Niacin is underutilised because of flushing. Lack of a quantitative tool to assess niacin-induced flushing has precluded the objective evaluation of flushing associated with extended-release (ER) niacin formulations. We developed the Flushing Symptom Questionnaire© (FSQ), a quantitative tool to assess patient-reported flushing, and assessed its ability to characterise ER niacin-induced flushing.Methods
This study focused on the responses to one question in the FSQ, the Global Flushing Severity Score (GFSS), reported on a 0–10 scale (none = 0, mild = 1–3, moderate = 4–6, severe = 7–9 and extreme = 10) to assess flushing during ER niacin initiation (week 1) and maintenance (weeks 2–8).Results
Flushing severity with ER niacin was greatest during week 1 and remained greater than placebo for the study duration. During weeks 2–8, 40% of patients on ER niacin vs. 8% of those on placebo had > 1 day/week with ‘moderate or greater’ GFSS.Conclusions
In conclusion, the GFSS component of the FSQ was a sensitive and responsive quantitative measure of ER niacin-induced flushing that will aid in the objective comparison of novel strategies intended to improve tolerability and adherence to niacin, an agent proven to reduce cardiovascular risk.