Avandia, I’m afraid. Should I ask to take Actos instead?

The continuing controversy surrounding the cardiovascular risk of GlaxoSmithKline’s diabetes drug Avandia has led to sharp declines in its use and a surge in sales of the competing drug, Actos. Although the drugs are similar and both had FDA warnings in 2007, Takeda’s Actos has been perceived to be safer for the treatment of type 2 diabetes. Avandia (Rosiglitazone) and Actos (pioglitazone) belong to the same class of drugs, called TZDs or thiazolidinediones. They help the body use insulin more effectively by boosting...

A new study has found that popular diabetes drugs Actos and Avandia boost the risk of fracture in older women. The researchers, lead by William H. Herman, MD, MPH, professor of medicine and epidemiology at the University of Michigan, Ann Arbor, evaluated a large database of managed care patients who had diabetes. He found that those who suffered fractures were more likely to be taking the class of drugs known as TZDs (thiazolidinediones), such as Actos and Avandia. The researchers found that woman over 50 with fractures were...

GlaxoSmithKline confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA  review of recommendations from its  Advisory Committee meeting July 13-14. Patients already enrolled may continue in the trial. This post-marketing study is designed to examine the comparative cardiovascular safety of rosiglitazone (Avandia) and pioglitazone (Actos) in patients with type...

GlaxoSmithKline confirmed that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow the diabetes drug Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions (20) to withdrawal from the U.S. market (12). The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will now be considered...

Avandia Safety Questioned:  The New York Times reports that diabetes drug maker SmithKline did not reveal the results of a study showing its drug Avandia was riskier to the heart than a competing drug, Actos. The New York Times states, “instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.” Experts...

The diabetes drug, Avandia, may be more dangerous than was previously reported.  According to CNN,  a review of Avandia released last week by the FDA states that officials overseeing GlaxoSmithKline Plc’s RECORD study repeatedly submitted sloppy data and failed to follow up on reports of problems in patients — including reports of patient deaths. Next week an FDA panel will debate a series of steps that could include removing Avandia from the market. Avandia is used to control blood sugar levels in diabetics, but its...