Posts Tagged ‘Avandia’

A new analysis of several previous studies confirms that taking rosiglitazone, more commonly known as Avandia, actually increases the chances of having a heart attack but not the risk of dying of a cardiovascular cause. The study is published online ahead of print in the Archives of Internal Medicine. Here is some information about rosiglitazone: • It is a drug used to treat type 2 diabetes, which works by helping to increase the body’s sensitivity to insulin • Insulin helps the cells of the body absorb sugar, so the increased sensitivity to insulin helps reduce the abnormally high blood sugar levels seen in type 2 diabetes • Controversy has surrounded the drug in the past few years because of early studies suggesting it might increase the risk of heart attack and perhaps death from cardiovascular causes Researchers from The Cleveland Clinic Foundation analyzed data taken from 56 studies looking at the effects of rosiglitazone on cardiovascular adverse events, such as heart attacks and strokes. More than 35000 patients were included in these studies. Taking rosiglitazone was associated with a 28% increased risk of having a heart attack. The risk of dying from a cardiovascular cause was not higher among those taking this drug, however. We spoke with Dr. Steve Nissen, one of the investigator’s of this study, who offered some further insight. Today’s research confirms earlier findings that the risks of taking rosiglitazone may well outweigh the benefits.

A low dose combination of two antidiabetes medications may help stave off the development of type 2 diabetes among individuals with impaired glucose tolerance (IGT), according to research published online ahead of print in The Lancet. Here is some information about IGT: • It is a condition in which blood sugar (or glucose) levels are above normal but below those seen among those with diabetes • It is considered to be a pre-diabetes state, with many who suffer from the condition going on to develop type 2 diabetes • It is associated with a combination of impaired sensitivity to insulin and reduced release of insulin by the body Researchers from the University of Toronto randomly assigned over 200 individuals with IGT to receive a daily low dose of the antidiabetes drugs rosiglitazone, commonly known as Avandia, and metformin, commonly known as Glucophage, or a placebo. Treatment continued for an average of about four years, and the participants were regularly assessed for the presence of diabetes. Only 14% of those who took the medications developed diabetes, compared with 39% of those taking a placebo. This means that only four individuals with IGT would need to take the drugs for one case of type 2 diabetes to be prevented. In addition, 80% of those taking the medications actually developed a normal response to glucose, compared with only 53% of those on placebo. And while impaired sensitivity to insulin remained stable among those receiving treatment, it worsened among …

FDA Restricts Glaxo Diabetes Drug Avandia
The FDA restricts access to GlaxoSmithKline’s diabetes drug Avandia as questions arise about the drug’s safety.

FDA Announces It Will Significantly Restrict Access to the Diabetes Drug Avandia
The American Diabetes Association, the Endocrine Society and the American Association of Clinical Endocrinologists Joint Statement in Response to the FDA Decision to Restrict the Use of Avandia (rosiglitazone) in the U.S.

FDA Issues Hold On Debated Avandia Study
Federal health officials are barring new patients from enrolling in a safety study of GlaxoSmithKline’s controversial diabetes pill Avandia, a week after a panel of experts ruled that the drug increases heart risks.

US FDA panel recommends to keep GSK’s Avandia on market
GlaxoSmithKline confirmed a joint advisory committee to the US Food and Drug Administration (FDA) voted to allow Avandia to remain on the market.

FDA panel sees greater heart risks with Avandia
WASHINGTON – Federal health experts said today that the much-debated diabetes pill Avandia increases the risk of heart attack compared to other diabetes drugs.

Avandia Stays on the Market, But for How Long?
Although a federal advisory committee recommended continuing sales of Avandia, the vote could still be a devastating blow to the troubled antidiabetes medication

Avandia Survives, As Experts Support Continued Sales, With Caveats
A majority of experts on a panel advising the FDA voted to keep the controversial diabetes drug Avandia available for sale with tougher warnings. But a sizable minority called for withdrawing it.

Avandia: The Key Vote Is Negative
A liveblog of the vote on whether to keep the drug on the market.