Several Late-Breaking Clinical Trials presented Nov. 15 during AHA 2016 provide new insights on lipid therapies.

In the AEGIS-I Trial, C. Michael Gibson, MS, MD, FACC, et al., evaluated the safety profile of CSL112, an infusible formulation of human apolipoprotein A-I (apoA-I), and characterized its pharmacokinetic/ pharmacodynamic properties among patients with recent acute myocardial infarction. 1,258 patients were randomized to either 2 grams of CSL112, 6 grams of CSL112 or placebo via weekly infusion for four consecutive doses. The results of the study, simultaneously published in Circulation, show that the four weekly infusions of CSL112 are feasible, well-tolerated and not associated with any significant changes in liver or kidney function.

Meanwhile, the MILANO-PILOT Trial, led by Stephen Nicholls, MD, FACC, et al., examined the effect of five 20 mg/kg weekly infusions of MDCO-216 (apoA-I Milano) or placebo on patients with recent acute coronary syndrome. The results of the study show that the infusions of apoA-I Milano were well-tolerated and reduced HDL-C levels in patients receiving the treatment. However, the authors note that “MDCO-216 did not produce a significant effect on coronary disease progression, [and] … the findings from this pilot study do not provide the evidence required to proceed with further development.”

In a third trial evaluating the effectiveness of a unique drug in reducing atherogenic lipoproteins, Sotirios Tsimikas, MD, FACC, et al., found that ionis-angptl3-lRx may show promise for treating elevated triglycerides and LDL-C in patients with elevated cholesterol. In this phase 1/2a study, researchers examined the effects of suppressing ANGPTL3 in 44 healthy volunteers with elevated triglycerides. Results showed that IONIS-ANGPLT3-LRx reduced plasma levels of ANGPTL3 levels up to mean 83 percent.

Keywords: AHA16, American Heart Association, AHA Annual Scientific Sessions, Acute Coronary Syndrome, Apolipoprotein A-I, Lipoproteins, HDL, Myocardial Infarction, Syndrome, Upper Extremity, Atherosclerosis, Biomimetics, Coronary Artery Disease, Homeostasis, Lipids, Pilot Projects, Plasma, Syndrome

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