TY - JOUR
T1 - Fenofibrate therapy to lower serum triglyceride concentrations in persons with spinal cord injury
T2 - A preliminary analysis of its safety profile
AU - La Fountaine, Michael F.
AU - Cirnigliaro, Christopher M.
AU - Hobson, Joshua C.
AU - Lombard, Alexander T.
AU - Specht, Adam F.
AU - Dyson-Hudson, Trevor A.
AU - Bauman, William A.
N1 - Publisher Copyright:
©, This work was authored as part of the Contributor's official duties as an Employee of the United States Government and is therefore a work of the United States Government. In accordance with 17 USC. 105, no copyright protection is available for such works under US Law.
PY - 2020/9/2
Y1 - 2020/9/2
N2 - 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.
AB - 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.
KW - Cardiovascular diseases
KW - Lipids
KW - Lipoproteins
KW - Paraplegia
KW - Quadriplegia
UR - http://www.scopus.com/inward/record.url?scp=85062936373&partnerID=8YFLogxK
U2 - 10.1080/10790268.2019.1581694
DO - 10.1080/10790268.2019.1581694
M3 - Article
C2 - 30870136
AN - SCOPUS:85062936373
SN - 1079-0268
VL - 43
SP - 704
EP - 709
JO - Journal of Spinal Cord Medicine
JF - Journal of Spinal Cord Medicine
IS - 5
ER -