Article

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.
CI - Copyright (c) 2011 American Congress of Rehabilitation Medicine. Published by
Elsevier Inc. All rights reserved.

Langue : ANGLAIS