Physicians' Academy for Cardiovascular Education

PCSK9 inhibitor reduces CV risk irrespective of age

Effect of alirocumab on cardiovascular outcomes after acute coronary syndromes according to age: an ODYSSEY OUTCOMES trial analysis

Literature - Sinnaeve PR, Schwartz GG, Wojdyla DM et al., - Eur Heart J. 2020. doi: 10.1093/eurheartj/ehz809.

Introduction and methods

Lowering LDL-c with statins reduces CV risk irrespective of age, but evidence is less strong in older patients >75 years. In fact, because older patients are underrepresented in such trials [1], it remains uncertain whether benefits outweigh risks with intensive LDL-c lowering in older patients, particularly after an acute coronary syndrome (ACS). Older patients are less likely to be prescribed lipid-lowering therapies and statin doses are often lower [2]. In addition, older patients in secondary prevention have lower adherence to statins, associated with increased risk of death [3]. For these reasons, additional non-statin therapies might be appealing for older patients with established CAD [4].

The Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab (ODYSSEY OUTCOMES) trial showed a reduction in primary composite endpoint of death from CAD, non-fatal MI, fatal or non-fatal ischemic stroke, or unstable angina requiring hospitalization in patients (n=18924) after treatment with PCSK9 inhibitor alirocumab added to high-intensity or maximum-tolerated statin treatment as compared with placebo [5]. Included patients had been hospitalized with ACS (MI or unstable angina) 1-12 months before randomization, and were randomized to receive 75 mg alirocumab or matching placebo every 2 weeks.

This prespecified analysis of the ODYSSEY OUTCOMES trial assessed the impact of age on occurrence of primary endpoint and on efficacy of alirocumab to lower LDL-c and primary endpoint as compared to placebo. Treatment effects were assessed by analyzing age as categorical variables (prespecified<65 vs. ≥65 years and non-prespecified <75 vs. ≥75 years) and continuous variable.

Main results

Conclusion

In the ODYSSEY OUTCOMES trial, alirocumab added to maximally tolerated high-intensity statins significantly reduced CV risk in patients after ACS irrespective of age. More AEs occurred in older patients as compared to younger patients, but not between treatment groups. In addition, absolute benefit of alirocumab increased with advancing age, suggesting that additional PCSK9i therapy may be an important secondary preventive intervention after ACS in older patients.

References

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Find this article online at Eur Heart J

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