Patients with acute coronary syndromes (ACS), such as heart attack and recent-onset chest pain, remain at considerable risk of experiencing further serious cardiovascular problems despite improvements in care. HDL ("good" cholesterol) has properties that may protect these patients from further complications by reducing plaque in their coronary arteries.
The results of a study presented at the American College of Cardiology's 56th Annual Scientific Session showed that CSL-111, a drug that mimics HDL, did not significantly reduce plaque in coronary arteries in patients with a recent episode of ACS. However, patients taking the drug showed improvement in two indexes that assess changes in the blood vessels. The study will be simultaneously published in the Journal of the American Medical Association (JAMA) and will appear in the March 28 print issue.
The Effect of Reconstituted High-Density Lipoprotein on Atherosclerosis -- Safety and Efficacy trial, also known as ERASE, was coordinated by the Montreal Heart Institute with 17 sites throughout Canada. In this randomized, blinded clinical trial, 183 patients suffering an ACS event within the previous two weeks received up to four weekly infusions of placebo (n=60), 40 mg/kg (n=111) or 80 mg/kg (n=12) of CSL-111. The higher dosage of CSL-111 was discontinued early because of liver function test abnormalities. Assessment of coronary arteries was performed using intravenous ultrasound (IVUS) at baseline and at two to three weeks after the study infusions. IVUS is a technique in which a tiny ultrasound probe is inserted into the coronary arteries, providing a precise and reproducible method for determining the change in plaque, or atheroma, during treatment. Quantitative coronary angiography also was used to assess changes in the blood vessels.
A total of 145 patients had evaluable, serial IVUS examinations. The difference in reduction in coronary atheroma volume after four weekly infusions of CSL-111 or placebo (-3.4% versus -1.6% respectively) was not significantly different. However, when compared to baseline, the results for patients infused with CSL-111 were statistically significant (p<0.0001).
The plaque characterization indexes on IVUS and coronary score on quantitative coronary angiography were significantly different between the CSL-111 and placebo groups (p=0.01 and 0.03 respectively), suggesting a beneficial effect of CSL-111 on atherosclerosis.
"Short-term infusions of CSL-111 resulted in no significant reduction in change in atheroma volume compared with placebo, but did result in statistically significant improvement in the plaque characterization index and atherosclerosis score on quantitative coronary angiography" said Jean-Claude Tardif, M.D., of the Montreal Heart Institute and lead author of the study. "Elevation of HDL remains a valid target in atherosclerosis and further evaluation of the effects of HDL infusions with CSL-111 on clinical outcomes is warranted."
Dr. Tardif will present the results of "Effect of Reconstituted High-Density Lipoprotein on Atherosclerosis: Safety and Efficacy (The ERASE Trial)" on at the American College of Cardiology's 56th Annual Scientific Session.
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