The experimental apolipoprotein A1(apoA1) inducer, RVX-208, hoped to increase high-density lipoprotein (HDL) and reduce arterial plaque, failed to do so in the ApoA1 Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation (ASSURE)study. The data were presented at ESC, held in August-September in Amsterdam.
Investigators at the South Australian Health and Medical Research Institute and the Royal Adelaide Hospital in Adelaide, Australia conducted ASSURE, a prospective, randomized, double-blind clinical trial carried out at 60 centers. In it, researchers randomized 323 patients with low HDL and coronary disease who had a target blood vessel for imaging with less than 50% stenosis. All patients received treatment with either atorvastatin 10-40 mg daily or rosuvastatin 5-20 mg daily during the study and were also randomized to receive either RVX-208 100 mg (n=244) or placebo (n=80) twice daily for 26 weeks.
The primary and secondary outcomes of the study were change from baseline in percent atheroma volume (PAV) and normalized total atheroma (TAV), both measures of the amount of plaque present in the coronary artery. Intravascular ultrasonography was used at baseline and the end of the study to measure the outcomes. Of the 281 patients that remained in the study and had this imaging, while a trend towards plaque regression was observed with RVX-208 compared with baseline,there was no significant difference in efficacy outcomes between the groups.Further,there were more discontinuations due to adverse events in the RVX-280 group(3.7% vs 2.5%) as well as significantly more elevations of liver enzymes at triple the normal limit or more (7.0% vs 0%, P=0.009).