Efficacy and Safety of Fenofibric Acid in Chinese Hyperlipidemia Patients:a Randomized,Double-blinded and Placebo-controlled Clinical Trial
10.3969/j.issn.1000-3614.2024.05.008
- VernacularTitle:非诺贝特酸降脂疗效和安全性评价——一项中国区随机、双盲、安慰剂对照临床研究
- Author:
Shuiping ZHAO
1
;
Zeqi ZHENG
;
Lingling HU
;
Ying ZHAO
;
Weihong SONG
;
Qi YIN
;
Guogang ZHANG
;
Hao GONG
;
Yingxian SUN
;
Shuhong GUO
;
Yansong GUO
;
Fang WANG
;
Xiuli ZHAO
Author Information
1. 中南大学湘雅二医院 心内科,长沙 410011
- Keywords:
fenofibric acid;
hypertriglyceridemia;
mixed dyslipidemia;
efficacy;
safety
- From:
Chinese Circulation Journal
2024;39(5):477-483
- CountryChina
- Language:Chinese
-
Abstract:
Objectives:Fenofibric acid is extracted from the widely used hypolipemic fenofibrate,nowadays being approved for marketing around numerous nations and regions,nonetheless not in China.Present trial evaluated the efficacy and safety in the Chinese hypertriglyceridemia population. Methods:This is a multi-center,randomized,double-blind,placebo-controlled phase Ⅲ clinical trial.Patients from 3 different cohorts,including severe hypertriglyceridemia(HTG),moderate HTG and mixed-dyslipidemia(MD),were randomized at 1:1 ratio to receive fenofibric acid 135 mg or placebo daily for 12 weeks.The primary endpoint was the percentage change of triglyceridemia(TG)from baseline at week 12.Secondary endpoints were the percentage changes of other blood lipid indexes.At the same time,the incidence of medical adverse events was observed. Results:Among the three cohorts of patients with severe HTG(n=52),moderate HTG(n=23)and MD(n=52),the TG levels in the fenofibric acid-treated group decreased by(49.12±29.19)%,(49.95±25.19)%and(49.79±19.28)%,respectively from baseline to 12 weeks,while the corresponding placebo groups decreased by(18.88±40.69)%,(8.11±29.86)%and increased by(10.42±73.04)%,respectively from baseline to 12 weeks.The differences between treatment and placebo groups were statistically significant(P<0.017 for severe HTG cohort,P<0.05 for moderate and MD cohort).The high-density lipoprotein cholesterol(HDL-C)in the fenofibric acid-treated group increased by(25.51±21.45)%,(24.55±24.73)%,and(23.60±27.38)%,and the placebo group increased by(1.91±20.42)%,(2.40±9.32)%and(7.13±19.12)%,respectively,the differences between the two groups were statistically significant(all P<0.05).In the fenofibric acid group,adverse events with incidence>5%included upper respiratory tract infection(10.9%),abdominal pain(6.3%),and increased serum creatinine levels(6.3%),rates of adverse events were similar between the two groups(P>0.05). Conclusions:Fenofibric acid can significantly reduce triglycerides and elevate HDL-C levels safely in Chinese patients with severe to moderate HTG without statin or MD patients on top of statin therapy.
