To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.
1. Evaluate the efficacy and safety of lipid-lowering therapy in real clinical practice. 2. To evaluate the efficacy and safety of pitavastatin in patients undergoing liver transplantation and receiving immunosuppressive therapy. 3. Evaluate the efficacy and safety of PCSK9 inhibitors in patients undergoing liver transplantation and receiving immunosuppressive therapy. 4. To compare the efficacy and safety of pitavastatin and a PCSK9 inhibitor in patients undergoing liver transplantation and receiving immunosuppressive therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
First phase (6 months): Patients will be randomized 1:1 into 2 groups: 1. pitavastatin monotherapy 2. monotherapy with a PCSK9 inhibitor (evolocumab 140 mg or alirocumab 150 mg once every 2 weeks subcutaneously) In the group of Pitavastatin: Pitavastatin at visit 0 will be prescribed at a dose of 2 mg, after 1 month in the absence of side effects against the background of ongoing therapy, the dose will be increased to 4 mg. The lipid profile and safety of the therapy will be assessed in 1, 3 and 6 months after the start of the therapy. When triglyceride levels rise above 5.7 mmol/l in two consecutive analyzes, the addition of fenofibrate may be considered. Second phase (6 months): If the target level of LDL-C is not achieved during monotherapy with pitavastatin, the patient will be asked to continue treatment with combined lipid-lowering therapy (pitavastatin + PCSK9 inhibitor). There will be visits on the 7th, 9th and 12th months.
First phase (6 months): Patients will be randomized 1:1 into 2 groups: 1. pitavastatin monotherapy 2. monotherapy with a PCSK9 inhibitor (evolocumab 140 mg or alirocumab 150 mg once every 2 weeks subcutaneously) In the group of PCSK9 inhibitors:The lipid profile and safety of the therapy will be assessed in 1, 3 and 6 months after the start of the therapy. When triglyceride levels rise above 5.7 mmol/l in two consecutive analyzes, the addition of fenofibrate may be considered. Second phase (6 months): If the target level of LDL-C is not achieved during monotherapy with a PCSK9 inhibitor, the patient will be asked to continue treatment with combined lipid-lowering therapy (pitavastatin + PCSK9 inhibitor). Pitavastatin will initially be prescribed at a dose of 2 mg, after 1 month. in the absence of side effects against the background of ongoing therapy, the dose will be increased to 4 mg. There will be visits on the 7th, 9th and 12th months.
National Medical Research Centre for Therapy and Preventive Medicine of the Ministry of Health of Russia
Moscow, Russia
absolute change in LDL-C from baseline by months 1 and 3 of study therapy
absolute change in LDL-C from baseline
Time frame: months 1 and 3 of study therapy
percent change in LDL-C from baseline at months 1 and 3 of study therapy
percent change in LDL-C from baseline
Time frame: months 1 and 3 of study therapy
the proportion of patients who have reached the target level of LDL-C by month 1 of study therapy
the proportion of patients who have reached the target level of LDL-C
Time frame: month 1 of study therapy
the proportion of patients who have reached the target level of LDL-C by month 3 of study therapy
the proportion of patients who have reached the target level of LDL-C
Time frame: month 3 of study therapy
the timing of achieving the target level of LDL-C at months 1, 3, 6, 7, 9, 12 of study therapy
the timing of achieving the target level of LDL-C
Time frame: months 1, 3, 6, 7, 9, 12 of study therapy
percent of patients with target level of LDL-C at months 6 and 12 of study therapy
percent of patients with target level of LDL-C
Time frame: months 6 and 12 of study therapy
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