Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial©: results from a randomised placebo-controlled clinical trial

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Abstract

Introduction

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.

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