Journal of clinical lipidology · 2025
Effect of olezarsen on routinely measured lipase and amylase levels in familial chylomicronemia syndrome.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Alexander Veronica J, Prohaska Thomas A, Karwatowska-Prokopczuk Ewa, Xia Shuting, Tsimikas Sotirios
Аннотация
BACKGROUND: Olezarsen reduces acute pancreatitis events in patients with familial chylomicronemia syndrome (FCS). Lipase and amylase are biomarkers of acute pancreatitis released by the pancreas.
OBJECTIVE: To assess whether routinely measured plasma levels of lipase and amylase are modified by treatment with olezarsen in patients with FCS.
METHODS: Lipase and amylase were measured at baseline, and days 85, 169, 253, and 365 in patients randomly assigned to placebo, olezarsen 50 mg and 80 mg monthly for 365 days in the Balance trial.
RESULTS: Compared to placebo, significant differences were present in lipase levels in olezarsen 80 mg at days 85 (P = .026), 169 (P = .036) and 253 (P = .036) with a trend at day 365 (P = .096). Average percent change from baseline from day 1 to day 365 revealed a mean (SD) percent increase in lipase of 12.6% (32.4) in placebo, a 6.7% (45.4) increase in olezarsen 50 mg (P = .26 vs placebo) and a reduction of -10.4% (22.7) in olezarsen 80 mg (P = .035 vs placebo) groups. In patients without a reported adverse event of abdominal pain, the placebo group showed a mean percent increase in lipase ranging from 7.91% to 39.1% from day 1 to day 365, olezarsen 50 mg -8.47% to 24.0%, and olezarsen 80 mg -15.4% to -29.6%, leading to significant differences at day 85 (P = .014), day 169 (P = .028), day 253 (P = .008), and day 365 (P = .045) (P-values vs placebo). Changes in amylase mirrored changes in lipase but did not reach statistical significance.
CONCLUSION: Changes in routinely measured lipase levels may reflect subclinical pancreatic injury. Olezarsen favorably modifies changes in lipase in patients with FCS.
OBJECTIVE: To assess whether routinely measured plasma levels of lipase and amylase are modified by treatment with olezarsen in patients with FCS.
METHODS: Lipase and amylase were measured at baseline, and days 85, 169, 253, and 365 in patients randomly assigned to placebo, olezarsen 50 mg and 80 mg monthly for 365 days in the Balance trial.
RESULTS: Compared to placebo, significant differences were present in lipase levels in olezarsen 80 mg at days 85 (P = .026), 169 (P = .036) and 253 (P = .036) with a trend at day 365 (P = .096). Average percent change from baseline from day 1 to day 365 revealed a mean (SD) percent increase in lipase of 12.6% (32.4) in placebo, a 6.7% (45.4) increase in olezarsen 50 mg (P = .26 vs placebo) and a reduction of -10.4% (22.7) in olezarsen 80 mg (P = .035 vs placebo) groups. In patients without a reported adverse event of abdominal pain, the placebo group showed a mean percent increase in lipase ranging from 7.91% to 39.1% from day 1 to day 365, olezarsen 50 mg -8.47% to 24.0%, and olezarsen 80 mg -15.4% to -29.6%, leading to significant differences at day 85 (P = .014), day 169 (P = .028), day 253 (P = .008), and day 365 (P = .045) (P-values vs placebo). Changes in amylase mirrored changes in lipase but did not reach statistical significance.
CONCLUSION: Changes in routinely measured lipase levels may reflect subclinical pancreatic injury. Olezarsen favorably modifies changes in lipase in patients with FCS.