Another PCSK9 inhibitor safely reduces MACE in long term outcomes trial in high-risk patients
The ODYSSEY OUTCOMES Trial: Topline Results - Alirocumab in Patients After Acute Coronary Syndrome
Presented at ACC.18 by Ph. Gabriel Steg (Paris, France)News - Mar. 9, 2018
- Patients on alirocumab showed 62.7% decrease of LDL-c after 4 months, which represents 55.7 mg/dL reduction compared with placebo, and 54.7% at 48 months after randomization (48.1 mg/dL lower than placebo).
- Treatment with alirocumab lowered the primary efficacy endpoint of MACE by 15% over the study period (HR: 0.85, 95%CI: 0.78-0.93, P=0.0003, absolute risk reduction (ARR): 1.7%).
- Of the components of the primary MACE endpoint, CHD death was not significantly reduced (HR: 0.92, 95%CI: 0.76-1.11, P=0.38), but the other components were: non-fatal MI: HR: 0.86 (95%CI: 0.77-0.96, P=0.006), ischemic stroke: HR: 0.73 (95%CI: 0.57-0.93, P=0.01) and unstable angina: HR: 0.61 (95%CI: 0.41-0.92, P=0.02).
- All-cause death was significantly reduced with alirocumab treatment as compared with placebo, but it should be noted that this was not a primary outcome (HR: 0.85, 95%CI: 0.73-0.98, nominal P=0.026, ARR: 0.6%).
- Analysis of the subgroup of patients with baseline LDL-c ≥100 mg/dL showed that these patients benefitted more from treatment with alirocumab than the overall cohort, with MACE showing a 24% reduction (HR: 0.76, 95%CI: 0.65-0.87, ARR: 3.4%, NNT: 29) and all-cause death 29% (HR: 0.71, 95%CI: 0.56-0.90, ARR: 1.7%, NNT: 60).
- Safety events were generally similar between treatment arms (including diabetes worsening or diabetic complications, new onset diabetes, allergic reactions and neurocognitive disorders), without new safety signals. Patients treated with alirocumab did show more local injection site reactions (3.8% vs. 2.1% on placebo).
These results of the ODYSSEY OUTCOMES study show that compared with placebo, in patients with recent ACS, alirocumab 75 or 150 mg Q2W reduced the primary endpoint of MACE. Moreover, a secondary analysis showed that alirocumab treatment was associated with a lower rate of all-cause death. Treatment with this PCSK9 inhibitor was safe and well tolerated over the duration of the trial.
Our coverage of ACC.18 is based on the information provided during the congress.