Lipoprotein(a) Reduction in Persons with Cardiovascular Disease
Sotirios Tsimikas, Ewa Karwatowska‐Prokopczuk, Ioanna Gouni‐Berthold, Jean‐Claude Tardif, Seth J. Baum, Elizabeth Steinhagen-Thiessen, Michael D. Shapiro, Erik S.G. Stroes, Patrick M. Moriarty, Børge G. Nordestgaard, Shuting Xia, Jonathan Guerriero, Nicholas J. Viney, Louis O’Dea, Joseph L. Witztum
Abstract
BACKGROUND: Lipoprotein(a) levels are genetically determined and, when elevated, are a risk factor for cardiovascular disease and aortic stenosis. There are no approved pharmacologic therapies to lower lipoprotein(a) levels. METHODS: (20, 40, or 60 mg every 4 weeks; 20 mg every 2 weeks; or 20 mg every week), or saline placebo subcutaneously for 6 to 12 months. The lipoprotein(a) level was measured with an isoform-independent assay. The primary end point was the percent change in lipoprotein(a) level from baseline to month 6 of exposure (week 25 in the groups that received monthly doses and week 27 in the groups that received more frequent doses). RESULTS: dose and placebo with respect to platelet counts, liver and renal measures, or influenza-like symptoms. The most common adverse events were injection-site reactions. CONCLUSIONS: reduced lipoprotein(a) levels in a dose-dependent manner in patients who had elevated lipoprotein(a) levels and established cardiovascular disease. (Funded by Akcea Therapeutics; ClinicalTrials.gov number, NCT03070782.).