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  4. Fenofibrate therapy to lower serum triglyceride concentrations in persons with spinal cord injury: A preliminary analysis of its safety profile

Fenofibrate therapy to lower serum triglyceride concentrations in persons with spinal cord injury: A preliminary analysis of its safety profile

The Journal of Spinal Cord Medicine, 2020 · DOI: 10.1080/10790268.2019.1581694 · Published: July 1, 2020

Spinal Cord InjuryPharmacologyGenetics

Simple Explanation

Fenofibrate is a medication used to lower high triglyceride levels in the blood. People with spinal cord injuries often have different lipid profiles, and standard treatment guidelines may not apply to them. This study looks at whether fenofibrate is safe for people with spinal cord injuries when used to lower triglyceride levels based on modified intervention thresholds. The study involved 15 participants with spinal cord injuries who took fenofibrate daily for 4 months. Researchers monitored their liver and kidney function, as well as their overall health, to check for any negative side effects. The results suggest that fenofibrate, when used with modified intervention thresholds, does not lead to more adverse events in people with spinal cord injuries compared to the general population, indicating it is generally well-tolerated.

Study Duration
4 months
Participants
15 persons with spinal cord injury
Evidence Level
Not specified

Key Findings

  • 1
    Four out of 15 participants experienced an adverse event, including gastrointestinal distress and elevated liver enzymes, leading to three subjects discontinuing the medication.
  • 2
    Two participants discontinued treatment after 2 months due to not responding to treatment (less than 25% reduction in serum TG concentration).
  • 3
    Ten participants completed the 4-month trial without experiencing an adverse event.

Research Summary

This study investigated the safety of fenofibrate therapy in persons with SCI to determine the safety profile of 4 months of once-daily fenofibrate treatment when initiated using modified intervention thresholds. The study found that fenofibrate therapy, when initiated at lower threshold serum TG concentrations, did not result in an increased incidence of adverse events compared to that reported in the general population. The authors conclude that fenofibrate therapy appears to be well-tolerated in persons with SCI, but acknowledge that a larger clinical trial is required to confirm these findings and to comprehensively evaluate potential adverse events.

Practical Implications

Clinical Practice

Fenofibrate can be considered as a treatment option for managing dyslipidemia in SCI patients, but with careful monitoring of liver function and gastrointestinal symptoms.

Further Research

A larger clinical trial is needed to confirm the safety and efficacy of fenofibrate in the SCI population and to assess its long-term effects on cardiovascular outcomes.

Personalized Medicine

Modified intervention thresholds for initiating fenofibrate therapy may be necessary in SCI patients due to their unique metabolic characteristics.

Study Limitations

  • 1
    Small sample size (n=15)
  • 2
    Open-label trial design (no placebo control)
  • 3
    Short study duration (4 months)

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