Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w
Statin and PSCK9-inhibitor treatment affect LDL-C reductions in patients treated with inclisiran in a real-world multi-center setting in Germany
U. Makhmudova1, U. Schatz2, U. Kassner3, K. Stach-Jablonski4, P. Stürzebecher5, D. Sinning6, A. Vogt7, T. Westhoff8, C. Axthelm9, M. Scholl10, C. Paitazoglou11, I. Eitel11, E. Steinhagen-Thiessen3, W. Koenig12, C. Schulze1, U. Landmesser6, U. Laufs5, O. Weingärtner1, für die Studiengruppe: GIN
1Klinik für Innere Medizin I - Kardiologie, Universitätsklinikum Jena, Jena; 2Medizinische Klinik & Poliklinik III, Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden; 3Klinik für Endokrinologie und Stoffwechselerkrankungen, Charité - Universitätsmedizin, Berlin; 4V. Medizinische Klinik, Universitätsklinikum Mannheim, Mannheim; 5Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig; 6CC 11: Med. Klinik für Kardiologie, Charité - Universitätsmedizin Berlin, Berlin; 7Medizinische Klinik und Poliklinik München, MU Klinikum München Campus Großhadern, München; 8Medizinische Klinik I, Marien Hospital Herne, Herne; 9Cardiologicum Dresden und Pirna, Prina; 10Medizinisches Versorgungszentrum, Mühlhausen; 11Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Lübeck; 12Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München;

Background: The aim of this retrospective, multi-center analysis was to use individual patient data to determine the variability in LDL-C reductions after inclisiran administration in a "real-world" setting.
Methods: Since February 2021 the German Inclisiran Network (GIN) enrolled 143 patients who were referred to lipid clinics in Germany for elevated LDL-C levels. Inclisiran was administered to a broad range of patients with elevated LDL-C who were on statins, ezetimibe, bempedoic acid, on lipoprotein apheresis, as well as to patients who were naive to lipid-lowering drugs.
Results: Mean LDL-C at baseline was 3.7 mmol/L (IQR 2.4-5.0). Inclisiran reduced LDL-C in this special patient cohort by 33.5 % (95% CI, -29 to 37.5) after 3 months and by 28.7 % (95% CI, -22.3 to 34.7) after 9 months. Fifty-four patients (37.8%) had received PCSK9-mAbs in the past and these patients were characterized by less effective LDL-C lowering (22.3 % vs. 40.3 %; p=0.000003), whereas patients on statins+ezetimibe demonstrated more effective LDL-C reductions (47.2 % vs. 30.7 %; p=0003).There was a high inter-individual variability in LDL-C reductions (figure 1 a, 1 b). Inclisiran was well tolerated without any serious side-effects.
Conclusion: This special patient population referred to lipid clinics in Germany for elevated LDL-C levels is characterized by a high inter-individual variability in LDL-C reductions. Further research is warranted to elucidate reasons for the high inter-individual variability in this "real-world" setting.
https://dgk.org/kongress_programme/jt2023/aP2147.html