Flushing and other dermatologic adverse events associated with extended-release niacin therapy.

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The analysis pools previously unpublished data on flushing and related side effects from four randomized, double-blind studies of niacin ER, and also reviews long-term data on flushing from a 96-week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.