Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis

Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis: A Pilot Randomised Controlled Trial

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.

Overall, 40 patients with HTG-AP will be included. These patients will be randomly assigned in a 1:1 ratio to the conventional lipid-lowering therapy group and the conventional lipid-lowering therapy + evolocumab group. The primary endpoints are the TG levels at days 3 and 7 after treatment, and the rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L at the same time points. Secondary endpoints include blood levels of total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and lipoprotein(a) at days 3 and 7; the incidence of recurrent acute pancreatitis (RAP), SAP, and other complications; as well as the length of hospital stay and total hospitalization costs.

Inclusion Criteria:

• Age 18~75 years
• Patients with HTG-AP
• Mixed hyperlipidemia
• Sign the informed consent form

Exclusion Criteria:

• Patients who have received lipid-lowering drugs or blood purification treatment
• Patients who have used evolocumab within one month before admission
• 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
• Patients who are pregnant or breastfeeding
• Patients with allergic asthma, allergic urticaria, eczema, and those who have a clear history of multiple drug and food allergies
• Other circumstances that researchers consider not suitable for participation in this study