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| 7. Diabetes Medicine Updates |
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| Sanofi's Lantus Isn't Linked to Cancer in FDA Review | |||
In July 2009, FDA issued an Early Communication About Safety of Lantus (insulin glargine) to inform the public that it was reviewing four published observational studies, three of which suggested an increased risk of cancer associated with the use of Lantus. FDA has reviewed the four studies and has determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis. These limitations prevent their ability to attribute the observed cancer risk to Lantus |
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| New Drug for macrovascular complications in diabeteic patients is on its way | |||
Aleglitazar, a New Dual PPAR Agonist showed reduced hyperglycemia and favorably modified levels of HDL-C and triglycerides with an acceptable safety profile in its phase II trial.Agonism of the peroxisome proliferator-activated receptors (PPARs) has long been an attractive target for antidiabetic therapy due to the role of PPARs in glycemic control and lipid metabolism. PPAR-α agonism is the mechanism of action in the fibrate class of medications; these agents have been shown to increase high-density lipoprotein cholesterol (HDL-C) levels, reduce triglyceride levels, and improve cardiovascular outcomes. A large-scale clinical trial of the effect of aleglitazar on cardiovascular death, myocardial infarction, and stroke is currently ongoing. If successful, this investigation may lead to approval of the first agent specifically targeted to reduce the burden of cardiovascular disease in patients with diabetes. |
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