The severity of hypertriglyceridemia induced acute pancreatitis (HTG-AP) is closely related to the serum triglyceride (TG) levels. The higher the TG levels, the greater the risk of developing severe acute pancreatitis (SAP). Previous expert consensus has pointed out that the key to treating HTG-AP is to rapidly lower serum TG levels to below 5.65 mmol/L. Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, which is often used to treat familial hypercholesterolemia, mixed dyslipidemia and atherosclerotic cardiovascular disease. At the same time, evolocumab also has the effect of reducing TG and may provide a feasible option for the management of HTG-AP. However, its efficacy and safety in reducing TG in patients with HTG-AP remain controversial. This study is a multicenter randomized controlled trial to evaluate the efficacy and safety of adding evolocumab to conventional lipid-lowering therapy in patients with HTG-AP.
Age 18~75 years
Patients with HTG-AP
Mixed hyperlipidemia
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Patients who have received lipid-lowering drugs or blood purification treatment within one week before enrollment
Patients who have used evolocumab within one month before enrollment
Patients who are accompanied by diseases that can seriously affect the survival
Patients who have participated in the clinical research of other drugs within one month
Parallel
Evolocumab 140 MG/ML [Repatha]
DrugThe clinicians strictly follow the treatment strategy for HTG-AP as stipulated in the 2021 "Emergency Expert Consensus on Diagnosis and Treatment of Hypertriglyceridemia Induced Acute Pancreatitis" to provide conventional lipid-lowering treatment for the patients, including dietary adjustments, fibrates, low-molecular-weight heparin, and insulin, etc. On the basis of conventional lipid-lowering treatment, 140mg of evolocumab is added by slow subcutaneous injection every two weeks, and the patients' responses are observed during this period.
Conventional lipid-lowering therapy
DrugThis group only receives conventional lipid-lowering treatment without adding evolocumab.
The TG levels on the 3rd and 7th days after treatment
The rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L on the 3rd and 7th days after treatment
The serum levels of TC, HDL, LDL, and lipoprotein(a) on the 3rd and 7th days after treatment
The incidence of RAP, SAP, and other complications
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