A total of 1,617 patients, of whom 87.6% had established ASCVD and 12.4% had ASCVD risk-equivalents and elevated LDL-C despite treatment with maximally tolerated statins (with or without ezetimibe), were enrolled in the ORION-11 study. Mean age was 65 years; 28% was female and 35% of the cohort had diabetes. Mean baseline LDL-C was 112 mg/dl, and the vast majority of patients (95%) were treated with statins (95% on a high-intensity statin); approximately 7% were treated with ezetimibe. Patients were randomised to a subcutaneous inclisiran sodium 300 mg injection, a second injection after 3 months, and then injections every 6 months thereafter, vs placebo injections. The mean change in LDL-C at 510 days was -49% at the inclisiran group versus -4% in the placebo group (P<0.0001), which translates into a time-averaged 50% reduction in LDL-C for inclisiran vs placebo. Adverse events (AEs) occurred in both groups and the incidence was similar. Localised injection-site AEs were observed in 4.7% of patients who were treated with inclisiran versus 0.5% in those receiving placebo. Most AEs were mild and transient. Serious AEs (SAEs) occurred in 22.3% and 22.5%, respectively. All-cause mortality rates were 1.7% versus 1.9%, respectively. An exploratory cardiovascular endpoint (including cardiac death, any signs or symptoms of cardiac arrest, non-fatal myocardial infarction, or stroke) was observed in 7.8% of patients treated with inclisiran and 10.3% of patients with placebo [1].
1. Ray KK. Impact of inclisiran on LDL-C over 18 months in patients with ASCVD or risk-equivalent - Results of the Phase 3 ORION-11 trial. Abstract 2977. . ESC Congress 2019, 31 Aug-4 Sept, Paris, France.
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