Washington, DC — Cardiocore, a premier centralized cardiac testing lab, announced today that its Senior Scientist, Nelson Schiller, MD, FACC, presented data regarding the value of echocardiography in anti-diabetic drug development at the American College of Cardiology’s 59th Annual Scientific Session (ACC.10), this week in Atlanta, Georgia.
Dr. Schiller’s scientific poster, Effect of the Dual Peroxisome Proliferator-Activated Receptor PPAR Alpha/Gamma Agonist, Muraglitazar, on Cardiac Structure and Function in Type 2 Diabetic Patients, describes a 555 patient, 87 site, global, Phase-III, sub-study that Cardiocore’s echocardiography (ECHO) experts performed for a Top Ten pharmaceutical company. Co-authors include Cardiocore Vice President of Medical Operations, Polina Voloshko, MD, Cardiocore Head of Echocardiography, Dean Alokozai, MD and UCSF cardiology fellow, Vijay Rao, MD, PhD.
The study’s objective was to investigate the influence of chronic exposure to the dual perixosome-proliferator activated receptor a/g agonist, muraglitazar, compared to glimepiride on cardiac structure and function in type 2 diabetic patients. Data points analyzed by the centralized ECHO core laboratory included left ventricular mass, mass index, ejection fraction, end-systolic volume and end-diastolic volume, following American Society of Echocardiography (ASE) guidelines.
“The results showed that centralized echocardiography may be used to collect valuable, actionable data regarding an anti-diabetic drug’s affect on cardiac function, within a rapid 6-to-12 month sub-study,” explained Dr. Voloshko. She noted, “This use of targeted ECHO testing offers great efficiency to drug developers as they consider implementation of much larger cardiac safety clinical trials per FDA recommendations.”
The FDA issued Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes in December, 2008. This publication recommends that anti-diabetic drug developers conduct late phase studies to assess their drugs’ risk of contributing to major adverse cardiac events (MACE). In most cases, large-scale studies are required to achieve statistical power for identifying MACE risks. Echo sub-studies, such as the one presented this week at ACC.10, may enable sponsors to develop cardiac risk profiles more rapidly and far less expensively.
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