Author + information
- 1The Second Xiangya Hospital of Central South University
- 2Beijing Hospital of the Ministry of Health
- 3Wuhan Asia Heart Hospital
- 4Hainan Province Nongken Sanya Hospital
- 5China Meitan General Hospital
- 6Union Hospital Tongji Medical College Huazhong University of Science and Technology
- 7The First Affiliated Hospital, Sun Yat-sen University
The hypothesis of lipid exchange and metabolism indicated that reducing TG level would reconvert TG and cholesterol exchanging direction among different lipoprotein particles and size of LDL particles would enlarge. In previous Chinese statin/fenofibrate combination trials showed mean plasma TG decreased by 38.1% while mean LDL-C level increased by 14.9%after 8 weeks treatment.
Purpose:To investigate the effectof combination therapy on LDL-C and ApoB in different groups.
The study was a prospective, multi-center, open-label, single arm, and interventional clinical trial in 28 sites from 14 cities nationwide across China. Fenofibrate (200 mg daily) was added to the existing statin treatment for 8 weeks in 506 subjects whose TG still above 1.7mmol/L. Subgroups were defined as follows: LDL-C(≥2.6or <2.6 mmol/L) and atherogenic dyslipidemia (defined as TG ≥2.26 mmol/L and HDL-C <1.04 mmol/L, yes or no).
After weeks treatment, overall mean LDL-C level increased by 14.9% (0.17±0.87mmol/L) with no significant change in ApoB (2.4±50.5%,-0.02±0.39g/L). The group with higher LDL-C levels had a 10.0% decrease and the group with lower baseline LDL-C levels had a 29.6%increase in LDL-C levels(-0.36±0.90 mmol/Lvs 0.49±0.68 mmol/L, p<0.001).Subjects with atherogenic dyslipidemia had a higher increase in LDL-C levels (28.1±37.2 %vs 7.11±39.28 %, p<0.001), while no significant difference in percentage change of ApoB between two groups (7.8±44.7 %vs -0.8±55.6 %, p=0.069).
Fenofibrate can further decrease the LDL-C level in high LDL-C patients on top of statin treatment and do not increase the ApoB level. The decrease in TG levels with fenofibrate might have modified cholesterol exchange among different lipoproteins.