John R Guyton1, Phillip D Simmons. 1. Duke University Medical Center, Durham, PO Box 3510, Baker House, Room 281, Trent Drive, NC 27710 USA.
Abstract
BACKGROUND: Niacin lowers levels of atherogenic apolipoprotein-B-containing lipoproteins, including lipoprotein(a), and raises levels of atheroprotective high-density lipoproteins. However, cutaneous flushing has been a major impediment to the clinical use of niacin. OBJECTIVE: Extended-release niacin (niacin ER) is a once-daily prescription niacin formulated to limit flushing. An analysis of flushing events with niacin ER should facilitate its clinical use. METHODS: The analysis pools previously unpublished data on flushing and related side effects from four randomized, double-blind studies of niacin ER, and also reviews long-term data on flushing from a 96-week open label, uncontrolled study. RESULTS: Among 333 patients treated with niacin ER (once daily at bedtime) for 3 to 6 months, 83% reported at least one flushing episode, compared to 18% of patients treated with placebo or gemfibrozil. Approximately 50% had ≤5 flushing events, and only 5% reported >20 flushing events. The majority (76%) of patients treated with niacin ER rated flushing events as mild to moderate in intensity; 6% of patients withdrew due to flushing. In an 8-week comparison of niacin ER once daily at bedtime with immediate-release niacin three times daily at equivalent total daily doses, the total number of flushing events was 76% lower in the niacin ER group. CONCLUSION: Niacin ER can help control flushing events while providing favorable effects on lipids and lipoproteins. The generalizability of this analysis may be limited by self-selection and motivation of research subjects, and further studies of flushing in the clinical practice setting are warranted.
BACKGROUND:Niacin lowers levels of atherogenic apolipoprotein-B-containing lipoproteins, including lipoprotein(a), and raises levels of atheroprotective high-density lipoproteins. However, cutaneous flushing has been a major impediment to the clinical use of niacin. OBJECTIVE: Extended-release niacin (niacin ER) is a once-daily prescription niacin formulated to limit flushing. An analysis of flushing events with niacin ER should facilitate its clinical use. METHODS: The analysis pools previously unpublished data on flushing and related side effects from four randomized, double-blind studies of niacin ER, and also reviews long-term data on flushing from a 96-week open label, uncontrolled study. RESULTS: Among 333 patients treated with niacin ER (once daily at bedtime) for 3 to 6 months, 83% reported at least one flushing episode, compared to 18% of patients treated with placebo or gemfibrozil. Approximately 50% had ≤5 flushing events, and only 5% reported >20 flushing events. The majority (76%) of patients treated with niacin ER rated flushing events as mild to moderate in intensity; 6% of patients withdrew due to flushing. In an 8-week comparison of niacin ER once daily at bedtime with immediate-release niacin three times daily at equivalent total daily doses, the total number of flushing events was 76% lower in the niacin ER group. CONCLUSION:Niacin ER can help control flushing events while providing favorable effects on lipids and lipoproteins. The generalizability of this analysis may be limited by self-selection and motivation of research subjects, and further studies of flushing in the clinical practice setting are warranted.
Authors: Stefan Schandelmaier; Matthias Briel; Ramon Saccilotto; Kelechi K Olu; Armon Arpagaus; Lars G Hemkens; Alain J Nordmann Journal: Cochrane Database Syst Rev Date: 2017-06-14
Authors: Robert H Knopp; Barbara M Retzlaff; Brian Fish; Alice Dowdy; Barbara Twaddell; Thuy Nguyen; Pathmaja Paramsothy Journal: J Clin Lipidol Date: 2009 Impact factor: 4.766