Alirocumab lowers major adverse CV event risk in ACS irrespective of statin intensity
Alirocumab reduced the relative risk for major adverse CV events in patients after ACS regardless of background statin treatment, researchers found in the ODYSSEY OUTCOMES trial.
Patients with ACS, dyslipidemia
In the randomized trial published in the European Journal of Preventive Cardiology, Rafael Diaz, MD, director of Estudios Clínicos Latino América at Instituto Cardiovascular de Rosario in Argentina, and colleagues analyzed data from 18,924 patients with ACS and dyslipidemia even with statin therapy from the ODYSSEY OUTCOMES trial. Patients were assigned alirocumab (Praluent, Sanofi/Regeneron; n = 9,462) or placebo (n = 9,462).
As Healio previously reported, the ODYSSEY OUTCOMES trial found that reducing LDL to very low levels with the PCSK9 inhibitor alirocumab lowered risk for major adverse CV events and all-cause mortality in patients with ACS on statin therapy compared with placebo.
Major adverse CV events, the primary outcome for the trial, were defined as a composite of CHD death, fatal or nonfatal ischemic stroke, nonfatal MI or unstable angina requiring hospitalization. Patients were followed up for a median of 2.8 years.
At baseline, 88.8% were taking high-intensity statin treatment (median baseline LDL, 86 mg/dL), 8.7% were taking low- to moderate-intensity statin treatment (median baseline LDL, 89 mg/dL) and 2.4% were not on background statin treatment (139 mg/dL; P < .001).
Although alirocumab led to similar relative LDL reductions from baseline across the statin treatment subgroups, the mean absolute reductions differed in patients on high-intensity statins (52.9 mg/dL), low- to moderate-intensity statins (56.7 mg/dL) and no statins (86.1 mg/dL; P < .001).
Major adverse CV events in patients assigned placebo occurred in 10.8% in the high-intensity statin group, 10.7% in the low- to moderate-intensity statin group and 26% in the no statin group. In contrast, patients assigned alirocumab had reductions in major adverse CV events in those taking high-intensity statins (HR = 0.88; 95% CI, 0.8-0.96), low- to moderate-intensity statins (HR = 0.68; 95% CI, 0.49-0.94) and no statins (HR = 0.65; 95% CI, 0.44-0.97; P for interaction = .14).
Compared with placebo, alirocumab led to absolute risk reductions of 1.25% in the high-intensity statin group (95% CI, 0.34-2.16), 3.16% in the low- to moderate-intensity statin group (95% CI, 0.38-5.95) and 7.97% in the no statin group (95% CI, 0.42-15.51; P for interaction = .106). This corresponded to a number needed to treat, for 2.8 years, of 13 for patients taking high-intensity statins, 32 for those taking low- to moderate-intensity statins and 80 for patients not taking statins.
‘Effective therapeutic option’
“The present data indicate that statin intolerance is associated with a markedly elevated cardiovascular risk in patients with recent ACS,” Diaz and colleagues wrote. “Major adverse CV events [were] reduced regardless of statin intolerance or statin intensity. The availability of lipid-lowering treatment with the PCSK9 inhibitor alirocumab provides and effective therapeutic option for this group of patients to reduce major adverse CV events.”