Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial.

ABSTRACT:

Aims

Data describing the long-term efficacy and tolerability of inclisiran are limited. This was explored in ORION-8, an open-label extension of preceding Phase 2 and Phase 3 placebo-controlled and open-label extension trials.

Methods and results

Following completion of the parent trial, adult patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalent, or heterozygous familial hypercholesterolaemia received open-label inclisiran twice yearly (after initial and 3-month doses) until Day 990, followed by an end-of-study visit at Day 1080 or ≥ 90 days after the last dose. The study endpoints included the proportion of patients achieving pre-specified low-density lipoprotein cholesterol (LDL-C) goals [ASCVD: < 1.8 mmol/L (< 70 mg/dL); ASCVD risk equivalen

SUBMITTER: Wright RS 

PROVIDER: S-EPMC11481169 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature