TY - JOUR
T1 - Safety, tolerance, and efficacy of extended-release niacin monotherapy for treating dyslipidemia risks in persons with chronic tetraplegia
T2 - A randomized multicenter controlled trial
AU - Nash, Mark S.
AU - Lewis, John E.
AU - Dyson-Hudson, Trevor A.
AU - Szlachcic, Yaga
AU - Yee, Florence
AU - Mendez, Armando J.
AU - Spungen, Ann M.
AU - Bauman, William A.
N1 - Funding Information:
Supported by a Spinal Cord Injury Collaborative Research Project (grant no. H133A111105 ) from the National Institute on Disability and Rehabilitation Research, U.S. Department of Education ; and Kos Pharmaceuticals, Inc .
PY - 2011/3
Y1 - 2011/3
N2 - Objective To test the safety, tolerance, and efficacy of extended-release niacin monotherapy on dyslipidemia in persons with chronic tetraplegia. Design Placebo-controlled, blinded, multicenter, randomized controlled trial. Setting Three spinal cord injury research/rehabilitation centers. Participants Persons with chronic tetraplegia (N=54) and low plasma high-density lipoprotein cholesterol (HDL-C) levels. Intervention Extended-release niacin monotherapy (48 weeks; n=31) on a dose-titration schedule versus matched placebo (n=23). Main Outcome Measures Safety was assessed by using percentages of treatment-emergent adverse events and increased levels of hepatic transaminases, uric acid, glycosylated hemoglobin, and fasting glucose. Tolerance was assessed by using participant reports for frequency and intensity of adverse effects of extended-release niacin. Primary effectiveness outcomes were fasting HDL-C level and plasma total cholesterol (TC)/HDL-C ratio. Secondary outcomes included plasma low-density lipoprotein cholesterol (LDL-C) and TC levels and LDL-C/HDL-C ratio. Results Significant increases in fasting HDL-C levels (24.5%) were accompanied by decreases in TC/HDL-C and LDL-C/HDL-C ratios, LDL-C levels, and TC levels (all P<.05). No evidence of sustained hepatotoxicity or hyperglycemia was observed. Treatment-emergent withdrawals (12.9%) accompanied flushing (n=1), hypotension/presyncope (n=1), and diarrhea (n=2). One subject experienced transient hyperuricemia. Other drug-reported symptoms did not differ from those for placebo. Conclusions Extended-release niacin monotherapy is safe, tolerated, and effective for most persons with chronic tetraplegia. Special precautions for changes in bowel habits and postadministration hypotension should be observed.
AB - Objective To test the safety, tolerance, and efficacy of extended-release niacin monotherapy on dyslipidemia in persons with chronic tetraplegia. Design Placebo-controlled, blinded, multicenter, randomized controlled trial. Setting Three spinal cord injury research/rehabilitation centers. Participants Persons with chronic tetraplegia (N=54) and low plasma high-density lipoprotein cholesterol (HDL-C) levels. Intervention Extended-release niacin monotherapy (48 weeks; n=31) on a dose-titration schedule versus matched placebo (n=23). Main Outcome Measures Safety was assessed by using percentages of treatment-emergent adverse events and increased levels of hepatic transaminases, uric acid, glycosylated hemoglobin, and fasting glucose. Tolerance was assessed by using participant reports for frequency and intensity of adverse effects of extended-release niacin. Primary effectiveness outcomes were fasting HDL-C level and plasma total cholesterol (TC)/HDL-C ratio. Secondary outcomes included plasma low-density lipoprotein cholesterol (LDL-C) and TC levels and LDL-C/HDL-C ratio. Results Significant increases in fasting HDL-C levels (24.5%) were accompanied by decreases in TC/HDL-C and LDL-C/HDL-C ratios, LDL-C levels, and TC levels (all P<.05). No evidence of sustained hepatotoxicity or hyperglycemia was observed. Treatment-emergent withdrawals (12.9%) accompanied flushing (n=1), hypotension/presyncope (n=1), and diarrhea (n=2). One subject experienced transient hyperuricemia. Other drug-reported symptoms did not differ from those for placebo. Conclusions Extended-release niacin monotherapy is safe, tolerated, and effective for most persons with chronic tetraplegia. Special precautions for changes in bowel habits and postadministration hypotension should be observed.
KW - Cardiovascular diseases
KW - Cholesterol, HDL
KW - Cholesterol, LDL
KW - Niacin
KW - Randomized controlled trial, publication type
KW - Rehabilitation
UR - http://www.scopus.com/inward/record.url?scp=79952058313&partnerID=8YFLogxK
U2 - 10.1016/j.apmr.2010.06.029
DO - 10.1016/j.apmr.2010.06.029
M3 - Article
C2 - 21276961
AN - SCOPUS:79952058313
SN - 0003-9993
VL - 92
SP - 399
EP - 410
JO - Archives of Physical Medicine and Rehabilitation
JF - Archives of Physical Medicine and Rehabilitation
IS - 3
ER -