Open AccessMeasuring flushing symptoms with extended‐release niacin using the flushing symptom questionnaire © : results from a randomised placebo‐controlled clinical trial
Author(s) -
Paolini J. F.,
Mitchel Y. B.,
Reyes R.,
ThompsonBell S.,
Yu Q.,
Lai E.,
Watson D. J.,
Norquist J. M.,
McCrary Sisk C.,
Bays H. E.
Publication year - 2008
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/j.1742-1241.2008.01739.x
Subject(s) - niacin , flushing , medicine , placebo , tolerability , adverse effect , endocrinology , pathology , alternative medicine
Summary 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.