Michael F La Fountaine1,2,3,4, Christopher M Cirnigliaro1, Joshua C Hobson1,5, Alexander T Lombard1, Adam F Specht1, Trevor A Dyson-Hudson6,7, William A Bauman1,8. 1. Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA. 2. Department of Physical Therapy, School of Health and Medical Sciences, Seton Hall University, South Orange, New Jersey, USA. 3. Departments of Medical Sciences and Neurology, Seton Hall-Hackensack Meridian School of Medicine, South Orange, New Jersey, USA. 4. The Institute for Advanced Study of Rehabilitation and Sports Science, School of Health and Medical Sciences, Seton Hall University, South Orange, New Jersey, USA. 5. Department of Kinesiology and Applied Physiology, University of Delaware, Newark, Delaware, USA. 6. Kessler Foundation, West Orange, New Jersey, USA. 7. Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA. 8. Departments of Medicine and Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Abstract
Context: Fenofibrate is used to treat elevated serum triglyceride (TG) concentrations (e.g. ≥150 mg/dl). The lipoprotein profile of most individuals with spinal cord injury (SCI) would not satisfy conventional criteria to initiate lipid-lowering therapies. Serum TG concentrations of 115 and 137 mg/dl were recently identified as potential intervention thresholds for persons with a SCI proximal to the 4th and below the 5th thoracic vertebrae, respectively. Fenofibrate therapy has not been tested for safety in persons with SCI. Methods: An open-label trial was performed in 15 persons with SCI to determine the safety profile of 4 months of once-daily fenofibrate (145 mg tablet) treatment when initiated using modified intervention thresholds. Fasting blood tests and a review of systems were performed monthly to determine changes in liver and kidney function, as well as overall health status. Results: Fifteen subjects participated and 4 had an adverse event (e.g. 2 with gastrointestinal distress; 2 with elevated liver enzymes). Three subjects discontinued the trial within the first month and one participant remained in the trial with no further adverse events. Two participants were discontinued from fenofibrate after 2 months after not responding to treatment, as per protocol, and 10 participants completed the 4-month trial without experiencing an adverse event. Conclusion: In persons with SCI, 4 months of fenofibrate therapy 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. Fenofibrate therapy appears to be well tolerated in persons with SCI.
Context:Fenofibrate is used to treat elevated serum triglyceride (TG) concentrations (e.g. ≥150 mg/dl). The lipoprotein profile of most individuals with spinal cord injury (SCI) would not satisfy conventional criteria to initiate lipid-lowering therapies. Serum TG concentrations of 115 and 137 mg/dl were recently identified as potential intervention thresholds for persons with a SCI proximal to the 4th and below the 5th thoracic vertebrae, respectively. Fenofibrate therapy has not been tested for safety in persons with SCI. Methods: An open-label trial was performed in 15 persons with SCI to determine the safety profile of 4 months of once-daily fenofibrate (145 mg tablet) treatment when initiated using modified intervention thresholds. Fasting blood tests and a review of systems were performed monthly to determine changes in liver and kidney function, as well as overall health status. Results: Fifteen subjects participated and 4 had an adverse event (e.g. 2 with gastrointestinal distress; 2 with elevated liver enzymes). Three subjects discontinued the trial within the first month and one participant remained in the trial with no further adverse events. Two participants were discontinued from fenofibrate after 2 months after not responding to treatment, as per protocol, and 10 participants completed the 4-month trial without experiencing an adverse event. Conclusion: In persons with SCI, 4 months of fenofibrate therapy 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. Fenofibrate therapy appears to be well tolerated in persons with SCI.
Authors: M H Frick; O Elo; K Haapa; O P Heinonen; P Heinsalmi; P Helo; J K Huttunen; P Kaitaniemi; P Koskinen; V Manninen Journal: N Engl J Med Date: 1987-11-12 Impact factor: 91.245
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