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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status

Enrolling

Conditions

Hypertriglyceridemia Induced Acute Pancreatitis

Treatments

Drug: Evolocumab 140 MG/ML [Repatha]

Drug: Conventional lipid-lowering therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07388420

XHNKKY-HTGAP

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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