Top selling diabetes drug to carry back box warning

October 21, 2017

Avandia (rosiglitazone) is a drug used by many with type 2 diabetes and is designed to make the body more sensitive to insulin.

The warning says the diabetes drug could cause chest pain or heart attacks.

The FDA says drug company GlaxoSmithKline will conduct a trial comparing Avandia with another rival drug Actos produced by Takeda in order to establish if the risks are unique to Avandia.

The study which will begin next year, will not be completed until 2014, but the FDA will review the data as the study progresses for any indication something is amiss.

Doctors are being advised to closely monitor patients taking Avandia for any heart effects.

The FDA says it is allowing Avandia to remain on the market because the evidence of the risk for heart attack or cardiac ischemia, though higher than for other type-2 diabetes drugs, is inconclusive.

The FDA says studies already conducted which appear to show a risk, compare Avandia to a placebo; the top-selling diabetes drug has been under scrutiny since a U.S. analysis last May linked it to a 43 percent higher risk of heart attack in patients.

Glaxo's chief medical office Dr. Ronald Krall, says Avandia remains a safe and effective medicine for most patients with type-2 diabetes when it is used appropriately.

FDA officials insist they carried out a comprehensive consultation process before allowing Avandia to remain on the market.

Apparently two different advisory committees took part in the decision making and a very broad range of opinions were considered.

The FDA says drugs such as Avandia were not meant to reduce the heart risks caused by diabetes.

In 2006 Avandia was Glaxo's second-biggest seller with sales of $3 billion.

Using a synthetic elastic layer that is similar to a real blood vessel wall, endothelial cells are plated on the top surface and smooth muscle cells on the bottom surface. Then, the different blood flow patterns modeled from human circulation are applied to the endothelial cells through rotation of a motor-driven cone system. The findings: the blood flow can influence both endothelial and smooth muscle cell behaviors.

When subjected to atheroprotective blood flow patterns, the endothelial cells aligned with the direction of the blood flow, and the smooth muscle cells aligned perpendicularly to the flow as is true in a healthy blood vessel. In stark contrast, the atheroprone type of flow caused the endothelial cells to move away from their parallel structure while smooth muscle cells moved away from their perpendicular structure. This remodeling mimics the early phases of the diseased state of the artery; the blood flow pattern associated with atheroprone areas resulted in inflammation in both cells reminiscent of early hallmarks of atherosclerosis. This was confirmed through evaluating gene and protein expression profiles in both cell types.

"The results of this study validate the use of this novel co-culture system as a relevant biomimetic vascular model for studying early atherosclerotic events," said Tom Skalak, professor and chair of the U.Va. Department of Biomedical Engineering. "The cells' responses to these carefully controlled models of blood flow can now be used to develop therapeutic interventions for detection and treatment of vascular diseases ?? it has the potential to be revolutionary."

Blackman,Wamhoff, and Dr. Norbert Leitinger (department of pharmacology) have formed a collaborative entity ?? the Laboratory of Atherogenesis ?? to begin using the HemoShear system to make these translatable discoveries in atherosclerosis.

A provisional patent has been filed for HemoShear 2.0. The research that HemoShear 2.0 made possible was spearheaded by a biomedical engineering graduate student, Nicole Hastings ('08), and is published in the American Journal of Physiology ?? Cell Physiology.


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