PCSK9 inhibition in clinical practice: Treatment patterns and attainment of lipid goals in a large health maintenance organization

BACKGROUND: Proprotein convertase subtilisin/kexin type-9 inhibitors (PCSK9i) effec-tively reduce low-density lipoprotein cholesterol (LDL-C), improving cardiovascular outcomes inclin-ical trials when added to statin therapy. OBJECTIVES: As real-world evidence is lacking, we aimed to evaluate treatment and adherence pat-terns using PCSK9i in clinical practice. METHODS: We investigated 1600 patients initiating PCSK9i between January 2016 and December 2019 in a large health maintenance organization. Treatment discontinuation was defined as a gap >= 60 days between last days' supply of one prescription and the start of the next. Re-initiation rates as well as proportion of days covered (PDC) over 1-year period and attainment of lipid goals under PCSK9i, were analyzed. RESULTS: Evolocumab 140 mg was initiated by 50.7%, alirocumab 75 mg by 29.5% and 150 mg by 19.8%. Cumulative discontinuation rates were 28.1% after 6-months and 49.9% after 3-years. Over-all, 58% of the patients that discontinued therapy have re-initiated PCSK9i (31% after 3-months from discontinuation). Mean PDC over 1-year of therapy was 56% +/- 29, with PDC >= 80% evident in 29%. Of those with established cardiovascular disease (n = 991), 55% achieved LDL-C<70 mg/dL and 38% LDL-C<55 mg/dL. Attainment rates were lower in patients with PDC<80%, baseline LDL-C>190 mg/dL and in those not treated with concurrent statin therapy. CONCLUSIONS: In real-world practice of patients treated by PCSK9i, high proportion of early treat-ment discontinuation was evident, with non-negligible re-initiation rates but overall low medication coverage over time. This have contributed to sub-optimal attainment of LDL-C treatment goals, particularly observed in patients with severe hypercholesterolemia, inadequate drug adherence, and those using PCSK9i as monotherapy. (C) 2020 National Lipid Association. All rights reserved.

Automated summary

The study found that in real-world clinical practice, there is a high proportion of early treatment discontinuation, with some patients re-initiating treatment but overall low medication coverage. This has resulted in suboptimal attainment of LDL-C treatment goals, particularly among patients with severe hypercholesterolemia or inadequate drug adherence.