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Makhmudova, U.* ; Schatz, U.* ; Perakakis, N. ; Kassner, U.* ; Schumann, F.* ; Axthelm, C.* ; Stürzebecher, P.* ; Sinning, D.L.* ; Doevelaar, A.* ; Rohn, B.* ; Westhoff, T.* ; Vogt, A.* ; Scholl, M.* ; Kästner, U.* ; Geiling, J.A.* ; Stach, K.* ; Mensch, J.* ; Lorenz, E.* ; Paitazoglou, C.* ; Eitel, I.* ; Baessler, A.* ; Steinhagen-Thiessen, E.* ; Koenig, W.* ; Schulze, P.C.* ; Landmesser, U.* ; Laufs, U.* ; Weingärtner, O.*

High interindividual variability in LDL-cholesterol reductions after inclisiran administration in a real-world multicenter setting in Germany.

Clin. Res. Cardiol. 112, 1639-1649 (2023)

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BACKGROUND AND AIMS: Low-density lipoprotein cholesterol (LDL-C) is the main therapeutic target in the treatment of hypercholesterolemia. Small interfering RNA (siRNA) inclisiran is a new drug, which targets PCSK9 mRNA in the liver, reducing concentrations of circulating LDL-C. In randomized trials, inclisiran demonstrated a substantial reduction in LDL-C. The German Inclisiran Network (GIN) aims to evaluate LDL-C reductions in a real-world cohort of patients treated with inclisiran in Germany. METHODS: Patients who received inclisiran in 14 lipid clinics in Germany for elevated LDL-C levels between February 2021 and July 2022 were included in this analysis. We described baseline characteristics, individual LDL-C changes (%) and side effects in 153 patients 3 months (n = 153) and 9 months (n = 79) after inclisiran administration. RESULTS: Since all patients were referred to specialized lipid clinics, only one-third were on statin therapy due to statin intolerance. The median LDL-C reduction was 35.5% at 3 months and 26.5% at 9 months. In patients previously treated with PCSK9 antibody (PCSK9-mAb), LDL-C reductions were less effective than in PCSK9-mAb-naïve patients (23.6% vs. 41.1% at 3 months). Concomitant statin treatment was associated with more effective LDL-C lowering. There was a high interindividual variability in LDL-C changes from baseline. Altogether, inclisiran was well-tolerated, and side effects were rare (5.9%). CONCLUSION: In this real-world patient population referred to German lipid clinics for elevated LDL-C levels, inclisiran demonstrated a high interindividual variability in LDL-C reductions. Further research is warranted to elucidate reasons for the interindividual variability in drug efficacy.

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