It’s not all bad news for rosiglitazone

June 17, 2009 by  
Filed under DIABETES

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capsuleRemember the controversy about the diabetic drug rosiglitazone (market name Avandia)? Remember the issues surrounding the APPROACH Trial – Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in Type 2 Diabetes Patients with Cardiovascular History? The drug was thought to increase cardiovascular risk, which brings to mind the problems faced by Vioxx.

Well, it seems that new trials indicate that it is not all bad news about rosiglitazone. In a late-breaking clinical trial using IVUS technology, rosiglitazone was compared with another diabetic drug glipizide. The trial’s primary endpoint, which is “a significant difference in percent atheroma, or plaque, buildup in coronary arteries“, was not met, but it did bring up some good points about rosiglitazone, especially with the secondary end points. The recent results show that:

IVUS stands for intravascular ultrasound and is the world’s largest study of diabetic patients with established coronary artery disease (CAD). The study involved 672 patients from 92 hospitals in 19 countries worldwide. The effect of diabetic drugs on the progression of CAD was assessed using the intravascular ultrasound technique. This was done by measuring the plaque burden using IVUS in a 40 mm segment of an atherosclerotic artery which hasn’t undergone any intervention because level of plaque build up was considered to be too low to require treatment.

People suffering from diabetes have increased risks for atherosclerosis, heart attack, stroke, and other cardiovascular disorders. Diabetes a metabolic disorder which interferes with blood sugar metabolism due to problems with insulin, the hormone produced by pancreas needed to metabolize glucose in the blood.

About the two drugs:

Rosiglitazone is a member of the thiazolidinedione class of diabetes drugs. It works by making the cells of the body more sensitive to insulin. In addition, the drug also has a positive impact on blood pressure, high density lipoprotein (HDL “good”) cholesterol and has anti-inflammatory properties. However, in 2007, the US FDA issued warnings about rosiglitazone increasing risk of cardiac events.

In a more recent report, the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial reports that rosiglitazone “does not increase overall cardiovascular risk.

Glipizide belongs to the sulfonylurea class of insulin secretagogues. It works by inducing the pancreas to secrete more insulin. It has been on the market for more than 40 years.

Photo credit: stock.xchng

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