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Cardiovascular Side Effects of Pioglitazone and Rosiglitazone Linked to Vascular and Energy Pathways by Genomas Clinical Study
Date:1/21/2009

Basis Established for DNA-Guided Decision Support in Diabetes Drug Therapy

HARTFORD, Conn., Jan. 21 /PRNewswire/ -- Research by Genomas has shown statistically significant associations of certain genes in vascular and energy pathways to body mass index (BMI) and edema (fluid retention) in patients taking the thiazolidinedione (TZD) drugs pioglitazone and rosiglitazone. The study, co-authored with investigators from Joslin Diabetes Center Affiliate at The Hospital of Central Connecticut, Hartford Hospital and Yale, appears in the February 2009 issue of the leading laboratory medicine journal Clinica Chimica Acta. The findings are being used to develop a DNA-guided decision support system for diabetic pharmacotherapy.

TZDs are powerful diabetes drugs currently utilized in patients failing first-line therapy with metformin and sulfonylureas. Patients given TZDs typically are at greater risk of diabetic complications and represent an advanced stage of the disease. However, TZDs have been observed to have side effects of weight gain and abdominal obesity, which exacerbate the diabetic condition itself, and to cause edema and exacerbate congestive heart failure in certain patients. Individuals vary in their risk and there is no known method for predicting such side effects. FDA-mandated "black box" warnings on the drug labels underscore the urgent need to better understand the mechanisms underlying these potentially serious side effects. Uncertainties surrounding the use of these drugs may place patients at risk, reduce patient compliance, burden medical management and increase healthcare costs.

The study involved an analysis of patients taking either pioglitazone or rosiglitazone. A total of 222 cardiometabolic and neuroendocrine genes were selected and a physiogenomic analysis was performed. For BMI, the strongest associations were found among genes involved in energy homeostasis, adiposity, glucose metabolism, and lipid metabolism. For edema, associations were found among the genes involved in vascular inflammation or regulation, lipid metabolism and glucose metabolism.

"For the first time in diabetic care, we can assess that genes in interlocking cardiometabolic and neuroendocrine pathways can be integrated into a PhyzioType System, a multi-gene array and clinical model predictive of drug side effects," said Gualberto Ruano, M.D., Ph.D., President and CEO of Genomas. "Our existing PhyzioType Systems for statin neuro-myopathy and antipsychotic-related diabetes are now being complemented by a third one for TZD-induced cardiovascular side effects for comprehensive DNA-guided medicine in modern healthcare."

ABOUT GENOMAS

Genomas(R) Inc. is a biomedical company advancing DNA-guided medicine and personalized healthcare. The company develops revolutionary PhyzioType(TM) Systems for DNA-guided diagnosis and prevention of metabolic disorders induced by drugs used to treat diabetes, and cardiovascular and psychiatric illnesses. PhyzioType Systems are designed to provide physicians with an unprecedented capability to select for each patient the safest drug treatment to enhance compliance. Genomas is located in Hartford, CT on the campus of Hartford Hospital. Please visit www.genomas.net for more information.


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SOURCE Genomas Inc.
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