Journal of clinical lipidology · 2026
Comparative efficacy and safety of olezarsen vs plozasiran for familial chylomicronemia syndrome: A matching-adjusted indirect comparison.
СтатьяСравнительное исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sikora Kessler Asia, Serafini Paul, Pushkarna Divya, Pourrahmat Mir-Masoud, Baum Seth J, Tsimikas Sotirios, Vera-Llonch Montserrat
Аннотация
BACKGROUND: Familial chylomicronemia syndrome (FCS) is a rare genetic form of primary hypertriglyceridemia with an increased risk of acute pancreatitis (AP). Apolipoprotein C-III (apoC-III) inhibitors, olezarsen and plozasiran, provide therapeutic approaches to reduce triglycerides in patients with FCS.
OBJECTIVE: To compare the efficacy and safety of olezarsen (Balance) with plozasiran (PALISADE) in FCS.
METHODS: An anchored matching-adjusted indirect comparison was conducted. Outcome analyses included only the approved dosages of study therapies, while the AP analysis also pooled high- and low-dose regimens.
RESULTS: Analyses showed no statistically significant differences in 52-week efficacy or safety. Mean differences (olezarsen vs plozasiran) in triglycerides and apoC-III reduction were -15.5% (95% CI: -76.2, 45.2) and -8.4% (95% CI: -69.7, 53.0). Relative risks of AP, treatment-emergent, and serious adverse events were 0.70 (95% CI: 0.07, 6.66), 0.81 (95% CI: 0.58, 1.13), and 0.50 (95% CI: 0.10, 2.58).
CONCLUSION: Overall, there was no evidence of differences in efficacy or safety between olezarsen and plozasiran in the treatment of patients with FCS.
OBJECTIVE: To compare the efficacy and safety of olezarsen (Balance) with plozasiran (PALISADE) in FCS.
METHODS: An anchored matching-adjusted indirect comparison was conducted. Outcome analyses included only the approved dosages of study therapies, while the AP analysis also pooled high- and low-dose regimens.
RESULTS: Analyses showed no statistically significant differences in 52-week efficacy or safety. Mean differences (olezarsen vs plozasiran) in triglycerides and apoC-III reduction were -15.5% (95% CI: -76.2, 45.2) and -8.4% (95% CI: -69.7, 53.0). Relative risks of AP, treatment-emergent, and serious adverse events were 0.70 (95% CI: 0.07, 6.66), 0.81 (95% CI: 0.58, 1.13), and 0.50 (95% CI: 0.10, 2.58).
CONCLUSION: Overall, there was no evidence of differences in efficacy or safety between olezarsen and plozasiran in the treatment of patients with FCS.