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Cleveland Clinic research finds no benefit over placebo in ASSURE trial
Date:9/8/2013

Monday, Sept. 3, 2013, Cleveland: Patients with coronary artery disease and low levels of "good cholesterol or high-density lipoprotein (HDL) who were treated with a drug designed to increase HDL levels and reduce coronary plaque build-up, experienced no better results than those treated with placebo, according to research conducted by the Cleveland Clinic Coordinating Center for Clinical Research (C5Research).

The drug, RVX-208, induces the production of apolipoprotein A1 (apoA1), a major protein in HDL. Prior research has shown that higher levels of HDL are associated with improved coronary health, so the ASSURE trial was designed to test whether increased production of apoA1 with the drug RVX-208 would raise HDL levels and slow the progression of coronary atherosclerosis, or plaque build-up in the coronary arteries.

The results of the ASSURE (ApoA1 Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation) trial were presented at the European Society of Cardiology Congress 2013. ASSURE was a prospective, randomized, multicenter, double-blind clinical trial.

A team of researchers led by Stephen J. Nicholls, M.D., Ph.D., senior consultant to Cleveland Clinic's C5Research and Professor of Cardiology and Deputy Director at the South Australian Health & Medical Research Institute (SAHMRI) in Adelaide, Australia, used intravascular ultrasonography (IVUS) to assess the degree of coronary disease in study subjects at baseline and after 26 weeks on oral RVX-208 or placebo. IVUS is a medical imaging technology in which a small ultrasound probe is inserted via a catheter into an artery, allowing physicians to examine the inside of arteries via sonogram. The researchers also took baseline and 26-week measurements of apoA1 and HDL.

The primary endpoint the change in percent atheroma volume (PAV), or the amount of artery volume taken up by disease was not met. The PAV decreased by 0.4 perc
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Contact: Wyatt DuBois
duboisw@ccf.org
216-445-9946
Cleveland Clinic
Source:Eurekalert

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