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  4. A Four Month Randomized Controlled Trial on the Efficacy of Once-daily Fenofibrate Monotherapy in Persons with Spinal Cord Injury

A Four Month Randomized Controlled Trial on the Efficacy of Once-daily Fenofibrate Monotherapy in Persons with Spinal Cord Injury

Scientific Reports, 2019 · DOI: 10.1038/s41598-019-53753-7 · Published: November 5, 2019

Spinal Cord InjuryCardiovascular ScienceGenetics

Simple Explanation

This study investigated the effectiveness of fenofibrate, a drug that lowers triglyceride levels, in people with spinal cord injuries (SCI). Persons with SCI often have abnormal lipid profiles that increase their risk of cardiovascular disease. The research found that fenofibrate treatment for four months significantly improved lipid profiles in SCI patients. This suggests fenofibrate could reduce the risk of heart disease in this population. The study suggests that the threshold for considering lipid-lowering drug intervention may be lower in people with SCI compared to the general population.

Study Duration
4 Months
Participants
10 SCI persons in treatment group, 8 SCI persons in control group
Evidence Level
Level 1, Randomized Controlled Trial

Key Findings

  • 1
    Fenofibrate treatment resulted in a 40% reduction in serum triglyceride (TG) concentration after both 2 and 4 months.
  • 2
    The treatment group experienced a 28% increase in serum high-density lipoprotein cholesterol (HDL-C) after 2 months and a 23% increase after 4 months.
  • 3
    There was an 18% reduction in serum low-density lipoprotein cholesterol (LDL-C) concentration after 4 months of fenofibrate treatment.

Research Summary

This study evaluated the efficacy of fenofibrate monotherapy on the lipoprotein profile of persons with SCI. The intervention had a robust effect to produce favorable changes to the serum TG, HDL-C and LDL-C concentrations with relatively few side/adverse effects. The study design had a SCI-centric TG threshold concentration for screening and potential study inclusion, which was based on our prior reports that describe the effect of functionally impaired SNS innervation to the abdomen In conclusion, four months of fenofibrate monotherapy initiated in persons with SCI resulted in a 40% and 18% reduction in serum TG and LDL-C concentrations, respectively, as well as a 23% increase in serum HDL-C with few adverse side effects.

Practical Implications

Clinical Practice

The findings support considering fenofibrate treatment for improving lipid profiles and potentially reducing CVD risk in individuals with SCI, even at lower TG concentrations than typically used in the general population.

Future Research

The study suggests the need for larger, longer-term clinical trials to further assess the efficacy and safety of fenofibrate and other hypolipidemic agents in the SCI population.

Personalized Medicine

The study highlights the importance of considering SCI-specific thresholds for lipid management due to the unique cardiometabolic risk factors associated with SCI.

Study Limitations

  • 1
    Small sample size
  • 2
    Single geographical region limits generalizability
  • 3
    Limited female representation in the study cohort

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