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
General Hospital of Shenyang Military Region
40 participants
Jan 2, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Age 18~75 years
- Patients with HTG-AP
- Mixed hyperlipidemia
- Sign the informed consent form
Exclusion Criteria7
- 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
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Interventions
The 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.
This group only receives conventional lipid-lowering treatment without adding evolocumab.
Locations(1)
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NCT07388420