Safety, tolerance, and efficacy of extended-release niacin monotherapy for treating dyslipidemia risks in persons with chronic tetraplegia: a randomized multicenter controlled trial.

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.