Background: After heart transplantation (HTx) patients are at very high risk for developing cardiovascular diseases. Post-transplant management includes the initiation of lipid-lowering therapy (LLT) in all heart recipients.
Objective: to analyze results of Inclisiran management in recipients after HTx.
Materials and methods: From January 2010 to February 2024 HTx was performed in 244 patients, 13 of them were children (10-16-year-old). Early after HTx statins were prescribed in all of them. In long-term follow-up due not effectiveness statins were up-titrated (Atorvastatin, £20mg) and other LLT was added: Fenofibrate (145mg; n=55), Ezetimibe (10mg; n=23) and Alirocumab (75mg; n=5). From May 2023 to February 2024 indications for Inclisiran treatment have been determined in 4 recipients. We estimated their clinical characteristics and outcomes of Inclisiran management.
Results: Patients’ age were from 39 to 65-year-old, 2 of them were male. Causes of heart failure were ischaemic heart disease (n=2), hypertrophic cardiomyopathy (n=1) and radiation-induced heart disease (n=1). All 4 recipients had chronic kidney disease (CKD) stages 4-5. Two patients (9 and 12 years after HTx) with generalized atherosclerosis were on top of oral LLT (Atorvastatin 20mg, Fenofibrate 145mg, Ezetimibe 10mg) but their lipid profiles were abnormal and due to deterioration of renal function Fenofibrate was discontinued. Early-term after HTx of patient №2 (51-year-old, male) was complicated with acute kidney injury leaded to the CKD stage C5 and regular renal replacement therapy. Ten months after HTx while being on 20mg of Atorvastatin his lipid profile was as follows: total cholesterol (TC) 7.54 mmol/l, triglycerides (TG) 7.92 mmol/l, low-density lipoprotein cholesterol (LDL-C) 3.62 mmol/l then Inclisiran was prescribed. Six months after 1st injection: TC 3.82 mmol/l, TG 3.07 mmol/l, LDL-C 1.53 mmol/l; Omega-3 fatty acids (2g/day) were added. Two months after HTx toxic hepatitis developed in 39-year-old woman (№3) with CKD stage 4 because of what she was limited to receive any of oral LLT. Patient №1 has already received 3 injections of Inclisiran and his lipid profile in February 2024 was: TC 2.75 mmol/l, TG 2.7 mmol/l, LDL-C 0.71 mmol/l; Omega-3 fatty acids (4g/day) were prescribed. Recipients №2 and №3 has already got 2 injections and №4 is going to receive it. Lipid profile significantly improved after 1st injection and remained stable during observed period. There were no adverse events in analyzed patients. Serum levels of Tacrolimus and Everolimus, C-reactive protein and creatinine did not change after injections.
Conclusion: While initiation of LLT is obligatory to all heart recipients, decision on up-titration of it should be based on their lipid profile. Inclisiran is safe and effective lipid-lowering medication for transplant recipients. Limitations to up-titration of oral LLT is an indication to prescribe Inclisiran injections in transplant patients.