MONDAY, June 3, 2024 (HealthDay News) -- For individuals with mixed hyperlipidemia, plozasiran reduces triglyceride levels at 24 weeks, according to a study published online May 28 in the New England Journal of Medicine.
Christie M. Ballantyne, M.D., from the Baylor College of Medicine and Texas Heart Institute in Houston, and colleagues conducted a 48-week, randomized trial assessing the safety and efficacy of plozasiran in 353 patients with mixed hyperlipidemia. Within each of four cohorts, participants were assigned to receive plozasiran or placebo in a 3:1 ratio. In the first three cohorts, participants received 10-, 25-, or 50-mg subcutaneous injections of plozasiran or placebo on day 1 and week 12 (quarterly dose), while participants received 50 mg plozasiran or placebo on day 1 and week 24 (half-yearly dose) in the fourth cohort.
The researchers identified significant reductions in the fasting triglyceride level with plozasiran at week 24, with differences in the least-squares mean percent change from baseline of −49.8, −56.0, −62.4, and −44.2 percentage points with the 10-mg, 25-mg, and 50-mg quarterly doses and the 50-mg half-yearly dose, respectively, compared with placebo. Ten percent of those receiving placebo had worsening glycemic control, as did 12, 7, 20, and 21 percent of those receiving the 10-, 25-, and 50-mg quarterly doses and the 50-mg half-yearly dose, respectively.
"This trial has helped in laying the groundwork for a more extensive outcomes trial, which would more rigorously test whether plozasiran reduces levels of non-high-density lipoprotein cholesterol and cholesterol remnants and the risk of atherosclerotic cardiovascular disease," the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Arrowhead, which manufactures plozasiran and funded the study.
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