
A post hoc analysis of completed and ongoing trials (ORION-1, -3, -5, -9, -10, -11, -8) involving 3,576 patients treated with inclisiran for up to 6 years and 1,968 patients with placebo for 1.5 years demonstrated its long-term safety. The incidences of treatment-emergent adverse events (TEAEs), abnormal laboratory measures, and antidrug antibodies were comparable between inclisiran and placebo groups. Major cardiovascular events reported as TEAEs were numerically fewer with inclisiran. Overall, inclisiran showed a well-tolerated safety profile in diverse dyslipidemia patients without new concerns.
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