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Treatment of dyslipidemia using inclisiran in a case series of patients after kidney and liver transplantation
DOI: https://dx.doi.org/10.18565/nephrology.2024.2.13-23
Kordonova O.O., Gubarev K.K., Frolova N.F., Svetlakova D.S., Voskanyan S.E., Artyukhina L.Yu.
1) Burnazyan Federal Medical and Biological Center of the Federal Medical and Biological Agency of Russia, Moscow, Russia; 2) City Clinical Hospital No. 52 of the Moscow Healthcare Department, Moscow, Russia; 3) Russian University of Medicine, Moscow, Russia
Objective. Evaluation of the effectiveness and safety of inclisiran in patients with a transplanted kidney or liver.
Material and methods. A pilot multicenter observational uncontrolled study of inclisiran use was conducted in 11 patients after kidney or liver transplantation. The drug was administered subcutaneously on days 1 and 90. Efficacy was assessed based on decrease in low-density lipoprotein (LDL) levels and achievement of blood LDL level <1.4 mmol/L. The dynamics of changes in triglycerides (TG) and high-density lipoproteins (HDL) in the blood were also studied. Safety was assessed based on complaints, data from general examination, examination of injection site, alanine aminotransferase and aspartate aminotransferase levels, glomerular filtration rate, blood concentration of immunosuppressive drugs, and the frequency of unplanned patient visits associated with acute dysfunction of the transplanted organ. Biochemical parameters were assessed before the first injection - day 0 (one day before the 1st injection - 1st time point), as well as 30 days after the 1st injection (2nd time point), before the 2nd injection (90- 1st day after the 1st injection – 3rd time point) and 1 month after the 2nd injection of the drug (4 months after the 1st injection – 4th time point). Efficacy and safety criteria were determined at the 2nd, 3rd and 4th time points.
Results. Statistically significant decrease in LDL levels (the difference between the mean difference at the 4th and 1st time points was 2.4 mmol/l (95% CI 1.7–3.2; p <0.001) was noted. The dynamics of HDL and TG levels were not statistically significant (p = 0.828 and p = 0.248, respectively). Four patients received inclisiran monotherapy and 7 received combination therapy (statins + ezetimibe + inclisiran). The type of therapy was statistically significantly associated with the rate of decrease in LDL levels (p < 0.001 for the interaction of time and therapy factors). but not HDL and TG levels (p=0.902 and p=0.299, respectively).
Conclusion. Two-fold use of inclisiran in the study group of patients showed effectiveness in reducing the mean LDL level by 57.1% in the entire group (n=11), while in patients on inclisiran monotherapy (n=4) - by 45.3%, and on combined lipid-lowering therapy (n=7) – by 61.4%. Three (18.2%) patients achieved LDL levels <1.4 mmol/L. There were no signs of poor tolerability of the drug.
About the Autors
Olga O. Kordonova – Therapist at the Surgical Department No. 2, Center for Surgery and Transplantology, Burnazyan Federal Medical and Biological Center of the Federal Medical and Biological Agency of Russia. Address: 23 Marshal Novikov st., Moscow, 123098. ORCID: https://orcid.org/0009-0003-9173-4535.
Konstantin K. Gubarev – Dr.Sci. (Med.), Head of the Surgical Department of Coordination of Organ and (or) Human Tissue Donation, Burnazyan Federal Medical and Biological Center of the Federal Medical and Biological Agency of Russia. Address: 23 Marshal Novikov st., Moscow, 123098; e-mail: kkgubarev@gmail.com.
ORCID: https://orcid.org/0000-0001-9006-163X.
Nadiya F. Frolova – Cand.Sci. (Med.), Associate Professor at the Department of Nephrology, Faculty of Additional Professional Education, A.I. Evdokimov Moscow State University of Medicine and Dentistry, Deputy Chief Physician for Nephrology, City Clinical Hospital No. 52 of the Moscow Healthcare Department.
https://orcid.org/0000-0002-6086-5220.
Daria S.Svetlakova – Junior Reseacher at the Laboratory of New Surgical Technologies, Surgeon of the Surgical Department for Coordination of Organ and (or) Human Tissue Donation, Burnazyan Federal Medical and Biological Center of the Federal Medical and Biological Agency of Russia. Address: 23 Marshal Novikov st., Moscow, 123098.
ORCID: https://orcid.org/0000-0002-2274-6204.
Sergey E. Voskanyan – Dr.Sci. (Med.), Professor, Corresponding Member of RAS, Deputy Chief Physician for Surgical Care, Head of the Center for Surgery and Transplantology, Burnazyan Federal Medical and Biological Center of the Federal Medical and Biological Agency of Russia. Address: 23 Marshal Novikov st., Moscow, 123098.
ORCID: https://orcid.org/0000-0001-5691-5398
Lyudmila Yu. Artyukhina – Cand.Sci. (Med.), Head of the Nephrological Department No. 1 of GBUZ "GKB No. 52" DZM, Moscow, Russia; https://orcid.org/0000-0003-3353-1636
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