A significant majority-20 of 26 members attending a combined meeting of FDA advisory committees-has voted to modify or remove the current restrictive label and distribution regulations affecting the type 2 drug Avandia.
The Food and Drug Administration has approved US sale of generic pioglitazone (trade name Actos) for the treatment of type 2 diabetes. Actos, originally developed and trademarked by Takeda Pharmaceuticals, works by decreasing insulin resistance in type 2 patients. The prescription drug, which belongs to the class of drugs known as thiazolidinediones (TZDs), has enjoyed great commercial success in the United States since its introduction in 1999, posting estimated sales last year of $2.7 billion.
A recent article in the Chicago Tribune reports that patients using Lipitor, Actos, or Plavix may start enjoying savings of up to 90 percent as patents on those drugs expire. The three drugs comprise a significant percentage of the $300 billion brand-name U.S. pharmaceutical market, according to the Tribune.
The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
Scientists have identified five genetic biomarkers that predict how well a type 2 patient will respond to the drug Actos. Their work could be the first step toward a system that would allow doctors to predetermine which drugs will best help each person with diabetes.
Results from DURATION-2, a 26-week test comparing the diabetic drugs Januvia, Actos, and experimental long-acting Byetta (Byetta LAR) show that Byetta produced lower A1c's and more weight loss than the other two drugs.
Physicians who treat people with type 2 diabetes face difficult choices when selecting the best medical therapy for each patient. The decision process is further complicated by the fact that because type 2 diabetes is a progressive disease, therapeutic agents that were initially successful may fail five or ten years later.
The FDA has spoken: the heart risk warnings on labels of Avandia (rosiglitazone) and Actos (pioglitazone) will now be surrounded by an emphatic black outline known as a black box. Black boxes will also be added to the warnings on Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepiride).
The September 2007 Journal of the American Medical Association (JAMA) has published two new studies, one a meta-analysis of Avandia (rosiglitazone) and the other a meta-analysis of Actos (pioglitazone).
On July 30, 2007, a Food and Drug Administration (FDA) panel voted 22 to 1 to keep Avandia on the market, right after agreeing by a vote of 20 to 3 that Avandia does increase heart risks. Now the FDA will decide what kind of warning should appear on the Actos and Avandia labels. It has already called for a black box warning, the sternest possible, on Avandia.
Analysis of several recent studies indicates that Avandia (rosiglitazone), a type 2 diabetes medication that's been taken by more than six million people worldwide, is associated with a 43 percent increased risk of heart attack and with a borderline-significant increased risk of heart attack-related death.
New Zealand researchers say that in clinical trials of people with type 2 diabetes, Actos as stand-alone therapy or in combination with metformin, repaglinide, insulin or a sulphonylurea induced “both long- and short-term improvements in [blood glucose] control and serum lipid profiles.”
It was the belle of the ball at last summer’s ADA Scientific Sessions in San Diego. Now it appears that muraglitazar (Pargluva) is clinging to life after a scathing report recently published by the Journal of the American Medical Association.
Actos (pioglitazone HCl) is an oral agent for type 2 diabetes belonging to the thiazolidinedione (TZD) class of drugs. TZDs help lower insulin resistance, a core dysfunction in people with type 2. They act by helping the body use its available amounts of insulin more effectively. Actos is known as an “insulin sensitizer” because it directly targets insulin resistance, a condition in which the body cannot use the insulin it produces efficiently.
Actos, an insulin sensitizer in the glitazone class of type 2 oral diabetes medications, was found to reduce carotid artery intima-media thickness (IMT) as well as insulin resistance in a German study.
A shift in fat distribution from visceral (the internal abdominal area) to subcutaneous (under the skin) could be the reason the insulin sensitizer Actos (pioglitazone) helps to lower blood-glucose levels in people with insulin resistance.
A shift in fat distribution from visceral (the internal abdominal area) to subcutaneous (under the skin) could be the reason the insulin sensitizer Actos (pioglitazone) helps to lower blood glucose levels in people with insulin resistance.
Once again, Diabetes Health has read through more than 2,500 abstracts of research presented at the American Diabetes Association's annual Scientific Sessions and selected a few of the more interesting ones to pass along to you as part of our annual "Research Extravaganza" feature.
Two new drugs have received approval from the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes. In clinical trials, Avandia (rosiglitazone maleate) and ACTOS (pioglitazone hydrochloride) lowered blood sugars an average of 76 mg/dl and 95 mg/dl respectively, when compared to a placebo.
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