Hypertriglyceridemia Induced Acute Pancreatitis
Conditions
Keywords
Hypertriglyceridemia Induced Acute Pancreatitis, Evolocumab, Conventional lipid-lowering therapy
Brief 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.
Detailed 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.
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.
DRUGConventional lipid-lowering therapy
This group only receives conventional lipid-lowering treatment without adding evolocumab.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The TG levels on the 3rd and 7th days after treatment | 3 days and 7days |
| The rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L on the 3rd and 7th days after treatment | 3 days and 7 days |
Secondary
| Measure | Time frame |
|---|---|
| The serum levels of TC, HDL, LDL, and lipoprotein(a) on the 3rd and 7th days after treatment | 3 days and 7days |
| The incidence of RAP, SAP, and other complications | 6 months |
Countries
China
Contacts
CONTACTXingshun Qi
CONTACTYifan Guo
Outcome results
None listed